(b) Controlled substances listed in schedules III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies 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.

(c) This section shall also apply to nonpractitioners authorized to conduct research or chemical analysis under another registration.

§ 301.76 Other security controls for practitioners.

(a) The registrant shall not employ as an agent or employee who has access to controlled substances any person who has had an application for registration denied, or has had his registration revoked, at any time.

(b) The registrant shail notify the Regional Office of the Bureau in his region of the theft or significant loss of any controlled substances upon discovery of such loss or theft. The registrant shall also complete BND Form 106 regarding such loss or theft.

[36 F.R. 7778, Apr. 24, 1971, as amended at 36 F.R. 18731, Sept. 21, 1971]

As used in this part, the following terms shall have the meanings specified: (a) The term "commercial container" means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term "commercial container" does not include any package liner, package insert or other material kept with or within a commercial container, nor any carton, crate, drum, or other package in which commercial containers are stored or are used for shipiment of controlled substances.

(b) 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.

(c) The term "labeling" means all labels and other written, printed, or graphic matter (1) upon any controlled substance or any of its commercial containers or wrappers, or (2) accompanying such controlled substance.

(d) 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 administration or dispensing such substance in the course of his 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.

(e) Any term not defined in this section shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or § 301.02 of this chapter.

[36 F.R. 7785, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971]

§ 302.03 Symbol required; exceptions.

(a) Each commercial container of a controlled substance (except for a controlled substance excepted by the Director pursuant to § 308.31 of this chapter) shall have printed on the label the symbol designating the schedule in which such controlled substance is listed. Each

The word "schedule" need not be used. No distinction need be made between narcotic and nonnarcotic substances.

(d) The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily legible through such carton or wrapper.

(e) The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an ultimate user.

(f) The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance being utilized in clinical research involving blind and double blind studies. [36 F.R. 7785, Apr. 24, 1971, as amended at 36 F.R. 18731, Sept. 21, 1971] § 302.04

label.

Location and size of symbol on

(a) The symbol shall be prominently located on the right upper corner of the principal panel of the label of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance listed in schedules I through V. The symbol must be at least two times as large as the largest type otherwise printed on the label.

(b) In lieu of locating the symbol in the corner of the label, as prescribed in paragraph (a) of this section, the symbol may be overprinted on the label, in which case the symbol must be printed at least one-half the height of the label and in a contrasting color providing

The symbol shall be prominently located on all labeling other than labels covered by § 302.04. In all cases the symbol shall be clear and large enough to afford prompt identification of the controlled substance upon inspection of the labeling.

§ 302.06 Effective dates of labeling requirements.

(a) All labels on commercial containers of, and all labeling of, a controlled substance which is listed in any schedule on May 1, 1971, and which is packaged after December 1, 1971, shall comply with the requirements of § 302.03.

(b) All labels on commercial containers of, and all labeling of, a controlled substance which either is listed in any schedule on May 1, 1971, and thereafter transferred to another schedule or is added to any schedule after May 1, 1971, and which is packaged more than 180 days following the date on which the transfer or addition becomes effective, shall comply with the requirements of § 302.03.

(c) The Director may, in the case of any controlled substance, require compliance with the requirements of § 302.03 within a period of time shorter than required by this section if he finds that public health or safety necessitate an earlier effective date.

(d) Until compliance is required under this section, the label on commercial container containing, and the labeling of, any controlled substance shall comply with any requirements under Federal law as to labels of such containers and as to labeling of such substances existing prior to the effective date prescribed in this section.

§ 302.07 Sealing of controlled sub

stances.

(a) On each bottle, multiple dose vial, or other commercial container of any controlled substance listed in schedules I or II or of any narcotic controlled substance listed in schedule III or IV, there shall be securely affixed to the stopper, cap, lid, covering, or wrapper or such

(c) The sealing requirements § 302.07 apply to every bottle, multiple dose vial, or other commercial container of any controlled substance listed in schedule I or II, or of 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, as defined in § 311.02 of this chapter.

