Consolidation, Elimination, and Clarification of Various Regulations

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1307, 1308,

1309, 1310, 1311, 1312, 1313, and 1316

[DEA Number 139P]

RIN Number 1117-AA33

Consolidation, Elimination, and Clarification of Various

Regulations

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: DEA proposes to amend the language in title 21, Code of

Federal Regulations, parts 1300 through 1316. In concert with the

President's National Performance Review, Regulatory Reinvention

Initiative (NPR), DEA proposes to consolidate, eliminate, and clarify

many of its regulations to address areas of confusion frequently raised

by the pharmaceutical, chemical, and health care industries; and to

correct inaccurate citations, office designations, and typographical

errors.

DATES: Written comments or objections must be received by July 3, 1996.

ADDRESSES: Comments and objections should be submitted in quintuplicate

to the Deputy Administrator, Drug Enforcement Administration,

Washington, DC 20537, Attention: DEA Federal Register Representative/

CCR.

FOR FURTHER INFORMATION CONTACT: G. Thomas Gitchel, Chief, Liaison and

Policy Section, Office of Diversion Control, Drug Enforcement

Administration, Washington, DC 20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION: A comprehensive review has been conducted of

title 21, Code of Federal Regulations (21 CFR), parts 1300 through

1316. Title 21 contains the rules and regulations by which DEA

implements the Controlled Substances Act, the Narcotic Addict Treatment

Act, the Controlled Substances Import/Export Act, the Chemical

Diversion and Trafficking Act, and the Domestic Chemical Diversion

Control Act. These regulations are designed to detect and deter the

diversion of controlled substances and listed chemicals. DEA undertook

this review to update, simplify, and consolidate its regulations in

concert with the President's Regulatory Reform Initiative under the

NPR; to clarify areas of confusion which have been raised by the

pharmaceutical, chemical, and health care industries; and to correct

inaccurate citations, office designations and typographical errors. In

this effort, DEA intends to reduce some of the regulatory burden on the

affected industries. The changes proposed herein build upon DEA's

longstanding commitment to internal self-examination, to respond to

technological advances, and to work with industry to develop the most

effective and least intrusive methods of preventing and detecting the

diversion of controlled substances and listed chemicals.

Among the changes being proposed, which are further described

below, are the consolidation into a chart of the frequency of

registration, coincident activities, and fee schedules; allowing

manufacturers more latitude to set individual labeling standards;

reducing the frequency of ARCOS reports from monthly to quarterly, and

reducing the number of transactions to be reported by manufacturers;

permitting some pharmacies to file prescriptions without marking them

with a red ``C'', to transfer prescriptions for refill purposes more

than once, and to retain faxed prescriptions as original documents for

patients in home hospice care; and combining and streamlining various

reporting, recordkeeping, and inventory requirements.

The following summarizes the changes proposed to be made to each

part of the regulations:

Part 1300

DEA is proposing to move the definitions set out in 21 CFR parts

1301 through 1313 into a new part 1300. This will provide a single

source for definition of the terms used in 21 CFR parts 1301 through

1313, avoiding the need for duplicate definitions in the various parts.

The definitions set out in Part 1316 will remain listed in that part

due to the specificity of the definitions to the subject matter of the

part.

Part 1301

DEA is proposing to amend 21 CFR, part 1301 to provide a simple and

clear set of requirements concerning the registration of manufacturers,

distributors, dispensers, importers and exporters of controlled

substances. In this regard, DEA is proposing to incorporate into 21

CFR, part 1301 the requirements relating to the registration of

importers and exporters which were previously set out in 21 CFR, part

1311.

In order to provide easier reference to the primary regulations

regarding registration (including separate registration for independent

activities, coincident activities, the application forms and fees

required for registration and reregistration, and the registration

period for the various activities) DEA is proposing to amend 21 CFR,

part 1301 to list such requirements in table form. Use of the table

form allows for ``at-a-glance'' reference to the fundamental

regulations concerning the registration requirements, rather than

requiring reference to multiple pages of text in separate sections.

In addition to revising the format of 21 CFR, part 1301, DEA is

proposing to transfer the definitions previously listed in Sec. 1301.02

to the proposed new part 1300, and to remove Secs. 1301.27, 1301.29,

and 1301.53, relating to civil defense authorities, provisional

registration of narcotic treatment programs (NTP), and waiver and

modification of rules in hearings, respectively. Sections 1301.27 and

1301.29 are obsolete and Sec. 1301.53 is duplicated by Sec. 1316.44.

With respect to civil defense authorities, DEA will continue to work

with the appropriate Federal and state agencies to insure that the

proper policies and procedures are in place to deal with the

availability and

[[Page 8504]]

security of controlled substances during emergencies. Further, the fee

exemption provisions (formerly in Sec. 1301.13 and now in Sec. 1301.21)

and the provision regarding when a registrant may apply for

reregistration (formerly in Sec. 1301.31(b) and now in Sec. 1301.13(b))

have been amended. The fee exemption provision has been amended to

provide that Federal, state or local officials who must obtain an

individual practitioner registration in order to carry out their

official duties are exempted from the fees for registration and

reregistration. This action is being taken to insure that those

individual government practitioners who are not able to practice under

the registration number of a hospital or clinic are subject to the same

exemption as those government physicians carrying out official duties

in such facilities. The reregistration provision has been amended to

allow that a person registered as either a bulk manufacturer of

Schedule I or II controlled substances or an importer of Schedule I or

II controlled substances may apply to be reregistered no more than 120

days prior to the expiration date of his/her registration. The current

limitation of no more than 60 days prior to the expiration date does

not allow sufficient time prior to the applicant's expiration date to

satisfy the notice and comment and hearing procedures required under

Secs. 1301.33 and 1301.34 of this chapter. The additional 60 days

should provide sufficient time to allow for satisfaction of those

requirements for most applications prior to the expiration date.

However, in no circumstances will DEA grant such an applicant

reregistration more than 60 days prior to the applicant's registration

expiration date.

DEA is also proposing to incorporate the language found in

Sec. 1307.12 of this chapter into the coincident activities table and

the language found in Sec. 1307.14 into Sec. 1301.62. Additionally, DEA

is proposing to combine Secs. 1301.62 and 1301.63 into one section and

revise the new section to allow that a registration cannot be assigned

or transferred unless specific, written authority has been granted by

the Administration.

The proposed changes will result in a substantial restructuring of

part 1301, including the redesignation of most of the sections within

the part. Only the sections relating to the Security Requirements

(Sec. 1301.71-1301.76) and Employee Screening--Non-Practitioners

(Sec. 1301.90-1301.93) are unchanged. For the sake of clarity, DEA is

proposing in the regulatory text to remove the old Secs. 1301.11

through 1301.63 and replace them with new Secs. 1301.11 through

1301.52. While the appearance of the new sections is significantly

changed, readers should keep in mind that there are only minor changes

to the specific regulatory requirements contained in the old parts 1301

and 1311.

Part 1302

This part contains the requirements governing the labeling and

packaging of controlled substances pursuant to sections 305 and 1008(e)

of the Act (21 U.S.C. 825 and 958(e)). The proposed changes made in

part 1302 would move the definitions into Part 1300 for ease of

reference and, in general, allow more latitude to the registrant in the

design of labels for products which contain controlled substances.

While continuing to require an identifiable marking on labels of a

commercial container which contains a controlled substance, the

proposed changes would allow the registrant to meet the requirement by

its own design of a label and placement of the required symbol.

Further, language regarding labeling requirements at the inception of

the Controlled Substances Act (on May 1, 1971) has been proposed to be

removed as no longer necessary. The effective date for implementing the

labeling requirements for substances transferred or added to a schedule

is proposed to be established in the final order. Finally, the

requirement for sealing of a commercial package is proposed to be

amended to include all controlled substances, making it consistent with

the Federal Food, Drug, and Cosmetic Act, and to allow more latitude in

the design of the seal, while retaining the primary purpose of a seal

which is to detect tampering of the commercial package.

Part 1303

This part contains the procedures governing the establishment of

production and manufacturing quotas for basic classes of controlled

substances listed in Schedules I and II. Changes are being proposed in

this part to correct inaccurate citations and typographical errors and

to move the definitions to part 1300 for ease of reference.

Part 1304

This part sets forth inventory and recordkeeping requirements for

registrants who handle controlled substances. In accordance with 21

U.S.C. 827 and 958(e), registrants who manufacture, distribute, or

dispense controlled substances must maintain complete and accurate

records of such substances manufactured, received, sold, delivered or

otherwise disposed of. Modifications to several sections of part 1304

are being proposed to eliminate the requirement for reports which are

outdated, to remove redundancies in recordkeeping and inventory

requirements, to change obsolete references, and to correct

typographical errors.

Section 1304.02 is proposed to be revised to remove all definitions

to Part 1300.

Section 1304.03 is proposed to be revised to combine researcher

activities into one paragraph, thereby eliminating redundancies in the

recordkeeping requirements.

Section 1304.04 is proposed to be revised to correct a

typographical error in paragraph (a), to update language in paragraph

(e), and amend paragraph (h)(2) to permit pharmacies with automatic

data processing systems to file Schedule III-V prescriptions without

marking them with a red ``C''.

Section 1304.11 is proposed to be revised to combine all general

requirements for inventories thereby eliminating redundancies.

Paragraphs (b) and (c) were combined and the frequency statement was

revised to permit the biennial inventory to be taken on any date as

long as it is within two years of the previous biennial inventory; the

requirements contained in Secs. 1304.12, 1304.13, 1304.14, 1304.15,

1304.16, 1304.17, 1304.18 and 1304.19 were combined and included in

1304.11. In Sec. 1304.12, the reference to the May 1, 1971 date is

proposed to be deleted. Paragraph references are proposed to be changed

to reflect revisions.

Section 1304.21 paragraph (a): The May 1, 1971 date is proposed to

be deleted and paragraph references changed to reflect revisions.

Sections 1304.22, 1304.23, 1304.24, 1304.25 and 1304.26 are

proposed to be combined. Paragraph references are proposed to be

changed to reflect revisions.

Sections 1304.31 through 1304.38 are proposed to be revised,

combined, or removed to delete obsolete forms and references, and

reflect changes to manufacturer reporting from existing regulations to

conform with current practice. Reporting requirements are proposed to

be revised to reflect changes in frequency of reporting (from monthly

to quarterly) and to reduce the number of transactions (i.e., quality

control samples, manufacturing waste, etc.) required to be reported by

manufacturers.

Part 1305

This part contains the procedures governing the issuance, use, and

preservation of order forms pursuant to

[[Page 8505]]

section 308 of the Act (21 U.S.C. 828). The changes proposed to be made

in part 1305, in general, delete redundant requirements and move the

definitions into part 1300 for ease of reference. Section 1305.05,

Power of Attorney, is amended only to correct certain citations;

however, the existing Power of Attorney format is repeated in its

entirety. Additionally, the Official Order Form for Schedule I & II

Controlled Substances contains instructions that need not be repeated

in the regulations. Regulations requiring reporting of lost or stolen

Order Forms are modified to standardize reporting to local DEA offices

of responsibility.

Part 1306

This part contains the specific regulatory requirements for the

issuance, filling, and filing of prescriptions. Changes to this part

are being proposed to reduce regulatory requirements for pharmacies.

Additional changes are being made to correct typographical errors in

the existing text.

Section 1306.02 contains a number of definitions which are proposed

to be moved to part 1300 for ease of reference.

Section 1306.11 establishes the requirements for prescriptions for

controlled substances listed in Schedule II. Under Sec. 1306.11, the

length of time a pharmacy is permitted to obtain a written prescription

to cover an emergency oral prescription for a Schedule II controlled

substance is 72 hours. Many pharmacists have expressed the view that

there often is not enough time to meet their obligation within the time

permitted. DEA is therefore proposing to extend the time allowed to

obtain the written prescription from 72 hours to 7 days.

This same section permits pharmacists to dispense Schedule II

narcotics to patients in Long Term Care Facilities (LTCFs) pursuant to

prescriptions transmitted by facsimile. The facsimile then acts as the

original written prescription for recordkeeping purposes. DEA is

proposing to add a paragraph to Sec. 1306.11 to give pharmacies the

same authority to fill Schedule II narcotic prescriptions transmitted

by facsimile for patients in a home hospice setting as exists for

patients in LTCFs. The physician issuing the prescription will be

required to note that the patient is a hospice patient on the face of

the faxed prescription.

Section 1306.13 contains the rules for the partial filling of

Schedule II prescriptions. A prescription for a Schedule II controlled

substance written for a patient in a LTCF or for a patient with a

medical diagnosis documenting a terminal illness may be filled in

partial quantities to include individual dosage units. Section

1306.13(b) requires that prior to any subsequent partial filling the

pharmacist must determine that the additional partial fillings are

necessary. DEA is proposing to remove this requirement.

The requirements for Schedule III and IV controlled substances are

currently delineated separately from those in Schedule V. In order to

more clearly differentiate those requirements that are identical from

those that are not, where appropriate, identical rules affecting the

controlled substances in Schedule V are proposed to be merged with

those for Schedule III and IV. DEA is proposing to add Schedule V

references to Sec. 1306.21 and delete the corresponding Sec. 1306.31.

The language in these two sections is virtually identical and,

therefore, will have no effect on the requirements currently in place.

Several typographical errors and an obsolete term are proposed to

be corrected in Sec. 1306.22.

Section 1306.23, which currently allows for the partial filling of

Schedule III and IV prescriptions, is proposed to be expanded to add

Schedule V controlled substances.

Section 1306.25, which refers to the rules for filing Schedule III

and IV prescriptions contained in Sec. 1304.04(h), is proposed to be

removed and replaced by a new paragraph (Sec. 1306.24(c)).

Section 1306.26 establishes the rules for the transfer between

pharmacies of prescription information for Schedules III, IV, and V

controlled substances for refill purposes. A principal requirement for

transferring prescription information is that the original prescription

may be transferred on a one time basis only. This limitation was and is

extremely important in preventing illegal and unauthorized refills from

being dispensed. The prevention of diversion through unauthorized

refills is significantly impacted by the ability of pharmacists and

investigators to locate and confirm the authenticity of original

prescription records. However, in situations where the prescription

information, to include the entire refill history, is immediately

accessible to the pharmacist, some exceptions to the one time only rule

are proposed.

