Code of Federal Regulations: Containing a Codification of Documents of ...

(10) Phentermine; and (11) Pipradrol.

Data shall be presented in such a manner as to identify the particular form, strength, and trade name, if any, of the product containing the controlled substance for which the report is being made. For this purpose, persons filing reports shall utilize the National Drug Code Number assigned to the product under the National Drug Code System of the Food and Drug Administration. (b) Transactions reported. Reports shall provide data on each acquisition to inventory (identifying whether it is, e.g., by purchase or transfer, return from a customer, recovery of waste material, manufacture from other materials, or supplied by the Federal Government) and each reduction from inventory (identifying whether it is, e.g., by sale or transfer, sampling, use in production, loss through nonrecoverable waste, theft, destruction, or seizure by Government agencies). These reports shall be filed every month not later than the 15th day of the month succeeding the month for which it is submitted; except that a registrant may be given permission to file more frequently or less frequently (but not less than quarterly), depending on the number of transactions being reported each time by that registrant.

(c) Inventories reported. Reports shall provide data on the stocks of each reported controlled substance on hand as of the close of business on December 31 of each year, indicating whether the substance is in storage or in process of manufacturing. These reports shall be filed no later than January 15 of the following year.

(d) Registrants manufacturing etorphine diprenorphine shall, on a weekly basis, forward a copy of the order forms received for these substances to the Administration.

(Approved by the Office of Management and Budget under control number 1117-0003)

[37 FR 28714, Dec. 29, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 17838, May 21, 1974; 49 FR 37060, Sept. 21, 1984. Redesignated and amended at 51 FR 5320, Feb. 13, 1986]

§ 1304.36 Reports from packagers and labelers.

Each person who is registered to manufacture controlled substances and who only packages, repackages, labels, or relabels such substances shall report as follows:

(a) Substances covered. Reports shall include data on each controlled substance listed in Schedule I and II and on each narcotic controlled substance listed in Schedule III (but not on any material, compound, mixture, or preparation containing a quantity of a substance having a stimulant effect on the central nervous system, which material, compound, mixture, or preparation is listed in Schedule III or on any narcotic controlled substance listed in Schedule V). Data shall be presented in such a manner as to identify the particular form, strength, and trade name, if any, of the product containing the controlled substance for which the report is being made. For this purpose, persons filing reports shall utilize the National Drug Code Number assigned to the product under the National Drug Code System of the Food and Drug Administration.

(b) Transactions reported. Reports shall provide data on each acquisition to inventory (identifying whether it is, e.g., by purchase or transfer, return from a customer, or supply by the Federal Government and each reduction from inventory (identifying whether it is, e.g., by sale or transfer, sampling, theft, destruction, or seizure by Government agencies). These reports shall be filed every month not later than the 15th day of the month succeeding the month for which it is submitted; except that a registrant may be given permission to file more frequently or less frequently (but not less than quarterly), depending on the number of transactions being reported each time by that registrant.

(c) Inventories reported. Reports shall provide data on the stocks of each reported controlled substance on hand as of the close of business on December 31 of each year. These reports shall be filed no later than January 15 of the following year.

(d) Exceptions. A registered institutional practitioner who repackages or relabels exclusively for distribution to

and dispensing by agents, employees, or affiliated institutional practitioners of the registrant may be exempted from filing reports under this section by applying to the ARCOS Unit of the Administration.

(Approved by the Office of Management and Budget under control number 1117-0003)

[37 FR 28714, Dec. 29, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 38 FR 34998, Dec. 21, 1973; 46 FR 28841, May 29, 1981; 49 FR 37060, Sept. 21, 1984. Redesignated at 51 FR 5320, Feb. 13, 1986]

§ 1304.37 Reports from distributors.

Each person who is registered to distribute controlled substances shall report as follows:

(a) Substances covered. Reports shall include data on each controlled substance listed in Schedules I and II and on each narcotic controlled substance listed in Schedule III (but not on any material, compound, mixture or preparation containing a quantity of a substance having a stimulant effect on the central nervous system, which material, compound, mixture or preparation is listed in Schedule III or on any narcotic controlled substance listed in Schedule V). Data shall be presented in such a manner as to identify the particular form, strength, and trade name, if any, of the product containing the controlled substance for which the report is being made. For this purpose, persons filing reports shall utilize the National Drug Code Number assigned to the product under the National Drug Code System of the Food and Drug Administration.

(b) Transactions reported. Reports shall provide data on each acquisition to inventory (identifying whether it is, e.g., by purchase or transfer, return from a customer, or supply by the Federal Government) and each reduction from inventory (identifying whether it is, e.g., by sale or transfer, sampling, theft, destruction, or seizure by Government agencies). These reports shall be filed every month not later than the 15th day of the month succeeding the month for which it is submitted: except that a registrant may be given permission to file more frequently or less frequently (but not less than quarterly), depending on the number of trans

actions being reported each time by that registrant.

