STATE BOARD OF PHARMACY RULES AND REGULATIONS
ColoradoRegulations
Ask Donna
How this section applies to your facts.
Code of Colorado Regulations › 700 Department of Regulatory Agencies › 719 Division of Professions and Occupations - State Board of Pharmacy › 3 CCR 719-1
Text
1
Department of Regulatory Agencies
State Board of Pharmacy
STATE BOARD OF PHARMACY RULES AND REGULATIONS
3 CCR 719-1
[Editor’s Notes follow the text of the rules at the end of this CCR Document.]
1.00.00
RULES OF PROFESSIONAL CONDUCT.
1.00.11
A pharmacist shall at all times conduct his/her profession in conformity
with all federal and state drug laws, rules and regulations; and shall uphold the
legal standards of the current official compendia.
1.00.12
A pharmacist shall not be a party or accessory to nor engage in any
fraudulent or deceitful practice or transaction in pharmacy, nor knowingly
participate in any practice which detrimentally affects the patient, nor discredit
his/her profession.
1.00.13
A pharmacist shall not enter into any agreement or arrangement with
anyone for the compounding of secret formula or coded orders, except for
investigational drugs.
1.00.16
Confidentiality.
a.
A pharmacist shall not exhibit, discuss, or reveal the contents of any order
or prescription, the therapeutic effect thereof, the nature, extent, or degree
of illness suffered by any patient or any medical information furnished by
the practitioner with any person other than the patient or his authorized
representative, the practitioner or another licensed practitioner then caring
for the patient, another pharmacist or intern serving the patient, or a
person duly authorized by law or by the patient to receive such
information.
b.
A pharmacist may disclose patient information to pharmacy technicians,
authorized law enforcement personnel, another pharmacist acquiring and
maintaining the records, third party entities responsible for payment and
any other parties allowed by federal privacy regulations.
c.
The pharmacist shall exercise his professional judgment in the release of
patient information to a patient or his authorized agent.
Code of Colorado Regulations
Secretary of State
State of Colorado
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
d
maintaining the records, third party entities responsible for payment and
any other parties allowed by federal privacy regulations.
c.
The pharmacist shall exercise his professional judgment in the release of
patient information to a patient or his authorized agent.
Code of Colorado Regulations
Secretary of State
State of Colorado
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
2
1.00.17
A pharmacist or prescription drug outlet shall not pay or offer to pay or
imply that payment might be made of any sum of money or other thing of value to
a practitioner, health care facility, nursing care or assisted living facility, or any
other health care provider or entity as consideration for any referral to, or
promotion of, a prescription drug outlet.
1.00.18
Patient Counseling. Except as specified in section 12-280-138, C.R.S., a
pharmacist shall provide patient counseling on new medication therapy and,
based on the pharmacist’s professional judgement and due diligence, may
provide patient counseling for any other prescription.
a.
If a pharmacist is unable to provide patient counseling orally due to
language barriers, a pharmacist shall use whatever alternative means are
necessary to assure the patient is properly counseled as to the medication
the patient is provided. This may include, but may not be limited to, written
communication in the corresponding language that the patient
understands.
b.
Any refusal on the part of the patient to accept patient counseling shall be
clearly documented in the corresponding record, which may include an
electronic record, directly linked to each affected corresponding order and
such documented refusal shall be readily retrievable and available for
inspection by the Board or its inspectors for at least two years following
the date of the refusal.
1.00.21
Violation of Board Orders or Negotiated Stipulations or Diversion Program
Contracts
documented in the corresponding record, which may include an
electronic record, directly linked to each affected corresponding order and
such documented refusal shall be readily retrievable and available for
inspection by the Board or its inspectors for at least two years following
the date of the refusal.
1.00.21
Violation of Board Orders or Negotiated Stipulations or Diversion Program
Contracts. It shall be considered unprofessional conduct for a Colorado-licensed
pharmacist or intern to violate a lawful Board order or negotiated stipulation
issued in result of a formal complaint against the licensee or to violate a peer
health assistance diversion program contract.
1.00.22
A pharmacist has a professional responsibility to report to the Board in a
timely manner any pattern of misconduct in the practice of pharmacy which
constitutes a danger to the health, safety, or welfare of a patient or the public.
1.00.23
Severability Clause. If any word, clause, sentence, paragraph, or section
of these Rules of Professional Conduct shall for any reason be adjudged by any
court of competent jurisdiction to be unconstitutional or otherwise invalid, such
judgment shall not affect, repeal, or invalidate the remainder thereof, but shall be
confined in its operation to the word, clause, sentence, paragraph, section
thereof so found to be unconstitutional or otherwise invalid.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
any reason be adjudged by any
court of competent jurisdiction to be unconstitutional or otherwise invalid, such
judgment shall not affect, repeal, or invalidate the remainder thereof, but shall be
confined in its operation to the word, clause, sentence, paragraph, section
thereof so found to be unconstitutional or otherwise invalid.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
3
1.00.24
Except as provided in sections 12-280-103(54)(b)(III) and 25.5-2.5-201
through 25.5-2.5-208, C.R.S., a prescription drug outlet shall ensure that all
prescription drugs and controlled substances are procured from another entity or
person registered by the Board. Any drug designated as an Investigational New
Drug from the Federal Food and Drug Administration is exempt from this
requirement provided the research requirements for the receipt of the product are
followed and it meets the requirements of section 12-280-131(2), C.R.S.
1.00.25
Colorado-licensed pharmacists with appropriate training may order and
administer CLIA-waived tests, including serology tests that have authorized by
the Food and Drug Administration (FDA), or equivalent regulatory authorization,
subject to the disclaimers and limitations required by the FDA for such tests.
1.00.26
REQUIRED DISCLOSURE TO PATIENTS – CONVICTION OF OR
DISCIPLINE BASED ON SEXUAL MISCONDUCT (Section 12-30-115, C.R.S.)
A.
On or after March 1, 2021, a provider shall disclose to a patient, as defined in
section 12-30-115(1)(a), C.R.S., instances of sexual misconduct, including a
conviction or guilty plea as set forth in section 12-30-115 (2)(a), C.R.S., or final
agency action resulting in probation or limitation of provider ability to practice as
set forth is section 12-30-115(2)(b), C.R.S.
B.
Form of Disclosure: The written disclosure shall include all information specified
in section 12-30-115(3), C.R.S., and consistent with the sample model disclosure
form as set forth in Appendix D to these rules
set forth in section 12-30-115 (2)(a), C.R.S., or final
agency action resulting in probation or limitation of provider ability to practice as
set forth is section 12-30-115(2)(b), C.R.S.
B.
Form of Disclosure: The written disclosure shall include all information specified
in section 12-30-115(3), C.R.S., and consistent with the sample model disclosure
form as set forth in Appendix D to these rules. The patient must, through his or
her signature on the disclosure form, acknowledge the receipt of the disclosure
and agree to treatment with the provider.
C.
Timing of Disclosure: This disclosure shall be provided to a patient the same day
the patient schedules a “professional services” appointment with the provider. If
an appointment is scheduled the same day that services will be provided, the
disclosure must be provided in advance of the treatment.
1.
The written disclosure and agreement to treatment must be completed
prior to each treatment appointment with a patient/client, unless the
treatment will occur in a series over multiple appointments or a
patient/client schedules follow-up treatment appointments.
2.
For treatment series or follow-up treatment appointments, one disclosure
prior to the first appointment is sufficient, unless the information the
provider is required to disclose pursuant to section 12-30-115, C.R.S., has
changed since the most recent disclosure, in which case an updated
disclosure must be provided to a patient/client and signed before
treatment may continue.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
appointments, one disclosure
prior to the first appointment is sufficient, unless the information the
provider is required to disclose pursuant to section 12-30-115, C.R.S., has
changed since the most recent disclosure, in which case an updated
disclosure must be provided to a patient/client and signed before
treatment may continue.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
4
3.
For the purpose of this Rule 1.00.25, “professional services” shall include
face-to-face counseling including, but not limited to, the administration of
drugs and vaccines, collaborative pharmacy practice, and allowable
testing and diagnostics.
4.
A provider who does not have a direct treatment relationship or have
direct contact with the patient is not required to make the disclosure
required by this section.
D.
As set forth in section 12-30-115(3)(e), C.R.S., the requirement to disclose the
conviction, guilty plea, or agency action ends when the provider has satisfied the
requirements of the probation or other limitation and is no longer on probation or
otherwise subject to a limitation on the ability to practice the provider's
profession.
E.
A provider is not required to provide the written disclosure BEFORE providing
professional services to the patient in the following instances as set forth in
section 12-30-115(4), C.R.S.:
1.
The patient is unconscious or otherwise unable to comprehend the
disclosure and sign an acknowledgment of receipt of the disclosure
pursuant to section 12-30-115(3)(d), C.R.S., and a guardian of the patient
is unavailable to comprehend the disclosure and sign the
acknowledgment;
2.
The patient visit occurs in an emergency room or freestanding emergency
department or the visit is unscheduled, including consultations in inpatient
facilities; or
3.
The provider who will be treating the patient during the visit is not known
to the patient until immediately prior to the start of the visit.
F
f the patient
is unavailable to comprehend the disclosure and sign the
acknowledgment;
2.
The patient visit occurs in an emergency room or freestanding emergency
department or the visit is unscheduled, including consultations in inpatient
facilities; or
3.
The provider who will be treating the patient during the visit is not known
to the patient until immediately prior to the start of the visit.
F.
The provider who does not have a direct treatment relationship or have direct
contact with the patient is not required to make the disclosure required by this
section.
[Appendix D is located at the end of the Rules]
2.00.00
ORDERS.
2.00.10
Receipt of Order.
a.
Only a pharmacist or intern may receive and reduce to writing an oral
order except for chart orders as provided in section 12-280-120(11),
C.R.S.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
5
b.
An electronically transmitted order (ETO) may be accepted in a PDO for
dispensing.
2.01.10
Information to Appear on Each Order. The following information must
appear on each written or oral order except as provided for chart orders for
hospitalized patients (hospital chart orders):
a.
The date the order was compounded and dispensed;
b.
The assigned serial number (hospital chart orders are exempt from this
requirement);
c.
The quantity dispensed if differs from the quantity ordered (LTCF chart
orders are exempt from this requirement provided this information is
recorded within another appropriate uniformly maintain and readily
retrievable permanent record of the dispensing pharmacy);
d.
In the case of a controlled substance order, the patient address, prescriber
address, and prescriber’s Drug Enforcement Administration (DEA)
registration;
e.
Patient address, prescriber address, and prescriber DEA registration
number need not appear on any type of order for a non-controlled
substance prescription; and
f
ntain and readily
retrievable permanent record of the dispensing pharmacy);
d.
In the case of a controlled substance order, the patient address, prescriber
address, and prescriber’s Drug Enforcement Administration (DEA)
registration;
e.
Patient address, prescriber address, and prescriber DEA registration
number need not appear on any type of order for a non-controlled
substance prescription; and
f.
Minor adaptations to an order as allowed pursuant to section 12-280-
125.3, C.R.S., which shall detail the date and identity of the pharmacist
making the minor adaptations.
2.01.20
Additional Information. The following shall also appear on the prescription
or LTCF chart order, or corresponding readily available and retrievable electronic
record of the prescription or LTCF chart order, when appropriate:
a.
Any change in or clarification of an order shall be documented on the
order and shall bear the initials or unique identifier of the responsible
pharmacist, pharmacy intern, or pharmacy technician, the date contacted
and the name of the individual conveying such change or clarification.
b.
When a substitution is made, the order shall indicate the following:
(1)
The names of both the drug prescribed and the drug actually
dispensed, as well as the date on which such substitution was
initially made.
(2)
The order shall also indicate the name of the distributor of the drug
dispensed as it appears on the package or the national drug code
number.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
6
(3)
On an order for a schedule II controlled substance, substitution
shall not be deemed to be an alteration of the order.
(4)
On subsequent refilling of any order, any change in the name of the
distributor or the national drug code number as it appears on the
package shall be recorded on the order unless the computer
system used at that prescription drug outlet changes only the
affected transaction(s) (any computer entry change must not alter
previous transaction records).
be deemed to be an alteration of the order.
(4)
On subsequent refilling of any order, any change in the name of the
distributor or the national drug code number as it appears on the
package shall be recorded on the order unless the computer
system used at that prescription drug outlet changes only the
affected transaction(s) (any computer entry change must not alter
previous transaction records).
(5)
In addition to the information provided in this Rule 2.01.20(c), when
a substitution is made on a prescription order pursuant to section
12-280-125(1)(a.5), C.R.S., the dispensing pharmacist shall clearly
document that the prescription was an intentional substitution within
the same therapeutic drug class by writing the words “Intentional
Therapeutic Drug Class Substitution” or a substantially equivalent
statement on the date the substitution occurred.
c.
In the case of a chart order for a hospitalized patient (hospital chart order),
the following information need not necessarily appear on the chart order,
provided that such information is recorded on another appropriate,
uniformly maintained and readily retrievable permanent record which
reflects:
(1)
The identity of the pharmacist making the initial interpretation;
(2)
The identity of the pharmacist making the final evaluation each time
a drug is dispensed, if different from the pharmacist making the
initial interpretation;
(3)
The quantity dispensed and
(4)
The date of dispensing.
ecorded on another appropriate,
uniformly maintained and readily retrievable permanent record which
reflects:
(1)
The identity of the pharmacist making the initial interpretation;
(2)
The identity of the pharmacist making the final evaluation each time
a drug is dispensed, if different from the pharmacist making the
initial interpretation;
(3)
The quantity dispensed and
(4)
The date of dispensing.
(5)
Any record of a controlled substance dispensed pursuant to a chart
order for an individual patient shall be visually identifiable from
records of non-controlled substances.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
7
2.01.30
Responsibility of a Pharmacist in Recording Refills. When a prescription
order is refilled, the following information must be recorded on the back of the
prescription order, or on the daily computer printout as specified in Rule
11.00.00, and may be entered by a pharmacy technician if no interpretation is
required: Date refilled and quantity, if different from the quantity shown on the
face of the prescription order. If authority to refill is obtained, the name of the
individual conveying such authority must be recorded. The entry shall also bear
the name, initials, license number, or secure electronic identifier of the
pharmacist making the final evaluation. This information shall be maintained and
available for inspection for a period of two years from the date of any transaction
relating to the order unless otherwise required by statute.
2.01.40
Prescription Order Copies. A pharmacist may issue a written copy
conspicuously marked “COPY FOR REFERENCE ONLY” to the patient or
patient's agent. A pharmacist who issues such a written copy of a prescription
order shall place on the original prescription order his/her initials, the date, and
an indication that a written copy has been issued. No information regarding
authority to refill shall be issued in a written copy.
2.01.50
Transfer of Prescription Orders Between Prescription Drug Outlets.
a
ENCE ONLY” to the patient or
patient's agent. A pharmacist who issues such a written copy of a prescription
order shall place on the original prescription order his/her initials, the date, and
an indication that a written copy has been issued. No information regarding
authority to refill shall be issued in a written copy.
2.01.50
Transfer of Prescription Orders Between Prescription Drug Outlets.
a.
A prescription label or a written copy of a prescription order from another
pharmacy may be used for informational purposes only and shall not be
considered to be a valid prescription order. A pharmacist, pharmacy
intern, or pharmacy technician who receives such a label or prescription
order copy shall either contact the prescribing practitioner for authorization
to dispense the prescription, or, alternatively, shall comply with 2.01.52
through 2.01.59.
b.
A pharmacist, pharmacy intern, or pharmacy technician may orally transfer
prescription order information for non-controlled substances for the
purpose of dispensing a prescription.
c.
A prescription drug outlet may transfer a prescription order electronically
to another prescription drug outlet for the purpose of dispensing a
prescription order.
(1)
If the prescription order information is transmitted by facsimile, the
transferring pharmacist, pharmacy intern, or pharmacy technician
shall comply with rule 2.01.52.