DEA is proposing to permit pharmacies sharing a real-time, on-line

electronic database, to transfer prescription information for refill

purposes for Schedule III, IV, and V controlled substances as often as

refills are authorized by law and the original prescription. In

addition to the requirements currently imposed on prescription

transfers, it is proposed that a pharmacy filling a transferred

prescription will be required to record the dates of all previous

refills.

Part 1307

This part is a miscellaneous part which addresses the application

of state law and other Federal Law, exceptions to regulations, special

exceptions for manufacture and distribution of controlled substances,

disposal of controlled substances, and special exempt persons. Changes

to this part are being proposed to correct citation errors and

omissions and to consolidate similar requirements. Section 1307.01

contains a definition which is proposed to be moved to part 1300. DEA

proposes to remove Sec. 1307.12 and include its provisions in the chart

of coincident activities contained in Part 1301. DEA proposes to

incorporate Sec. 1307.14, Distribution upon discontinuance or transfer

of business, with the redesignated Sec. 1301.52, Transfer of

registration. Section 1307.21 is proposed to be amended so that the

requirements for reporting controlled substances to be disposed of will

be uniform for all registrants regardless of whether or not they file

reports to ARCOS.

Part 1308

This part sets forth the schedules of controlled substances and

mechanisms for scheduling, rescheduling, or decontrolling a substance.

Section 1308.04 is proposed to be removed as unnecessary since it is

outdated. The following tables are proposed to be removed which contain

information given out routinely to the industry and is available upon

request: Section 1308.24--Exempt Chemical Preparations; Sec. 1308.26--

Excluded Veterinary Anabolic Steroid Implant Products; Sec. 1308.32--

Exempted prescription products; and Sec. 1308.34--Exempt Anabolic

Steroid Products. The sections will contain a reference on the

procedure to request a copy of the tables.

Sections 1308.43, 1308.46, and 1308.47 relating to hearings are

proposed to be removed as their requirements are already contained in

part 1316. Proposed to be added to Section 1308.42 is a sentence which

provides information on where to locate additional information on

hearings related to this part.

Part 1309

Part 1309 is proposed to be amended by moving the definitions set

out in Sec. 1309.02 into part 1300. This will

[[Page 8506]]

provide a centralized source for all definitions for parts 1301 through

1313.

Further, Secs. 1309.53 and 1309.57 are proposed to be removed, as

they duplicate Sec. 1316.44 and 1316.67 respectively. Sections 1309.54

through 1309.56 are proposed to be redesignated as Secs. 1309.53

through 1309.55. In addition, Secs. 1309.21 (a) and (b), 1309.25 (a)

and (b), and 1309.71(a)(2) are proposed to be amended to change the

citation from Sec. 1310.01(f)(1)(iv) to Sec. 1300.01(c)(28)(i)(D).

Part 1310

Part 1310 is proposed to be amended by moving the definitions set

out in Sec. 1310.01 into part 1300. Sections 1310.05 and 1310.08 will

be amended to remove references to definitions in Sec. 1310.01. Section

1310.10(a) is proposed to be amended to change the citation from

Sec. 1310.01(f)(1)(iv) to Sec. 1300.01(c)(28)(i)(D) and

Secs. 1310.14(a) and 1310.15(d) are proposed to be amended to change

the citation from Sec. 1310.01(f)(1)(iv)(A) to

Sec. 1300.01(c)(28)(i)(D)(1). Finally, Sec. 1310.09 is proposed to be

removed, as this section was applicable only during the initial

chemical registration period.

Part 1311

This part is proposed to be removed and reserved. The requirements

contained in part 1311 have been incorporated into the proposed

revisions to part 1301.

Part 1312

This part contains the procedures governing the importation,

exportation, transshipment, and intransit shipment of controlled

substances. Changes are being proposed in this part to correct

inaccurate citations and typographical errors, to update office

designations and addresses, and to move the definitions to part 1300

for ease of reference.

Part 1313

Part 1313 is proposed to be amended by moving the definitions set

out in Sec. 1313.02 into part 1300. In addition, Secs. 1313.15, 1313.21

and 1313.24 are proposed to be amended to remove references to the

definitions in Sec. 1313.02.

Part 1316

This part contains the regulatory requirements and authorities

related to Administrative Inspections, Protection of Researchers and

Research Subjects, Enforcement Proceedings, Administrative Hearings,

Seizure, Forfeiture, and Disposition of Property and Expedited

Forfeiture Proceedings for Certain Property. Changes to this part are

being proposed to correct citation errors and omissions and to

consolidate similar requirements. DEA proposes to revise Sec. 1316.13

to replace the present schedule of inspections with a system where the

frequency of inspections will be determined by the history of the

registrant, potential for diversion, or the amount of controlled

substances found in the illicit market. DEA will focus inspection

resources on diversion prevention and problem areas, reducing the

intended frequency of inspections of registrants with a demonstrated

record of compliance. This revision only applies to distributors of

controlled substances listed in Schedules II through V and

manufacturers of controlled substances listed in Schedules III through

V. The yearly inspection for manufacturers of controlled substances

listed in Schedules I and II and distributors of controlled substances

listed in Schedule I remains unchanged. This proposal is intended to

reduce the expenditure of time and effort, both on the part of DEA and

the registrants who have shown a history of compliance in the past and

continue to comply with the requirements of the CSA.

The Deputy Administrator, in accordance with the Regulatory

Flexibility Act (5 U.S.C. 605(b)), has reviewed this proposed

regulation and by approving it certifies that this proposed regulation

will not have a significant economic impact on a substantial number of

small entities. This proposed regulation will streamline the current

regulations set out in title 21, Code of Federal Regulations, parts

1300 to end and to provide regulatory relief to registrants.

This proposed regulation has been drafted in accordance with

Executive Order 12866, section 1(b), Principles of Regulation. The

Office of Managment and Budget has reviewed this proposed rule and

determined that it is not a ``significant regulatory action'' under

Executive Order 12866, section 3(f), Regulatory Planning and Review.

This regulation will not have substantial direct effects on the

States, on the relationship between the national government and the

States, or on distribution of power and responsibilities among the

various levels of government. Therefore, in accordance with Executive

Order 12612, it is determined that this rule does not have sufficient

federalism implications to warrant the preparation of a Federalism

Assessment.

List of Subjects in 21 CFR Parts 1300-1316

Administrative practice and procedure, Drug traffic control,

Security measures, Exports, Imports, Labeling, Packaging and

containers, Reporting requirements, Prescription drugs, Narcotics, List

I and List II chemicals, Research, Seizures and forfeitures.

21 CFR Part 1300 is proposed to be added to read as follows:

PART 1300--DEFINITIONS

Sec.

1300.01 Definitions relating to controlled substances.

1300.02 Definitions relating to listed chemicals.

Authority: 21 U.S.C. 802, 871(b), 951, 958(f).

Sec. 1300.01 Definitions relating to controlled substances.

(a) Any term not defined in this part shall have the definition set

forth in section 102 of the Act (21 U.S.C. 802), except that certain

terms used in part 1316 of this chapter are defined at the beginning of

each subpart of that part.

(b) As used in parts 1301 through 1308 and part 1312 of this

chapter, the following terms shall have the meanings specified:

(1) The term Act means the Controlled Substances Act, as amended

(84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import

and Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951).

(2) The term Administration means the Drug Enforcement

Administration.

(3) The term Administrator means the Administrator of the Drug

Enforcement Administration. The Administrator has been delegated

authority under the Act by the Attorney General (28 CFR 0.100).

(4) The term anabolic steroid means any drug or hormonal substance,

chemically and pharmacologically related to testosterone (other than

estrogens, progestins, and corticosteroids) that promotes muscle

growth, and includes:

(i) Boldenone;

(ii) Chlorotestosterone (4-chlortestosterone);

(iii) Clostebol;

(iv) Dehydrochlormethyltestosterone;

(v) Dihydrotestosterone (4-dihydrotestosterone);

(vi) Drostanolone;

(vii) Ethylestrenol;

(viii) Fluoxymesterone;

(ix) Formebulone (formebolone);

(x) Mesterolone;

(xi) Methandienone;

(xii) Methandranone;

(xiii) Methandriol;

(xiv) Methandrostenolone;

[[Page 8507]]

(xv) Methenolone;

(xvi) Methyltestosterone;

(xvii) Mibolerone;

(xviii) Nandrolone;

(xix) Norethandrolone;

(xx) Oxandrolone;

(xxi) Oxymesterone;

(xxii) Oxymetholone;

(xxiii) Stanolone;

(xxiv) Stanozolol;

(xxv) Testolactone;

(xxvi) Testosterone;

(xxvii) Trenbolone; and

(xxviii) Any salt, ester, or isomer of a drug or substance

described or listed in this paragraph, if that salt, ester, or isomer

promotes muscle growth. Except such term does not include an anabolic

steroid which is expressly intended for administration through implants

to cattle or other nonhuman species and which has been approved by the

Secretary of Health and Human Services for such administration. If any

person prescribes, dispenses, or distributes such steroid for human

use, such person shall be considered to have prescribed, dispensed, or

distributed an anabolic steroid within the meaning of this paragraph.

(5) The term basic class means, as to controlled substances listed

in Schedules I and II:

(i) Each of the opiates, including its isomers, esters, ethers,

salts, and salts of isomers, esters, and ethers whenever the existence

of such isomers, esters, ethers, and salts is possible within the

specific chemical designation, listed in Sec. 1308.11(b) of this

chapter;

(ii) Each of the opium derivatives, including its salts, isomers,

and salts of isomers whenever the existence of such salts, isomers, and

salts of isomers is possible within the specific chemical designation,

listed in Sec. 1308.11(c) of this chapter;

(iii) Each of the hallucinogenic substances, including its salts,

isomers, and salts of isomers whenever the existence of such salts,

isomers, and salts of isomers is possible within the specific chemical

designation, listed in Sec. 1308.11(d) of this chapter;

(iv) Each of the following substances, whether produced directly or

indirectly by extraction from substances of vegetable origin, or

independently by means of chemical synthesis, or by a combination of

extraction and chemical synthesis:

(A) Opium, including raw opium, opium extracts, opium fluid

extracts, powdered opium, granulated opium, deodorized opium and

tincture of opium;

(B) Apomorphine;

(C) Codeine;

(D) Etorphine hydrochloride;

(E) Ethylmorphine;

(F) Hydrocodone;

(G) Hydromorphone;

(H) Metopon;

(I) Morphine;

(J) Oxycodone;

(K) Oxymorphone;

(L) Thebaine;

(M) Mixed alkaloids of opium listed in Section 1308.12(b)(2) of

this chapter;

(N) Cocaine; and

(O) Ecgonine;

(v) Each of the opiates, including its isomers, esters, ethers,

salts, and salts of isomers, esters, and ethers whenever the existence

of such isomers, esters, ethers, and salts is possible within the

specific chemical designation, listed in Sec. 1308.12(c) of this

chapter; and

(vi) Methamphetamine, its salts, isomers, and salts of its isomers;

(vii) Amphetamine, its salts, optical isomers, and salts of its

optical isomers;

(viii) Phenmetrazine and its salts;

(ix) Methylphenidate;

(x) Each of the substances having a depressant effect on the

central nervous system, including its salts, isomers, and salts of

isomers whenever the existence of such salts, isomers, and salts of

isomers is possible within the specific chemical designation, listed in

Sec. 1308.12(e) of this chapter.

(6) The term commercial container means any bottle, jar, tube,

ampule, or other receptacle in which a substance is held for

distribution or dispensing to an ultimate user, and in addition, any

box or package in which the receptacle is held for distribution or

dispensing to an ultimate user. The term commercial container does not

include any package liner, package insert or other material kept with

or within a commercial container, nor any carton, crate, drum, or other

package in which commercial containers are stored or are used for

shipment of controlled substances.

(7) The term compounder means any person engaging in maintenance or

detoxification treatment who also mixes, prepares, packages or changes

the dosage form of a narcotic drug listed in Schedules II, III, IV or V

for use in maintenance or detoxification treatment by another narcotic

treatment program.

(8) The term Controlled Substance has the meaning given in section

802(6) of Title 21, United States Code (U.S.C.).

(9) The term customs territory of the United States means the

several States, the District of Columbia, and Puerto Rico.

(10) The term detoxification treatment means the dispensing, for a

period of time as specified below, of a narcotic drug or narcotic drugs

in decreasing doses to an individual to alleviate adverse physiological

or psychological effects incident to withdrawal from the continuous or

sustained use of a narcotic drug and as a method of bringing the

individual to a narcotic drug-free state within such period of time.

There are two types of detoxification treatment: Short-term

detoxification treatment and long-term detoxification treatment.

(i) Short-term detoxification treatment is for a period not in

excess of 30 days.

(ii) Long-term detoxification treatment is for a period more than

30 days but not in excess of 180 days.

(11) The term dispenser means an individual practitioner,

institutional practitioner, pharmacy or pharmacist who dispenses a

controlled substance.

(12) The term export means, with respect to any article, any taking

out or removal of such article from the jurisdiction of the United

States (whether or not such taking out or removal constitutes an

exportation within the meaning of the customs and related laws of the

United States).

(13) The term exporter includes every person who exports, or who

acts as an export broker for exportation of, controlled substances

listed in any schedule.

(14) The term hearing means:

(i) In part 1301 of this chapter, any hearing held for the

granting, denial, revocation, or suspension of a registration pursuant

to sections 303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).

(ii) In part 1303 of this chapter, any hearing held regarding the

determination of aggregate production quota or the issuance,

adjustment, suspension, or denial of a procurement quota or an

individual manufacturing quota.

(iii) In part 1308 of this chapter, any hearing held for the

issuance, amendment, or repeal of any rule issuable pursuant to section

201 of the Act (21 U.S.C. 811).

(15) The term home infusion pharmacy means a pharmacy which

compounds solutions for direct administration to a patient in a private

residence, Long Term Care Facility or hospice setting by means of

parenteral, intravenous, intramuscular, subcutaneous or intraspinal

infusion.