(d) Exceptions. A registered institutional practitioner which distributes exclusively to (for dispensing by) agents, employees, or affiliated institutional practitioners of the registrant may be exempted from filing reports under this section by applying to the ARCOS Unit of the Administration.

[37 FR 28714, Dec. 29, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 38 FR 34998, Dec. 21, 1973; 46 FR 28841, May 29, 1981. Redesignated at 49 FR 37060, Sept. 21, 1984. Redesignated at 51 FR 5320, Feb. 13, 1986]

con

§ 1304.38 Reports from manufacturers importing poppy straw or centrate of poppy straw.

(a) Every manufacturer importing poppy straw or concentrate of poppy straw shall submit in addition to Form 333, Form DEA 247(c) accounting for the importation and for all manufacturing operations performed between importation and the production in bulk of finished marketable products, standardized in accordance with the U.S. Pharmacopeia, National Formulary, or other recognized medical standards. Subsequent manufacture from such products, including bottling or packaging operations, shall be accounted for in the returns on DEA Form 333 (§ 1304.38) and its supplements. DEA Form 247(c) shall be submitted quarterly to the Drug Control Section, Drug Enforcement Administration, Department of Justice, Washington, DC 20537, on or before the 15th day of the month immediately following the period for which it is submitted.

(b) The report of manufacture from poppy straw or concentrate of poppy straw shall consist of summaries with supporting detail sheets accounting for original manufacture from poppy straw to concentrate, and from concentrate of poppy straw, production from morphine for further manufacture and also accounting for all stocks of poppy

straw, concentrate of poppy straw, morphine for further manufacture and other crude alkaloids.

(c) The detail sheets (DEA 247(c)) supporting the summary of manufacture from poppy straw or concentrate of poppy straw shall show separately the amount of poppy straw or concentrate imported, the poppy straw used for production of concentrate, the concentrate used for extraction of alkaloids, subsequent manufacture from those alkaloids and the inventory of poppy straw and concentrate of poppy straw at the close of the reporting period.

(d) Upon importation of poppy straw or concentrate of poppy straw, samples will be selected and assays made by the importing manufacturer in a manner and according to a method previously approved by DEA. Where final assay data is not determined at the time of rendering report, the report shall be made on the basis of the best data available, subject to adjustment, and the necessary adjusting entries shall be made on the next report.

(e) Upon withdrawal of poppy straw or concentrate of poppy straw from Customs custody, the importing manufacturer shall assign to each lot or container an identification number by which the poppy straw or concentrate will be associated with the lot assay and identified in reports.

(f) Where factory procedure is such that partial withdrawals of poppy straw or concentrate are made from individual containers, there shall be attached to each container a stock record card on which shall be kept a complete record of all withdrawals therefrom.

(g) Concentrate of poppy straw and derivatives produced for exclusive use in further manufacturing purposes shall be reported produced when they come into existence in that form in which they are to be so used. Alkaloids or derivatives produced exclusively for distribution shall be reported as produced when manufacture has actually been completed and the finished marketable product ready for packaging and distribution. Such products shall be regarded as ready for packaging and distribution as soon as all processing other than mere packaging has been completed. Products manufactured

partly for distribution and partly for use in further manufacture will be reported produced as soon as manufacture is complete and they are ready either for use in further manufacture or for packaging for distribution.

(h) Subject to §1303.24(c) of this chapter, no accumulations of morphine or other narcotic controlled substances in their pure or near-pure states shall be permitted to remain inactively in process for an unreasonable time in light of efficient industrial practices. All such products nearing completion of their respective processes and approaching a condition of purity shall be carefully protected, promptly completed, and immediately transferred to finished stocks, and reported as produced.

(i) In making conversions of concentrate of poppy straw alkaloids and their salts to anhydrous morphine the quantity of the particular alkaloid or salt in avoirdupois ounces shall be multiplied by a conversion factor arrived at by ascertaining the ratio, carried to the fourth decimal place, between the respective molecular weight of such alkaloid or salt and the molecular weight of anhydrous morphine (285.16), such weights being computed to the third decimal place from the chemical formulae of the substances and the atomic weights of elements, as adopted by the International Committee on Chemical Elements and published in the latest edition of the U.S. Pharmacopoeia.

[40 FR 6779, Feb. 14, 1975, as amended at 40 FR 42866, Sept. 17, 1975; 46 FR 28841, May 29, 1981. Redesignated at 49 FR 37060, Sept. 21, 1984. Redesignated and amended at 51 FR 5319, 5320, Feb. 13, 1986]

1305.13 Preservation of order forms. 1305.14 Return of unused order forms. 1305.15 Cancellation and voiding of order forms.

1305.16 Special procedure for filling certain order forms.

AUTHORITY: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.