(2)
Prescription order information may be transmitted electronically
between two compatible computer systems that are capable of
complying with the requirements of rules 2.01.52 and 2.01.53 (1)-
(10). In the case of electronic transfers, the transferring and
receiving pharmacist, pharmacy intern, or pharmacy technician may
be the same person.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
8
ion order information may be transmitted electronically
between two compatible computer systems that are capable of
complying with the requirements of rules 2.01.52 and 2.01.53 (1)-
(10). In the case of electronic transfers, the transferring and
receiving pharmacist, pharmacy intern, or pharmacy technician may
be the same person.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
8
(3)
In the case of prescription drug outlets that access and share the
same data storage device and that can electronically retrieve all
necessary information, if the original prescription order information
is not invalidated, each dispensing prescription drug outlet shall be
capable of accessing a transaction record that indicates the
following information: (a) date, (b) time, and (c) location from which
the prescription was dispensed. If the prescription order is assigned
a new prescription number at the receiving pharmacy, the
prescription information at the originating pharmacy shall be
invalidated.
d.
The one-time transfer of original prescription information for a controlled
substance listed in schedules III, IV, or V for the purpose of refill
dispensing is permissible between pharmacies. However, pharmacies
electronically sharing a real-time, on-line database may transfer up to the
maximum refills permitted by law and the prescriber’s authorization. If the
prescription order is assigned a new prescription number at the receiving
pharmacy, the prescription may be transferred on a one-time basis only.
Verbal transfers of CIII-CV electronically submitted prescriptions are
permitted in Colorado.
e.
The one-time transfer of an electronic prescription for a schedule II-V
controlled substance, for initial dispensing, is permissible if the transfer
information is communicated between two licensed pharmacists; the
transferred prescription remains in its electronic form; and the prescription
information is not altered during the transmission.
f
submitted prescriptions are
permitted in Colorado.
e.
The one-time transfer of an electronic prescription for a schedule II-V
controlled substance, for initial dispensing, is permissible if the transfer
information is communicated between two licensed pharmacists; the
transferred prescription remains in its electronic form; and the prescription
information is not altered during the transmission.
f.
A pharmacist may authorize pharmacy technician or pharmacy intern to
electronically transfer an order, for the purpose of redispensing said order,
provided that the electronic transfer is between two compatible computer
systems and no changes are made. The pharmacist shall be identified on
the transfer record as required by 2.01.52 and 2.01.53.
2.01.52
The transferring pharmacist, pharmacy intern, or pharmacy technician
shall:
a.
Write the word “void” across the face of the original prescription order to
make the order invalid;
b.
Record on the reverse side of the invalidated prescription order:
(1)
His/her name, license or certification number, initials, or secure
electronic identifier;
(2)
The name, license number, initials, or secure electronic identifier of
the receiving pharmacist or pharmacy intern or pharmacy
technician;
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
9
(3)
The name of the receiving prescription drug outlet;
(4)
The address and telephone number of the receiving prescription
drug outlet; and
(5)
The date of the transfer.
tronic identifier;
(2)
The name, license number, initials, or secure electronic identifier of
the receiving pharmacist or pharmacy intern or pharmacy
technician;
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
9
(3)
The name of the receiving prescription drug outlet;
(4)
The address and telephone number of the receiving prescription
drug outlet; and
(5)
The date of the transfer.
(6)
In the case of a controlled substance in schedule III through V, the
Drug Enforcement Administration registration number of the
receiving prescription drug outlet.
c.
A pharmacy utilizing a computer for storage and retrieval of information
regarding prescription transactions shall be exempt from the requirements
of paragraphs (a) and (b) of this rule if the computer is capable of
invalidating the prescription order and retaining as part of the permanent
record the information specified in paragraph (b) of this rule.
2.01.53
The pharmacist, pharmacy intern, or pharmacy technician receiving the
transferred prescription order information shall:
Reduce the transferred information to writing or print; write or print the
word “transfer” on the face of the transferred prescription order; and
provide all information required by law or rule to be on the prescription
order, including:
(1)
The date of issue of the original prescription order;
(2)
The date of initial compounding and dispensing of the original
prescription order;
(3)
The number of refills authorized and the original quantity prescribed
or any limitations placed on the prescription;
(4)
The number of valid refills remaining;
(5)
The date of the last refill of the original prescription order;
(6)
The prescription order number from which the prescription order
information was transferred;
(7)
The name, license or certification number, initials, or secure
electronic identifier of the transferring pharmacist, pharmacy intern,
or pharmacy technician;
(8)
The name of the transferring prescription drug outlet;
lls remaining;
(5)
The date of the last refill of the original prescription order;
(6)
The prescription order number from which the prescription order
information was transferred;
(7)
The name, license or certification number, initials, or secure
electronic identifier of the transferring pharmacist, pharmacy intern,
or pharmacy technician;
(8)
The name of the transferring prescription drug outlet;
(9)
The address and telephone number of the transferring prescription
drug outlet;
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
10
(10)
In the case of a controlled substance in schedules III through V, the
Drug Enforcement Administration number of the transferring
prescription drug outlet, and the practitioner's Drug Enforcement
Administration number.
2.01.54
The transferring prescription drug outlet shall retain the original
prescription order as required by Rule 11.04.10.
2.01.55
The receiving prescription drug outlet shall retain the transferred
prescription order as required by Rule 11.04.10.
2.01.56
The pharmacist, pharmacy intern, or pharmacy technician at the receiving
prescription drug outlet at the time of the dispensing of the transferred
prescription, shall inform the patient that the prescription order is now invalid at
the prescription drug outlet from which it was transferred.
2.01.59
A prescription order for a controlled substance in schedule III through V
may be transferred only one time, that transfer being from the prescription drug
outlet where the prescription was originally filled. It shall not be further transferred
by, or to, any other prescription drug outlet.
2.01.60
A prescription order for a non-controlled prescription drug may be
transferred from a prescription drug outlet to another prescription drug outlet as
provided in Rule 2.01.50 only so long as there are refills remaining and each
prescription drug outlet can establish that a valid refill existed at the time of
dispensing
t be further transferred
by, or to, any other prescription drug outlet.
2.01.60
A prescription order for a non-controlled prescription drug may be
transferred from a prescription drug outlet to another prescription drug outlet as
provided in Rule 2.01.50 only so long as there are refills remaining and each
prescription drug outlet can establish that a valid refill existed at the time of
dispensing.
2.01.80
When a prescription drug outlet discontinues business and the
prescription order files are moved to another prescription drug outlet, those
orders shall be considered void and shall not be refilled. However, if the receiving
pharmacist, pharmacy intern, or pharmacy technician can establish that an
authorized refill or authorized refills remain on any such order, such authorization
may, at the sole discretion of the pharmacist, be used to establish a new order.
a.
If the record which reflects the authorized refill or refills is the original
prescription order, the serial number of the original prescription order shall
be recorded on the new order, and the serial number of the new
prescription order shall be recorded on the original order.
b.
If the record which reflects the authorized refill or refills is electronic, the
pharmacist, pharmacy intern, or pharmacy technician shall maintain in
written or printed form a record which indicates both the serial number of
the original prescription order and the serial number of the new
prescription order. This record may be made part of the daily printout
required by Rule 11.04.20 if it is routinely recorded in such printout. The
refill authorization(s) contained in the original electronic record must be
invalidated to prevent further refilling.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
11
c.
The files from the prescription drug outlet that has discontinued business
may be transferred to another prescription drug outlet under the following
conditions:
it is routinely recorded in such printout. The
refill authorization(s) contained in the original electronic record must be
invalidated to prevent further refilling.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
11
c.
The files from the prescription drug outlet that has discontinued business
may be transferred to another prescription drug outlet under the following
conditions:
(1)
The computer or electronic database from the prescription drug
outlet that discontinued business is located and will remain at the
pharmacy to which it is transferred for at least two years.
(2)
The computer or electronic database must be capable of complying
with Rule 2.01.52(c).
3.00.00
DISPENSING.
3.00.10
Limitations. Except as provided in section 12-280-123(2), C.R.S., no order
shall be dispensed or refilled after one year from the date of issue by the
practitioner.
3.00.20
Medical Need.
(a)
No licensee or registrant shall prescribe, administer, compound, dispense,
deliver or distribute any drug to any person in such quantity or in any
situation where the licensee or registrant knows or reasonably should
know said drug has no recognized medical utility or application. Violation
of this Rule shall constitute prima facie proof of violation of section 12-280-
126, C.R.S.
(b)
One additional bottle of a prescription eye drop may be dispensed to a
patient if the following conditions are met:
1.
The corresponding patient’s health benefit plan provides coverage
for the prescription eye drops;
2.
The additional bottle is requested by the insured or the health care
provider at the time the original prescription is dispensed;
3.
The original order states that one additional bottle is needed by the
insured for use in a day care center, school, or adult day program;
4.
The additional bottle is limited to one additional bottle every three
months; and
5
overage
for the prescription eye drops;
2.
The additional bottle is requested by the insured or the health care
provider at the time the original prescription is dispensed;
3.
The original order states that one additional bottle is needed by the
insured for use in a day care center, school, or adult day program;
4.
The additional bottle is limited to one additional bottle every three
months; and
5.
The total number of bottles dispensed does not exceed the total
number of bottles prescribed as stated on the original order when
accounting for authorized refills assigned to the original order by
the prescriber, if applicable.
(c)
A prescription eye drop may be refilled if the following conditions are met:
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
12
1.
The refill is requested by the insured at least twenty-one days for a
thirty day supply of eye drops, forty-two days for a sixty day supply
of eye drops, or sixtythree days for a ninety day supply of eye
drops, from the later of the date that the original prescription was
dispensed to the insured or the date that the last refill of the
prescription was dispensed to the insured; and
2.
The original prescription order states that additional quantities of
prescription eye drops are needed and the refill requested by the
insured does not exceed the number of additional quantities
needed.
(d)
The pharmacist may not dispense a prescription drug or a controlled
substance to a practitioner based on an order that does not list a specific
patient. A prescription order for “office use” is not a valid order.
Compounded prescription drugs distributed to veterinarians for “office
stock” as defined in section 12-280-121(5)(b), C.R.S., must comply with
the requirements of Rules 11.00.00 and 21.00.00.
3.00.21
A pharmacist shall make every reasonable effort to ensure that any order,
regardless of the means of transmission, has been issued for a legitimate
medical purpose by an authorized practitioner
order.
Compounded prescription drugs distributed to veterinarians for “office
stock” as defined in section 12-280-121(5)(b), C.R.S., must comply with
the requirements of Rules 11.00.00 and 21.00.00.
3.00.21
A pharmacist shall make every reasonable effort to ensure that any order,
regardless of the means of transmission, has been issued for a legitimate
medical purpose by an authorized practitioner. A pharmacist shall not dispense a
prescription drug if the pharmacist knows or should know that the order for such
drug was issued without a valid preexisting patient-practitioner relationship. Such
relationship need not involve an in-person encounter between the patient and
practitioner if otherwise permissible under Colorado law. A pharmacist may, in
good faith, prescribe or dispense an opiate antagonist pursuant to an order that
was issued without a valid preexisting patient-practitioner relationship that is
approved by the Federal Food and Drug Administration for the treatment of a
drug overdose.
3.00.22
The prescribing or dispensing of an opiate antagonist, as described in
Rule 3.00.21, by a pharmacist shall not constitute unprofessional conduct
pursuant to section 12-280-126, C.R.S., if he or she prescribed or dispensed the
opiate antagonist in good faith pursuant to an order or standing orders and
protocols issued to or for individuals or entities described in section 12-30-110,
C.R.S.
a.
Each prescription drug outlet shall maintain, in a uniform and readily
retrievable manner for at least two years from the date of latest transaction
related to a pharmacist initiated order or standing order, the following
record detailing the dispensing of an opioid antagonist pursuant to a
pharmacist initiated order or standing order:
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
h prescription drug outlet shall maintain, in a uniform and readily
retrievable manner for at least two years from the date of latest transaction
related to a pharmacist initiated order or standing order, the following
record detailing the dispensing of an opioid antagonist pursuant to a
pharmacist initiated order or standing order:
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
13
1)
The full name of the patient, person who is in a position to assist a
person who is at increased risk of experiencing or likely to
experience an opiate-related drug overdose event, first responder,
unit of local government, or harm reduction organization receiving
the drug;
2)
The full address of the first responder, unit of local government, or
harm reduction organization receiving the drug;
3)
The name, strength and dosage form of the drug dispensed;
4)
The quantity of drug dispensed; and
5)
The date of dispensing.
3.00.23
Dispensing without an order.
a.
A pharmacist may dispense an emergency supply of a chronic
maintenance drug, as defined in section 12-280-103(9.5)(a) and (b),
C.R.S., to a patient without a current, valid order under the conditions set
forth in section 12-280-125.5, C.R.S. When an emergency dispensing
occurs, the dispensing pharmacist, or their designee, shall immediately
notify the practitioner of record related to the emergency dispensing, in
writing, detailing the:
(1)
Name, address, and telephone number of dispensing pharmacy;
(2)
Name, strength, dosage form, directions, and quantity of drug
dispensed;
(3)
Name of patient and corresponding patient’s date of birth; and
n emergency dispensing
occurs, the dispensing pharmacist, or their designee, shall immediately
notify the practitioner of record related to the emergency dispensing, in
writing, detailing the:
(1)
Name, address, and telephone number of dispensing pharmacy;
(2)
Name, strength, dosage form, directions, and quantity of drug
dispensed;
(3)
Name of patient and corresponding patient’s date of birth; and
(4)
Date of emergency dispensing.
b.
Records related to the dispensing of an emergency supply of a chronic
maintenance drug shall be detailed and maintained in the same manner
as all other dispensing transactions in compliance with all applicable
provisions of Board Rules 2.00.00, 3.00.00, 11.00.00, 21.00.00, and
26.00.00.
3.00.25
First Dose Dispensing. A pharmacist at a prescription drug outlet may
dispense up to a seventy- two hour supply of a non-controlled substance
prescription drug to an LTCF resident pursuant to a duplicate copy of an LTCF
chart order provided by another prescription drug outlet for the purpose of
providing immediate patient care, on a one time per order basis, if the following
conditions are met:
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
14
a.
The receiving prescription drug outlet records on the prescription order the
name and address of the originating prescription drug outlet and the date
the order was received by the receiving prescription drug outlet;
b.
The receiving prescription drug outlet maintains the order as a prescription
order and complies with all requirements for prescription orders specified
in Rules 2.01.10 through 2.01.40, 3.00.10 through 3.00.51, and 11.04.10;
and
c.
The originating prescription drug outlet records on the LTCF chart order
the name and address of the receiving prescription drug outlet and the
date the order was provided to the receiving prescription drug outlet.
3.00.27
Outlet to Outlet Drug Reconstitution
lies with all requirements for prescription orders specified
in Rules 2.01.10 through 2.01.40, 3.00.10 through 3.00.51, and 11.04.10;
and
c.
The originating prescription drug outlet records on the LTCF chart order
the name and address of the receiving prescription drug outlet and the
date the order was provided to the receiving prescription drug outlet.
3.00.27
Outlet to Outlet Drug Reconstitution. A pharmacist at a prescription drug
outlet may reconstitute a prescription originally dispensed in an unreconstituted
form pursuant to a patient-specific order at another prescription drug outlet or
nonresident prescription drug outlet provided the following conditions are met:
a.
The prescription is delivered directly from the originating outlet to the
receiving outlet;
b.
The prescription is at no time in the physical possession of the patient until
after the prescription has been reconstituted;
c.
The prescription is reconstituted according to the corresponding
manufacturer’s directions;
d.
The prescription is not a controlled substance;
e.
The pharmacist at the receiving outlet does not alter the prescription or its
original labeling in any way other than to reconstitute, re-label for re-
dispensing for administration, and properly store the prescription; and
f.
The originating outlet is ultimately accountable to the Board for the
accurate dispensing of the original prescription, and the receiving outlet is
ultimately accountable for the accurate reconstitution and re-dispensing of
the prescription.
