Consolidation, Elimination, and Clarification of Various Regulations

SUMMARY: This final rule is issued by the Acting Deputy Administrator

of the Drug Enforcement Administration to institute the proposed

changes to Title 21, Code of Federal Regulations, Parts 1300 through

1316, published in the Federal Register on March 5, 1996 (61 FR 8503).

In concert with the President's National Performance Review, Regulatory

Reinvention Initiative (NPR), DEA proposed 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.

EFFECTIVE DATE: March 28, 1997.

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

Policy Section, Office of Diversion Control, Drug Enforcement

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

SUPPLEMENTARY INFORMATION: On March 5, 1996, DEA published in the

Federal Register a notice of proposed rule making (NPRM) entitled

Consolidation, Elimination, and Clarification of Various Regulations

(61 FR 8503). This NPRM was the culmination of a comprehensive review

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. 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 so doing it was DEA's intention to reduce

some of the regulatory burden on the affected industries. Interested

parties were given 120 days to submit written comments regarding the

proposed rule.

Comments

Twenty-five organizations submitted comments in response to the

proposed rule. One organization expressed support for the entire

proposed rule as published, two others expressed support for one

specific element within the proposal with no further substantive

comment, and six others expressed their support for the comments

submitted by their industry trade group. These and the comments of the

other sixteen respondents are addressed below.

Part 1300

Two commentors expressed their support for the consolidation of the

definitions in new Secs. 1300.01 and 1300.02. One commentor suggested

that the definition of ``home infusion pharmacy'' be deleted as

unnecessary because all retail pharmacies are qualified to provide home

infusion services, and the expression ``compounds for intramuscular

infusion'' is confusing since the commentor was unaware of any pharmacy

which actually compounds, as opposed to dispenses, intramuscular

infusion solutions. DEA agrees that a definition of home infusion

pharmacy is unnecessary as the distinction between home infusion

services and other dispensing activities is adequately addressed within

Sec. 1306.11(e), which permits the retention of faxed Schedule II

prescriptions as original documents for home infusion prescriptions.

Therefore, the definition of home infusion pharmacy will be removed

from Sec. 1300.01 and the words ``home infusion pharmacy'' in

Sec. 1306.11(e) will be replaced by the word ``pharmacy.'' When the

original rule was published, DEA determined that there were in fact

pharmacies which compound solutions for intramuscular injection. Even

if this activity is no longer being performed by pharmacies, keeping

this phrase in the definition allows for the possibility that in the

future such activities may again be conducted.

One commentor recommended that the definition of ``inventory'' be

modified to include the terms ``bulk active drug substance, in-process

materials (work in progress), and finished dosage form inventory.''

This definition, which was previously contained in part 1303, was not

changed as part of this proposed rule and will, therefore, remain

unchanged in the Final Rule. However, due to this comment and other

questions previously raised by industry, a new definition of

``inventory'' will be published for comment in the near future.

One commentor expressed the opinion that the definitions of

``hearing'', ``interested person'', and ``proceeding'' are unclear with

respect to proceedings pursuant to 21 U.S.C. 952; that a definition of

research be added which is in accordance with DEA's Policy Statement on

Coincident Activities of Researchers, 60 FR 55310 (10/31/95); that the

definitions which are repeated in Secs. 1300.01 and 1300.02 be removed

from one of the sections; and that the references to ``this section''

in Sec. 1300.02(b)(12) and to ``this part'' in

Sec. 1300.02(b)(28)(i)(B) are unclear. DEA does not agree that the

definitions of ``hearing'', ``interested person'', and ``proceeding''

are not sufficiently clear. These definitions were not changed as part

of the proposal and are sufficiently precise to fulfill their intended

purpose.

Since the only ambiguity regarding the term ``research'' addressed

in the cited Policy Statement related to whether certain manufacturing

activities may be conducted as coincident activities of a researcher

registration or require a manufacturer registration, a statement

consistent with the espoused policy will be added to the table of

coincident activities, Sec. 1301.13(e)(1)(v), noting that dosage form

development is not an authorized coincident activity of a researcher

registration.