[36 F.R. 18731, Sept. 21, 1971]

HEARINGS

Hearings generally.

Purpose of hearing.

Waiver or modification of rules.

Request for hearing or appearance; waiver.

Burden of proof.

Time and place of hearing.
Final order.

TRANSITIONAL REGULATIONS

Quota system for 1971.

Quota system for 1972.

AUTHORITY: The provisions of this Part 303 issued under secs. 301, 306, 501 (b), 84 Stat. 1253, 1257, 1258, 1271; 21 U.S.C. 821, 826, 871(b).

SOURCE: The provisions of this Part 303 appear at 36 F.R. 7786, Apr. 24, 1971, unless otherwise noted.

§ 303.01

GENERAL INFORMATION

Scope of Part 303.

Procedures governing the establishment of production and manufacturing quotas on basic classes of controlled substances listed in schedules I and II pursuant to section 306 of the Act (21 U.S.C. 826) are governed generally by that section and specifically by the sections of this part.

As used in this part, the following terms shall have the meanings specified:

(a) The term "hearing" means any hearing held pursuant to this part regarding the determination of aggregate production quota or the issuance, adjustment, suspension, or denial of a procurement quota or an individual manufacturing quota.

(b) 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).

(c) The term "net disposal" means the quantity of a basic class of controlled substance sold, exchanged, given away, used in the production of another substance (whether a controlled substance or not), contained in or combined with other substances, or otherwise consumed by or transferred to another person by the registrant during a stated pe

riod, less the quantity returned to the registrant by any purchaser and the quantity sold or transferred by the registrant to another registered manufacturer of the same basic class of controlled substance.

(d) The term "registrant" means any person registered pursuant to section 303 of the Act (21 U.S.C. 823).

(e) Any term not defined in this section shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) and § 301.02 of this chapter.

[36 F.R. 7786, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971]

AGGREGATE PRODUCTION AND PROCUREMENT QUOTAS

§ 303.11

Aggregate production quotas.

(a) The Director shall, on or before May 1 of each year, determine the total quantity of each basic class of controlled substance listed in schedule I or II necessary to be manufactured during the following calendar year to provide for the estimated medical, scientific, research and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks.

(b) In making his determinations, the Director shall consider the following factors:

(1) Total net disposal of the class by all manufacturers during the current and 2 preceding years;

(2) Trends in the national rate of net disposal of the class;

(3) Total actual (or estimated) inventories of the class and of all substances manufactured from the class, and trends in inventory accumulation;

(4) Projected demand for such class as indicated by procurement quotas requested pursuant to § 303.12; and

(5) Other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Director finds relevant, including changes in the currently accepted medical use in treatment with the class or the substances which are manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires.

(c) The Director shall, on or before May 1 of each year, publish in the FEDERAL REGISTER general notice of an aggregate production quota for any basic class determined by him under this section. A copy of notice shall be mailed simultaneously to each person registered as a bulk manufacturer of the basic class. Any interested person may, within 30 days from the date of publication of the notice, request a hearing on the aggregate production quota by filing with the Director a written request for a hearing in accordance with § 303.34. If a hearing is requested and reasonable grounds are shown, the Director shall hold a public hearing on the aggregate production quota for the basic class. Notice of the hearing shall be published in the FEDERAL REGISTER at least 30 days prior to the hearing and mailed simultaneously to all persons to whom the notice of the determination of the aggregate production quota was mailed. Any interested person may participate in the hearing by filing a notice of appearance in accordance with § 303.34.

[36 F.R. 7786, Apr. 24, 1971, as amended at 36 F.R. 18731, Sept. 21, 1971]

§ 303.12 Procurement quotas.

(a) In order to determine the estimated needs for, and to insure an adequate and uninterrupted supply of, basic classes of controlled substances listed in schedules I and II (except raw opium) the Director shall issue procurement quotas authorizing persons to procure and use quantities of each basic class of such substances for the purpose of manufacturing such class into dosage forms or into other substances.