3.00.30
Labeling.
a.
When a prescription drug is dispensed pursuant to an order, the name of
the drug that appears on the container label shall correspond with the
identity of the drug contained therein unless otherwise requested by the
practitioner.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
accountable for the accurate reconstitution and re-dispensing of
the prescription.
3.00.30
Labeling.
a.
When a prescription drug is dispensed pursuant to an order, the name of
the drug that appears on the container label shall correspond with the
identity of the drug contained therein unless otherwise requested by the
practitioner.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
15
b.
When a prescription drug is dispensed to a patient for outpatient use and
contains an opioid that is not prescribed for the treatment of a substance
use disorder or is a partial opioid antagonist, the label or container shall
bear a notification that states, or is substantially equivalent to: “Caution:
Opioids carry a risk of overdose and addiction.”
c.
In addition to complying with all applicable accessibility labeling
requirements, including but not limited to requirements relating to visual
impairment, pursuant to section 12-280-124, C.R.S., each prescription
drug outlet shall apply to the Board, for its approval, if the prescription
drug outlet offers a patient an alternative method to access a prescription
drug label other than the methods specified in section 12-280-124(4)(b)(I)
to (4)(b)(IV), C.R.S. When applying to the Board for an alternative method,
each prescription drug outlet shall demonstrate to the Board that the
method to access a prescription drug label is substantially similar to the
method of access the patient requested and meets the needs of the
patient.
3.00.40
Expiration Dating. No drug or device shall be dispensed which will be
outdated prior to utilization by the consumer, based on the practitioner's
directions for use.
3.00.50
Initial Interpretation and Final Evaluation.
a.
Initial interpretation means the review of an order accompanied by order
entry. The pharmacist(s) conducting the initial interpretation shall be held
accountable for the accuracy of the electronic order entry/manual
transcription and for drug regimen review.
b
ior to utilization by the consumer, based on the practitioner's
directions for use.
3.00.50
Initial Interpretation and Final Evaluation.
a.
Initial interpretation means the review of an order accompanied by order
entry. The pharmacist(s) conducting the initial interpretation shall be held
accountable for the accuracy of the electronic order entry/manual
transcription and for drug regimen review.
b.
Final evaluation means the review of the final prescription to ensure that
the ordered medication is properly prepared and placed in a suitable
container with appropriate labeling. The pharmacist(s) conducting the final
evaluation shall be held accountable for assuring that the identity of the
drug that appears on the prescription label corresponds with identity of
drug contained therein. When refills are dispensed, the pharmacist
conducting the final evaluation shall be held accountable for the
appropriate dispensing of refills including all drug utilization reviews as
they pertain to refill dispensing.
c.
Drug regimen review includes but is not limited to the evaluation of
order(s) and patient records(s) for:
1)
Known allergies;
2)
Rational therapy and contraindications;
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
16
3)
Reasonable dose, duration of use, and route of administration
considering age, gender, and other patient factors;
4)
Reasonable directions for use;
5)
Potential or actual adverse drug reactions;
6)
Drug-drug interactions;
7)
Drug-food interactions;
8)
Drug-disease contraindications;
9)
Therapeutic duplication;
10)
Proper utilization (including over- or under-utilization) and optimum
therapeutic outcomes; and
11)
Abuse/misuse.
d.
A pharmacist shall conduct an initial interpretation of each new order and
a pharmacist shall conduct the final evaluation of each order dispensed.
When refills are dispensed, the pharmacist making the final evaluation
shall be held accountable for the appropriate dispensing of refills
per utilization (including over- or under-utilization) and optimum
therapeutic outcomes; and
11)
Abuse/misuse.
d.
A pharmacist shall conduct an initial interpretation of each new order and
a pharmacist shall conduct the final evaluation of each order dispensed.
When refills are dispensed, the pharmacist making the final evaluation
shall be held accountable for the appropriate dispensing of refills. The
pharmacist manager shall be held accountable for the maintenance of all
appropriate records.
e.
The pharmacist making the initial interpretation and final evaluation on
prescription or LTCF chart orders shall be identified by either license
number, initials, name, or secure electronic identifier on a uniformly
maintained, readily retrievable document. The uniformly maintained,
readily retrievable document shall bear the license number, initials, name,
or secure electronic identifier of any additional pharmacists involved in the
dispensing of the order. The pharmacist conducting the initial
interpretation and final evaluation may be the same person.
f.
In the case where the computer software utilized is not password
protected, the initial interpretation and final evaluation shall be maintained
in a handwritten format bearing the license number, initials, or name of the
responsible pharmacist. In addition, the identification of any other
pharmacists involved in the dispensing shall be maintained in the same
handwritten format.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
ed is not password
protected, the initial interpretation and final evaluation shall be maintained
in a handwritten format bearing the license number, initials, or name of the
responsible pharmacist. In addition, the identification of any other
pharmacists involved in the dispensing shall be maintained in the same
handwritten format.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
17
3.00.51
Records of Initial Interpretation and Final Evaluation.
a.
Records detailing both the initial interpretation and final evaluation shall be
retained at the prescription drug outlet for each prescription dispensed and
for at least two years from the date of any transaction pertaining to the
order. These records shall include at least the following:
1)
The license number, initials, name, or secure electronic identifier of
the pharmacist conducting the initial interpretation for each new
order;
2)
The license number, initials, name, or secure electronic identifier of
the pharmacist conducting the final evaluation for each new and
refill prescription; and
3)
The specific date on which each initial interpretation and final
evaluation occurred. In the event the initial interpretation and final
evaluation for a new order are conducted on separate dates, both
dates shall be recorded to state specifically when both occurred.
b.
Each outlet shall maintain, in written format, a notice detailing how initial
interpretations and final evaluations are documented in the outlet. Such
notice shall include and comply with the following:
1)
The manner in which initial interpretations are recorded and
maintained in the outlet for all new orders.
2)
The manner in which final evaluations are recorded in the outlet for
all new and refill prescriptions.
3)
A statement that all pharmacy personnel involved in the dispensing
of prescriptions have the ability to print, upon request, a record
detailing the initial interpretation for each new prescription
dispensed and final evaluation for each new and refill prescription
dispensed
all new orders.
2)
The manner in which final evaluations are recorded in the outlet for
all new and refill prescriptions.
3)
A statement that all pharmacy personnel involved in the dispensing
of prescriptions have the ability to print, upon request, a record
detailing the initial interpretation for each new prescription
dispensed and final evaluation for each new and refill prescription
dispensed.
4)
Such written notice shall be signed and dated or electronically
approved if version and approval histories are available by the
pharmacist manager. In the event the pharmacist manager
changes, the incoming pharmacist manager shall review,
electronically approve, or sign and date the notice within seventy-
two hours of assuming the duties of pharmacist manager. In the
event there is a lapse between the time one pharmacist manager
ceases the duty and another assumes the duty, the previous
method of recording initial interpretations and final evaluations shall
remain in effect.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
18
5)
If there are any changes to the outlet’s method of documenting
initial interpretations and final evaluations, a new written notice
detailing the requirements of sections 1, 2, 3, and 4 above shall be
executed. This notice shall detail the effective date of change.
6)
The outlet shall post these notices on a wall directly next to the
outlet’s most current Board registration or electronically publish a
secure version of the notice.
7)
These notices shall be retained at the outlet for a period of three
years from the date last utilized.
8)
In the event such notices are not posted or electronically published,
the pharmacist manager shall be held accountable for the failure to
post the required notice and any dispensing errors
the
outlet’s most current Board registration or electronically publish a
secure version of the notice.
7)
These notices shall be retained at the outlet for a period of three
years from the date last utilized.
8)
In the event such notices are not posted or electronically published,
the pharmacist manager shall be held accountable for the failure to
post the required notice and any dispensing errors. In the event
such notices are not posted during the period of time between one
pharmacist manager leaving the position and another assuming the
position, the outlet shall be held accountable for the failure to post
the required notice and any dispensing errors.
3.00.55
Prescription Flavoring. A flavor additive may be incorporated into a non-
sterile prescription under the following conditions:
a.
The patient, patient’s caregiver, or practitioner who authorized the original
prescription shall authorize the flavoring of each new and, if applicable,
refilled prescription;
b.
The flavor additive shall in no way compromise the stability, safety, or
efficacy of the dispensed drug.
c.
No expired flavor additive shall be incorporated into a prescription. No
flavor additive shall be incorporated which will expire prior to utilization by
the patient, based on the practitioner’s directions for use.
d.
For flavoring additives that do not have expiration dates assigned by the
manufacturer or supplier, a pharmacist shall clearly and legibly label the
container with the date of receipt and assign a conservative expiration
date, not to exceed three years after receipt, to the flavoring additive. In no
event shall the labeled date of receipt or assigned expiration date be later
altered after originally labeling the container.
e.
The following information shall be recorded and maintained in a suitable
hard-copy or electronic dispensing record for a period of two years from
the date of flavoring the corresponding new or refilled prescription
ee years after receipt, to the flavoring additive. In no
event shall the labeled date of receipt or assigned expiration date be later
altered after originally labeling the container.
e.
The following information shall be recorded and maintained in a suitable
hard-copy or electronic dispensing record for a period of two years from
the date of flavoring the corresponding new or refilled prescription. This
record shall be made available, in printed form, for the Board or its
representatives immediately upon the request of the Board or its
representatives.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
19
1)
Additive’s flavor;
2)
Flavor additive’s manufacturer
3)
Flavor additive’s lot number (if available); and
4)
Flavor additive’s expiration date.
f.
The pharmacist responsible for conducting the final evaluation of a new or
refilled prescription shall also be responsible for the flavoring of the
prescription as specified in subsections a., b., and c. of this Rule 3.00.55.
g.
The pharmacist manager shall be responsible for subsection d. of this
Rule 3.00.55 and the maintenance of records as specified in subsection e.
of this Rule 3.00.55.
3.00.60
When a substitution is made on a prescription order, a patient shall be
given oral and written notice of this fact at the time such substitution initially
occurs, except as provided in section 12-280-125, C.R.S. On subsequent refilling
of a prescription order, such oral and written notices shall not be required unless,
in the professional judgment of the pharmacist, the best interest of the patient will
be served by giving such notices.
3.00.70
Responsibility for pharmacy technicians. A pharmacist shall be
responsible for pharmacy technicians and shall at all times comply with section
12-280-118(5), C.R.S
On subsequent refilling
of a prescription order, such oral and written notices shall not be required unless,
in the professional judgment of the pharmacist, the best interest of the patient will
be served by giving such notices.
3.00.70
Responsibility for pharmacy technicians. A pharmacist shall be
responsible for pharmacy technicians and shall at all times comply with section
12-280-118(5), C.R.S.
3.00.75
The placement of a prescription into another outer container and the
labeling of the container with the patient’s name or any other identifying
information constitutes the “Practice of Pharmacy” as a function of preparation,
packaging, labeling and delivery under section 12-280-103(39), C.R.S.
Individuals who perform this function shall be included in the ratio of pharmacy
technicians or interns a pharmacist is permitted to supervise pursuant to 12-280-
122(1), C.R.S.
3.00.80
Definition for Return or Exchange of Medicine, Prescriptions, Medical
Devices, and Medical Supplies for Dispensing or Donation.
The following definition applies to donors or donation recipients of medicine, medical
supplies, or medical devices pursuant to Section 12-280-135, C.R.S.
“Traditional dispensing system” means a drug package system in which individual
doses are not packaged in unit dose packages or unit of issue packages.
3.00.81
General Provisions
a.
Rules 3.00.81 through 3.00.83 apply to donors or donation recipients of
medicine pursuant to Section 12-280-135.5, C.R.S.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
to Section 12-280-135, C.R.S.
“Traditional dispensing system” means a drug package system in which individual
doses are not packaged in unit dose packages or unit of issue packages.
3.00.81
General Provisions
a.
Rules 3.00.81 through 3.00.83 apply to donors or donation recipients of
medicine pursuant to Section 12-280-135.5, C.R.S.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
20
3.00.82
Donation Records of Medicine
a.
The donation recipient shall retain written or electronic donation records
for at least two years that contain the following information:
1)
For each accepted or transferred drug, the name, strength, and
quantity. Lot number may be recorded, however, inclusion of lot
number is not required. ;
2)
The name, address and phone number of the donor, individual
donor, or transferring entity;
3.00.83
Dispensing of Donated Medicine.
a.
Except as otherwise specified in Section 12-280-135.5, C.R.S., when
administering or redispensing donated medicine, a donation recipient
shall:
1)
Ensure proper labeling in accordance with 3 CCR 719-1 3 3.00.30;
2)
Maintain eligible patient-specific written or electronic records in
accordance with 3 CCR 719-1-2-00-00, 3.00.00, and 11.00.00.
3.00.84
Record Retention
a.
All records of receipt and dispensing shall be maintained for a period of
two years from the date of receipt, or from the last dispensing transaction
date. Such records shall be maintained separately from all other records
of the prescription drug outlet.
b.
All records of donation shall be maintained for a period of three years from
the date of donation. Such records shall be maintained separately from all
other records of the prescription drug outlet.
3.00.85
Prescriptions Dispensed but Not Delivered. When a drug has been
dispensed pursuant to a prescription or LTCF chart order but has not been
delivered to the ultimate consumer, the drug may be returned to stock for
subsequent redispensing provided that:
a
three years from
the date of donation. Such records shall be maintained separately from all
other records of the prescription drug outlet.
3.00.85
Prescriptions Dispensed but Not Delivered. When a drug has been
dispensed pursuant to a prescription or LTCF chart order but has not been
delivered to the ultimate consumer, the drug may be returned to stock for
subsequent redispensing provided that:
a.
It is stored in the container in which it was dispensed, and maintains a
label that accurately identifies its contents with respect to the original
prescription label.
(1)
A prescription label may be removed if the container is in the
manufacturer’s original sealed packaging and the removal of the
label does not cause an unreadable expiration date and lot number
on the manufacturer’s packaging.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
21
b.
A separate written record or a separate record printable upon request is
maintained for prescriptions returned to stock. Such record shall indicate
only prescriptions returned to stock and shall list at minimum the following:
(1)
Prescription number;
(2)
Drug name and strength;
(3)
Quantity returned to stock;
(4)
Date of return; and
(5)
If centrally filled, the location where filled.
c.
The expiration date of the drug shall not be more than one year from the
date it was dispensed. Unless it was dispensed in the manufacturer’s
original container and bears the manufacturer’s original label and
expiration date; and
d.
The drug remains under the same ownership from which it was originally
dispensed or is dispensed from a pharmacy in which the pharmacy has a
contractual affiliation for central fill processing;
e.
If the drug was delivered to another prescription drug outlet for delivery to
the ultimate consumer, the following apply:
(1)
The lot number and manufacturer’s expiration date must be placed
on the label of the drug container by the original dispensing
prescription drug outlet; or
ed or is dispensed from a pharmacy in which the pharmacy has a
contractual affiliation for central fill processing;
e.
If the drug was delivered to another prescription drug outlet for delivery to
the ultimate consumer, the following apply:
(1)
The lot number and manufacturer’s expiration date must be placed
on the label of the drug container by the original dispensing
prescription drug outlet; or
(2)
The original dispensing prescription drug outlet can access and
provide the expiration date and lot number upon request.
(3)
No controlled substance prescriptions may be returned to stock.
(4)
No compounded or flavored prescriptions may be returned to stock.
3.00.86
Prescriptions dispensed by prescription drug outlets for delivery to
consumers in other other outlet settings. When a drug has been dispensed
pursuant to prescription order at a prescription drug outlet but has not been
delivered to the ultimate consumer at an other outlet, the drug may be returned to
stock only at the originating Prescription Drug Outlet, for subsequent
redispensing provided that:
a.
The prescription drug outlet complies with Rules 3.00.90(a), (b), and (c);
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
22
b.
The storage conditions during the transport of the prescription to and from
the other outlet do not in any way compromise the integrity or stability of
the drug;
c.