The purpose of providing two sets of definitions, one for

controlled substance handlers and one for chemical handlers, was to

direct an interested person to a single source for all definitions

relevant to that person's business activity. Therefore, it was deemed

more appropriate and less confusing to repeat those few definitions

which are common to both groups rather than to compel each person to

identify which definitions pertain to them. The reference to ``this

section'' in Sec. 1300.02(b)(12) will be replaced with the phrase ``for

purposes of this definition'' and the reference to ``this part'' in

Sec. 1300.02(b)(28)(i)(B) will be changed to reflect the part to which

it refers, i.e. part 1310.

Part 1301

Two commentors expressed support for the proposed change to

Sec. 1301.21, Exemptions to Registrations and Fees. Another commentor

expressed support for the proposal to extend the renewal period for

bulk manufacturers to 120 days contained in Sec. 1301.13. One commentor

stated that references to the

[[Page 13939]]

``Secretary'' in Sec. 1301.32 are unclear; the reference to ``these

substances'' in Sec. 1301.34(b)(3) should be clarified; the reference

to ``hearing'' in Sec. 1301.35(b) could be misinterpreted as referring

to third-party hearings and recommended that the phrase ``in response

to a show cause order'' be added; Sec. 1301.42 should reference the

possibility that the hearing could involve the granting of any

application for registration to import by adding the phrase ``to import

or'' after the words ``for registration''; and Sec. 1301.46 should be

clarified to indicate that if an application for registration to import

a Schedule I or II substance is granted, the order should include an

explanation of the basis for such granting by adding the phrase ``to

import or'' after the words ``for registration''. The references in

Sec. 1301.32 will be changed to identify the individual in question as

the Secretary of Health and Human Services; the term ``these

substances'' comes directly from the applicable statute and, therefore,

cannot be changed by regulation; the phrase ``in response to a show

cause order'' will be added to Sec. 1301.35(b); and the phrase ``to

import or'' will be added to Secs. 1301.42 and 1301.46.

Part 1304

Two comments were received supporting the acceptability of filing

Schedule III-V prescriptions without marking them with a red ``C'' if

the pharmacy can retrieve certain information with its data processing

system as required by Sec. 1304.04(h)(2). One commentor recommended

that the sentence ``Registrants who desire to continue maintaining

central records will make notification to the local Special Agent in

Charge as provided in paragraph (a) of this section'' be removed from

Sec. 1304.04(e). This sentence was in fact removed in the proposed

rule.

Two commentors supported the change to Sec. 1304.11(c) which allows

a registrant to conduct its biennial inventory on any date within two

years from the date of its previous biennial inventory. One of these

commentors noted that the proposed regulatory language implementing the

proposed rule had not changed. The corrected language was published in

the Federal Register on March 21, 1996 (61 FR 11594). One commentor

suggested that the requirements of Sec. 1304.11(e)(3)(ii) were

misstated. The commentor believed that DEA was intending to require

dispensers and researchers to make an exact inventory count of Schedule

III-V drugs in opened containers when the containers held fewer than

1,000 tablets or capsules, and an estimate if the containers held more

than 1,000. The language in the proposed rule, which is unchanged from

the existing regulation, is correct as stated in the proposed rule.

Two comments were received which recommended that the terms

``receipt'' and ``distribution'' contained in Secs. 1304.22(a)(2)(iv)

and 1304.22(a)(2)(vii) be changed to ``acquisition to inventory'' and

``reduction from inventory'' for purposes of clarity and consistency

with the terms used for ARCOS reporting. The recommended terms will be

incorporated into those sections.

Four commentors expressed their support for the change to

Sec. 1304.33 which puts ARCOS reporting on a quarterly rather than a

monthly schedule. One commentor recommended that Sec. 1304.33(b) be

modified to specify that controlled substances in the various stages of

production be included in the year-end ARCOS inventory. The language in

the current regulation indicating that registrants should identify

whether each reported substance is in storage or in process of

manufacturing was inadvertently omitted and will be reinstated. The

final rule will also be amended to permit quarterly reporting, as well

as annual reporting, of manufacturing transactions if the reporting

registrant so chooses.