(b) Any person who is registered to manufacture controlled substances listed in any schedule and who desires to use during the next calendar year any basic class of controlled substances listed in schedule I or II (except raw opium) for purposes of manufacturing, shall apply on BND Form 250 for a procurement quota for such basic class. A separate application must be made for each basic class desired to be procured or used. The applicant shall state whether he intends to manufacture the basic class himself or purchase it from another manufacturer. The applicant shall state separately each purpose for which the basic class is desired, the quantity desired for that purpose during the next calendar year, and the quantities used and estimated to be used, if any, for that purpose

during the current and preceding 2 calendar years. If the purpose is to manufacture the basic class into dosage form, the applicant shall state the official name, common or usual name, chemical name, or brand name of that form. If the purpose is to manufacture another substance, the applicant shall state the official name, common or usual name, chemical name, or brand name of the substance, and, if a controlled substance listed in any schedule, the schedule number and Bureau Controlled Substances Code Number, as set forth in Part 308 of this chapter, of the substance. If the purpose is to manufacture another basic class of controlled substance listed in schedule I or II, the applicant shall also state the quantity of the other basic class which the applicant has applied to manufacture pursuant to § 303.22 and the quantity of the first basic class necessary to manufacture a specified unit of the second basic class. BND Form 250 shall be filed on or before April 1 of the year preceding the calendar year for which the procurement quota is being applied. Copies of BND Form 250 may be obtained from, and shall be filed with, the Distribution Audit Branch, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Washington, D.C. 20537.

(c) The Director shall, on or before July 1 of the year preceding the calendar year during which the quota shall be effective, issue to each qualified applicant a procurement quota authorizing him to procure and use:

(1) All quantities of such class necessary to manufacture all quantities of other basic classes of controlled substances listed in schedules I and II which the applicant is authorized to manufacture pursuant to § 303.23; and

(2) Such other quantities of such class as the applicant has applied to procure and use and are consistent with his past use, his estimated needs, and the total quantity of such class that will be produced.

(d) Any person to whom a procurement quota has been issued may at any time request an adjustment in the quota by applying to the Director with a statement showing the need for the adjustment. Such application shall be filed with the Distribution Audit Branch, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Washington, D.C. 20537. The Director shall increase or decrease the procurement quota of such person if

66-017 0-72

and to the extent that he finds, after considering the factors enumerated in paragraph (c) of this section and any occurrences since the issuance of the procurement quota, that the need justifies an adjustment.

(e) The following persons need not obtain a procurement quota:

(1) Any person who is registered to manufacture a basic class of controlled substance listed in schedule I or II and who uses all of the quantity he manufactures in the manufacture of a substance not controlled under the Act;

(2) Any person who is registered or authorized to conduct chemical analysis with controlled substances (for controlled substances to be used in such analysis only); and

(3) Any person who is registered to conduct research with a basic class of controlled substance listed in schedule I or II and who is authorized to manufacture a quantity of such class pursuant to § 301.22(b) of this chapter.

[36 F.R. 7786, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971; 36 F.R. 18731, Sept. 21, 1971]

INDIVIDUAL MANUFACTURING QUOTAS § 303.21 manufacturing

quotas.

Individual

(a) The Director shall, on or before July 1 of each year, fix for and issue to each person who is registered to manufacture a basic class of controlled substance listed in schedule I or II, and who applies for a manufacturing quota, an individual manufacturing quota authorizing that person to manufacture during the next calendar year a quantity of that basic class. Any manufacturing quota fixed and issued by the Director shall be subject to his authority to reduce or limit it at a later date pursuant to § 303.26 and to his authority to revoke or suspend it at any time pursuant to §§ 301.45 and 301.46 of this chapter.

(b) No individual manufacturing quota shall be required for registrants listed in § 303.12(e).

§ 303.22 Procedure for applying for individual manufacturing quotas.

Any person who is registered to manufacture any basic class of controlled substance listed in schedule I or II and who desires to manufacture a quantity of such class shall apply on BND Form 189 for a manufacturing quota for such quantity of such class. Copies of BND Form 189 may be obtained from, and