No controlled substance prescriptions may be returned to stock; and
d.
No compounded or flavored prescription may be returned to stock.
3.00.87
A prescription drug that has been dispensed by an automated cassette
device may be returned to a pharmacy cassette or any automated dispensing
device receptacle for redispensing as long as the integrity of the medication has
not been altered, bar code scanning technology is used for returning the drug,
qualifications for returning the drug are maintained, and the expiration date of the
drug has not passed. A pharmacy technician may carry out the process of
prepackaging the drug into an automated cassette
sette or any automated dispensing
device receptacle for redispensing as long as the integrity of the medication has
not been altered, bar code scanning technology is used for returning the drug,
qualifications for returning the drug are maintained, and the expiration date of the
drug has not passed. A pharmacy technician may carry out the process of
prepackaging the drug into an automated cassette.
3.01.00
Packaging.
3.01.10
a.
In a prescription drug outlet packaging shall only be done by a pharmacist,
or by an intern or pharmacy technician under the supervision of a
pharmacist. In an other outlet, packaging may be done by a person not
licensed as a pharmacist pursuant to protocols approved by the Board.
b.
Such packaged drugs shall only be dispensed or distributed from the
premises where packaged. Such packaged drugs shall only be distributed
as provided in Rule 3.01.10(d).
c.
Any container used for packaging shall meet compendia requirements.
d.
The following prescription drug outlets may distribute packaged
medications without limitation to prescription drug outlets and other outlets
under common ownership:
1.
Prescription drug outlets owned and operated by a hospital that is
accredited by the joint commission on accreditation of healthcare
organizations or a successor organization pursuant to 12-280-
120(15)(b), C.R.S;
2.
Prescription drug outlets operated by a health maintenance
organization as defined in section 10-16-102, C.R.S.; and
3.
The Colorado Department of Corrections.
3.01.20
Each packaged container, whether for use in a unit dose distribution
system or a traditional dispensing system, shall be labeled in accordance with
this Rule. Any packaged unit dose, single dose or unit of issue container for
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
organization as defined in section 10-16-102, C.R.S.; and
3.
The Colorado Department of Corrections.
3.01.20
Each packaged container, whether for use in a unit dose distribution
system or a traditional dispensing system, shall be labeled in accordance with
this Rule. Any packaged unit dose, single dose or unit of issue container for
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
23
which return for restocking and redispensing, pursuant to Rule 3.00.80, is
anticipated, shall be labeled in accordance with this Rule. Additionally, any
packaged container from which subsequent dispensing may occur, shall be
labeled in accordance with this Rule. Such labeling shall include at least the
following:
a.
If a suitable internal record is maintained in the prescription drug outlet or
other outlet, the requirements of (d), (e), (f), (g), and (h) of this Rule may
be omitted from the labeling and maintained in such record. An internal lot
number shall be assigned and shall appear in the labeling. In a
prescription drug outlet the record shall be signed by the pharmacist
responsible for each lot packaged. In another outlet the record shall be
signed by the person specified in the Board approved protocol. The record
shall be retained for two years from the date of packaging unless
otherwise required by law or rule.
b.
Name and strength of the medication, and, in the case of a single dose
package, the total number of individual tablets or capsules per dose;
c.
A suitable expiration date, which shall be not later than the expiration date
on the manufacturer’s container, or one year from the date the drug is
packaged, whichever is less. Sterile packaged product beyond-use dating
shall comply with Rule 3.01.34(h)(3));
d.
The identity of the manufacturer or distributor;
e.
The manufacturer's or distributor's lot number;
f.
The manufacturer’s or distributor’s expiration date;
g.
The date the product was packaged;
h
the expiration date
on the manufacturer’s container, or one year from the date the drug is
packaged, whichever is less. Sterile packaged product beyond-use dating
shall comply with Rule 3.01.34(h)(3));
d.
The identity of the manufacturer or distributor;
e.
The manufacturer's or distributor's lot number;
f.
The manufacturer’s or distributor’s expiration date;
g.
The date the product was packaged;
h.
The identity of the pharmacist responsible for packaging in a prescription
drug outlet, or, in the case of an other outlet, the identity of the non-
pharmacist permitted to do so pursuant to protocols approved by the
Board.
i.
The name and address of the packaging pharmacy if the drug is
distributed by a prescription drug outlet owned and operated by a hospital
that is accredited by the Joint Commission of Accreditation of Healthcare
Organizations or a successor organization or by a prescription drug outlet
operated by a health maintenance organization as defined in section 10-
16-102, C.R.S. Such drugs may only be distributed to prescription drug
outlets under common ownership.
3.01.21
If the unit dose package or unit of issue package is obtained from the
manufacturer or distributor and complies with applicable federal requirements,
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
24
such package may be dispensed without additional labeling as required in Rule
3.01.20 above.
3.01.22
Filling of automated cassettes.
a.
If a multi-source drug, the outlet may not use drugs in the same cassette
from multiple manufacturers or distributors;
b.
Automated cassettes, without electronic maintenance or records, shall be
labeled with the following:
1.
If a suitable internal record is maintained in the prescription drug
outlet or other outlet, the requirements of 4, 5, 6, 7, and 8 of this
Rule may be omitted from the labeling and maintained in such
record. The record shall be retained for two years from the date of
packaging, unless otherwise required by law or rule.
2.
Name and strength of the medication;
3
all be
labeled with the following:
1.
If a suitable internal record is maintained in the prescription drug
outlet or other outlet, the requirements of 4, 5, 6, 7, and 8 of this
Rule may be omitted from the labeling and maintained in such
record. The record shall be retained for two years from the date of
packaging, unless otherwise required by law or rule.
2.
Name and strength of the medication;
3.
A suitable expiration date, which shall be not later than the
expiration date on the manufacturer’s container, or one year from
the date the drug is packaged, whichever is sooner;
4.
The identity of the manufacturer or distributor;
5.
The manufacturer's or distributor's lot number(s);
6.
The manufacturer’s or distributor’s expiration date;
7.
The date the product was packaged;
8.
The identity of the individual responsible for packaging, or in the
case as provided in this Rule 3.01.22(f), the identity of the persons
responsible for packaging;
9.
All records detailing item 1-8 above, shall be retained at the
pharmacy for at least two years.
d.
In the event that the automation associated with the cassettes deactivates
the cassette when the suitable expiration date is reached, and the outlet
either prints packaging printouts on a daily basis or is capable of
electronically maintaining the packaging information, the cassette need
only be labeled with the name and strength of the drug.
e.
In the event of a product recall, the pharmacist manager shall reasonably
ensure that all recalled drug has been removed from the cassette.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
er prints packaging printouts on a daily basis or is capable of
electronically maintaining the packaging information, the cassette need
only be labeled with the name and strength of the drug.
e.
In the event of a product recall, the pharmacist manager shall reasonably
ensure that all recalled drug has been removed from the cassette.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
25
f.
A pharmacy technician or pharmacy intern may replenish automated
cassettes without the need for a pharmacist’s verification as long as the
pharmacy technician uses bar code technology that checks the accuracy
of the medication or a second pharmacy technician performs the
verification.
3.01.23
Maintenance of automated cassette records.
A prescription drug outlet may utilize a computer (automated data processing
system) for storage and retrieval of information regarding packaging in
automated cassettes. The following requirements shall be met:
a.
All information required by Rule 3.01.22 c (1-8) shall be entered into the
system at the time of the transaction.
b.
Every twenty-four hours the system must produce a hard-copy document
that, for the purposes of these Rules, shall be known as the “packaging
printout”. It shall consist of a single, uniform, complete document. The
packaging printout shall list, separately, each packaging transaction for
the previous twenty-four hours and shall contain all information required
by this Rule. Packaging printouts shall be retained in a chronological
manner. If the printouts are bound, the sheets shall be separated into
individual pages that are then placed in the same order as printed and
bound uniformly. If the pages are bound in any other manner so that they
are not uniform in placement or appearance, they shall be deemed not
readily retrievable and available.
3.01.24
Electronic Maintenance of Packaging Records
e retained in a chronological
manner. If the printouts are bound, the sheets shall be separated into
individual pages that are then placed in the same order as printed and
bound uniformly. If the pages are bound in any other manner so that they
are not uniform in placement or appearance, they shall be deemed not
readily retrievable and available.
3.01.24
Electronic Maintenance of Packaging Records.
A prescription drug outlet which utilizes a computer (automated data processing
system) for storage and retrieval of information regarding packaging transactions
need not print the packaging printout required by Rule 3.01.23 if the prescription
drug outlet and the computer system utilized are capable of complying with the
following requirements:
a.
The prescription drug outlet must be able to provide on-line retrieval of all
information required by this Rule for all packaging transactions during the
two years preceding the request.
b.
The prescription drug outlet must ensure a daily (i.e., every twenty-four
hours) back up is performed for use in restoring required information in
case of a system failure.
c.
The prescription drug outlet must:
(1)
Have and maintain a complete on-line transaction file that is
printable on the inspector’s request,
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
26
Or
(2)
Have a “lock-out” feature that prevents editing of packaging
information.
d.
The Board or its inspectors must be able to inspect and review the
packaging transactions of the prescription drug outlet. Therefore,
immediately upon the oral or written request of the Board or its inspectors,
the prescription drug outlet shall either:
F COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
26
Or
(2)
Have a “lock-out” feature that prevents editing of packaging
information.
d.
The Board or its inspectors must be able to inspect and review the
packaging transactions of the prescription drug outlet. Therefore,
immediately upon the oral or written request of the Board or its inspectors,
the prescription drug outlet shall either:
(1)
Print a report of all packaging transactions for such period of time
as the Board or its inspector(s) may specify. The system must be
capable of retrieving and printing such a report within a limited time
not to exceed two hours. Additionally within seventy-two hours, the
system must be capable of retrieving and printing the information
sorted according to the variables which include, but are not limited
to, date packaged; drug name, strength and dosage form; lot
number, manufacturer/distributor; or expiration date.
(2)
Provide a computer terminal and monitor for the sole use of the
Board or its inspector(s) to inspect and review packaging
transactions, and, if necessary, provide a person to assist the
Board or its inspector(s) for a period of time not to exceed two
hours in operating the system. If the prescription drug outlet elects
to comply with this subparagraph (d), the system must also be
capable of printing the same reports described in subparagraph (1).
(3)
It is the responsibility of the prescription drug outlet manager to
ensure that all prescription drug outlet staff are aware of the
requirements of subparagraphs (1) and (2). Any failure or refusal by
the prescription drug outlet manager and/or a staff pharmacist to
comply with a request by the Board or its inspector(s) will be
deemed to be a willful violation of these Rules.
e.
Whether the prescription drug outlet elects to comply with Rule 3.01.24(d),
the system and any reports printed on request shall contain, as a
minimum, the following information for each transaction:
1.
Name and strength of the medication;
2
outlet manager and/or a staff pharmacist to
comply with a request by the Board or its inspector(s) will be
deemed to be a willful violation of these Rules.
e.
Whether the prescription drug outlet elects to comply with Rule 3.01.24(d),
the system and any reports printed on request shall contain, as a
minimum, the following information for each transaction:
1.
Name and strength of the medication;
2.
A suitable expiration date, which shall be not later than the
expiration date on the manufacturer’s container, or one year from
the date the drug is packaged, whichever is sooner;
3.
The identity of the manufacturer or distributor;
4.
The manufacturer's or distributor's lot number(s);
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
27
5.
The manufacturer’s or distributor’s expiration date;
6.
The date the product was packaged;
7.
The identity of the pharmacist responsible for packaging in a
prescription drug outlet, or, in the case of an other outlet, the
identity of the non-pharmacist permitted to do so pursuant to
protocols approved by the Board;
3.01.25
Maintenance and cleaning of automated cassettes
a.
The outlet must maintain, on-site and available for inspection, the
manufacturer’s guidelines for maintenance and cleaning of the cassettes.
b.
The maintenance and cleaning schedule recommended by the
manufacturer shall be adhered to and records of performed maintenance
shall be available for inspection for a period of at least two years.
c.
If the outlet changes the drug used in a cassette, the cassette must be
thoroughly cleaned per manufacturer’s recommendations prior to using
the cassette for a different drug.
3.01.26
Responsibility for unit-dose medications packaged with automated
cassettes is the responsibility of the pharmacist responsible for loading the
cassette.
3.01.27
The pharmacist responsible for the final evaluation of any prescriptions
dispensed using drugs packaged in automated cassettes shall be held
accountable for the accuracy of the product
or to using
the cassette for a different drug.
3.01.26
Responsibility for unit-dose medications packaged with automated
cassettes is the responsibility of the pharmacist responsible for loading the
cassette.
3.01.27
The pharmacist responsible for the final evaluation of any prescriptions
dispensed using drugs packaged in automated cassettes shall be held
accountable for the accuracy of the product.
3.03.00
Customized Patient Medication Packages (Med Paks).
3.03.10
When a unit dose, single dose, unit of issue or customized patient
medication package is dispensed pursuant to an order, the prescription shall
comply with all requirements of section 12-280-124(2), C.R.S. Container
requirements of a prescription for the purpose of unit dose systems may be
broadened to include trays, bins, carts and locked cabinets or drawers.
Additionally, a customized patient medication package shall comply with all the
following requirements:
a.
Labeling
The patient med pak shall bear a label stating
(1)
The name of the patient;
(2)
A serial number for each of the orders detailing the drug products
contained therein;
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
28
(3)
The name, strength, and total quantity of each drug product
contained therein;
(4)
The directions for use and cautionary statements, if any, contained
in the prescription order for each drug product therein;
(5)
Any storage instructions or cautionary statements;
(6)
The name of the prescriber of each drug product therein;
(7)
The date of preparation of the patient med pak, the expiration date
shall not exceed 90 days from the date of preparation; and
(8)
The name, address, and telephone number of the dispenser.
b.
Record Keeping.
(1)
Patient name and address;
(2)
The serial number of the order for each drug in product contained
therein;
(3)
Descriptive information sufficient to allow subsequent preparation of
an identical patient med pak;
(4)
Date of preparation of the patient med pak and the expiration date
assigned;
date of preparation; and
(8)
The name, address, and telephone number of the dispenser.
b.
Record Keeping.
(1)
Patient name and address;
(2)
The serial number of the order for each drug in product contained
therein;
(3)
Descriptive information sufficient to allow subsequent preparation of
an identical patient med pak;
(4)
Date of preparation of the patient med pak and the expiration date
assigned;
(5)
Any special labeling instructions; and
(6)
The identity of the pharmacist who prepared the patient med pak.
c.
Packaging
(1)
Each container shall meet or exceed United States Pharmacopoeia
standards.
(2)
Each container shall be either not reclosable or so designed as to
show evidence of having been opened.
3.03.20
It shall not be considered redispensing for a prescription drug outlet to
modify a customized medication package which it has previously dispensed if the
following criteria are met:
a.
The med pak is modified for the same patient for which it was originally
dispensed.
b.
The med pak is returned to the prescription drug outlet from which it was
originally dispensed.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
29
c.
Only discontinued medication may be removed from the med pak.
Additional medications may not be added.
d.
The medications removed from the med pak are destroyed. They may not
be redispensed.
e.
The med pak is assigned a new serial number.
f.
The labeling of the med pak is modified to comply with Rule 3.03.10(a).
The expiration date affixed to the label prior to modification must be
retained.
g.
Records are maintained for the modified med pak which comply with Rule
3.03.10(b).
3.04.00
Colorado Cancer Drug Repository Program. [Repealed]
3.05.00
Pharmacist Prescribing and Dispensing Over-the-Counter Medications
3.05.10
Pharmacists, pursuant to 12-280-103(34), C.R.S., may prescribe and
dispense certain over-the-counter medications (“OTC Medications”) to recipients
under the Colorado Medical Assistance Act
intained for the modified med pak which comply with Rule
3.03.10(b).