Part 1305

One commentor objected to the removal of the information from the

regulations which is contained on the back of DEA-222 Order Forms, as

this information might be needed at a training site which is a non-

registered location and, therefore, would be unavailable for reference

purposes. When needed for training or other off-site purposes, the

backs of the order forms containing the requisite information could be

photocopied and provided to students at least as easily as providing

copies of the CFR. Therefore, the information will be deleted as

originally proposed.

One commentor suggested that the phrase used in Sec. 1305.06(b),

``last line completed,'' was inconsistent with the recently changed

term used on the DEA-222 Order Forms themselves. The commentor is

correct. The phrase used on the Order Forms, ``No. of lines

completed,'' was adopted recently for purposes of clarity and has been

substituted in the final rule for the language contained in the

proposed rule. Another commentor recommended that Sec. 1305.06(b) be

modified to acknowledge that some substances may require more than one

line to fully describe the substance being ordered. DEA believes that

the amount of space provided on a single line is generally sufficient

to completely identify the controlled substance. This same commentor

recommended that Sec. 1305.09(e) be amended to explain that an item on

an Order Form can be partially filled with less but not more than the

quantity ordered. The paragraph in question states that a purchaser

must record the date and quantity of the items received on copy 3 of

the Order Form. The statement being recommended for inclusion in

paragraph (e) is clearly and appropriately contained in paragraph (b)

of this section which relates to what can be supplied. This commentor

also recommended that Sec. 1305.11(a)(1) be modified to explain when an

Order Form is not ``complete.'' DEA believes that the term ``complete''

is self-explanatory, i.e. the purchaser must enter all the information

called for in the spaces provided except those that specifically state

that the information is to be filled in by the supplier.

Part 1306

Five commentors expressed support for the extension of time to 7

days from 72 hours within which pharmacies must obtain written

prescriptions to cover emergency oral prescriptions for Schedule II

controlled substances, as required by Sec. 1306.11(d)(4).

Five comments were received regarding the proposal to allow

pharmacies to retain faxed Schedule II prescription records as original

documents for patients in a home hospice setting. One commentor

supported the change without further elaboration. A second commentor

recommended that the terms ``terminal illness'' or ``terminally ill''

be substituted for the word ``hospice,'' so as to make the rule less

restrictive; if the terms hospice or home hospice were retained, it was

recommended that they be defined. The last three commentors suggested

that the rule be changed to allow pharmacies to accept faxed Schedule

II prescriptions for individuals in all hospice settings, not just

individuals in home hospice settings who have been released from

registered institutions and are receiving daily skilled nursing care.

It was suggested by two of these commentors that this would be best

achieved by replacing the relevant language in the proposed rule with

the phrase: ``a hospice certified by Medicare under Title XVIII or

licensed by the state.'' As stated in the proposed rule, it was DEA's

intention to allow faxed Schedule II prescriptions to be retained as

original documents in order

[[Page 13940]]

to ease the recordkeeping burden for physicians and pharmacies for non-

institutionalized patients who require frequent and/or unanticipated

changes in their Schedule II narcotic medication. It was DEA's belief

that individuals residing in a hospice facility licensed by the state

would already be covered by the existing exception to the rule afforded

to patients residing in Long Term Care Facilities. This proposal was

directed at individuals who require a similar level of care but reside

at home rather than in an institution. However, based on the comments

received and to insure that no properly affected individuals will be

inadvertently excluded from the exception, the recommended phrase, ``a

hospice certified by Medicare under Title XVIII or licensed by the

state,'' will be incorporated into the final rule.

Two commentors expressed support for the removal of the

requirement, previously contained in Sec. 1306.13(b), that a pharmacist

determine that subsequent partial fillings of Schedule II prescriptions

for patients in Long Term Care Facilities are still necessary. One

commentor pointed out that a sentence was needlessly repeated in this

paragraph; one of which will be removed.

Two commentors voiced their support for the proposal to permit

Schedule III-V prescription information to be transferred for refill

purposes up to the maximum number of times authorized by the physician

among pharmacies sharing a real-time, on-line electronic database.