(16) The term import means, with respect to any article, any

bringing in or introduction of such article into either the

jurisdiction of the United States or the customs territory of the

United States, and from the jurisdiction of the United States into the

customs territory of the United States (whether or not such bringing in

or introduction constitutes an importation within the

[[Page 8508]]

meaning of the tariff laws of the United States).

(17) The term importer includes every person who imports, or who

acts as an import broker for importation of, controlled substances

listed in any schedule.

(18) The term individual practitioner means a physician, dentist,

veterinarian, or other individual licensed, registered, or otherwise

permitted, by the United States or the jurisdiction in which he/she

practices, to dispense a controlled substance in the course of

professional practice, but does not include a pharmacist, a pharmacy,

or an institutional practitioner.

(19) The term institutional practitioner means a hospital or other

person (other than an individual) licensed, registered, or otherwise

permitted, by the United States or the jurisdiction in which it

practices, to dispense a controlled substance in the course of

professional practice, but does not include a pharmacy.

(20) The term interested person means any person adversely affected

or aggrieved by any rule or proposed rule issuable pursuant to section

201 of the Act (21 U.S.C. 811).

(21) The term inventory means all factory and branch stocks in

finished form of a basic class of controlled substance manufactured or

otherwise acquired by a registrant, whether in bulk, commercial

containers, or contained in pharmaceutical preparations in the

possession of the registrant (including stocks held by the registrant

under separate registration as a manufacturer, importer, exporter, or

distributor).

(22) The term isomer means the optical isomer, except as used in

Sec. 1308.11(d) and Sec. 1308.12(b)(4). As used in Sec. 1308.11(d), the

term isomer means the optical, positional, or geometric isomer. As used

in Sec. 1308.12(b)(4), the term isomer means the optical or geometric

isomer.

(23) The term jurisdiction of the United States means the customs

territory of the United States, the Virgin Islands, the Canal Zone,

Guam, American Samoa, and the Trust Territories of the Pacific Islands.

(24) The term label means any display of written, printed, or

graphic matter placed upon the commercial container of any controlled

substance by any manufacturer of such substance.

(25) The term labeling means all labels and other written, printed,

or graphic matter:

(i) Upon any controlled substance or any of its commercial

containers or wrappers, or

(ii) accompanying such controlled substance.

(26) The term Long Term Care Facility (LTCF) means a nursing home,

retirement care, mental care or other facility or institution which

provides extended health care to resident patients.

(27) The term maintenance treatment means the dispensing for a

period in excess of twenty-one days, of a narcotic drug or narcotic

drugs in the treatment of an individual for dependence upon heroin or

other morphine-like drug.

(28) The term manufacture means the producing, preparation,

propagation, compounding, or processing of a drug or other substance or

the packaging or repackaging of such substance, or the labeling or

relabeling of the commercial container of such substance, but does not

include the activities of a practitioner who, as an incident to his/her

administration or dispensing such substance in the course of his/her

professional practice, prepares, compounds, packages or labels such

substance. The term manufacturer means a person who manufactures a drug

or other substance, whether under a registration as a manufacturer or

under authority of registration as a researcher or chemical analyst.

(29) The term mid-level practitioner means an individual

practitioner, other than a physician, dentist, veterinarian, or

podiatrist, who is licensed, registered, or otherwise permitted by the

United States or the jurisdiction in which he/she practices, to

dispense a controlled substance in the course of professional practice.

Examples of mid-level practitioners include, but are not limited to,

health care providers such as nurse practitioners, nurse midwives,

nurse anesthetists, clinical nurse specialists and physician assistants

who are authorized to dispense controlled substances by the state in

which they practice.

(30) The term name means the official name, common or usual name,

chemical name, or brand name of a substance.

(31) The term narcotic drug means any of the following whether

produced directly or indirectly by extraction from substances of

vegetable origin or independently by means of chemical synthesis or by

a combination of extraction and chemical synthesis:

(i) Opium, opiates, derivatives of opium and opiates, including

their isomers, esters, ethers, salts, and salts of isomers, esters, and

ethers whenever the existence of such isomers, esters, ethers and salts

is possible within the specific chemical designation. Such term does

not include the isoquinoline alkaloids of opium.

(ii) Poppy straw and concentrate of poppy straw.

(iii) Coca leaves, except coca leaves and extracts of coca leaves

from which cocaine, ecgonine and derivatives of ecgonine or their salts

have been removed.

(iv) Cocaine, its salts, optical and geometric isomers, and salts

of isomers.

(v) Ecgonine, its derivatives, their salts, isomers and salts of

isomers.

(vi) Any compound, mixture, or preparation which contains any

quantity of any of the substances referred to in paragraphs (b)(31) (i)

through (v) of this section.

(32) The term narcotic treatment program means a program engaged in

maintenance and/or detoxification treatment with narcotic drugs.

(33) The term net disposal means, for a stated period, the quantity

of a basic class of controlled substance distributed by the registrant

to another person, plus the quantity of that basic class used by the

registrant in the production of (or converted by the registrant into)

another basic class of controlled substance or a noncontrolled

substance, plus the quantity of that basic class otherwise disposed of

by the registrant, less the quantity of that basic class returned to

the registrant by any purchaser, and less the quantity of that basic

class distributed by the registrant to another registered manufacturer

of that basic class for purposes other than use in the production of,

or conversion into, another basic class of controlled substance or a

noncontrolled substance or in the manufacture of dosage forms of that

basic class.

(34) The term pharmacist means any pharmacist licensed by a State

to dispense controlled substances, and shall include any other person

(e.g., pharmacist intern) authorized by a State to dispense controlled

substances under the supervision of a pharmacist licensed by such

State.

(35) The term person includes any individual, corporation,

government or governmental subdivision or agency, business trust,

partnership, association, or other legal entity.

(36) The term prescription means an order for medication which is

dispensed to or for an ultimate user but does not include an order for

medication which is dispensed for immediate administration to the

ultimate user. (e.g., an order to dispense a drug to a bed patient for

immediate administration in a hospital is not a prescription.)

(37) The term proceeding means all actions taken for the issuance,

amendment, or repeal of any rule issued pursuant to section 201 of the

Act (21

[[Page 8509]]

U.S.C. 811), commencing with the publication by the Administrator of

the proposed rule, amended rule, or repeal in the Federal Register.

(38) The term purchaser means any registered person entitled to

obtain and execute order forms pursuant to Sec. 1305.04 and 1305.06.

(39) The term readily retrievable means that certain records are

kept by automatic data processing systems or other electronic or

mechanized recordkeeping systems in such a manner that they can be

separated out from all other records in a reasonable time and/or

records are kept on which certain items are asterisked, redlined, or in

some other manner visually identifiable apart from other items

appearing on the records.

(40) The terms register and registration refer only to registration

required and permitted by sections 303 or 1007 of the Act (21 U.S.C.

823 or 957).

(41) The term registrant means any person who is registered

pursuant to either section 303 or section 1008 of the Act (21 U.S.C.

823 or 958).

(42) The term supplier means any registered person entitled to fill

order forms pursuant to Sec. 1305.08.

Sec. 1300.02 Definitions relating to listed chemicals.

(a) Any term not defined in this part shall have the definition set

forth in section 102 of the Act (21 U.S.C. 802), except that certain

terms used in part 1316 of this chapter are defined at the beginning of

each subpart of that part.

(b) As used in parts 1309, 1310 and 1313 of this chapter, the

following terms shall have the meaning specified:

(1) The term Act means the Controlled Substances Act, as amended

(84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import

and Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951) as amended.

(2) The term Administration means the Drug Enforcement

Administration.

(3) The term Administrator means the Administrator of the Drug

Enforcement Administration. The Administrator has been delegated

authority under the Act by the Attorney General (28 CFR 0.100).

(4) The terms broker and trader mean any individual, corporation,

corporate division, partnership, association, or other legal entity

which assists in arranging an international transaction in a listed

chemical by--

(i) Negotiating contracts;

(ii) Serving as an agent or intermediary; or

(iii) Fulfilling a formal obligation to complete the transaction by

bringing together a buyer and seller, a buyer and transporter, or a

seller and transporter, or by receiving any form of compensation for so

doing.

(5) The term chemical export means transferring ownership or

control, or the sending or taking of threshold quantities of listed

chemicals out of the United States (whether or not such sending or

taking out constitutes an exportation within the meaning of the Customs

and related laws of the United States).

(6) The term chemical exporter is a regulated person who, as the

principal party in interest in the export transaction, has the power

and responsibility for determining and controlling the sending of the

listed chemical out of the United States.

(7) The term chemical import means with respect to a listed

chemical, any bringing in or introduction of such listed chemical into

either the jurisdiction of the United States or into the Customs

territory of the United States (whether or not such bringing in or

introduction constitutes an importation within the meaning of the

tariff laws of the United States).

(8) The term chemical importer is a regulated person who, as the

principal party in interest in the import transaction, has the power

and responsibility for determining and controlling the bringing in or

introduction of the listed chemical into the United States.

(9) The term chemical mixture means a combination of two or more

chemical substances, at least one of which is not a listed chemical,

except that such term does not include any combination of a listed

chemical with another chemical that is present solely as an impurity or

which has been created to evade the requirements of the Act.

(10) The term customs territory of the United States means the

several States, the District of Columbia, and Puerto Rico.

(11) The term encapsulating machine means any manual, semi-

automatic, or fully automatic equipment which may be used to fill

shells or capsules with any powdered, granular, semi-solid, or liquid

material.

(12) The term established business relationship with a foreign

customer means the regulated person has exported a listed chemical at

least once within the past six months, or twice within the past twelve

months to a foreign manufacturer, distributor, or end user of the

chemical that has an established business in the foreign country with a

fixed street address. A person or business which functions as a broker

or intermediary is not a customer within the meaning of this section.

The term also means that the regulated person has provided the

Administration with the following information in accordance with the

Waiver of 15-day advance notice requirements of Sec. 1313.24 of this

chapter:

(i) The name and street address of the chemical exporter and of

each regular customer;

(ii) The telephone number, telex number, contact person, and where

available, the facsimile number for the chemical exporter and for each

regular customer;

(iii) The nature of the regular customer's business (i.e.,

importer, exporter, distributor, manufacturer, etc.), and if known, the

use to which the listed chemical or chemicals will be applied;

(iv) The duration of the business relationship;

(v) The frequency and number of transactions occurring during the

preceding 12-month period;

(vi) the amounts and the listed chemical or chemicals involved in

regulated transactions between the chemical exporter and regular

customer;

(vii) The method of delivery (direct shipment or through a broker

or forwarding agent); and

(viii) Other information that the chemical exporter considers

relevant for determining whether a customer is a regular customer.

(13) The term established record as an importer means that the

regulated person has imported a listed chemical at least once within

the past six months, or twice within the past twelve months from a

foreign supplier. The term also means that the regulated person has

provided the Administration with the following information in

accordance with the waiver of the 15-day advance notice requirements of

Sec. 1313.15 of this chapter:

(i) The name, DEA registration number (where applicable), street

address, telephone number, telex number, and, where available, the

facsimile number of the regulated person and of each foreign supplier;

and

(ii) The frequency and number of transactions occurring during the

preceding 12 month period.

(14) The term hearing means any hearing held for the granting,

denial, revocation, or suspension of a registration pursuant to

sections 303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).

(15) The term international transaction means a transaction

involving the shipment of a listed chemical across an international

border (other than a United States border) in which a broker or trader

located in the United States participates.

[[Page 8510]]

(16) The term jurisdiction of the United States means the customs

territory of the United States, the Virgin Islands, the Canal Zone,

Guam, American Samoa, and the Trust Territories of the Pacific Islands.

(17) The term listed chemical means any List I chemical or List II

chemical.

(18) The term List I chemical means a chemical specifically

designated by the Administrator in Sec. 1310.02(a) of this chapter

that, in addition to legitimate uses, is used in manufacturing a

controlled substance in violation of the Act and is important to the

manufacture of a controlled substance.

(19) The term List II chemical means a chemical, other than a List

I chemical, specifically designated by the Administrator in

Sec. 1310.02(b) of this chapter that, in addition to legitimate uses,

is used in manufacturing a controlled substance in violation of the

Act.

(20) The term name means the official name, common or usual name,

chemical name, or brand name of a substance.

(21) The term person includes any individual, corporation,

government or governmental subdivision or agency, business trust,

partnership, association, or other legal entity.

(22) The term readily retrievable means that certain records are

kept by automatic data processing systems or other electronic or

mechanized recordkeeping systems in such a manner that they can be

separated out from all other records in a reasonable time and/or

records are kept on which certain items are asterisked, redlined, or in

some other manner visually identifiable apart from other items

appearing on the records.

(23) The terms register and registration refer only to registration

required and permitted by sections 303 or 1007 of the Act (21 U.S.C.

823 or 957).

(24) The term registrant means any person who is registered

pursuant to either section 303 or section 1008 of the Act (21 U.S.C.

823 or 958).

(25) The term regular customer means a person with whom the

regulated person has an established business relationship for a

specified listed chemical or chemicals that has been reported to the

Administration subject to the criteria established in

Sec. 1300.01(b)(12).

(26) The term regular importer means, with respect to a listed

chemical, a person that has an established record as an importer of

that listed chemical that is reported to the Administrator.

(27) The term regulated person means any individual, corporation,

partnership, association, or other legal entity who manufactures,

distributes, imports, or exports a listed chemical, a tableting

machine, or an encapsulating machine, or who acts as a broker or trader

for an international transaction involving a listed chemical, tableting

machine, or encapsulating machine.