3.04.00
Colorado Cancer Drug Repository Program. [Repealed]
3.05.00
Pharmacist Prescribing and Dispensing Over-the-Counter Medications
3.05.10
Pharmacists, pursuant to 12-280-103(34), C.R.S., may prescribe and
dispense certain over-the-counter medications (“OTC Medications”) to recipients
under the Colorado Medical Assistance Act.
3.05.20
The formulary of the eligible OTC medications is determined by the
Colorado Department of Health Care Policy and Financing or its successor
agency. Pharmacists may only prescribe and dispense these eligible medications
pursuant to the policies established by the Colorado Department of Health Care
Policy and Financing or its successor agency.
3.05.30
When prescribing such OTC medications, the pharmacist shall issue a
prescription order as defined in 12-280-103(31)(a), C.R.S. The prescribing
pharmacist’s name shall be used on the prescription order as the name of the
practitioner.
3.05.40
When issuing the prescription order, the pharmacist shall consult with the
recipient to determine necessity and suitability of the medication for the recipient.
Written documentation of the necessity and suitability of the medication shall be
maintained with the prescription order.
3.05.50
Pharmacist prescribed OTC prescriptions shall require a written
prescription order.
3.05.60
Written prescription orders are not eligible for prescription transfer and
cannot be refilled.
3.05.70
The pharmacist shall review the recipient’s drug therapy history for
potential drug interactions.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
ined with the prescription order.
3.05.50
Pharmacist prescribed OTC prescriptions shall require a written
prescription order.
3.05.60
Written prescription orders are not eligible for prescription transfer and
cannot be refilled.
3.05.70
The pharmacist shall review the recipient’s drug therapy history for
potential drug interactions.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
30
3.05.80
When dispensing the medication, the pharmacist shall label the product
with all labeling requirements of 12-280-124, C.R.S. The prescribing pharmacist’s
name shall be used on the label as the name of the practitioner.
3.05.90
Upon delivery of the medication to the recipient, the pharmacist shall
provide consultation with the recipient or his or her caregiver as required by the
Colorado Department of Health Care Policy and Financing. The Colorado
Department of Health Care Policy and Financing sets forth the requirements in
10 CCR 2505-10, 8.800 of June 30, 2018. This incorporation does not include
later revisions of the rule. Copies of the rule are available for public inspection
during regular business hours at 1570 Grant Street, Denver, Colorado, 80203.
The rules are readily available in written or electronic form at
http://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=7643&fileNa
me=10%20CCR%202505-10%208.800. The rules are available for a reasonable
fee from the Department of Regulatory Agencies, Division of Professions and
Occupations.
3.05.95
The prescription order issued, documentation of medication necessity and
suitability, and records of dispensing shall be maintained at the prescription drug
outlet as required by Rule 11.00.00.
4.00.00
LICENSING.
4.00.10
Definitions
a.
“Academic examination” is the North American Pharmacist Licensure
Examination.
b.
“Board-approved foreign pharmacy graduate certification” means the
Foreign Pharmacy Graduate Equivalency Certification.
c.
“Board-approved jurisprudence examination” means the Colorado-specific
Multistate Pharmacy Jurisprudence Examination
outlet as required by Rule 11.00.00.
4.00.00
LICENSING.
4.00.10
Definitions
a.
“Academic examination” is the North American Pharmacist Licensure
Examination.
b.
“Board-approved foreign pharmacy graduate certification” means the
Foreign Pharmacy Graduate Equivalency Certification.
c.
“Board-approved jurisprudence examination” means the Colorado-specific
Multistate Pharmacy Jurisprudence Examination.
d.
“Board-approved school or college of pharmacy” is a professional degree
program of a school or college of pharmacy that has an accredited or
preaccredited status from the Accreditation Council for Pharmacy
Education (“ACPE”).
e.
“Board-designated clearinghouse for license transfer” means the National
Association of Boards of Pharmacy Clearinghouse operated by the
National Association of Boards of Pharmacy.
f.
“Disenrollment” means the current status of a pharmacy student who no
longer possesses the right or capacity to complete the curriculum in the
allotted time as set forth in the policies of the corresponding Board-
approved school or college of pharmacy.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
31
g.
“Enrollment” means the current status of a pharmacy student who
possesses the right or capacity to complete the curriculum in the allotted
time as set forth in the policies of the corresponding Board-approved
school or college of pharmacy.
h.
“Intern” means a person who is:
(1)
Enrolled in a professional degree program of a Board-approved
school or college of pharmacy, licensed by the Board to engage in
the practice of pharmacy, and satisfactorily progressing toward
meeting the requirements for licensure as a pharmacist;
(2)
A graduate of a Board-approved school or college of pharmacy or a
graduate who has established education equivalency by obtaining a
Board-approved foreign pharmacy graduate certification and who is
currently licensed by the Board for the purpose of obtaining
practical experience as a requirement for licensure as a
pharmacist; or
ng toward
meeting the requirements for licensure as a pharmacist;
(2)
A graduate of a Board-approved school or college of pharmacy or a
graduate who has established education equivalency by obtaining a
Board-approved foreign pharmacy graduate certification and who is
currently licensed by the Board for the purpose of obtaining
practical experience as a requirement for licensure as a
pharmacist; or
(3)
A qualified pharmacist applicant awaiting examination for licensure
as a pharmacist or meeting Board requirements for pharmacist
licensure.
i.
“License transfer or endorsement” is the licensing of an individual who is
licensed as a pharmacist by examination in another state and whose
license in that state is in good standing.
j.
For the purposes of this Rule 4.00.00, “manufacturer” means a
manufacturer of prescription drugs which is registered by the Board.
k.
“Pharmacist” means an individual licensed by this state to engage in the
practice of pharmacy.
l.
“Regulated individual” means any of the following individuals holding an
active, unrestricted license, registration, or certification from the Colorado
Department of Regulatory Agencies:
(1)
Clinical Social Worker;
(2)
Dentist;
(3)
Occupational Therapist;
(4)
Optometrist;
(5)
Physical Therapist;
(6)
Physician;
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
32
(7)
Physician Assistant;
(8)
Podiatrist;
(9)
Psychologist;
(10)
Registered Nurse or Advanced Practice Nurse;
(11)
Respiratory Therapist; and
rtification from the Colorado
Department of Regulatory Agencies:
(1)
Clinical Social Worker;
(2)
Dentist;
(3)
Occupational Therapist;
(4)
Optometrist;
(5)
Physical Therapist;
(6)
Physician;
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
32
(7)
Physician Assistant;
(8)
Podiatrist;
(9)
Psychologist;
(10)
Registered Nurse or Advanced Practice Nurse;
(11)
Respiratory Therapist; and
(12)
Veterinarian.
m.
“Score transfer” is the transfer of the academic examination score to
Colorado by participation in the NAPLEX Score Transfer Program
operated by the National Association of Boards of Pharmacy.
4.00.20
Requirements for Intern Licensure include the following;
a)
Submission of a completed application form provided by the Division of
Professions and Occupations with the appropriate fee.
b)
Submission of one of the following:
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
33
1)
Proof of enrollment in a Board-approved school or college of
pharmacy. A person on suspension from a Board-approved school
or college of pharmacy may not be licensed as an intern. A person
in good standing with a Board-approved school or college of
pharmacy may be licensed as an intern.
2)
If a graduate of a foreign school or college of pharmacy, a Foreign
Pharmacy Graduate Equivalency Certification;
3)
Proof of graduation within the prior two years from a Board-
approved school or college of pharmacy. If the applicant ceased to
be enrolled in a Board-approved school or college of pharmacy
more than two years prior to application, the applicant shall include
an explanation of “good cause” for licensure which the Board or its
designee shall review and act on in the normal course of business.
4)
If a pharmacist in another state awaiting pharmacist licensure in
Colorado, verification of an active, unrestricted license in another
state.
4.00.25
Requirement for Intern Reporting
pharmacy
more than two years prior to application, the applicant shall include
an explanation of “good cause” for licensure which the Board or its
designee shall review and act on in the normal course of business.
4)
If a pharmacist in another state awaiting pharmacist licensure in
Colorado, verification of an active, unrestricted license in another
state.
4.00.25
Requirement for Intern Reporting. An actively licensed intern shall report
to the Board, in writing, within thirty days of meeting the definition of
“Disenrollment” as defined in Rule 4.00.10(f) from a Board-approved school or
college of pharmacy.
4.00.30
Requirements for Pharmacist License by Exam or Score Transfer include
the following:
a.
Submission of a completed application form provided by the Division of
Professions and Occupation with the appropriate fee.
b.
Submission of a transcript and proof of graduation from a Board-approved
school or college of pharmacy or a Foreign Pharmacy Graduate
Equivalency Certification.
c.
Successful passage of the academic examination and Board-approved
jurisprudence examination. The passing scores for these examinations are
set by the examining entity. If an applicant passes only one of the required
examinations, the applicant shall be required to repeat the failed
examination. If, within the previous twenty-four months, the applicant has
not passed both required examinations, he or she shall be required to also
repeat the previously passed examination. Score transfer applicants shall
complete licensure within one year from the date their scores are received
by the Division of Professions and Occupations.
d.
Proof of completion of 1500 intern hours completed no more than five
years after graduation from a Board-approved school or college of
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
repeat the previously passed examination. Score transfer applicants shall
complete licensure within one year from the date their scores are received
by the Division of Professions and Occupations.
d.
Proof of completion of 1500 intern hours completed no more than five
years after graduation from a Board-approved school or college of
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
34
pharmacy. If a graduate of an unapproved school or college of pharmacy,
receipt of the Foreign Pharmacy Graduate Equivalency Certification.
Intern hours must be obtained under one or more of the following
conditions:
(1)
Engaged in the practice of pharmacy under the direct supervision of
a pharmacist.
(2)
Directly supervised by a manufacturer as part of the curriculum of
an approved school or college of pharmacy.
(3)
Directly supervised by a regulated individual as part of the
curriculum of an approved school or college of pharmacy. The
scope of practice of the regulated individual must overlap with that
of a pharmacist for the course of the hours supervised.
(4)
One year of practice of pharmacy as a licensed pharmacist in
another state may be accepted by the Board in lieu of the 1500
hours if the applicant has completed this year of pharmacy practice
prior to taking the examination.
e.
Education, training, or service gained in military services or licensure,
certification, registration, or enrolled in good standing through the federal
government as outlined in section 12-20-202, C.R.S., to be accepted and
applied towards receiving a license, must be substantially equivalent, as
determined by the Board, to the qualifications otherwise applicable at the
time of receipt of application. It is the applicant’s responsibility to provide
timely and complete evidence for review and consideration. Satisfactory
evidence of such education, training, or service will be assessed on a
case by case basis.
4.00.40
Requirements for License Transfer or Endorsement are as follows:
a
ent, as
determined by the Board, to the qualifications otherwise applicable at the
time of receipt of application. It is the applicant’s responsibility to provide
timely and complete evidence for review and consideration. Satisfactory
evidence of such education, training, or service will be assessed on a
case by case basis.
4.00.40
Requirements for License Transfer or Endorsement are as follows:
a.
Submission of a completed application and fee to the Board designated
clearinghouse for license transfer.
b.
Submission of a completed application form provided by the Division of
Professions and Occupations with the appropriate fee.
c.
Successful passage of the Board-approved jurisprudence examination.
The passing score is set by the examining entity.
d.
Applicants for license transfer must have been licensed as a pharmacist
for at least one year in another state or have served an Internship meeting
the Colorado requirements at the time of original licensure.
e.
A person duly licensed, certified, registered, or enrolled through the
federal government under the conditions set forth in section 12-20-202,
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
35
C.R.S., to practice pharmacy or who possesses the education, training, or
service gained in military services pursuant to section 12-20-202, C.R.S.,
is upon application to the Board, eligible for licensure.
f.
An applicant for license transfer shall apply for license transfer using a
license issued by examination in another state. Such license shall be
active, current, and in good standing. If the applicant holds pharmacist
licenses in multiple states, all licenses must be in good standing. For the
purposes of these Rules, “good standing” means that the applicant is not
currently subject to active disciplinary actions in any state.
4.03.00
Reinstatement or Reactivation of Pharmacist License.
a.
If the license has been inactive or expired for over twenty-four months, a
person wishing to reinstate or reactivate such license shall do the
following:
all licenses must be in good standing. For the
purposes of these Rules, “good standing” means that the applicant is not
currently subject to active disciplinary actions in any state.
4.03.00
Reinstatement or Reactivation of Pharmacist License.
a.
If the license has been inactive or expired for over twenty-four months, a
person wishing to reinstate or reactivate such license shall do the
following:
(1)
Submit the appropriate application with the required fee;
(2)
Submit one hour of continuing education for each month such
license was inactive or expired. Twenty-four of these hours shall
have been completed in the twenty-four months prior to application
for reinstatement or reactivation; and
(3)
Take and pass the approved jurisprudence examination. The
passing score shall be set by the examining entity.
b.
If the license has been expired or inactive for less than twenty-four
months, a person wishing to reinstate or reactivate such license shall do
the following:
(1)
Submit the appropriate application with the required fee; and
(2)
Submit twenty-four hours of continuing education completed within
the twenty-four months prior to application.
4.05.00
License Changes.
a.
Name change. A licensee shall report a name change and provide
appropriate supporting documentation within thirty days of such change. If
the licensee wishes to obtain a new wall license with the new name, the
licensee shall pay the requisite fee.
b.
Change of residential and electronic mail address. All pharmacists and
interns shall notify the Board in writing within thirty days of any change of
residential or electronic mail address.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
n thirty days of such change. If
the licensee wishes to obtain a new wall license with the new name, the
licensee shall pay the requisite fee.
b.
Change of residential and electronic mail address. All pharmacists and
interns shall notify the Board in writing within thirty days of any change of
residential or electronic mail address.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
36
c.
Change of manager. A pharmacist shall immediately notify the Board in
writing of the date he ceases to be the pharmacist manager of a
prescription drug outlet.
4.06.00
Identification of Licensee. A pharmacist, pharmacy intern, pharmacy
technician, pharmacy clerk, store manager, or assistant store manager shall at all
times while on duty within a prescription drug outlet wear a badge which is visible
to the patient and which shall state at least the title accurately reflecting a
person’s role in the outlet such as Pharmacist, Pharmacy Intern, Pharmacy
Technician, Pharmacy Clerk, Store Manager, or Assistant Store Manager.
5.00.00
OUTLETS.
5.00.01
Definitions. The following words and terms shall have the following
meanings, unless the context clearly indicates otherwise.
a.
Compounding / Dispensing Area: means any area in a prescription drug
outlet where “compounding / dispensing” is performed.
b.
In-State Prescription Drug Outlet: means any prescription drug outlet
located within Colorado that is registered pursuant to Title 12, Article 280,
C.R.S., where prescriptions are compounded and dispensed.
c.
Non-Resident 503 Outsourcing Facility: means a facility that is registered
by the Federal Food and Drug Administration, that is located outside the
state, and that distributes compounded drugs into the state without a
prescription order.
d.
Non-Resident Prescription Drug Outlet: means any pharmacy outlet
located outside this state that is registered pursuant to Title 12, Article
280, C.R.S., which ships, mails, or delivers, in any manner, drugs or
devices into this state pursuant to a prescription order.
e
tration, that is located outside the
state, and that distributes compounded drugs into the state without a
prescription order.
d.
Non-Resident Prescription Drug Outlet: means any pharmacy outlet
located outside this state that is registered pursuant to Title 12, Article
280, C.R.S., which ships, mails, or delivers, in any manner, drugs or
devices into this state pursuant to a prescription order.
e.
Risk-Base Assessment: means, pursuant to section 12-280-108(1)(a)(II),
C.R.S., to inspect a non-resident prescription drug outlet, a non-resident
503B outsourcing facility, or an out-of-state prescription drug wholesaler
when the Board determines, based on a complaint, that there may be an
imminent threat to the health, safety and welfare of Colorado consumers
and that such an inspection is imperatively necessary to preserve health,
safety and welfare of Colorado consumers.
f.