Part 1308

One commentor disagreed with the proposal to remove the tables of

exempted and excluded products from Secs. 1308.24, 1308.26, 1308.32,

and 1308.34. This commentor expressed concern that by removing the

tables, DEA would not be obligated to publish changes to the tables as

they occur, thus denying interested parties an opportunity to comment

and/or adapt operations as needed. The requirement to publish all

approvals of exempted and excluded products in the Federal Register in

order to allow an opportunity for comment remains unchanged in the

following sections: 1308.23(e), 1308.25(c), 1308.31(c), and 1308.33(d).

The tables will continue to be published for comment in the Federal

Register each year. Therefore, the proposal to remove these tables will

have no effect on the ability of interested parties to comment and/or

adapt their operations. Another commentor suggested that the rule be

modified to require DEA to provide state scheduling authorities which

do not receive the Federal Register separate notification of changes to

the lists of exempted and excluded products. States which do not

receive copies of the Federal Register directly can request updated

lists from the local DEA office or from DEA Headquarters.

Part 1316

Four commentors expressed support for the change to Sec. 1316.13

which replaces the present schedule of administrative inspections with

a system whereby the frequency of inspections will be determined by

factors such as the prior history of the registrant, the potential for

diversion, and the existence of pharmaceutical controlled substances

found in the illicit market. Three of these commentors suggested adding

a requirement that an exit interview be conducted at the completion of

the investigation. Although it is DEA policy to conduct an exit

interview, there are occasions when it would be premature and/or

inadvisable to discuss results at the completion of the on-site portion

of the investigation. Therefore, DEA declines to add such a

requirement.

In the proposed rule the table of registration categories under

Sec. 1301.13(e)(1)(iv) incorrectly included instructing as an

authorized activity with Schedule I substances. The words ``or

Instructing'' are being removed in the Final Rule. In the proposed rule

Sec. 1304.22(c) should have included a reference to paragraph

(a)(2)(vii) of this section which will be inserted in the Final Rule.

In the proposed rule the authority citation for subpart A of part 1316

omitted Section ``830(a)'' of 21 U.S.C. inadvertently. It is being

reinstated in the Final Rule. A typographical error in Sec. 1316.12

which was overlooked for correction in the proposed rule is being

corrected in the Final Rule; the reference should read ``21 U.S.C.

842(a)(6)'' not ``21 U.S.C. (a)(6).''

In addition to the comments previously discussed, several

commentors also identified typographical errors in the proposed rule

which will be corrected in the final rule.

Five of the commentors took this occasion to recommend that DEA

adopt new regulations and procedures in a number of areas that go

beyond what was published in the proposed rule. A number of these are

matters of internal procedures which do not require regulatory changes

and are under development and discussion with the commentors, e.g.

batch certification and renewal of applications. Several

recommendations addressed issues which were not part of this rulemaking

and since other interested parties have not been given an opportunity

to comment on them, were not considered, e.g. permitting pharmacies to

receive controlled substances from LTCFs for disposal purposes,

requiring hospitals to provide suffix information for affiliated

practitioners, adding an Affidavit for Power of Attorney to allow

pharmacies to be operated by an acquirer under the existing

registration pending approval of the new application.

Several commentors recommended that the regulations be changed to

permit registered distributors to utilize cross-docking/freight-

forwarding facilities. Although this was not part of the proposed rule,

on December 18, 1996, DEA published a proposed rule to permit such

activities. Still other commentors proposed changes which would modify

specific requirements mandated by law and, therefore, cannot be altered

by regulation, e.g. written prescriptions for Schedule II controlled

substances. As was stated in the proposed rule, DEA is committed to

constant self-examination, responsiveness to technological innovation,

and working with industry to develop effective and minimally intrusive

methods of preventing and detecting the diversion of controlled

substances. The comments which suggested additional changes not

proposed as part of this NPRM will be evaluated and, where appropriate,

addressed in future meetings and conferences with the regulated

industry.