(28) The term regulated transaction means:

(i) A distribution, receipt, sale, importation, or exportation of a

listed chemical, or an international transaction involving shipment of

a listed chemical, or if the Administrator establishes a threshold

amount for a specific listed chemical, a threshold amount as determined

by the Administrator, which includes a cumulative threshold amount for

multiple transactions, of a listed chemical, except that such term does

not include:

(A) A domestic lawful distribution in the usual course of business

between agents or employees of a single regulated person; in this

context, agents or employees means individuals under the direct

management and control of the regulated person;

(B) A delivery of a listed chemical to or by a common or contract

carrier for carriage in the lawful and usual course of the business of

the common or contract carrier, or to or by a warehouseman for storage

in the lawful and usual course of the business of the warehouseman,

except that if the carriage or storage is in connection with the

distribution, importation, or exportation of a listed chemical to a

third person, this paragraph does not relieve a distributor, importer,

or exporter from compliance with this part or parts 1309 and 1313 of

this chapter;

(C) Any category of transaction or any category of transaction for

a specific listed chemical or chemicals specified by regulation of the

Administrator as excluded from this definition as unnecessary for

enforcement of the Act;

(D) Any transaction in a listed chemical that is contained in a

drug that may be marketed or distributed lawfully in the United States

under the Federal Food, Drug, and Cosmetic Act unless--

(1) The drug contains ephedrine or its salts, optical isomers, or

salts of optical isomers as the only active medicinal ingredient or

contains ephedrine or its salts, optical isomers or salts of optical

isomers and therapeutically insignificant quantities of another active

medicinal ingredient. For purposes of this paragraph, the term

``therapeutically insignificant quantities'' shall apply if the product

formulation (i.e., the qualitative and quantitative composition of

active ingredients within the product) is not listed in any of the

following compendiums: American Pharmaceutical Association (Apha)

Handbook of Nonprescription Drugs; Drug Facts and Comparisons

(published by Wolters Kluwer Company); or USP DI (published by

authority of the United States Pharmacopeial Convention, Inc.); or the

product is not listed in Sec. 1310.15 of this chapter as an exempt drug

product. For drug products having formulations not found in the above

compendiums, the Administrator shall determine, pursuant to a written

request as specified in Sec. 1310.14 of this chapter, whether the

active medicinal ingredients are present in quantities considered

therapeutically significant for purposes of this paragraph; or

(2) The Administrator has determined pursuant to the criteria in

Sec. 1310.10 of this chapter that:

(i) The drug or group of drugs is being diverted to obtain the

listed chemical for use in the illicit production of a controlled

substance; and

(ii) The quantity of ephedrine or other listed chemical contained

in the drug included in the transaction or multiple transactions equals

or exceeds the threshold established for that chemical by the

Administrator;

(E) Any transaction in a chemical mixture listed in Sec. 1310.13 of

this chapter.

(ii) A distribution, importation, or exportation of a tableting

machine or encapsulating machine except that such term does not include

a domestic lawful distribution in the usual course of business between

agents and employees of a single regulated person; in this context,

agents or employees means individuals under the direct management and

control of the regulated person.

(29) The term retail distributor means a distributor whose List I

chemical activities are restricted to the sale of drug products that

are regulated as List I chemicals pursuant to

Sec. 1300.01(b)(28)(i)(D), directly to walk-in customers for personal

use.

(30) The term tableting machine means any manual, semi-automatic,

or fully automatic equipment which may be used for the compaction or

molding of powdered or granular solids, or semi-solid material, to

produce coherent solid tablets.

PART 1301--[AMENDED]

1. The authority citation for part 1301 continues to read as

follows:

Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 952,

956, 957, 958, unless otherwise noted.

2. Section 1301.01 is proposed to be revised to read as follows:

[[Page 8511]]

Sec. 1301.01 Scope of part 1301.

Procedures governing the registration of manufacturers,

distributors, dispensers, importers, and exporters of controlled

substances pursuant to sections 301-304 and 1007-1008 of the Act (21

U.S.C. 821-824 and 957-958) are set forth generally by those sections

and specifically by the sections of this part.

3. Section 1301.02 is proposed to be revised to read as follows:

Sec. 1301.02 Definitions.

Any term used in this part shall have the definition set forth in

section 102 of the Act (21 U.S.C. 802) or Part 1300 of this chapter.

4. As set forth in the Preamble, part 1301 is also proposed to be

amended by revising Secs. 1301.11 through 1301.52 and the undesignated

center headings and by removing Secs. 1301.53 through 1301.63 and the

undesignated center headings:

Registration

Sec. 1301.11 Persons required to register.

(a) Every person who manufactures, distributes, dispenses, imports,

or exports any controlled substance or who proposes to engage in the

manufacture, distribution, dispensing, importation or exportation of

any controlled substance shall obtain a registration unless exempted by

law or pursuant to Secs. 1301.22-1301.26. Only persons actually engaged

in such activities are required to obtain a registration; related or

affiliated persons who are not engaged in such activities are not

required to be registered. (For example, a stockholder or parent

corporation of a corporation manufacturing controlled substances is not

required to obtain a registration.)

Sec. 1301.12 Separate registrations for separate locations.

(a) A separate registration is required for each principal place of

business or professional practice at one general physical location

where controlled substances are manufactured, distributed, imported,

exported, or dispensed by a person.

(b) The following locations shall be deemed not to be places where

controlled substances are manufactured, distributed, or dispensed:

(1) A warehouse where controlled substances are stored by or on

behalf of a registered person, unless such substances are distributed

directly from such warehouse to registered locations other than the

registered location from which the substances were delivered or to

persons not required to register by virtue of subsection 302(c)(2) or

subsection 1007(b)(1)(B) of the Act (21 U.S.C. 822(c)(2) or

957(b)(1)(B));

(2) An office used by agents of a registrant where sales of

controlled substances are solicited, made, or supervised but which

neither contains such substances (other than substances for display

purposes or lawful distribution as samples only) nor serves as a

distribution point for filling sales orders; and

(3) An office used by a practitioner (who is registered at another

location) where controlled substances are prescribed but neither

administered nor otherwise dispensed as a regular part of the

professional practice of the practitioner at such office, and where no

supplies of controlled substances are maintained.

Sec. 1301.13 Application for registration; time for application;

expiration date; registration for independent activities; application

forms, fees, contents and signature; coincident activities.

(a) Any person who is required to be registered and who is not so

registered may apply for registration at any time. No person required

to be registered shall engage in any activity for which registration is

required until the application for registration is granted and a

Certificate of Registration is issued by the Administrator to such

person.

(b) Any person who is registered may apply to be reregistered not

more than 60 days before the expiration date of his/her registration,

except that a bulk manufacturer of Schedule I or II controlled

substances or an importer of Schedule I or II controlled substances may

apply to be reregistered no more than 120 days before the expiration

date of their registration.

(c) At the time a manufacturer, distributor, researcher, analytical

lab, importer, exporter or narcotic treatment program is first

registered, that business activity shall be assigned to one of twelve

groups, which shall correspond to the months of the year. The

expiration date of the registrations of all registrants within any

group will be the last date of the month designated for that group. In

assigning any of the above business activities to a group, the

Administration may select a group the expiration date of which is less

than one year from the date such business activity was registered. If

the business activity is assigned to a group which has an expiration

date less than three months from the date of which the business

activity is registered, the registration shall not expire until one

year from that expiration date; in all other cases, the registration

shall expire on the expiration date following the date on which the

business activity is registered.

(d) At the time a retail pharmacy, hospital/clinic, practitioner or

teaching institution is first registered, that business activity shall

be assigned to one of twelve groups, which shall correspond to the

months of the year. The expiration date of the registrations of all

registrants within any group will be the last day of the month

designated for that group. In assigning any of the above business

activities to a group, the Administration may select a group the

expiration date of which is not less than 28 months nor more than 39

months from the date such business activity was registered. After the

initial registration period, the registration shall expire 36 months

from the initial expiration date.

(e) Any person who is required to be registered and who is not so

registered, shall make application for registration for one of the

following groups of controlled substances activities, which are deemed

to be independent of each other. Application for each registration

shall be made on the indicated form, and shall be accompanied by the

indicated fee. Fee payments shall be made in the form of a personal,

certified, or cashier's check or money order made payable to the ``Drug

Enforcement Administration''. The application fees are not refundable.

Any person, when registered to engage in the activities described in

each subparagraph in this paragraph, shall be authorized to engage in

the coincident activities described without obtaining a registration to

engage in such coincident activities, provided that, unless

specifically exempted, he/she complies with all requirements and duties

prescribed by law for persons registered to engage in such coincident

activities. Any person who engages in more than one group of

independent activities shall obtain a separate registration for each

group of activities, except as provided in this paragraph under

coincident activities. A single registration to engage in any group of

independent activities listed below may include one or more controlled

substances listed in the schedules authorized in that group of

independent activities. A person registered to conduct research with

controlled substances listed in Schedule I may conduct research with

any substances listed in Schedule I for which he/she has filed and had

approved a research protocol.

(1)

[[Page 8512]]

--------------------------------------------------------------------------------------------------------------------------------------------------------

Application Coincident activities

Business activity Controlled substances DEA application forms fee Registration period allowed

--------------------------------------------------------------------------------------------------------------------------------------------------------

(i) Manufacturing................... Schedules I through V.. New--225............... $875 1 year................ Schedules I through V: May

Renewal--225a.......... 875 distribute that substance

or class for which

registration was issued;

may not distribute any

substance or class for

which not registered.

Schedules II through V:

May conduct chemical

analysis and preclinical

research (including

quality control analysis)

with substances listed in

those schedules for which

authorization as a

manufacturer was issued.

(ii) Distributing................... Schedules I through V.. New--225............... 438 1 year.

Renewal--225a.......... 438

(iii) Dispensing or Instructing Schedules II through V. New--224............... 210 3 years............... May conduct research and

(Includes Practitioner Hospital/ Renewal--224a.......... 210 instructional activities

Clinic, Retail Pharmacy, Teaching with those substances for

Institution). which registration was

granted, except that a mid-

level practitioner may

conduct such research only

to the extent expressly

authorized under state

statute. A pharmacist may

manufacture an aqueous or

oleaginous solution or

solid dosage form

containing a narcotic

controlled substance in

Schedule II through V in a

proportion not exceeding

20 percent of the complete

solution, compound, or

mixture.

(iv) Research or Instructing........ Schedule I............. New--225............... 70 1 year................ A researcher may

Renewal--225a.......... 70 manufacture or import the

basic class of substance

or substances for which

registration was issued,

provided that such

manufacture or import is

set forth in the protocol

required in Section

1301.18 and to distribute

such class to persons

registered or authorized

to conduct research with

such class of substance or

registered or authorized

to conduct chemical

analysis with controlled

substances.

(v) Research........................ Schedules II through V. New--225............... 70 1 year................ May conduct chemical

Renewal--225a.......... 70 analysis with controlled

substances in those

schedules for which

registration was issued;

manufacture such

substances if and to the

extent that such

manufacture is set forth

in a statement filed with

the application for

registration or

reregistration; import

such substances for

research purposes;

distribute such substances

to persons registered or

authorized to conduct

chemical analysis,

instructional activities,

or research with such

substances, and to persons

exempted from registration

pursuant to Section

1301.24, and to conduct

instructional activities

with controlled

substances.

(vi) Narcotic Treatment Program Narcotic Drugs in New--363............... 70 1 year.

(including compounder). Schedules II through V. Renewal--363a.......... 70

(vii) Importing..................... Schedules I through V.. New--225............... 438 1 year................ May distribute that

Renewal--225a.......... 438 substance or class for

which registration was

issued; may not distribute

any substance or class for

which not registered.

(viii) Exporting.................... Schedules I through V.. New--225............... 438 1 year.

Renewal--225a.......... 438

(ix) Chemical Analysis.............. Schedules I through V.. New--225............... 70 1 year................ May manufacture and import

Renewal--225a.......... 70 controlled substances for

analytical or

instructional activities;

may distribute such

substances to persons

registered or authorized

to conduct chemical

analysis, instructional

activities, or research

with such substances and

to persons exempted from

registration pursuant to

Section 1301.24; may

export such substances to

persons in other countries

performing chemical

analysis or enforcing laws

relating to controlled

substances or drugs in

those countries, and to

conduct instructional

activities with controlled

substances.

--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 8513]]

(2) DEA Forms 224, 225, and 363 may be obtained at any area office

of the Administration or by writing to the Registration Unit, Drug

Enforcement Administration, Department of Justice, Post Office Box

28083, Central Station, Washington, DC 20005.

(3) DEA Forms 224a, 225a, and 363a will be mailed, as applicable,

to each registered person approximately 60 days before the expiration

date of his/her registration; if any registered person does not receive

such forms within 45 days before the expiration date of his/her

registration, he/she must promptly give notice of such fact and request

such forms by writing to the Registration Unit of the Administration at

the foregoing address.

(f) Each application for registration to handle any basic class of

controlled substance listed in Schedule I (except to conduct chemical

analysis with such classes), and each application for registration to

manufacture a basic class of controlled substance listed in Schedule II

shall include the Administration Controlled Substances Code Number, as

set forth in part 1308 of this chapter, for each basic class to be

covered by such registration.

(g) Each application for registration to import or export

controlled substances shall include the Administration Controlled

Substances Code Number, as set forth in part 1308 of this chapter, for

each controlled substance whose importation or exportation is to be

authorized by such registration. Registration as an importer or

exporter shall not entitle a registrant to import or export any

controlled substance not specified in such registration.

(h) Each application for registration to conduct research with any

basic class of controlled substance listed in Schedule II shall include

the Administration Controlled Substances Code Number, as set forth in

part 1308 of this chapter, for each such basic class to be manufactured

or imported as a coincident activity of that registration. A statement

listing the quantity of each such basic class or controlled substance

to be imported or manufactured during the registration period for which

application is being made shall be included with each such application.

For purposes of this paragraph only, manufacturing is defined as the

production of a controlled substance by synthesis, extraction or by

agricultural/horticultural means.

(i) Each application shall include all information called for in

the form, unless the item is not applicable, in which case this fact

shall be indicated.

(j) Each application, attachment, or other document filed as part

of an application, shall be signed by the applicant, if an individual;

by a partner of the applicant, if a partnership; or by an officer of

the applicant, if a corporation, corporate division, association, trust

or other entity. An applicant may authorize one or more individuals,

who would not otherwise be authorized to do so, to sign applications

for the applicant by filing with the Registration Unit of the

Administration a power of attorney for each such individual. The power

of attorney shall be signed by a person who is authorized to sign

applications under this paragraph and shall contain the signature of

the individual being authorized to sign applications. The power of

attorney shall be valid until revoked by the applicant.

Sec. 1301.14 Filing of application; acceptance for filing; defective

applications.