Third-Party Logistics Provider: means a person that contracts with a
manufacturer to provide or coordinate warehousing, distribution, or other
services on behalf of a manufacturer but does not take title to a
prescription drug or have general responsibility to direct the prescription
drug’s sale or distribution.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
37
g.
“Automated Pharmacy Dispensing System” or “System” means a
mechanical system that dispenses prescription drugs to a person
interacting with a remote pharmacist and maintains related transaction
information.
(1)
An “Automated Pharmacy Dispensing System” may only be
operated under a Pharmacy Drug Outlet license type.
tribution.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
37
g.
“Automated Pharmacy Dispensing System” or “System” means a
mechanical system that dispenses prescription drugs to a person
interacting with a remote pharmacist and maintains related transaction
information.
(1)
An “Automated Pharmacy Dispensing System” may only be
operated under a Pharmacy Drug Outlet license type.
(2)
Automated pharmacy dispensing systems may be stocked or
loaded by a pharmacist, or a pharmacy technician (provisional and
non-provisional) or intern under the supervision of a pharmacist.
5.00.10
Registration. The applicant for registration shall obtain the appropriate
form as approved by the Board to register an outlet. In the case of an application
for a new in-state or non-resident prescription drug outlet or non-resident 503B
outsourcing facility or third-party logistics provider, for a transfer of ownership of
an in-state or non-resident prescription drug outlet or non-resident 503B
outsourcing facility or third-party logistics provider, or for the relocation of an in-
state or non-resident prescription drug outlet or non-resident 503B outsourcing
facility or third-party logistics provider, the applicant shall submit such additional
documentation as the Board may require.
5.00.15
Registration for nonresident prescription drug outlets. An applicant for a
new nonresident prescription drug outlet registration shall submit the following:
a.
The current application with required fee;
b.
A verification of the current pharmacy license or registration issued by the
applicant’s resident state board of pharmacy;
c.
A copy of the most recent report detailing an inspection of the nonresident
prescription drug outlet by either its resident state board of pharmacy or
the National Association of Boards of Pharmacy’s Verified Pharmacy
Program dated within the previous two years of submission of the
application; and
d
nt pharmacy license or registration issued by the
applicant’s resident state board of pharmacy;
c.
A copy of the most recent report detailing an inspection of the nonresident
prescription drug outlet by either its resident state board of pharmacy or
the National Association of Boards of Pharmacy’s Verified Pharmacy
Program dated within the previous two years of submission of the
application; and
d.
An affidavit attesting that the nonresident prescription drug outlet shall not
ship compounded or other prescription drugs into the State of Colorado
without a prescription order for a specific patient, except as provided
pursuant to Rule 21.00.20.
5.00.17
Non-Resident 503B Outsourcing Facility. A nonresident 503B outsourcing
facility shall submit the following to the Board with the application:
a.
Proof that the facility is actively registered with the Federal Food and Drug
Administration as a 503B outsourcing facility and is actively licensed,
permitted, or registered in the state in which it is a resident;
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
38
b.
The location, names, and titles of all principle entity officers and the name
of the pharmacist in charge of the operations of the facility;
c.
Verification that the facility complies with all lawful directions and requests
for information from the Federal Food and Drug Administration and from
the regulatory or licensing agency of the state in which it is licensed,
permitted, or registered, as well as all requests for information made by
the Board pursuant to this section; and
d.
A copy of the most recent inspection report resulting from an inspection by
the Federal Food and Drug Administration.
5.00.19
Third-Party Logistics Provider. A third-party logistics provider shall submit
the following to the Board with the application:
a.
Proof, if available, that the facility is actively registered with the Federal
Food and Drug Administration as third-party logistics provider;
b
A copy of the most recent inspection report resulting from an inspection by
the Federal Food and Drug Administration.
5.00.19
Third-Party Logistics Provider. A third-party logistics provider shall submit
the following to the Board with the application:
a.
Proof, if available, that the facility is actively registered with the Federal
Food and Drug Administration as third-party logistics provider;
b.
The location, names, and titles of all principle entity officers; and
c.
Verification that the facility complies with all lawful directions and requests
for information from the Federal Food and Drug Administration as well as
all requests for information made by the Board pursuant to this section.
5.00.20
Applications. The Board, or its agent, may require any applicant or
pharmacist manager of an outlet to meet with the Board, or its agent, before the
Board takes action on any registration.
5.00.21
Automated Pharmacy Dispensing System. Requirements for Registration.
Eligibility requirements for an Automated Pharmacy Dispensing System
application include the following:
a.
Automated Pharmacy Dispensing Systems do not include those that do
not involve direct patient interaction and are for internal operations use
only.
b.
A current Board issued registration of the managing prescription drug
outlet that engages in the compounding, dispensing, and delivery of drugs,
or provision of pharmaceutical care to patients receiving prescriptions from
the Automated Pharmacy Dispensing System;
c.
The submission of a separate application by the managing prescription
drug outlet on behalf of the Automated Pharmacy Dispensing System for
an Automated Pharmacy Dispensing System registration, on a form
provided by the Division of Professions and Occupations. The managing
prescription drug outlet shall submit an application for each individual
Automated Pharmacy Dispensing System to which the managing
prescription drug outlet will provide stock drugs;
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
ensing System for
an Automated Pharmacy Dispensing System registration, on a form
provided by the Division of Professions and Occupations. The managing
prescription drug outlet shall submit an application for each individual
Automated Pharmacy Dispensing System to which the managing
prescription drug outlet will provide stock drugs;
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
39
d.
A Drug Enforcement Administration registration specifically assigned to
the Automated Pharmacy Dispensing System if the managing prescription
drug outlet provides stock controlled substances to the Automated
Pharmacy Dispensing System;
e.
A pharmacist manager who, in addition to being responsible for the
operations of the managing prescription drug outlet in compliance with all
state and federal laws and rules, is responsible for the operations of the
Automated Pharmacy Dispensing System; and
f.
A secure Automated Pharmacy Dispensing System that prevents the
diversion of drugs and that limits the access to drugs within the Automated
Pharmacy Dispensing System only to those persons whom have been
given permission to access the Automated Pharmacy Dispensing System;
g.
The necessary fee;
h.
The APDS shall be located in the state of Colorado and a pharmacist
providing any clinical services, including initial and final interpretation,
must be licensed in the state of Colorado.
i.
Automated pharmacy dispensing systems may be stocked or loaded by a
pharmacist or a pharmacy technician (provisional and non-provisional) or
intern under the supervision of a pharmacist.
5.00.30
No two registered in-state or non-resident prescription drug outlets may
occupy the same physical space. If there are two (or more) registrants co-located
within the same building or at the same address, each must have its own area,
separated by floor to ceiling walls, and separate entrances.
5.00.40
Transfer of Ownership
nd non-provisional) or
intern under the supervision of a pharmacist.
5.00.30
No two registered in-state or non-resident prescription drug outlets may
occupy the same physical space. If there are two (or more) registrants co-located
within the same building or at the same address, each must have its own area,
separated by floor to ceiling walls, and separate entrances.
5.00.40
Transfer of Ownership. Application to transfer registration of an in-state or
non-resident prescription drug outlet or a non-resident 503B outsourcing facility
or third-party logistics provider shall be submitted to the Board within thirty (30)
days of the transfer of ownership. A transfer of ownership shall be deemed to
have occurred:
a.
In the event the in-state or non-resident prescription drug outlet or a non-
resident 503B outsourcing facility or third-party logistics provider is owned
by a corporation, upon sale or transfer of twenty percent or more of the
shares of said corporation to a single individual or entity.
b.
In the event the in-state or non-resident prescription drug outlet or a non-
resident 503B outsourcing facility or third-party logistics provider is owned
by a partnership, upon sale or transfer of twenty percent or more of any
ownership interest.
c.
In the event the in-state or non-resident prescription drug outlet or a non-
resident 503B outsourcing facility or third-party logistics provider is owned
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
non-
resident 503B outsourcing facility or third-party logistics provider is owned
by a partnership, upon sale or transfer of twenty percent or more of any
ownership interest.
c.
In the event the in-state or non-resident prescription drug outlet or a non-
resident 503B outsourcing facility or third-party logistics provider is owned
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
40
by a limited liability company (LLC), upon sale or transfer of twenty
percent or more of the membership interests.
d.
Upon incorporation of an existing in-state or non-resident prescription drug
outlet or non-resident 503B outsourcing facility or third-party logistics
provider.
5.00.50
Relocation.
a.
In the event of a relocation of an in-state or non-resident prescription drug
outlet or non-resident 503B outsourcing facility or third-party logistics
provider, the outlet shall submit an application provided by the board along
with the prescribed fee no more than thirty (30) days prior to the effective
date of relocation.
b.
The registration of a non-resident prescription drug outlet or non-resident
503B outsourcing facility or third-party logistics provider shall become void
and shall be cancelled if the non-resident prescription drug outlet or non-
resident 503B outsourcing facility or third-party logistics provider relocates
to a state other than that which appears on its registration. In the event the
non-resident prescription drug outlet or non-resident 503B outsourcing
facility or third-party logistics provider wishes to continue conducting
business in Colorado, it must apply for and receive a new Colorado
registration prior to conducting business in Colorado.
5.00.55
Reinstatement of an In-State or Non-Resident Prescription Drug Outlet
Registration.
a.
In-state Prescription Drug Outlet. If a registration has expired, a facility
seeking to reinstate such registration shall submit the following:
(1)
The current reinstatement application with the required fee;
must apply for and receive a new Colorado
registration prior to conducting business in Colorado.
5.00.55
Reinstatement of an In-State or Non-Resident Prescription Drug Outlet
Registration.
a.
In-state Prescription Drug Outlet. If a registration has expired, a facility
seeking to reinstate such registration shall submit the following:
(1)
The current reinstatement application with the required fee;
(2)
If the owner of the in-state prescription drug outlet is a corporation,
submit either a copy of the articles of incorporation as they were
filed with the Colorado Secretary of State or a Certificate of Good
Standing issued by the Colorado Secretary of State;
(3)
A letter stating whether the corporation is public or private as
follows:
(A)
If the corporation is a public corporation, submit a list of all
stockholders owning five percent or more of the stock; or
(B)
If the corporation is a private corporation, submit a list of all
stockholders;
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
41
(4)
An accurate drawn-to-scale floor plan of the prescription drug
outlet’s compounding / dispensing area detailing all counters, bays,
sinks, refrigerators and, if applicable, sterile and non-sterile
compounding hoods; and
(5)
A completed, dated and signed minimum equipment self-inspection
form as provided with the reinstatement application.
b.
Non-resident Prescription Drug Outlet or non-resident 503B outsourcing
facility or third-party logistics provider. If a registration has expired, a
facility seeking to reinstate such registration shall submit the following:
(1)
The current reinstatement application with the required fee;
(2)
A verification of the current pharmacy license, registration, or permit
issued by the resident state board of pharmacy for the non-resident
pharmacy or 503B outsourcing facility, and a verification of the
current license or registration issued by the Federal Food and Drug
Administration for a non-resident 503B outsourcing facility or third-
party logistics provider;
tion with the required fee;
(2)
A verification of the current pharmacy license, registration, or permit
issued by the resident state board of pharmacy for the non-resident
pharmacy or 503B outsourcing facility, and a verification of the
current license or registration issued by the Federal Food and Drug
Administration for a non-resident 503B outsourcing facility or third-
party logistics provider;
(3)
If the registration has expired for a non-resident pharmacy for more
than two years, a copy of the most recent report detailing an
inspection of the non-resident prescription drug outlet by its
resident state board of pharmacy dated within five years of
submission of the reinstatement application.
5.00.60
Closure.
a.
Closure shall mean the permanent cessation of the practice of pharmacy
in any in state or non-resident prescription drug outlet or the permanent
cessation of conducting business in Colorado for a non-resident 503B
outsourcing facility or third-party logistics provider. For in-state prescription
drug outlets, closure shall also be deemed to have occurred if the
compounding/dispensing area is not open for business the minimum hours
specified in Rule 5.01.40(a).
b.
Upon the closure of any in-state or non-resident prescription drug outlet, it
shall be the responsibility of the last pharmacist manager of record to
remove the prescriptions and/or chart orders to another prescription drug
outlet where patrons and/or practitioners are afforded reasonable access
to a pharmacist’s interpretation of such orders. Such relocation of records
shall be made within seventy-two hours after closure. The pharmacist
manager shall submit a notice, on a form and manner approved by the
Board, detailing the closure of the prescription drug outlet or nonresident
prescription drug outlet within seventy-two hours after closure. If the last
pharmacist manager of record fails to relocate the records as required
herein, the Board may direct the removal of the records to a suitable
wo hours after closure. The pharmacist
manager shall submit a notice, on a form and manner approved by the
Board, detailing the closure of the prescription drug outlet or nonresident
prescription drug outlet within seventy-two hours after closure. If the last
pharmacist manager of record fails to relocate the records as required
herein, the Board may direct the removal of the records to a suitable
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
42
location. The last pharmacist manager of record shall make a reasonable
effort to inform patrons of the prescription drug outlet of the location of the
records. A non-resident 503B outsourcing facility or third-party logistics
provider shall inform the Board, in writing, within seventy-two hours after
closure.
c.
The Board on request shall provide the owner of any prescription drug
outlet an instruction sheet applicable to the transaction prior to closure, or
conducting bankruptcy proceedings, or transferring or selling the
prescription drug inventory.
d.
The preceding subsections under 5.00.60 shall not apply if a public health
order is in effect and consequently and temporarily impacts operating
hours.
5.00.70
Change in Pharmacist manager.
a.
An in-state and non-resident prescription drug outlet shall be under the
direct charge of a pharmacist manager. A proprietor who is not a
pharmacist shall comply with this requirement and shall provide a
manager who is a pharmacist.
b.
The registration of any in-state and non-resident prescription drug outlet
shall become void if the pharmacist manager in whose name the
registration was issued ceases to be engaged as the manager, and the
owner shall close the outlet unless such owner has employed a
pharmacist manager and, within thirty days after termination of the former
manager’s employ23ment, has made application to transfer the
registration to the new pharmacist manager and has paid the transfer fee
therefor.
5.00.80
Disclosure
acist manager in whose name the
registration was issued ceases to be engaged as the manager, and the
owner shall close the outlet unless such owner has employed a
pharmacist manager and, within thirty days after termination of the former
manager’s employ23ment, has made application to transfer the
registration to the new pharmacist manager and has paid the transfer fee
therefor.
5.00.80
Disclosure. Any Board registered non-resident prescription drug outlet
shall disclose to the Board, in writing, the location, names, and titles of all
principal entity officers and all pharmacists who are dispensing drugs to residents
of this state on an annual basis and within thirty days after any change of office,
officer or pharmacist.
5.01.00
Prescription Drug Outlets (In-State).
5.01.10
Controlled Substance Inventory.
a.
Upon the change of pharmacist manager of a prescription drug outlet, an
inventory of all controlled substances shall be taken within seventy-two
hours, by the new pharmacist manager or the new pharmacist manager’s
designee. The inventory shall be taken either as of the opening or as of
the close of business activity on the inventory date and such time and date
taken shall be entered on the inventory record.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
43
b.
Upon the transfer of ownership of a prescription drug outlet, an inventory
of all controlled substances shall be taken by the pharmacist manager or
the pharmacist manager’s designee. The inventory shall be taken either
as of the opening or as of the close of business activity on the inventory
date and such time and date taken shall be entered on the inventory
record
State Board of Pharmacy
43
b.
Upon the transfer of ownership of a prescription drug outlet, an inventory
of all controlled substances shall be taken by the pharmacist manager or
the pharmacist manager’s designee. The inventory shall be taken either
as of the opening or as of the close of business activity on the inventory
date and such time and date taken shall be entered on the inventory
record.