The Acting Deputy Administrator, in accordance with the Regulatory

Flexibility Act (5 U.S.C. 605(b)) as amended by the Small Business

Regulatory Enforcement Act of 1996 (Pub. L. 104-121), has reviewed this

final rule and based on the supplemental information above certifies

that this rulemaking will not have a significant economic impact on a

substantial number of small entities. This final rule imposes no

additional regulatory burdens on small businesses. To the contrary, it

is primarily intended to streamline and simplify various regulations in

order to provide regulatory relief to registrants. Various regulations

and reports were either eliminated or reduced to allow greater

flexibility in complying with existing requirements. For example, the

frequency of reports to ARCOS were reduced to quarterly from monthly;

some pharmacies will be permitted to transfer prescription information

for refill purposes more frequently; all pharmacies will be permitted

to retain faxed prescriptions as original

[[Page 13941]]

documents for hospice patients; pharmacies will no longer be required

to determine if additional partial fillings of prescriptions are

necessary for patients in LTCFs; and all registrants will be given the

flexibility to establish the date for their biennial inventory.

This rulemaking has been drafted in accordance with Executive Order

12866, section 1(b), Principles of Regulation. The Office of Management

and Budget has reviewed this final 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 final 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,

Exports, Imports, Labeling, List I and List II chemicals, Narcotics,

Packaging and containers, Prescription drugs, Reporting requirements,

Research, Security measures, Seizures and forfeitures.

For the reasons stated in the preamble, 21 CFR Ch. II is amended as

follows:

21 CFR part 1300 is 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;

(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

[[Page 13942]]

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 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 meaning of the

tariff laws of the United States).

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

acts as an import broker for importation of, controlled substances

listed in any schedule.

(17) 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.

(18) 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.

(19) 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).

(20) 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).

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

Sec. 1308.11(d) and Sec. 1308.12(b)(4) of this chapter. As used in

Sec. 1308.11(d) of this chapter, the term isomer means the optical,

positional, or geometric isomer. As used in Sec. 1308.12(b)(4) of this

chapter, the term isomer means the optical or geometric isomer.

(22) 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.

(23) 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.

(24) 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.

(25) 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.

(26) 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.

(27) 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.

(28) 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,

[[Page 13943]]

nurse anesthetists, clinical nurse specialists and physician assistants

who are authorized to dispense controlled substances by the state in

which they practice.

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

chemical name, or brand name of a substance.

(30) 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.

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

maintenance and/or detoxification treatment with narcotic drugs.

(32) 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.

(33) 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.

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

government or governmental subdivision or agency, business trust,

partnership, association, or other legal entity.

(35) 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.)

(36) 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 U.S.C. 811), commencing with the publication by the

Administrator of the proposed rule, amended rule, or repeal in the

Federal Register.

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

obtain and execute order forms pursuant to Section 1305.04 and Section

1305.06.

(38) 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.

(39) 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).

(40) 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).

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

order forms pursuant to Sec. 1305.08 of this chapter.

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

[[Page 13944]]

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 for purposes of this definition. 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.

(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. 1300.02(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

[[Page 13945]]

exporter from compliance with parts 1309, 1310, 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. 1300.02(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 revised to read as follows:

Sec. 1301.01 Scope of this 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 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. Part 1301 is 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.

1301.12 Separate registrations for separate locations.

1301.13 Application for registration; time for application;

expiration date; registration for independent activities;

application forms, fees, contents and signature; coincident

activities.

1301.14 Filing of application; acceptance for filing; defective

applications.

1301.15 Additional Information.

1301.16 Amendments to and withdrawal of applications.

1301.17 Special procedures for certain applications.

1301.18 Research protocols.

Exceptions to Registration and Fees

1301.21 Exception from fees.

1301.22 Exemption of agents and employees; affiliated

practitioners.

1301.23 Exemption of certain military and other personnel.

1301.24 Exemption of law enforcement officials.

1301.25 Registration regarding ocean vessels, aircraft, and other

entities.

1301.26 Exemptions from import or export requirements for personal

medical use.

Action on Applications for Registration: Revocation or Suspension of

Registration

1301.31 Administrative review generally.

1301.32 Action on applications for research in Schedule I

substances.

1301.33 Application for bulk manufacture of Schedule I and II

substances.

1301.34 Application for importation of Schedule I and II

substances.