(a) All applications for registration shall be submitted for filing

to the Registration Unit, Drug Enforcement Administration, Department

of Justice, Post Office Box 28083, Central Station, Washington, DC

20005. The appropriate registration fee and any required attachments

must accompany the application.

(b) Any person required to obtain more than one registration may

submit all applications in one package. Each application must be

complete and should not refer to any accompanying application for

required information.

(c) Applications submitted for filing are dated upon receipt. If

found to be complete, the application will be accepted for filing.

Applications failing to comply with the requirements of this part will

not generally be accepted for filing. In the case of minor defects as

to completeness, the Administrator may accept the application for

filing with a request to the applicant for additional information. A

defective application will be returned to the applicant within 10 days

following its receipt with a statement of the reason for not accepting

the application for filing. A defective application may be corrected

and resubmitted for filing at any time; the Administrator shall accept

for filing any application upon resubmission by the applicant, whether

complete or not.

(d) Accepting an application for filing does not preclude any

subsequent request for additional information pursuant to Sec. 1301.15

and has no bearing on whether the application will be granted.

Sec. 1301.15 Additional Information.

The Administrator may require an applicant to submit such documents

or written statements of fact relevant to the application as he/she

deems necessary to determine whether the application should be granted.

The failure of the applicant to provide such documents or statements

within a reasonable time after being requested to do so shall be deemed

to be a waiver by the applicant of an opportunity to present such

documents or facts for consideration by the Administrator in granting

or denying the application.

Sec. 1301.16 Amendments to and withdrawal of applications.

(a) An application may be amended or withdrawn without permission

of the Administrator at any time before the date on which the applicant

receives an order to show cause pursuant to Sec. 1301.37. An

application may be amended or withdrawn with permission of the

Administrator at any time where good cause is shown by the applicant or

where the amendment or withdrawal is in the public interest.

(b) After an application has been accepted for filing, the request

by the applicant that it be returned or the failure of the applicant to

respond to official correspondence regarding the application, when sent

by registered or certified mail, return receipt requested, shall be

deemed to be a withdrawal of the application.

Sec. 1301.17 Special procedures for certain applications.

(a) If, at the time of application for registration of a new

pharmacy, the pharmacy has been issued a license from the appropriate

State licensing agency, the applicant may include with his/her

application an affidavit as to the existence of the State license in

the following form:

Affidavit for New Pharmacy

I, __________, the ________________________ (Title of officer,

official, partner, or other position) of ________________________

(Corporation, partnership, or sole proprietor), doing business as

________________ (Store name) at ________________ (Number and

Street), ________________ (City) ________________ (State)

________________ (Zip code), hereby certify that said store was

issued a pharmacy permit No. ________ by the

________________________ (Board of Pharmacy or Licensing Agency) of

the State of ____________________ on ____________ (Date).

This statement is submitted in order to obtain a Drug

Enforcement Administration registration number. I understand that if

any information is false, the Administration may immediately suspend

the registration for this store and commence proceedings to revoke

under 21 U.S.C. 824(a) because of the danger to public health and

safety. I further understand that any false information

[[Page 8514]]

contained in this affidavit may subject me personally and the above-

named corporation/partnership/business to prosecution under 21

U.S.C. 843, the penalties for conviction of which include

imprisonment for up to 4 years, a fine of not more than $30,000 or

both.

-----------------------------------------------------------------------

Signature (Person who signs Application for Registration) State of

____________

County of____________________------------------------------------------

Subscribed to and sworn before me this __________ day of

______________, 19____.

-----------------------------------------------------------------------

Notary Public

(b) Whenever the ownership of a pharmacy is being transferred from

one person to another, if the transferee owns at least one other

pharmacy licensed in the same State as the one the ownership of which

is being transferred, the transferee may apply for registration prior

to the date of transfer. The Administrator may register the applicant

and authorize him to obtain controlled substances at the time of

transfer. Such registration shall not authorize the transferee to

dispense controlled substances until the pharmacy has been issued a

valid State license. The transferee shall include with his/her

application the following affidavit:

Affidavit for Transfer of Pharmacy

I, ________________, the ________________________ (Title of

officer, official, partner or other position) of

________________________ (Corporation, partnership, or sole

proprietor), doing business as ________________ (Store name) hereby

certify:

(1) That said company was issued a pharmacy permit No. ________

by the ________________________ (Board of Pharmacy of Licensing

Agency) of the State of ________________ and a DEA Registration

Number __________ for a pharmacy located at ____________________

(Number and Street) ________________ (City) ____________________

(State) ________________ (Zip Code); and

(2) That said company is acquiring the pharmacy business of

________________ (Name of Seller) doing business as ________________

with DEA Registration Number __________ on or about ________________

(Date of Transfer) and that said company has applied (or will apply

on ________________ (Date) for a pharmacy permit from the board of

pharmacy (or licensing agency) of the State of ________________ to

do business as __________ (Store name) at ________________ (Number

and Street) ________________ (City) ________________ (State)

________________ (Zip Code).

This statement is submitted in order to obtain a Drug

Enforcement Administration registration number.

I understand that if a DEA registration number is issued, the

pharmacy may acquire controlled substances but may not dispense them

until a pharmacy permit or license is issued by the State board of

pharmacy or licensing agency.

I understand that if any information is false, the

Administration may immediately suspend the registration for this

store and commence proceedings to revoke under 21 U.S.C. 824(a)

because of the danger to public health and safety. I further

understand that any false information contained in this affidavit

may subject me personally to prosecution under 21 U.S.C. 843, the

penalties for conviction of which include imprisonment for up to 4

years, a fine of not more than $30,000 or both.

-----------------------------------------------------------------------

Signature (Person who signs Application for Registration)

State of---------------------------------------------------------------

County of--------------------------------------------------------------

Subscribed to and sworn before me this ____________ day of

________________, 19____.

-----------------------------------------------------------------------

Notary Public

(c) The Administrator shall follow the normal procedures for

approving an application to verify the statements in the affidavit. If

the statements prove to be false, the Administrator may revoke the

registration on the basis of section 304(a)(1) of the Act (21 U.S.C.

824(a)(1)) and suspend the registration immediately by pending

revocation on the basis of section 304(d) of the Act (21 U.S.C.

824(d)). At the same time, the Administrator may seize and place under

seal all controlled substances possessed by the applicant under section

304(f) of the Act (21 U.S.C. 824(f)). Intentional misuse of the

affidavit procedure may subject the applicant to prosecution for fraud

under section 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), and obtaining

controlled substances under a registration fraudulently gotten may

subject the applicant to prosecution under section 403(a)(3) of the Act

(21 U.S.C. 843(a)(3)). The penalties for conviction of either offense

include imprisonment for up to 4 years, a fine not exceeding $30,000 or

both.

Sec. 1301.18 Research protocols.

(a) A protocol to conduct research with controlled substances

listed in Schedule I shall be in the following form and contain the

following information where applicable:

(1) Investigator:

(i) Name, address, and DEA registration number; if any.

(ii) Institutional affiliation.

(iii) Qualifications, including a curriculum vitae and an

appropriate bibliography (list of publications).

(2) Research project:

(i) Title of project.

(ii) Statement of the purpose.

(iii) Name of the controlled substances or substances involved and

the amount of each needed.

(iv) Description of the research to be conducted, including the

number and species of research subjects, the dosage to be administered,

the route and method of administration, and the duration of the

project.

(v) Location where the research will be conducted.

(vi) Statement of the security provisions for storing the

controlled substances (in accordance with Sec. 1301.75) and for

dispensing the controlled substances in order to prevent diversion.

(vii) If the investigator desires to manufacture or import any

controlled substance listed in paragraph (a)(2)(iii) of this section, a

statement of the quantity to be manufactured or imported and the

sources of the chemicals to be used or the substance to be imported.

(3) Authority:

(i) Institutional approval.

(ii) Approval of a Human Research Committee for human studies.

(iii) Indication of an approved active Notice of Claimed

Investigational Exemption for a New Drug (number).

(iv) Indication of an approved funded grant (number), if any.

(b) In the case of a clinical investigation with controlled

substances listed in Schedule I, the applicant shall submit three

copies of a Notice of Claimed Investigational Exemption for a New Drug

(IND) together with a statement of the security provisions (as

prescribed in paragraph (a)(2)(v) of this section for a research

protocol) to, and have such submission approved by, the Food and Drug

Administration as required in 21 U.S.C. 355(i) and Sec. 130.3 of this

title. Submission of this Notice and statement to the Food and Drug

Administration shall be in lieu of a research protocol to the

Administration as required in paragraph (a) of this section. The

applicant, when applying for registration with the Administration,

shall indicate that such notice has been submitted to the Food and Drug

Administration by submitting to the Administration with his/her DEA

Form 225 three copies of the following certificate:

I hereby certify that on ________ (Date), pursuant to 21 U.S.C.

355(i) and 21 CFR 130.3, I, __________ __________ __________ (Name

and Address of IND Sponsor) submitted a Notice of Claimed

Investigational Exemption for a New Drug (IND) to the Food and Drug

Administration for:

[[Page 8515]]

----------------------------------------------------------------------

(Name of Investigational Drug).

____________ (Date)

----------------------------------------------------------------------

(Signature of Applicant).

(c) In the event that the registrant desires to increase the

quantity of a controlled substance used for an approved research

project, he/she shall submit a request to the Registration Unit, Drug

Enforcement Administration, Post Office Box 28083, Central Station,

Washington, DC 20005, by registered mail, return receipt requested. The

request shall contain the following information: DEA registration

number; name of the controlled substance or substances and the quantity

of each authorized in the approved protocol; and the additional

quantity of each desired. Upon return of the receipt, the registrant

shall be authorized to purchase the additional quantity of the

controlled substance or substances specified in the request. The

Administration shall review the letter and forward it to the Food and

Drug Administration together with the Administration comments. The Food

and Drug Administration shall approve or deny the request as an

amendment to the protocol and so notify the registrant. Approval of the

letter by the Food and Drug Administration shall authorize the

registrant to use the additional quantity of the controlled substance

in the research project.

(d) In the event the registrant desires to conduct research beyond

the variations provided in the registrant's approved protocol

(excluding any increase in the quantity of the controlled substance

requested for his/her research project as outlined in paragraph (c) of

this section), he/she shall submit three copies of a supplemental

protocol in accordance with paragraph (a) of this section describing

the new research and omitting information in the supplemental protocol

which has been stated in the original protocol. Supplemental protocols

shall be processed and approved or denied in the same manner as

original research protocols.

Exceptions To Registration and Fees

Sec. 1301.21 Exemption from fees.

(a) The Administrator shall exempt from payment of an application

fee for registration or reregistration:

(1) Any hospital or other institution which is operated by an

agency of the United States (including the U.S. Army, Navy, Marine

Corps., Air Force, and Coast Guard), of any State, or any political

subdivision or agency thereof.

(2) Any individual practitioner who is required to obtain an

individual registration in order to carry out his or her duties as an

official of an agency of the United States (including the U.S. Army,

Navy, Marine Corps., Air Force, and Coast Guard), of any State, or any

political subdivision or agency thereof.

(b) In order to claim exemption from payment of a registration or

reregistration application fee, the registrant shall have completed the

certification on the appropriate application form, wherein the

registrant's superior (if the registrant is an individual) or officer

(if the registrant is an agency) certifies to the status and address of

the registrant and to the authority of the registrant to acquire,

possess, or handle controlled substances.

(c) Exemption from payment of a registration or reregistration

application fee does not relieve the registrant of any other

requirements or duties prescribed by law.

Sec. 1301.22 Exemption of agents and employees; affiliated

practitioners.

(a) The requirement of registration is waived for any agent or

employee of a person who is registered to engage in any group of

independent activities, if such agent or employee is acting in the

usual course of his/her business or employment.

(b) An individual practitioner who is an agent or employee of

another practitioner (other than a mid-level practitioner) registered

to dispense controlled substances may, when acting in the normal course

of business or employment, administer or dispense (other than by

issuance of prescription) controlled substances if and to the extent

that such individual practitioner is authorized or permitted to do so

by the jurisdiction in which he or she practices, under the

registration of the employer or principal practitioner in lieu of being

registered him/herself.

(c) An individual practitioner who is an agent or employee of a

hospital or other institution may, when acting in the normal course of

business or employment, administer, dispense, or prescribe controlled

substances under the registration of the hospital or other institution

which is registered in lieu of being registered him/herself, provided

that:

(1) Such dispensing, administering or prescribing is done in the

usual course of his/her professional practice;

(2) Such individual practitioner is authorized or permitted to do

so by the jurisdiction in which he/she is practicing;

(3) The hospital or other institution by whom he/she is employed

has verified that the individual practitioner is so permitted to

dispense, administer, or prescribe drugs within the jurisdiction;

(4) Such individual practitioner is acting only within the scope of

his/her employment in the hospital or institution;

(5) The hospital or other institution authorizes the individual

practitioner to administer, dispense or prescribe under the hospital

registration and designates a specific internal code number for each

individual practitioner so authorized. The code number shall consist of

numbers, letters, or a combination thereof and shall be a suffix to the

institution's DEA registration number, preceded by a hyphen (e.g., APO

123456-10 or APO123456-A12); and

(6) A current list of internal codes and the corresponding

individual practitioners is kept by the hospital or other institution

and is made available at all times to other registrants and law

enforcement agencies upon request for the purpose of verifying the

authority of the prescribing individual practitioner.

Sec. 1301.23 Exemption of certain military and other personnel.

(a) The requirement of registration is waived for any official of

the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public

Health Service, or Bureau of Prisons who is authorized to prescribe,

dispense, or administer, but not to procure or purchase, controlled

substances in the course of his/her official duties. Such officials

shall follow procedures set forth in part 1306 of this chapter

regarding prescriptions, but shall state the branch of service or

agency (e.g., ``U.S. Army'' or ``Public Health Service'') and the

service identification number of the issuing official in lieu of the

registration number required on prescription forms. The service

identification number for a Public Health Service employee is his/her

Social Security identification number.

(b) The requirement of registration is waived for any official or

agency of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, or

Public Health Service who or which is authorized to import or export

controlled substances in the course of his/her official duties.

(c) If any official exempted by this section also engages as a

private individual in any activity or group of activities for which

registration is required, such official shall obtain a registration for

such private activities.