5.01.20
Compounding/Dispensing Area (In-State)
5.01.21
In the event a transfer of ownership of a prescription drug outlet occurs,
and the principal compounding/dispensing area or any satellite
compounding/dispensing area does not meet the physical requirements of this
Rule, the transfer of the registration may be approved, provided that compliance
with such requirements shall be accomplished within six months of the approval
of the transfer of the registration or by the next prescription drug outlet
registration renewal date, whichever time is greater.
5.01.31
Within every prescription drug outlet as defined in section 12-280-103(43),
C.R.S., there shall be one area designated as the principal
compounding/dispensing area. In addition to the principal
compounding/dispensing area there may be satellite compounding/dispensing
areas and drug storage areas (“satellites”) which are located at the same location
as the principal compounding/dispensing area. The principal
compounding/dispensing area and any satellite shall comply with the following
conditions:
a.
The principal compounding/dispensing area shall not be less than 225
continuous square feet, except that prescription drug outlets registered by
the Board prior to the effective date of this regulation that do not meet this
space requirement are hereby exempted from such requirement.
However, any new prescription drug outlet shall comply with this
requirement prior to the granting of the initial registration
al compounding/dispensing area shall not be less than 225
continuous square feet, except that prescription drug outlets registered by
the Board prior to the effective date of this regulation that do not meet this
space requirement are hereby exempted from such requirement.
However, any new prescription drug outlet shall comply with this
requirement prior to the granting of the initial registration. Any existing
prescription drug outlet which is being remodeled or is being moved from
one location to another, whether or not there is a change of address, shall
submit documentation required by the Board prior to remodeling or
relocation.
b.
All compounding/dispensing satellites and any drug storage satellites in
excess of the two permitted in subsection c below that are at the same
location as the principal compounding/dispensing area must not be less
than 100 continuous square feet and must be approved by the Board prior
to use for compounding/dispensing.
c.
In addition to the satellite areas permitted in the previous paragraph, up to
two satellites at the same location may be used solely for storage of
prescription drugs and controlled substances. Such drug storage satellites
must possess square footage commensurate for the safe storage and
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
44
removal of drugs within the affected satellites and approved by the Board
prior to use.
d.
Any room included within or adjacent to the principal compounding /
dispensing area that is separated from the principal compounding /
dispensing area by a door must meet the following:
(1)
The prescription drug outlet shall submit documentation required by
the board to remodel the principal compounding / dispensing area
prior to the utilizing the room or rooms for the purposes of
compounding and dispensing or for the storage of prescription
drugs and controlled substance stocks;
that is separated from the principal compounding /
dispensing area by a door must meet the following:
(1)
The prescription drug outlet shall submit documentation required by
the board to remodel the principal compounding / dispensing area
prior to the utilizing the room or rooms for the purposes of
compounding and dispensing or for the storage of prescription
drugs and controlled substance stocks;
(2)
The door must have a conspicuously displayed sign attached to it,
and facing the principal compounding / dispensing area, that states
“This room is part of the Board-approved designated principal
compounding / dispensing area”;
(3)
If a locked or otherwise secured door is used to separate parts of
the compounding / dispensing area, it shall be unlocked
immediately upon the request of the Board or of its inspectors and
be available for inspection.
e.
All compounding/dispensing areas and satellites shall be well-lighted and
well-ventilated with clean and sanitary surroundings devoted primarily to
compounding/dispensing or drug storage. These areas shall provide
necessary protection for drugs, chemicals and devices from deterioration
due to light, heat or evaporation and shall be arranged to protect all
prescription drugs and devices from pilferage or other unauthorized
removal. No areas shall be subject to any condition likely to lead to errors.
f.
In every prescription drug outlet and in every satellite where compounding
or dispensing is physically occurring, there shall be a minimum of twelve
continuous square feet of free and clear counter space, and a minimum of
six continuous square feet of free and clear counter space for each person
engaged in compounding/dispensing as defined. These counters and
surfaces shall be kept free and clear at all times for the purpose of
compounding/dispensing. Any computer workstation or other equipment
for the preparation of prescription labels and/or storage and retrieval of
records shall be in addition to the minimum free compounding/dispensing
area.
free and clear counter space for each person
engaged in compounding/dispensing as defined. These counters and
surfaces shall be kept free and clear at all times for the purpose of
compounding/dispensing. Any computer workstation or other equipment
for the preparation of prescription labels and/or storage and retrieval of
records shall be in addition to the minimum free compounding/dispensing
area.
(1)
The free floor space behind all compounding/dispensing counters
or work surfaces shall be not less than thirty inches in width;
(2)
The free floor space between shelving rows shall be not less than
twenty-four inches; and
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
45
(3)
There shall be sufficient shelf, drawer and/or cabinet space for
proper storage of prescription drugs and devices.
g.
In every satellite used for the sole purpose of storing prescription drugs or
controlled substances, there shall be:
(1)
At least twenty-four inches of free floor space between shelving
rows; and
(2)
At least thirty inches of free floor space behind any counters, if
counters are available.
h.
In the principal compounding/dispensing area there shall be a sink,
equipped with running hot and cold water, which is attached to an
approved drain, waste and vent system, or to a portable enclosed tank
which is emptied as frequently as necessary. Each satellite area shall also
be so equipped if appropriate to the compounding/dispensing activities
which are or will be performed therein.
i.
The prescription drug outlet shall have all the technical equipment
necessary for the appropriate compounding and dispensing it conducts.
j.
If refrigerated drugs are stored in the principal compounding/dispensing
area or in any satellite, there shall be a refrigerator, dedicated to storing
only drugs, meeting the compendia requirements and with an accurate
thermometer in the refrigerator
rein.
i.
The prescription drug outlet shall have all the technical equipment
necessary for the appropriate compounding and dispensing it conducts.
j.
If refrigerated drugs are stored in the principal compounding/dispensing
area or in any satellite, there shall be a refrigerator, dedicated to storing
only drugs, meeting the compendia requirements and with an accurate
thermometer in the refrigerator. The temperature of which shall be
maintained between two and eight degrees Celsius (2 and 8 degrees C.)
or thirty-six and forty-six degrees Fahrenheit (36 and 46 degrees F.) or in
accordance with the corresponding drug manufacturer’s directions. The
temperature shall be electronically monitored each calendar day. Records
detailing instances in which temperatures fall outside the aforementioned
range requirement, for any period of time, shall be maintained at the
prescription drug outlet and shall be made readily available for inspection
upon request by the Board or its representatives for a period of at least
two years preceding the request. Such records shall include the duration
of time the temperature fell outside the aforementioned range
requirement, based on the best available data, and measures taken by the
outlet as a result of the temperature falling outside the aforementioned
range requirement.
k.
If frozen drugs are stored in the principal compounding/dispensing area or
in any satellite, there shall be a freezer, dedicated to storing only drugs,
meeting the compendia requirements and with an accurate thermometer
in the freezer. The temperature of which shall be maintained between
twenty-five degrees below zero and ten degrees below zero Celsius (– 25
and – 10 degrees C.) or thirteen degrees below zero and fourteen degrees
Fahrenheit (– 13 and 14 degrees F.) or in accordance with the
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
he compendia requirements and with an accurate thermometer
in the freezer. The temperature of which shall be maintained between
twenty-five degrees below zero and ten degrees below zero Celsius (– 25
and – 10 degrees C.) or thirteen degrees below zero and fourteen degrees
Fahrenheit (– 13 and 14 degrees F.) or in accordance with the
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
46
corresponding drug manufacturer’s directions. The temperature shall be
electronically monitored each calendar day.
Records detailing instances in which temperatures fall outside the
aforementioned range requirement, for any period of time, shall be
maintained at the prescription drug outlet and shall be made readily
available for inspection upon request by the Board or its representatives
for a period of at least two years preceding the request. Such records shall
include the duration of time the temperature fell outside the
aforementioned range requirement, based on the best available data, and
measures taken by the outlet as a result of the temperature falling outside
the aforementioned range requirement.
l.
There shall be a professional reference library available in the prescription
drug outlet. If an electronic library is provided, workstations must be
provided in a compounding/dispensing area and must be readily available
for use by staff, interns and Board personnel. This library shall contain
current copies of the following:
(1)
A Title 12, Article 280, C.R.S.; the Pharmacists, Pharmacy
Businesses, and Pharmaceuticals Act;
(2)
Title 18, Article 18, C.R.S., the Uniform Controlled Substances Act
of 1992;
(3)
Board Rules;
(4)
21 Code of Federal Regulations (“CFR”) Part 1300 to End
containing Drug Enforcement Administration rules relating to
controlled substances;
(5)
If compounding sterile products, Guide to Parenteral Admixtures or
Handbook on Injectable Drugs or other comparable references as
determined by the pharmacist manager;
Article 18, C.R.S., the Uniform Controlled Substances Act
of 1992;
(3)
Board Rules;
(4)
21 Code of Federal Regulations (“CFR”) Part 1300 to End
containing Drug Enforcement Administration rules relating to
controlled substances;
(5)
If compounding sterile products, Guide to Parenteral Admixtures or
Handbook on Injectable Drugs or other comparable references as
determined by the pharmacist manager;
(6)
If compounding hazardous products, Technical Manual Section VI:
Chapter 2, Controlling Occupational Exposure to Hazardous Drugs
or ASHP Technical Assistance Bulletin on Handling Cytotoxic and
Hazardous Drugs; and
(7)
Any other references that the pharmacist manager of the
prescription drug outlet may deem necessary.
m.
If telephone prescription orders are accepted, a voice recording device
shall be provided to receive them, and they shall be played back and
transcribed to writing by the pharmacist or intern.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
47
n.
Written prescription orders and refill requests for prescription orders may
be delivered to the prescription drug outlet while the
compounding/dispensing areas are closed, provided a slot or drop box is
provided for the prescription order or prescription order refill requests.
o.
All prescription drug outlets shall maintain an adequate inventory of
prescription drugs and shall offer adequate pharmaceutical service to the
public they normally serve.
p.
Every prescription drug outlet shall display in the principal
compounding/dispensing area the report of the most recent inspection
conducted by the Board or a photocopy of the most recent self-inspection
performed by the pharmacist manager using the form provided by the
Board, whichever is more recent, and have readily available documents
sent or provided by the Board to clarify or assist in the legal operation of
the prescription drug outlet.
q
he principal
compounding/dispensing area the report of the most recent inspection
conducted by the Board or a photocopy of the most recent self-inspection
performed by the pharmacist manager using the form provided by the
Board, whichever is more recent, and have readily available documents
sent or provided by the Board to clarify or assist in the legal operation of
the prescription drug outlet.
q.
No person other than a pharmacist or intern employed by the prescription
drug outlet shall be permitted in the compounding/dispensing area without
the consent of the pharmacist in charge of the compounding/dispensing
area.
r.
If a computer terminal or other device is used by pharmacy personnel
outside the compounding/dispensing area, but within the same location
(building) as the prescription drug outlet, when a Colorado-licensed
pharmacist is in the building, for the purpose of processing, gathering or
storing prescription information, the pharmacist manager of the
prescription drug outlet shall determine procedures for the storage and
security of, the access to, and the confidentiality of patient information
within the computer terminal or other device and shall be subject to Rule
1.00.16, and the federal Health Insurance Portability and Accountability
Act of 1996.
5.01.33
The use of any tobacco product in any compounding/dispensing area is
hereby prohibited. However, this Rule shall not apply to the compounding,
dispensing or use of a drug which has been derived from a tobacco product and
which is being used as an adjunct to a smoking cessation program.
5.01.34
Delivery and Temporary Storage of Prescriptions. Upon the request of a
patient or an agent of the patient and with the approval of the pharmacist on duty
a prescription may be delivered or temporarily stored outside the confines of a
compounding/dispensing area
use of a drug which has been derived from a tobacco product and
which is being used as an adjunct to a smoking cessation program.
5.01.34
Delivery and Temporary Storage of Prescriptions. Upon the request of a
patient or an agent of the patient and with the approval of the pharmacist on duty
a prescription may be delivered or temporarily stored outside the confines of a
compounding/dispensing area. The pharmacist manager of the prescription drug
outlet shall determine or approve procedures for the storage and security of, the
access to, the confidentiality of, and the counseling regarding, prescriptions,
including record keeping.
5.01.40
Minimum Hours of Operation.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
48
a.
The principal compounding/dispensing area of a prescription drug outlet
shall be open for normal business a minimum of two designated days per
week (Monday through Sunday) and at least four continuous hours on
each such designated day. These minimum requirements shall not apply
within the first 120 calendar days after the prescription drug outlet has
been registered by the Board if the outlet has not obtained prescription
drug or controlled substance stocks.
b.
In the event that the principal compounding/dispensing area is open less
than thirty-two hours per week on an updated permanent basis (beyond a
2 week temporary basis), the pharmacist manager shall submit to the
Board a written statement of the designated days and hours when the
principal compounding/dispensing area will be open for business, and this
statement shall be submitted at least thirty days prior to the date on which
the hours of operation will be less than thirty-two hours per week.
c
eek on an updated permanent basis (beyond a
2 week temporary basis), the pharmacist manager shall submit to the
Board a written statement of the designated days and hours when the
principal compounding/dispensing area will be open for business, and this
statement shall be submitted at least thirty days prior to the date on which
the hours of operation will be less than thirty-two hours per week.
c.
In the event a pharmacy is not able to remain open during the posted
hours of operation on a temporary basis, then it must notify the public by
posting a sign in front of the closed pharmacy notifying the public of the
temporary closure and contact information of the nearest closest
pharmacy, their address, and phone number in an effort to provide
continuity of care. Additionally, closure must be noted on each telephone
greeting and pharmacy operated internet application as soon as possible,
with information on hours, prescription pick-ups, and alternative options for
the public to get their medication.
5.01.50
Security. In every prescription drug outlet, all compounding/dispensing
areas shall comply with this regulation.
a.
When any compounding/dispensing area of a prescription drug outlet is
occupied by any employee, a pharmacist must be physically present
within the same building of the prescription drug outlet, unless the
prescription drug outlet is defined as a Rural Independent Pharmacy in 12-
280-118(3)(d) and 12-280-103(46.7) C.R.S. This Rule shall not apply if the
prescription drug outlet does not possess prescription drug or controlled
substance stocks or patient information within the first 120 calendar days
after the prescription drug outlet has been registered by the Board.
b.
In the event a pharmacist is within the building but absent from a
compounding/dispensing area, it is the responsibility of the pharmacist to
ensure the proper safeguard of all drugs.
c
iption drug outlet does not possess prescription drug or controlled
substance stocks or patient information within the first 120 calendar days
after the prescription drug outlet has been registered by the Board.
b.
In the event a pharmacist is within the building but absent from a
compounding/dispensing area, it is the responsibility of the pharmacist to
ensure the proper safeguard of all drugs.
c.
If a compounding/dispensing area is continually attended by a pharmacist
when other people are in the building, the compounding/dispensing area
need not be enclosed. However, if other people are in the building when
there is not a pharmacist present, every compounding/dispensing area
must be enclosed by a barrier as specified in paragraph e below unless
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
49
the prescription drug outlet qualifies for the exemption provided under
Rule 5.01.50(a).
d.
If more than one prescription drug outlet is located within the same
building, a pharmacist shall not operate more than one outlet at the same
time. If a pharmacist physically leaves one outlet for the purpose of
entering into another outlet within the same building, any outlet not being
physically attended to by a pharmacist shall be enclosed by a barrier as
specified in paragraph e below and a non-pharmacist shall not remain
inside the enclosed outlet during that time unless the prescription drug
outlet qualifies for the exemption provided under Rule 5.01.50(a).
e.
A prescription drug outlet constituting part of a large establishment may be
closed while the balance of the establishment is open for business,
provided every compounding/dispensing area is enclosed with a secure
floor-to-ceiling physical barrier, which shall be a divider or secure total
enclosure, in which any openings shall not be large enough to permit
removal of items from the compounding/dispensing area. The barrier must
be of weight and strength sufficient to prevent it from being readily lifted,
removed, penetrated or bent.
f
ness,
provided every compounding/dispensing area is enclosed with a secure
floor-to-ceiling physical barrier, which shall be a divider or secure total
enclosure, in which any openings shall not be large enough to permit
removal of items from the compounding/dispensing area. The barrier must
be of weight and strength sufficient to prevent it from being readily lifted,
removed, penetrated or bent.
f.