1301.35 Certificate of registration; denial of registration.

1301.36 Suspension or revocation of registration; suspension of

registration pending final order; extension of registration pending

final order.

1301.37 Order to show cause.

Hearings

1301.41 Hearings generally.

1301.42 Purpose of hearing.

1301.43 Request for hearing or appearance; waiver.

1301.44 Burden of proof.

1301.45 Time and place of hearing.

1301.46 Final order.

Modification, Transfer, and Termination of Registration

1301.51 Modification in registration.

1301.52 Termination of registration; transfer of registration;

distribution upon discontinuance of business.

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

[[Page 13946]]

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)

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

Application Registration

Business activity Controlled DEA application fee period Coincident

substances forms (dollars) (years) activities allowed

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

(i) Manufacturing............ Schedules I New--225....... 875 1 Schedules I through

through V. Renewal--225a.. 875 V: May 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 New--225....... 438 1 ....................

through V. Renewal--225a.. 438

[[Page 13947]]

(iii) Dispensing or Schedules II New--224....... 210 3 May conduct research

Instructing (Includes through V. Renewal--224a.. 210 and instructional

Practitioner Hospital/ activities with

Clinic, Retail Pharmacy, those substances

Teaching Institution). for 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................ Schedule I..... New--225....... 70 1 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 New--225....... 70 1 May conduct chemical

through V. 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 and

provided that the

manufacture is not

for the purposes of

dosage form

development; 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

conduct

instructional

activities with

controlled

substances.

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

Program (including in Schedules Renewal--363a.. 70

compounder). II through V.

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

through V. 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 New--225....... 438 1 ....................

through V. Renewal--225a.. 438

[[Page 13948]]

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

through V. Renewal--225a.. 70 import 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 may conduct

instructional

activities with

controlled

substances.

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

(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 of 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

[[Page 13949]]

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 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 through registration by fraudulent means 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.

[[Page 13950]]

(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

proscribed in paragraph (a)(2)(vi) 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:

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

(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;

[[Page 13951]]

(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.,

APO123456-10 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.

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

[[Page 13952]]

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)----------------------------------------------

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

Number of Packages

Line No. packages ordered Size of packages Name of product distributed Date distributed

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

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

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

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

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

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

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 that wishes to distribute controlled

substances pursuant to this section shall be authorized to do so,

provided:

(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

[[Page 13953]]

(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; and

(c) The importation of the controlled substance for personal

medical use is authorized or permitted under other Federal laws and

state law.

Action on Application 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 (21 U.S.C. 823) or section 1008 (21

U.S.C. 958) of the Act 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 of Health and Human Services (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, 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 Section

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. 1301.13(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 Sec. 1301.35 or

Sec. 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

[[Page 13954]]

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 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 in response to a show cause order 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.

[[Page 13955]]

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. 1301.41.

(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 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. This 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,

[[Page 13956]]

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

sections 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 import or 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 Sec. 1301.32 or

Secs. 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 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 Sec. 1301.32 or Secs. 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

import or 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,

[[Page 13957]]

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, 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.

5. Section 1301.75 is amended by revising paragraph (b) to read as

follows:

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 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'.

[[Page 13958]]

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 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 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 removed.

5. Section 1302.06 is redesignated as Sec. 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 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 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 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 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 amendments set forth above, DEA is amending

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 Section............... Drug & Chemical Evaluation Section.

1303.12(d)............................ Drug Control Section............... Drug & Chemical Evaluation Section.

1303.12(e)(1)......................... subsance........................... substance.

1303.12(e)(3)......................... 1301.22(b)......................... 1301.13.

1303.21(a)............................ 1301.45 and 1301.46................ 1301.36.

1303.22, introductory text............ (or BND) each place it appears.....

1303.22, introductory text............ Drug Control Section............... Drug & Chemical Evaluation Section.

1303.26............................... 1301.45 or 1301.46................. 1301.36.

1303.27............................... Drug Control Section............... Drug & Chemical Evaluation Section.

1303.32(b)............................ 1301.45 or 1

This text is long and has been trimmed here. Open the source document for the complete record.