[[Page 8516]]

Sec. 1301.24 Exemption of law enforcement officials.

(a) The requirement of registration is waived for the following

persons in the circumstances described in this section:

(1) Any officer or employee of the Administration, any officer of

the U.S. Customs Service, any officer or employee of the United States

Food and Drug Administration, and any other Federal officer who is

lawfully engaged in the enforcement of any Federal law relating to

controlled substances, drugs or customs, and is duly authorized to

possess or to import or export controlled substances in the course of

his/her official duties; and

(2) Any officer or employee of any State, or any political

subdivision or agency thereof, who is engaged in the enforcement of any

State or local law relating to controlled substances and is duly

authorized to possess controlled substances in the course of his/her

official duties.

(b) Any official exempted by this section may, when acting in the

course of his/her official duties, procure any controlled substance in

the course of an inspection, in accordance with Sec. 1316.03(d) of this

chapter, or in the course of any criminal investigation involving the

person from whom the substance was procured, and may possess any

controlled substance and distribute any such substance to any other

official who is also exempted by this section and acting in the course

of his/her official duties.

(c) In order to enable law enforcement agency laboratories,

including laboratories of the Administration, to obtain and transfer

controlled substances for use as standards in chemical analysis, such

laboratories shall obtain annually a registration to conduct chemical

analysis. Such laboratories shall be exempted from payment of a fee for

registration. Laboratory personnel, when acting in the scope of their

official duties, are deemed to be officials exempted by this section

and within the activity described in section 515(d) of the Act (21

U.S.C. 885(d)). For purposes of this paragraph, laboratory activities

shall not include field or other preliminary chemical tests by

officials exempted by this section.

(d) In addition to the activities authorized under a registration

to conduct chemical analysis pursuant to Sec. 1301.13(e)(1)(ix),

laboratories of the Administration shall be authorized to manufacture

or import controlled substances for any lawful purpose, to distribute

or export such substances to any person, and to import and export such

substances in emergencies without regard to the requirements of part

1312 of this chapter if a report concerning the importation or

exportation is made to the Drug Operations Section of the

Administration within 30 days of such importation or exportation.

Sec. 1301.25 Registration regarding ocean vessels, aircraft, and other

entities.

(a) If acquired by and dispensed under the general supervision of a

medical officer described in paragraph (b) of this section, or the

master or first officer of the vessel under the circumstances described

in paragraph (d) of this section, controlled substances may be held for

stocking, be maintained in, and dispensed from medicine chests, first

aid packets, or dispensaries:

(1) On board any vessel engaged in international trade or in trade

between ports of the United States and any merchant vessel belonging to

the U.S. Government;

(2) On board any aircraft operated by an air carrier under a

certificate of permit issued pursuant to the Federal Aviation Act of

1958 (49 U.S.C. 1301); and

(3) In any other entity of fixed or transient location approved by

the Administrator as appropriate for application of this section (e.g.,

emergency kits at field sites of an industrial firm).

(b) A medical officer shall be:

(1) Licensed in a state as a physician;

(2) Employed by the owner or operator of the vessel, aircraft or

other entity; and

(3) Registered under the Act at either of the following locations:

(i) The principal office of the owner or operator of the vessel,

aircraft or other entity or

(ii) At any other location provided that the name, address,

registration number and expiration date as they appear on his/her

Certificate of Registration (DEA Form 223) for this location are

maintained for inspection at said principal office in a readily

retrievable manner.

(c) A registered medical officer may serve as medical officer for

more than one vessel, aircraft, or other entity under a single

registration, unless he/she serves as medical officer for more than one

owner or operator, in which case he/she shall either maintain a

separate registration at the location of the principal office of each

such owner or operator or utilize one or more registrations pursuant to

paragraph (b)(3)(ii) of this section.

(d) If no medical officer is employed by the owner or operator of a

vessel, or in the event such medical officer is not accessible and the

acquisition of controlled substances is required, the master or first

officer of the vessel, who shall not be registered under the Act, may

purchase controlled substances from a registered manufacturer or

distributor, or from an authorized pharmacy as described in paragraph

(f) of this section, by following the procedure outlined below:

(1) The master or first officer of the vessel must personally

appear at the vendor's place of business, present proper identification

(e.g., Seaman's photographic identification card) and a written

requisition for the controlled substances.

(2) The written requisition must be on the vessel's official

stationery or purchase order form and must include the name and address

of the vendor, the name of the controlled substance, description of the

controlled substance (dosage form, strength and number or volume per

container) number of containers ordered, the name of the vessel, the

vessel's official number and country of registry, the owner or operator

of the vessel, the port at which the vessel is located, signature of

the vessel's officer who is ordering the controlled substances and the

date of the requisition.

(3) The vendor may, after verifying the identification of the

vessel's officer requisitioning the controlled substances, deliver the

control substances to that officer. The transaction shall be

documented, in triplicate, on a record of sale in a format similar to

that outlined in paragraph (d)(4) of this section. The vessel's

requisition shall be attached to copy 1 of the record of sale and filed

with the controlled substances records of the vendor, copy 2 of the

record of sale shall be furnished to the officer of the vessel and

retained aboard the vessel, copy 3 of the record of sale shall be

forwarded to the nearest DEA Division Office within 15 days after the

end of the month in which the sale is made.

(4) The vendor's record of sale should be similar to, and must

include all the information contained in, the below listed format.

Sale of Controlled Substances to Vessels

(Name of registrant)

----------------------------------------------------------------------

(Address of registrant)

----------------------------------------------------------------------

(DEA registration number)

----------------------------------------------------------------------

* * * TABLE START * * *

[[Page 8517]]

----------------------------------------------------------------------------------------------------------------

Number of

Line No. packages Size of Name of Packages Date

ordered packages product distributed distributed

----------------------------------------------------------------------------------------------------------------

1............................... .............. .............. .............. .............. ..............

2............................... .............. .............. .............. .............. ..............

3............................... .............. .............. .............. .............. ..............

----------------------------------------------------------------------------------------------------------------

FOOTNOTE: Line numbers may be continued according to needs of the vendor.

* * * TABLE END * * *

Number of lines completed

----------------------------------------------------------------------

Name of vessel

----------------------------------------------------------------------

Vessel's official number

----------------------------------------------------------------------

Vessel's country of registry

----------------------------------------------------------------------

Owner or operator of the vessel

----------------------------------------------------------------------

Name and title of vessel's officer who presented the requisition

----------------------------------------------------------------------

Signature of vessel's officer who presented the requisition

----------------------------------------------------------------------

(e) Any medical officer described in paragraph (b) of this section

shall, in addition to complying with all requirements and duties

prescribed for registrants generally, prepare an annual report as of

the date on which his/her registration expires, which shall give in

detail an accounting for each vessel, aircraft, or other entity, and a

summary accounting for all vessels, aircraft, or other entities under

his/her supervision for all controlled substances purchased, dispensed

or disposed of during the year. The medical officer shall maintain this

report with other records required to be kept under the Act and, upon

request, deliver a copy of the report to the Administration. The

medical officer need not be present when controlled substances are

dispensed, if the person who actually dispensed the controlled

substances is responsible to the medical officer to justify his/her

actions.

(f) Any registered pharmacy which wishes to distribute controlled

substances pursuant to this section shall be authorized to do so,

provided that:

(1) The registered pharmacy notifies the nearest Division Office of

the Administration of its intention to so distribute controlled

substances prior to the initiation of such activity. This notification

shall be by registered mail and shall contain the name, address, and

registration number of the pharmacy as well as the date upon which such

activity will commence; and

(2) Such activity is authorized by state law; and

(3) The total number of dosage units of all controlled substances

distributed by the pharmacy during any calendar year in which the

pharmacy is registered to dispense does not exceed the limitations

imposed upon such distribution by Sec. 1307.11(a) (4) and (b) of this

chapter.

(g) Owners or operators of vessels, aircraft, or other entities

described in this section shall not be deemed to possess or dispense

any controlled substance acquired, stored and dispensed in accordance

with this section. Additionally, owners or operators of vessels,

aircraft, or other entities described in this section or in Article 32

of the Single Convention on Narcotic Drugs, 1961, or in Article 14 of

the Convention on Psychotropic Substances, 1971, shall not be deemed to

import or export any controlled substances purchased and stored in

accordance with that section or applicable article.

(h) The Master of a vessel shall prepare a report for each calendar

year which shall give in detail an accounting for all controlled

substances purchased, dispensed, or disposed of during the year. The

Master shall file this report with the medical officer employed by the

owner or operator of his/her vessel, if any, or, if not, he/she shall

maintain this report with other records required to be kept under the

Act and, upon request, deliver a copy of the report to the

Administration.

(i) Controlled substances acquired and possessed in accordance with

this section shall not be distributed to persons not under the general

supervision of the medical officer employed by the owner or operator of

the vessel, aircraft, or other entity, except in accordance with

Sec. 1307.21 of this chapter.

Sec. 1301.26 Exemptions from import or export requirements for

personal medical use.

Any individual who has in his/her possession a controlled substance

listed in schedules II, III, IV, or V, which he/she has lawfully

obtained for his/her personal medical use, or for administration to an

animal accompanying him/her, may enter or depart the United States with

such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C.

952-955), providing the following conditions are met:

(a) The controlled substance is in the original container in which

it was dispensed to the individual; and

(b) The individual makes a declaration to an appropriate official

of the U.S. Customs Service stating:

(1) That the controlled substance is possessed for his/her personal

use, or for an animal accompanying him/her; and

(2) The trade or chemical name and the symbol designating the

schedule of the controlled substance if it appears on the container

label, or, if such name does not appear on the label, the name and

address of the pharmacy or practitioner who dispensed the substance and

the prescription number, if any.

Action on Applications for Registration: Revocation or Suspension of

Registration

Sec. 1301.31 Administrative review generally.

The Administrator may inspect, or cause to be inspected, the

establishment of an applicant or registrant, pursuant to subpart A of

part 1316 of this chapter. The Administrator shall review, the

application for registration and other information gathered by the

Administrator regarding an applicant in order to determine whether the

applicable standards of section 303 of the Act (21 U.S.C. 823) or

section 1008 (21 U.S.C. 958) have been met by the applicant.

Sec. 1301.32

Action on applications for research in Schedule I substances.

(a) In the case of an application for registration to conduct

research with controlled substances listed in Schedule I, the

Administrator shall process the application and protocol and forward a

copy of each to the Secretary within 7 days after receipt. The

Secretary shall determine the qualifications and competency of the

applicant, as well as the merits of the protocol (and shall notify the

Administrator of his/her determination) within 21 days after receipt of

the application and complete protocol, except that in the case of a

clinical investigation, the Secretary shall have 30 days to make such

determination and notify the Administrator. The Secretary, in

determining the merits of the protocol,

[[Page 8518]]

shall consult with the Administrator as to effective procedures to

safeguard adequately against diversion of such controlled substances

from legitimate medical or scientific use.

(b) An applicant whose protocol is defective shall be notified by

the Secretary within 21 days after receipt of such protocol from the

Administrator (or in the case of a clinical investigation within 30

days), and he/she shall be requested to correct the existing defects

before consideration shall be given to his/her submission.

(c) If the Secretary determines the applicant qualified and

competent and the research protocol meritorious, he/she shall notify

the Administrator in writing of such determination. The Administrator

shall issue a certificate of registration within 10 days after receipt

of this notice, unless he/she determines that the certificate of

registration should be denied on a ground specified in section 304(a)

of the Act (21 U.S.C. 824(a)). In the case of a supplemental protocol,

a replacement certificate of registration shall be issued by the

Administrator.

(d) If the Secretary determines that the protocol is not

meritorious and/or the applicant is not qualified or competent, he/she

shall notify the Administrator in writing setting forth the reasons for

such determination. If the Administrator determines that grounds exist

for the denial of the application, he/she shall within 10 days issue an

order to show cause pursuant to Sec. 1301.37 and, if requested by the

applicant, hold a hearing on the application pursuant to Sec. 1301.41.

If the grounds for denial of the application include a determination by

the Secretary, the Secretary or his duly authorized agent shall furnish

testimony and documents pertaining to his determination at such

hearing.

(e) Supplemental protocols will be processed in the same manner as

original research protocols. If the processing of an application or

research protocol is delayed beyond the time limits imposed by this

section, the applicant shall be so notified in writing.

Sec. 1301.33 Application for bulk manufacture of Schedule I and II

substances.

(a) In the case of an application for registration or

reregistration to manufacture in bulk a basic class of controlled

substance listed in Schedule I or II, the Administrator shall, upon the

filing of such application, publish in the Federal Register a notice

naming the applicant and stating that such applicant has applied to be

registered as a bulk manufacturer of a basic class of narcotic or

nonnarcotic controlled substance, which class shall be identified. A

copy of said notice shall be mailed simultaneously to each person

registered as a bulk manufacturer of that basic class and to any other

applicant therefor. Any such person may, within 60 days from the date

of publication of the notice in the Federal Register, file with the

Administrator written comments on or objections to the issuance of the

proposed registration.

(b) In order to provide adequate competition, the Administrator

shall not be required to limit the number of manufacturers in any basic

class to a number less than that consistent with maintenance of

effective controls against diversion solely because a smaller number is

capable of producing an adequate and uninterrupted supply.

(c) This section shall not apply to the manufacture of basic

classes of controlled substances listed in Schedules I or II as an

incident to research or chemical analysis as authorized in

Sec. 01.13(e)(1).

Sec. 1301.34 Application for importation of Schedule I and II

substances.

(a) In the case of an application for registration or

reregistration to import a controlled substance listed in Schedule I or

II, under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C.