Unless the prescription drug outlet is defined as a Rural Independent
Pharmacy in 12-280-118(3)(d) and 12-280-103(46.7) CRS, all entrances
to every compounding/dispensing area shall be secured from
unauthorized entry when the pharmacist leaves the building except as
provided in Rule 5,01.50(a). No one other than a pharmacist shall be
permitted to enter any compounding/dispensing area containing drugs,
devices or patient information except in extreme emergencies, which shall
be defined as a threat to property, public disaster or other catastrophe
whereby the public is better served by overlooking the security restrictions
of drugs and devices. If any compounding/dispensing area containing
drugs, devices or patient information is opened in the absence of a
pharmacist or left unsecured from unauthorized entry when the pharmacist
leaves the building, the pharmacist manager shall notify the Board in
writing within ten days of the discovery of the occurrence. This written
notice shall state:
(1)
The name of the person authorizing the opening of the
compounding/dispensing area if known, or the name of the
pharmacist responsible for securing the compounding/dispensing
area from unauthorized entry;
(2)
The name of the person opening the compounding/dispensing area
if known; and
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
50
urrence. This written
notice shall state:
(1)
The name of the person authorizing the opening of the
compounding/dispensing area if known, or the name of the
pharmacist responsible for securing the compounding/dispensing
area from unauthorized entry;
(2)
The name of the person opening the compounding/dispensing area
if known; and
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
50
(3)
A description of the situation requiring opening of the
compounding/dispensing area including the date and time of the
opening.
g.
While the compounding/dispensing area is closed and the rest of the
establishment is open, a person on duty in the establishment shall be able
to contact a pharmacist in case of emergency.
h.
The hours of business of the compounding/dispensing area shall be
submitted to the Board in writing.
i.
No prescription drug outlet shall avail itself of the privileges of this Rule
until the barrier system and other requirements have been acknowledged,
subject to final approval by the Board.
j.
This paragraph applies only to the compounding/dispensing areas of a
hospital which operates a prescription drug outlet pursuant to a certificate
of compliance; or which operates a registered prescription drug outlet on
the premises of the hospital for the primary purpose of providing
pharmaceutical services to the hospital’s in-patients; or permits a
registered prescription drug outlet to be operated on the premises of the
hospital by another business entity for the primary purpose of providing
pharmaceutical service to the hospital’s in-patients.
iance; or which operates a registered prescription drug outlet on
the premises of the hospital for the primary purpose of providing
pharmaceutical services to the hospital’s in-patients; or permits a
registered prescription drug outlet to be operated on the premises of the
hospital by another business entity for the primary purpose of providing
pharmaceutical service to the hospital’s in-patients.
(1)
In an emergency situation and when a pharmacist is not on the
premises of the hospital and administration of a drug to, or use of a
device by or on, an in-patient is necessary pursuant to a chart
order, and such drug or device is only available from a locked
compounding/dispensing area, an authorized registered nurse may
enter a locked compounding/dispensing area to obtain the drug or
device. In the case of a drug, only pre-labeled packages, such as
unit dose or unit-of-use packages, or a pre-labeled container, may
be removed from the compounding/dispensing area.
(2)
The following information regarding the removal of such drug or
device shall be consistently recorded and maintained in a
retrievable document: date; time; name, strength and dosage form
of drug, and/or name, and size, if applicable, of device; total
quantity of drug or device removed; name and location of patient for
whose use the drug or device is necessary; name of the practitioner
ordering the drug or device; and the initials or signature of the
nursing obtaining the drug or device. This document shall be
available for inspection by the Board for a period of two years.
Additionally, the original, duplicate or electronic or mechanical
facsimile of the chart order shall be left with the above document by
the nurse at the time of obtaining the drug or device.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
51
nature of the
nursing obtaining the drug or device. This document shall be
available for inspection by the Board for a period of two years.
Additionally, the original, duplicate or electronic or mechanical
facsimile of the chart order shall be left with the above document by
the nurse at the time of obtaining the drug or device.
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
51
(3)
Any unused portion of a drug or device so removed shall be
returned to the compounding/dispensing area when a pharmacist is
again on the premises. Additional quantities of the drug or device
shall be supplied by a pharmacist and properly recorded as
required by sections 12-280-120(4) and 12-280-123(1), C.R.S., and
Rule 11.05.20.
6.00.00
[Repealed eff. 05/15/2020]
7.00.00
PHARMACIST MANAGER RESPONSIBILITIES.
7.00.10
Reporting Violations. The pharmacist manager of a prescription drug
outlet shall report to the Board, in writing, within the timelines set forth below:
a.
Diversion, theft or significant unaccountable loss of prescription drugs or
controlled substances from the pharmacy, hospital or health maintenance
organization (as defined in section 10-16-102, C.R.S.) within one business
day of a substantiated loss. When a Drug Enforcement Administration
(DEA) Form 106 is submitted to the DEA in instances involving controlled
substances, a copy of the completed DEA Form 106 along with a detailed
written explanation shall be submitted to the Board within one business
day of signing the form. When determining whether an unaccountable loss
is significant, the pharmacist manager shall consider, among others
factors, the following:
(1)
The actual quantity of drug lost in relation to the type of business;
(2)
The specific drug lost;
(3)
Whether the loss of the drug can be associated with access to
those drugs by specific individuals, or whether the loss can be
attributed to unique activities that may take place involving the
drug;
loss
is significant, the pharmacist manager shall consider, among others
factors, the following:
(1)
The actual quantity of drug lost in relation to the type of business;
(2)
The specific drug lost;
(3)
Whether the loss of the drug can be associated with access to
those drugs by specific individuals, or whether the loss can be
attributed to unique activities that may take place involving the
drug;
(4)
A pattern of losses over a specific time period, whether the losses
appear to be random, and the results of efforts taken to resolve the
losses;
(5)
Whether the specific drug is a likely candidate for diversion; and
(6)
Local trends and other indicators of the diversion potential of the
missing drug.
b.
Security breaches within the pharmacy or pharmacy area of the
establishment within ten days of discovery.
c.
Any pharmacist working in the pharmacy who is impaired due to the use of
alcohol or drugs, or a pharmacist with a mental or physical impairment
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
52
which affects his ability to perform his job competently. In such instance
the report shall be submitted to the Board immediately upon discovery.
d.
Significant errors related to the practice of pharmacy, including those
related to compounding, such as those that result in serious personal
injury or death of a patient. In such instance the report shall be submitted
to the Board immediately upon discovery.
7.00.20
Administrative Reporting Responsibilities:
a.
A pharmacist manager shall immediately notify the Board in writing of the
date he ceases to be the pharmacist manager of a prescription drug
outlet.
b.
Upon the change of pharmacist manager of a prescription drug outlet, the
new pharmacist manager or the new pharmacist manager’s designee shall
take an inventory of all controlled substances within seventy-two hours
ve Reporting Responsibilities:
a.
A pharmacist manager shall immediately notify the Board in writing of the
date he ceases to be the pharmacist manager of a prescription drug
outlet.
b.
Upon the change of pharmacist manager of a prescription drug outlet, the
new pharmacist manager or the new pharmacist manager’s designee shall
take an inventory of all controlled substances within seventy-two hours.
The inventory shall be taken either as of the opening or as of the close of
business activity on the inventory date and such time and date taken shall
be entered on the inventory record.
c.
Upon the transfer of ownership of a prescription drug outlet, the
pharmacist manager or the pharmacist manager’s designee shall take an
inventory of all controlled substances. The inventory shall be taken either
as of the opening or as of the close of business activity on the inventory
date and such time and date taken shall be entered on the inventory
record.
d.
The pharmacist manager shall determine or approve procedures for
prescriptions delivered or temporarily stored outside the confines of a
compounding/dispensing area at the request of a patient or an agent of
the patient. This procedure shall include the storage of, security of, the
access to, the confidentiality of, and the counseling regarding,
prescriptions and necessary record keeping.
e.
Upon the closure of a prescription drug outlet it shall be the responsibility
of the last pharmacist manager of record to remove the prescription and/or
chart orders to another prescription drug outlet where patrons and/or
practitioners are afforded reasonable access to a pharmacist’s
interpretation of such orders.
f.
The daily printout shall contain all information as required by rule. This
applies to both prescription order and chart order dispensing.
g
the responsibility
of the last pharmacist manager of record to remove the prescription and/or
chart orders to another prescription drug outlet where patrons and/or
practitioners are afforded reasonable access to a pharmacist’s
interpretation of such orders.
f.
The daily printout shall contain all information as required by rule. This
applies to both prescription order and chart order dispensing.
g.
It is the responsibility of the pharmacist manager to ensure that all
prescription drug outlet staff are aware that they must be able to print a
report of all prescription order or chart order transactions for such period
of time as the Board or its inspector(s) may specify, or to provide a
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
53
computer terminal and monitor for the sole use of the Board or its
inspector(s) to inspect and review dispensing transactions, and, if
necessary, provide a person to assist the Board or its inspector(s) for a
period of time not to exceed two hours in operating the system. (If the
prescription drug outlet elects to comply with the latter requirement of
providing equipment and/or personnel, the system must also be capable
of printing the reports previously described.) Any failure or refusal by the
pharmacist manager and/or a staff pharmacist to comply with a request by
the Board or its inspector(s) will be deemed to be a willful violation of
these Rules.
h.
It is the responsibility of the pharmacist manager to maintain records as
required by Rule 11.00.00.
I.
It is the responsibility of the pharmacist manager to maintain records of
initial interpretation and final evaluation as required by Rule 3.00.51(a)
and (b).
J.
It is the responsibility of the pharmacist manager to maintain and to assure
the outlet’s compliance with a policy and procedure manual, where
applicable, encompassing all aspects of non-sterile and sterile
compounding as required by Rules 21.10.10 and 21.20.30, respectively
macist manager to maintain records of
initial interpretation and final evaluation as required by Rule 3.00.51(a)
and (b).
J.
It is the responsibility of the pharmacist manager to maintain and to assure
the outlet’s compliance with a policy and procedure manual, where
applicable, encompassing all aspects of non-sterile and sterile
compounding as required by Rules 21.10.10 and 21.20.30, respectively.
The annual review of such manual or manuals shall be signed and dated
by the pharmacist manager. In the event the pharmacist manager
changes, the new manager shall review, sign, and date the manual within
thirty days of becoming the pharmacist manager.
7.00.30
Compliance of Outlet:
a.
The manager of a prescription drug outlet is responsible for the operation
of the outlet in compliance with all state and federal laws, rules, and
regulations.
b.
Except as provided in sections 12-280-103(54)(b)(III) and 25.5-2.5-201
through 25.5-2.5-208, C.R.S., the pharmacist manager is responsible for
ensuring that all prescription drugs and controlled substances are
procured by the outlet from an entity or person registered by the Board.
Any drug designated as an Investigational New Drug from the Federal
Food and Drug Administration is exempt from this requirement provided
the research requirements for the receipt of the product are followed and it
meets the requirements of section 12-280-131(2), C.R.S.
8.00.00
ADVERTISING.
8.00.10
Labels. At least one address shall appear on a prescription label and that
shall include the address of the prescription drug outlet from which the
prescription was dispensed. In the case of a central fill prescription processing
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
are followed and it
meets the requirements of section 12-280-131(2), C.R.S.
8.00.00
ADVERTISING.
8.00.10
Labels. At least one address shall appear on a prescription label and that
shall include the address of the prescription drug outlet from which the
prescription was dispensed. In the case of a central fill prescription processing
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
54
contract, the label shall contain at least the name and address of the originating
and/or fulfillment pharmacy.
8.00.30
Multiple Names. A prescription drug outlet shall only use, operate or
advertise under the name that appears on the current registration issued by the
Board.
8.00.40
Truth in Advertising. No pharmacist or prescription drug outlet shall
advertise or allow advertisement that is untrue or misleading in any manner
regarding prescription drugs.
9.00.00
LEGAL PROCEEDINGS.
9.00.10
Reporting.
a.
A licensee or registrant shall notify The Board in writing within seventy-two
hours of the licensee or registrant receiving service of process or
knowledge by other means of any legal proceedings in Colorado or
anywhere wherein it is alleged that the licensee or registrant has violated
any law or rule pertaining to drugs or devices. This includes civil
malpractice cases.
1.
The notice to the Board shall include the following information:
(a)
The court;
(b)
The jurisdiction;
(c)
The case name;
(d)
The case number; and
g service of process or
knowledge by other means of any legal proceedings in Colorado or
anywhere wherein it is alleged that the licensee or registrant has violated
any law or rule pertaining to drugs or devices. This includes civil
malpractice cases.
1.
The notice to the Board shall include the following information:
(a)
The court;
(b)
The jurisdiction;
(c)
The case name;
(d)
The case number; and
(e)
A description of the matter and a copy of the indictment or
charges.
2.
The licensee or registrant shall notify the Board in writing within
thirty days of the disposition of such proceeding.
b.
All licensees or registrants shall notify the Board in writing within thirty
days of any disciplinary action against them in another state. Such
notification shall include the following:
1.
The state;
2.
The jurisdiction;
3.
The case name;
4.
The case number;
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
55
5.
A description of the matter and a copy of the indictment or charges;
6.
A copy of the discipline; and
7.
Proof of completion of any requirements set forth in the order, if
applicable.
c.
All licensees or registrants shall notify the Board in writing of any criminal
conviction or deferred judgment against them (including, but not limited to,
“driving under the influence” and “driving while ability impaired”), and petty
offenses within thirty days after such conviction or judgment.
1.
For purposes of this Rule, a “conviction” includes:
(a)
A guilty verdict;
(b)
A plea of guilty accepted by the court;
(c)
A plea of nolo contendere (no contest) accepted by the
court; or
(d)
A deferred judgment or sentence.
2.
The notice to the Board shall include the following information:
(a)
The court;
(b)
The jurisdiction;
(c)
The case name;
(d)
The case number;
(e)
A description of the matter and a copy of the indictment or
charges;
(f)
A copy of the plea agreement or verdict; and
ilty accepted by the court;
(c)
A plea of nolo contendere (no contest) accepted by the
court; or
(d)
A deferred judgment or sentence.
2.
The notice to the Board shall include the following information:
(a)
The court;
(b)
The jurisdiction;
(c)
The case name;
(d)
The case number;
(e)
A description of the matter and a copy of the indictment or
charges;
(f)
A copy of the plea agreement or verdict; and
(g)
Proof of completion of court ordered requirements, if
applicable.
d.
The registrant or licensee notifying the Board may submit a written
statement with any notice required under this Rule to be included in the
registrant or licensee records.
e.
Each insurance company licensed to do business in Colorado and
engaged in the writing of malpractice insurance for licensed pharmacists
and each pharmacy that self-insures shall send to the Board, information
relating to each malpractice claim against a licensed pharmacist which is
CODE OF COLORADO REGULATIONS
3 CCR 719-1
State Board of Pharmacy
56
settled or in which judgment is rendered against the insured. Such
information shall be provided to the Board within 30 days of the settlement
or judgment.
10.00.00
EMERGENCY KITS.
10.00.05
Definitions.
a.
“Emergency kit” or “kit” means a tamper-evident sealed and secured
container or secured electronic system containing drugs which are used
for either immediate administration to patients of facilities delineated in
10.00.10 or in an emergency situation or as a starter dose.
b.
“Starter dose” means a dose of medication contained in an emergency kit
for the purpose of starting the initial therapy for a patient residing in a
facility delineated in Rule 10.00.10.
10.00.10
A prescription drug outlet or a hospital other outlet may provide an
emergency kit to any of the following facilities that are licensed or certified by the
Colorado Department of Public Health and Environment: Long-Term Care
Facilities, Hospices, Acute Treatment Units and H
This text is long and has been trimmed here. Open the source document for the complete record.
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.