952(a)(2)(B)), the Administrator shall, upon the filing of such

application, publish in the Federal Register a notice naming the

applicant and stating that such applicant has applied to be registered

as an importer of a Schedule I or II controlled substance, which

substance shall be identified. A copy of said notice shall be mailed

simultaneously to each person registered as a bulk manufacturer of that

controlled substance and to any other applicant therefor. Any such

person may, within 30 days from the date of publication of the notice

in the Federal Register, file written comments on or objections to the

issuance of the proposed registration, and may, at the same time, file

a written request for a hearing on the application pursuant to

Sec. 1301.43. If a hearing is requested, the Administrator shall hold a

hearing on the application in accordance with Sec. 1301.41. Notice of

the hearing shall be published in the Federal Register, and shall be

mailed simultaneously to the applicant and to all persons to whom

notice of the application was mailed. Any such person may participate

in the hearing by filing a notice of appearance in accordance with

Sec. 1301.43 of this chapter. Notice of the hearing shall contain a

summary of all comments and objections filed regarding the application

and shall state the time and place for the hearing, which shall not be

less than 30 days after the date of publication of such notice in the

Federal Register. A hearing pursuant to this section may be

consolidated with a hearing held pursuant to Secs. 1301.35 or 1301.36

of this part.

(b) The Administrator shall register an applicant to import a

controlled substance listed in Schedule I or II if he/she determines

that such registration is consistent with the public interest and with

U.S. obligations under international treaties, conventions, or

protocols in effect on May 1, 1971. In determining the public interest,

the following factors shall be considered:

(1) Maintenance of effective controls against diversion of

particular controlled substances and any controlled substance in

Schedule I or II compounded therefrom into other than legitimate

medical, scientific research, or industrial channels, by limiting the

importation and bulk manufacture of such controlled substances to a

number of establishments which can produce an adequate and

uninterrupted supply of these substances under adequately competitive

conditions for legitimate medical, scientific, research, and industrial

purposes;

(2) Compliance with applicable State and local law;

(3) Promotion of technical advances in the art of manufacturing

these substances and the development of new substances;

(4) Prior conviction record of applicant under Federal and State

laws relating to the manufacture, distribution, or dispensing of such

substances;

(5) Past experience in the manufacture of controlled substances,

and the existence in the establishment of effective control against

diversion;

(6) That the applicant will be permitted to import only:

(i) Such amounts of crude opium, poppy straw, concentrate of poppy

straw, and coca leaves as the Administrator finds to be necessary to

provide for medical, scientific, or other legitimate purposes; or

(ii) Such amounts of any controlled substances listed in Schedule I

or II as the Administrator shall find to be necessary to provide for

the medical, scientific, or other legitimate needs of the United States

during an emergency in which domestic supplies of such substances are

found by the Administrator to be inadequate; or

(iii) Such amounts of any controlled substance listed in Schedule I

or II as the Administrator shall find to be necessary to provide for

the medical, scientific, or other legitimate needs of the United States

in any case in which

[[Page 8519]]

the Administrator finds that competition among domestic manufacturers

of the controlled substance is inadequate and will not be rendered

adequate by the registration of additional manufacturers under section

303 of the Act (21 U.S.C. 823); or

(iv) Such limited quantities of any controlled substance listed in

Schedule I or II as the Administrator shall find to be necessary for

scientific, analytical or research uses; and

(7) Such other factors as may be relevant to and consistent with

the public health and safety.

(c) In determining whether the applicant can and will maintain

effective controls against diversion within the meaning of paragraph

(b) of this section, the Administrator shall consider among other

factors:

(1) Compliance with the security requirements set forth in

Secs. 1301.71-1301.76 and

(2) Employment of security procedures to guard against in-transit

losses within and without the jurisdiction of the United States.

(d) In determining whether competition among the domestic

manufacturers of a controlled substance is adequate within the meaning

of paragraphs (b)(1) and (b)(6)(iii) of this section, as well as

section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the

Administrator shall consider:

(1) The extent of price rigidity in the light of changes in:

(i) Raw materials and other costs and

(ii) Conditions of supply and demand;

(2) The extent of service and quality competition among the

domestic manufacturers for shares of the domestic market including:

(i) Shifts in market shares and

(ii) Shifts in individual customers among domestic manufacturers;

(3) The existence of substantial differentials between domestic

prices and the higher of prices generally prevailing in foreign markets

or the prices at which the applicant for registration to import is

committed to undertake to provide such products in the domestic market

in conformity with the Act. In determining the existence of substantial

differentials hereunder, appropriate consideration should be given to

any additional costs imposed on domestic manufacturers by the

requirements of the Act and such other cost-related and other factors

as the Administrator may deem relevant. In no event shall an importer's

offering prices in the United States be considered if they are lower

than those prevailing in the foreign market or markets from which the

importer is obtaining his/her supply;

(4) The existence of competitive restraints imposed upon domestic

manufacturers by governmental regulations; and

(5) Such other factors as may be relevant to the determinations

required under this paragraph.

(e) In considering the scope of the domestic market, consideration

shall be given to substitute products which are reasonably

interchangeable in terms of price, quality and use.

(f) The fact that the number of existing manufacturers is small

shall not demonstrate, in and of itself, that adequate competition

among them does not exist.

Sec. 1301.35 Certificate of registration; denial of registration.

(a) The Administrator shall issue a Certificate of Registration

(DEA Form 223) to an applicant if the issuance of registration or

reregistration is required under the applicable provisions of sections

303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that the

issuance of registration or reregistration is not required, the

Administrator shall deny the application. Before denying any

application, the Administrator shall issue an order to show cause

pursuant to Sec. 1301.37 and, if requested by the applicant, shall hold

a hearing on the application pursuant to Sec. 1301.41.

(b) If a hearing is requested by an applicant for registration or

reregistration to manufacture in bulk a basic class of controlled

substance listed in Schedule I or II, notice that a hearing has been

requested shall be published in the Federal Register and shall be

mailed simultaneously to the applicant and to all persons to whom

notice of the application was mailed. Any person entitled to file

comments or objections to the issuance of the proposed registration

pursuant to Sec. 1301.33(a) may participate in the hearing by filing

notice of appearance in accordance with Sec. 1301.43. Such persons

shall have 30 days to file a notice of appearance after the date of

publication of the notice of a request for a hearing in the Federal

Register.

(c) The Certificate of Registration (DEA Form 223) shall contain

the name, address, and registration number of the registrant, the

activity authorized by the registration, the schedules and/or

Administration Controlled Substances Code Number (as set forth in part

1308 of this chapter) of the controlled substances which the registrant

is authorized to handle, the amount of fee paid (or exemption), and the

expiration date of the registration. The registrant shall maintain the

certificate of registration at the registered location in a readily

retrievable manner and shall permit inspection of the certificate by

any official, agent or employee of the Administration or of any

Federal, State, or local agency engaged in enforcement of laws relating

to controlled substances.

Sec. 1301.36 Suspension or revocation of registration; suspension of

registration pending final order; extension of registration pending

final order.

(a) For any registration issued under section 303 of the Act (21

U.S.C. 823), the Administrator may:

(1) Suspend the registration pursuant to section 304(a) of the Act

(21 U.S.C. 824(a)) for any period of time.

(2) Revoke the registration pursuant to section 304(a) of the Act

(21 U.S.C. 824(a)).

(b) For any registration issued under section 1008 of the Act (21

U.S.C. 958), the Administrator may:

(1) Suspend the registration pursuant to section 1008(d) of the Act

(21 U.S.C. 958(d)) for any period of time.

(2) Revoke the registration pursuant to section 1008(d) of the Act

(21 U.S.C. 958(d)) if he/she determines that such registration is

inconsistent with the public interest as defined in section 1008 or

with the United States obligations under international treaties,

conventions, or protocols in effect on October 12, 1984.

(c) The Administrator may limit the revocation or suspension of a

registration to the particular controlled substance, or substances,

with respect to which grounds for revocation or suspension exist.

(d) Before revoking or suspending any registration, the

Administrator shall issue an order to show cause pursuant to

Sec. 1301.37 and, if requested by the registrant, shall hold a hearing

pursuant to Sec. 13.01.41.

(e) The Administrator may suspend any registration simultaneously

with or at any time subsequent to the service upon the registrant of an

order to show cause why such registration should not be revoked or

suspended, in any case where he/she finds that there is an imminent

danger to the public health or safety. If the Administrator so

suspends, he/she shall serve with the order to show cause pursuant to

Sec. 1301.37 an order of immediate suspension which shall contain a

statement of his findings regarding the danger to public health or

safety.

(f) Upon service of the order of the Administrator suspending or

revoking registration, the registrant shall immediately deliver his/her

Certificate of Registration, any order forms, and

[[Page 8520]]

any import or export permits in his/her possession to the nearest

office of the Administration. The suspension or revocation of a

registration shall suspend or revoke any individual manufacturing or

procurement quota fixed for the registrant pursuant to part 1303 of

this chapter and any import or export permits issued to the registrant

pursuant to part 1312 of this chapter. Also, upon service of the order

of the Administrator revoking or suspending registration, the

registrant shall, as instructed by the Administrator:

(1) Deliver all controlled substances in his/her possession to the

nearest office of the Administration or to authorized agents of the

Administration; or

(2) Place all controlled substances in his/her possession under

seal as described in sections 304(f) or 1008(d)(6) of the Act (21

U.S.C. 824(f) or 958(d)(6)).

(g) In the event that revocation or suspension is limited to a

particular controlled substance or substances, the registrant shall be

given a new Certificate of Registration for all substances not affected

by such revocation or suspension; no fee shall be required to be paid

for the new Certificate of Registration. The registrant shall deliver

the old Certificate of Registration and, if appropriate, any order

forms in his/her possession to the nearest office of the

Administration. The suspension or revocation of a registration, when

limited to a particular basic class or classes of controlled

substances, shall suspend or revoke any individual manufacturing or

procurement quota fixed for the registrant for such class or classes

pursuant to part 1303 of this chapter and any import or export permits

issued to the registrant for such class or classes pursuant to part

1312 of this chapter. Also, upon service of the order of the

Administrator revoking or suspending registration, the registrant

shall, as instructed by the Administrator:

(1) Deliver to the nearest office of the Administration or to

authorized agents of the Administration all of the particular

controlled substance or substances affected by the revocation or

suspension which are in his/her possession; or

(2) Place all of such substances under seal as described in

sections 304(f) or 958(d)(6) of the Act (21 U.S.C. 824(f) or

958(d)(6)).

(h) Any suspension shall continue in effect until the conclusion of

all proceedings upon the revocation or suspension, including any

judicial review thereof, unless sooner withdrawn by the Administrator

or dissolved by a court of competent jurisdiction. Any registrant whose

registration is suspended under paragraph (e) of this section may

request a hearing on the revocation or suspension of his/her

registration at a time earlier than specified in the order to show

cause pursuant to Sec. 1301.37, which request shall be granted by the

Administrator, who shall fix a date for such hearing as early as

reasonably possible.

(i) In the event that an applicant for reregistration (who is doing

business under a registration previously granted and not revoked or

suspended) has applied for reregistration at least 45 days before the

date on which the existing registration is due to expire, and the

Administrator has issued no order on the application on the date on

which the existing registration is due to expire, the existing

registration of the applicant shall automatically be extended and

continue in effect until the date on which the Administrator so issues

his/her order. The Administrator may extend any other existing

registration under the circumstances contemplated in this section even

though the registrant failed to apply for reregistration at least 45

days before expiration of the existing registration, with or without

request by the registrant, if the Administrator finds that such

extension is not inconsistent with the public health and safety.

Sec. 1301.37 Order to show cause.

(a) If, upon examination of the application for registration from

any applicant and other information gathered by the Administration

regarding the applicant, the Administrator is unable to make the

determinations required by the applicable provisions of section 303

and/or section 1008 of the Act (21 U.S.C. 823 and 958) to register the

applicant, the Administrator shall serve upon the applicant an order to

show cause why the registration should not be denied.

(b) If, upon information gathered by the Administration regarding

any registrant, the Administrator determines that the registration of

such registrant is subject to suspension or revocation pursuant to

section 304 or section 1008 of the Act (21 U.S.C. 824 and 958), the

Administrator shall serve upon the registrant an order to show cause

why the registration should not be revoked or suspended.

(c) The order to show cause shall call upon the applicant or

registrant to appear before the Administrator at a time and place

stated in the order, which shall not be less than 30 days after the

date of receipt of the order. The order to show cause shall also

contain a statement of the legal basis for such hearing and for the

denial, revocation, or suspension of registration and a summary of the

matters of fact and law asserted.

(d) Upon receipt of an order to show cause, the applicant or

registrant must, if he/she desires a hearing, file a request for a

hearing pursuant to Sec. 1301.43. If a hearing is requested, the

Administrator shall hold a hearing at the time and place stated in the

order, pursuant to Sec. 1301.41.

(e) When authorized by the Administrator, any agent of the

Administration may serve the order to show cause.

Hearings

Sec. 1301.41 Hearings generally.

(a) In any case where the Administrator shall hold a hearing on any

registration or application therefor, the procedures for such hearing

shall be governed generally by the adjudication procedures set forth in

the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by

Secs. 303, 304, and 1008 of the Act (21 U.S.C. 823-824 and 958), by

Secs. 1301.42-1301.46 of this part, and by the procedures for

administrative hearings under the Act set forth in Secs. 1316.41-

1316.67 of this chapter.

(b) Any hearing under this part shall be independent of, and not in

lieu of, criminal prosecutions or other proceedings under the Act or

any other law of the United States.

Sec. 1301.42 Purpose of hearing.

If requested by a person entitled to a hearing, the Administrator

shall hold a hearing for the purpose of receiving factual evidence

regarding the issues involved in the denial, revocation, or suspension

of any registration, and the granting of any application for

registration to manufacture in bulk a basic class of controlled

substance listed in Schedule I or II. Extensive argument should not be

offered into evidence but rather presented in opening or closing

statements of counsel or in memoranda or proposed findings of fact and

conclusions of law.

Sec. 1301.43 Request for hearing or appearance; waiver.

(a) Any person entitled to a hearing pursuant to Secs. 1301.32 or

1301.34-1301.36 and desiring a hearing shall, within 30 days after the

date of receipt of the order to show cause (or the date of publication

of notice of the application for registration in the Federal Register

in the case of

[[Page 8521]]

Sec. 1301.34), file with the Administrator a written request for a

hearing in the form prescribed in Sec. 1316.47 of this chapter.

(b) Any person entitled to participate in a hearing pursuant to

Sec. 1301.34 or Sec. 1301.35(b) and desiring to do so shall, within 30

days of the date of publication of notice of the request for a hearing

in the Federal Register, file with the Administrator a written notice

of intent to participate in such hearing in the form prescribed in

Sec. 1316.48 of this chapter. Any person filing a request for a hearing

need not also file a notice of appearance.

(c) Any person entitled to a hearing or to participate in a hearing

pursuant to Sec. 1301.32 or Secs. 1301.34-1301.36 may, within the

period permitted for filing a request for a hearing or a notice of

appearance, file with the Administrator a waiver of an opportunity for

a hearing or to participate in a hearing, together with a written

statement regarding such person's position on the matters of fact and

law involved in such hearing. Such statement, if admissible, shall be

made a part of the record and shall be considered in light of the lack

of opportunity for cross-examination in determining the weight to be

attached to matters of fact asserted therein.

(d) If any person entitled to a hearing or to participate in a

hearing pursuant to Secs. 1301.32 or 1301.34-1301.36 fails to file a

request for a hearing or a notice of appearance, or if such person so

files and fails to appear at the hearing, such person shall be deemed

to have waived the opportunity for a hearing or to participate in the

hearing, unless such person shows good cause for such failure.

(e) If all persons entitled to a hearing or to participate in a

hearing waive or are deemed to waive their opportunity for the hearing

or to participate in the hearing, the Administrator may cancel the

hearing, if scheduled, and issue his/her final order pursuant to

Sec. 1301.46 without a hearing.

Sec. 1301.44 Burden of proof.

(a) At any hearing on an application to manufacture any controlled

substance listed in Schedule I or II, the applicant shall have the

burden of proving that the requirements for such registration pursuant

to section 303(a) of the Act (21 U.S.C. 823(a)) are satisfied. Any

other person participating in the hearing pursuant to Sec. 1301.35(b)

shall have the burden of proving any propositions of fact or law

asserted by such person in the hearing.

(b) At any hearing on the granting or denial of an applicant to be

registered to conduct a narcotic treatment program or as a compounder,

the applicant shall have the burden of proving that the requirements

for each registration pursuant to section 303(g) of the Act (21 U.S.C.

823(g)) are satisfied.

(c) At any hearing on the granting or denial of an application to

be registered to import or export any controlled substance listed in

Schedule I or II, the applicant shall have the burden of proving that

the requirements for such registration pursuant to sections 1008 (a)

and (d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any other

person participating in the hearing pursuant to Sec. 1301.34 shall have

the burden of proving any propositions of fact or law asserted by him/

her in the hearings.

(d) At any other hearing for the denial of a registration, the

Administration shall have the burden of proving that the requirements

for such registration pursuant to section 303 or section 1008 (c) and

(d) of the Act (21 U.S.C. 823 or 958 (c) and (d)) are not satisfied.

(e) At any hearing for the revocation or suspension of a

registration, the Administration shall have the burden of proving that

the requirements for such revocation or suspension pursuant to section

304(a) or section 1008(d) of the Act (21 U.S.C. 824(a) or 958(d)) are

satisfied.

Sec. 1301.45 Time and place of hearing.

The hearing will commence at the place and time designated in the

order to show cause or notice of hearing published in the Federal

Register (unless expedited pursuant to Sec. 1301.36(h)) but thereafter

it may be moved to a different place and may be continued from day to

day or recessed to a later day without notice other than announcement

thereof by the presiding officer at the hearing.

Sec. 1301.46 Final order.

As soon as practicable after the presiding officer has certified

the record to the Administrator, the Administrator shall issue his/her

order on the granting, denial, revocation, or suspension of

registration. In the event that an application for registration to

manufacture in bulk a basic class of any controlled substance listed in

Schedule I or II is granted, or any application for registration is

denied, or any registration is revoked or suspended, the order shall

include the findings of fact and conclusions of law upon which the

order is based. The order shall specify the date on which it shall take

effect. The Administrator shall serve one copy of his/her order upon

each party in the hearing.

Modification, Transfer and Termination of Registration

Sec. 1301.51 Modification in registration.

Any registrant may apply to modify his/her registration to

authorize the handling of additional controlled substances or to change

his/her name or address, by submitting a letter of request to the

Registration Unit, Drug Enforcement Administration, Department of

Justice, Post Office Box 28083, Central Station, Washington, DC 20005.

The letter shall contain the registrant's name, address, and

registration number as printed on the certificate of registration, and

the substances and/or schedules to be added to his/her registration or

the new name or address and shall be signed in accordance with

Sec. 1301.13(j). If the registrant is seeking to handle additional

controlled substances listed in Schedule I for the purpose of research

or instructional activities, he/she shall attach three copies of a

research protocol describing each research project involving the

additional substances, or two copies of a statement describing the

nature, extent, and duration of such instructional activities, as

appropriate. No fee shall be required to be paid for the modification.

The request for modification shall be handled in the same manner as an

application for registration. If the modification in registration is

approved, the Administrator shall issue a new certificate of

registration (DEA Form 223) to the registrant, who shall maintain it

with the old certificate of registration until expiration.

Sec. 1301.52 Termination of registration; transfer of registration;

distribution upon discontinuance of business.

(a) Except as provided in paragraph (b) of this section, the

registration of any person shall terminate if and when such person

dies, ceases legal existence, or discontinues business or professional

practice. Any registrant who ceases legal existence or discontinues

business or professional practice shall notify the Administrator

promptly of such fact.

(b) No registration or any authority conferred thereby shall be

assigned or otherwise transferred except upon such conditions as the

Administration may specifically designate and then only pursuant to

written consent. Any person seeking authority to transfer a

registration shall submit a written request, providing full details

regarding the proposed transfer of registration, to the Deputy

Assistant Administrator, Office of Diversion Control, Drug Enforcement

Administration,

[[Page 8522]]

Department of Justice, Washington, DC 20537.

(c) Any registrant desiring to discontinue business activities

altogether or with respect to controlled substances (without

transferring such business activities to another person) shall return

for cancellation his/her certificate of registration, and any

unexecuted order forms in his/her possession, to the Registration Unit,

Drug Enforcement Administration, Department of Justice, Post Office Box

28083, Central Station, Washington, DC 20005. Any controlled substances

in his/her possession may be disposed of in accordance with

Sec. 1307.21 of this chapter.

(d) Any registrant desiring to discontinue business activities

altogether or with respect to controlled substance (by transferring

such business activities to another person) shall submit in person or

by registered or certified mail, return receipt requested, to the

Special Agent in Charge in his/her area, at least 14 days in advance of

the date of the proposed transfer (unless the Special Agent in Charge

waives this time limitation in individual instances), the following

information:

(1) The name, address, registration number, and authorized business

activity of the registrant discontinuing the business (registrant-

transferor);

(2) The name, address, registration number, and authorized business

activity of the person acquiring the business (registrant-transferee);

(3) Whether the business activities will be continued at the

location registered by the person discontinuing business, or moved to

another location (if the latter, the address of the new location should

be listed);

(4) Whether the registrant-transferor has a quota to manufacture or

procure any controlled substance listed in Schedule I or II (if so, the

basic class or class of the substance should be indicated); and

(5) The date on which the transfer of controlled substances will

occur.

(e) Unless the registrant-transferor is informed by the Special

Agent in Charge, before the date on which the transfer was stated to

occur, that the transfer may not occur, the registrant-transferor may

distribute (without being registered to distribute) controlled

substances in his/her possession to the registrant-transferee in

accordance with the following:

(1) On the date of transfer of the controlled substances, a

complete inventory of all controlled substances being transferred shall

be taken in accordance with Sec. 1304.11 of this chapter. This

inventory shall serve as the final inventory of the registrant-

transferor and the initial inventory of the registrant-transferee, and

a copy of the inventory shall be included in the records of each

person. It shall not be necessary to file a copy of the inventory with

the Administration unless requested by the Special Agent in Charge.

Transfers of any substances listed in Schedule I or II shall require

the use of order forms in accordance with part 1305 of this chapter.

(2) On the date of transfer of the controlled substances, all

records required to be kept by the registrant-transferor with reference

to the controlled substances being transferred, under part 1304 of this

chapter, shall be transferred to the registrant-transferee.

Responsibility for the accuracy of records prior to the date of

transfer remains with the transferor, but responsibility for custody

and maintenance shall be upon the transferee.

(3) In the case of registrants required to make reports pursuant to

part 1304 of this chapter, a report marked ``Final'' will be prepared

and submitted by the registrant-transferor showing the disposition of

all the controlled substances for which a report is required; no

additional report will be required from him, if no further transactions

involving controlled substances are consummated by him. The initial

report of the registrant-transferee shall account for transactions

beginning with the day next succeeding the date of discontinuance or

transfer of business by the transferor-registrant and the substances

transferred to him shall be reported as receipts in his/her initial

report.

Sec. 1301.75 Physical security controls for practitioners.

* * * * *

(b) Controlled substances listed in Schedules II, III, IV, and V

shall be stored in a securely locked, substantially constructed

cabinet. However, pharmacies and institutional practitioners may

disperse such substances throughout the stock of noncontrolled

substances in such a manner as to obstruct the theft or diversion of

the controlled substances.

* * * * *

6. Section 1301.76 is proposed to be amended by revising paragraph

(c) to read as follows:

Sec. 1301.76 Other security controls for practitioners.

* * * * *

(c) Whenever the registrant distributes a controlled substance

(without being registered as a distributor, as permitted in

Sec. 1301.13(e)(1) and/or Secs. 1307.11-1307.12) he/she shall comply

with the requirements imposed on nonpractitioners in Sec. 1301.74 (a),

(b), and (e).

Sec. 1301.72 [Amended]

7. In 21 CFR 1301.72(b)(4)(i)(b) remove the word ``lay'' and add,

in its place, the word ``lag''.

PART 1302--[AMENDED]

1. The authority citation for part 1302 continues to read as

follows:

Authority: 21 U.S.C. 821, 825, 871(b), 958 (e).

2. Section 1302.02 is proposed to be revised to read as follows:

Sec. 1302.02 Definitions.

Any term contained in this part shall have the definition set forth

in section 102 of the Act (21 U.S.C. 802) or Part 1300 of this chapter.

3. Section 1302.04 is proposed to be revised to read as follows:

Sec. 1302.04 Location and size of symbol on label and labeling.

The symbol shall be prominently located on the label or the

labeling of the commercial container and/or the panel of the commercial

container normally displayed to dispensers of any controlled substance.

The symbol on labels shall be clear and large enough to afford easy

identification of the schedule of the controlled substance upon

inspection without removal from the dispenser's shelf. The symbol on

all other labeling shall be clear and large enough to afford prompt

identification of the controlled substance upon inspection of the

labeling.

Sec. 1302.05 [Removed]

4. Section 1302.05 is proposed to be removed.

5. Section 1302.06 is proposed to be redesignated as Section

1302.05 and revised to read as follows:

Sec. 1302.05 Effective dates of labeling requirements.

All labels on commercial containers of, and all labeling of, a

controlled substance which either is transferred to another schedule or

is added to any schedule shall comply with the requirements of

Sec. 1302.03, on or before the effective date established in the final

order for the transfer or addition.

6. Section 1302.07 is proposed to be redesignated as Sec. 1302.06

and revised to read as follows:

Sec. 1302.06 Sealing of controlled substances.

On each bottle, multiple dose vial, or other commercial container

of any

[[Page 8523]]

controlled substance, there shall be securely affixed to the stopper,

cap, lid, covering, or wrapper or such container a seal to disclose

upon inspection any tampering or opening of the container.

7. Section 1302.08 is proposed to be redesignated as Sec. 1302.07,

and revised to read as follows:

Sec. 1302.07 Labeling and packaging requirements for imported and

exported substances.

(a) The symbol requirements of Secs. 1302.03-1302.05 apply to every

commercial container containing, and to all labeling of, controlled

substances imported into the jurisdiction of and/or the customs

territory of the United States.

(b) The symbol requirements of Secs. 1302.03-1302.05 do not apply

to any commercial containers containing, or any labeling of, a

controlled substance intended for export from the jurisdiction of the

United States.

(c) The sealing requirements of Sec. 1302.06 apply to every bottle,

multiple dose vial, or other commercial container of any controlled

substance listed in schedule I or II, or any narcotic controlled

substance listed in schedule III or IV, imported into, exported from,

or intended for export from, the jurisdiction of and/or the customs

territory of the United States.

PART 1303--[AMENDED]

1. The authority citation for part 1303 continues to read as

follows:

Authority: 21 U.S.C. 821, 826, 871(b).

2. Section 1303.02 is proposed to be revised to read as follows:

Sec. 1303.02 Definitions.

Any term contained in this part shall have the definition set forth

in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

3. In addition to the proposed amendments set forth above, DEA is

proposing to amend each section indicated in the left column by

removing the words indicated in the middle column and adding the words

in the right column:

------------------------------------------------------------------------

Section Remove Add

------------------------------------------------------------------------

1303.12(b)...................... (or BND) each

place it appears.

1303.12(b)...................... Drug Control Drug & Chemical

Section. Evaluation

Section.

1303.12(d)...................... Drug Control Drug & Chemical

Section. Evaluation

Section.

1303.12(e)(1)................... subsance.......... substance.

1303.12(e)(3)................... 1301.22(b)........ 1301.13.

1303.21(a)...................... 1301.45 and 1301.36.

1301.46.

1303.22......................... (or BND) each

place it appears.

1303.22......................... Drug Control Drug & Chemical

Section. Evaluation

Section.

1303.26......................... 1301.45 or 1301.46 1301.36.

1303.27......................... Drug Control Drug & Chemical

Section. Evaluation

Section.

1303.32(b)...................... 1301.45 or 1301.46 1301.36.

1303.35(a)...................... aggregrate........ aggregate.

------------------------------------------------------------------------

PART 1304--[AMENDED]

1. The authority citation for part 1304 is proposed to be corrected

to read as follows:

Authority: 21 U.S.C. 821, 827, 871(b), 958(e), 965, unless

otherwise noted.

2. Section 1304.02 is proposed to be revised to read as follows:

Sec. 1304.02 Definitions.

Any term contained in this part shall have the definition set forth

in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

3. Section 1304.03 is proposed to be amended by removing paragraphs

(g) and (h), and revising paragraph (f) to read as follows:

Sec. 1304.03 Persons requi

This text is long and has been trimmed here. Open the source document for the complete record.