SOURCE: 36 FR 7796, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

§ 1305.01 Scope of Part 1305.

Procedures governing the issuance, use, and preservation of order forms pursuant to section 1308 of the Act (21 U.S.C. 828) are set forth generally by that section and specifically by the sections of this part.

§ 1305.02 Definitions.

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

(a) The term Act means the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951).

(b) The term purchaser means any registered person entitled to obtain and execute order forms pursuant to § 1305.04 and § 1305.06.

(d) 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 §§ 1301.02 and 1302.02 of this chapter.

§ 1305.03 Distributions requiring order forms.

An order form (DEA Form 222) is required for each distribution of a controlled substance listed in Schedule I or II, except for the following:

(a) The exportation of such substances from the United States in conformity with the Act;

(b) The delivery of such substances to or by a common or contract carrier for carriage in the lawful and usual course of its business, or to or by a warehouseman for storage in the lawful and usual course of its business (but excluding such carriage or storage by the owner of the substance in connection with the distribution to a third person);

(c) The procurement of a sample of such substances by an exempt law enforcement official pursuant to § 1301.26(b) of this chapter, provided that the receipt required by that section is used and is preserved in the manner prescribed in this part for order forms;

(d) The procurement of such substances by a civil defense or disaster relief organization, pursuant to § 1301.27 of this chapter, provided that the Civil Defense Emergency Order Form required by that section is used and is preserved with other records of the registrant; and

(e) The purchase of such sustances by the master or first officer of a vessel pursuant to §1301.28 of this chapter: Provided, That copies of the record of sale are generated, distributed and preserved by the vendor according to that section.

(f) The delivery of such substances to a registered analytical laboratory, or its agent approved by DEA, from an anonymous source for the analysis of the drug sample, provided the laboratory has obtained a written waiver of the order form requirement from the Special Agent in Charge of the Area in which the laboratory is located, which waiver may be granted upon agreement of the laboratory to conduct its activities in accordance with Administration guidelines.

[36 FR 7796, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 15031, Apr. 30, 1974; 47 FR 41735, Sept. 22, 1982; 50 FR 31590, Aug. 5, 1985; 51 FR 5320, Feb. 13, 1986; 53 FR 4963, Feb. 19, 1988]

§ 1305.04 Persons entitled to obtain and execute order forms.

(a) Order forms may be obtained only by persons who are registered under section 303 of the Act (21 U.S.C. 823) to handle controlled substances listed in Schedules I and II, and by persons who are registered under section 1008 of the Act (21 U.S.C. 958) to export such substances. Persons not registered to handle controlled substances listed in Schedule I or II and persons registered only to import controlled substances listed in any schedule are not entitled to obtain order forms.

(b) An order form may be executed only on behalf of the registrant named thereon and only if his registration as to the substances being purchased has not expired or been revoked or suspended.

§ 1305.05 Procedure for obtaining order forms.

(a) Order Forms are issued in mailing envelopes containing either seven or fourteen forms, each form containing an original duplicate and triplicate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit, which is based on the business activity of the registrant, will be imposed on the number of order forms which will be furnished on any requisition unless additional forms are specifically requested and a reasonable need for such additional forms is shown.

(b) Any person applying for a registration which would entitle him to obtain order forms may requisition such forms by so indicating on the application form; order forms will be supplied upon the registration of the applicant. Any person holding a registration entitling him to obtain order forms may requisition such forms for the first time by contacting any Division Office or the Registration Unit of the Administration. Any person already holding order forms may requisition additional forms on DEA Form 222a which is mailed to a registrant approximately 30 days after each shipment of order forms to that registrant or by contacting any Division Office or the Registration Unit of the Administration. All requisition forms (DEA Form 222a) shall be submitted to the Registration Unit, Drug Enforcement Administration, Department of Justice, Post Office Box 28083, Central Station, Washington, DC 20005.

(c) Each requisition shall show the name, address, and registration number of the registrant and the number of books of order forms desired. Each requisition shall be signed and dated by the same person who signed the most recent application for registration or for reregistration, or by any person authorized to obtain and execute order forms by a power of attorney pursuant to § 1305.07.

(d) Order forms will be serially numbered and issued with the name, address and registration number of the registrant, the authorized activity and schedules of the registrant. This information cannot be altered or changed by the registrant; any errors must be corrected by the Registration Unit of the Administration by returning the forms with notification of the error.

[36 FR 7796, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 FR 5319, Feb. 13, 1986; 53 FR 4963, Feb. 19, 1988]

(a) Order forms shall be prepared and executed by the purchaser simultaneously in triplicate by means of interleaved carbon sheets which are part of the DEA Form 222. Order forms shall be prepared by use of a typewriter, pen, or indelible pencil.

(b) Only one item shall be entered on each numbered line. There are ten lines on each order form. If one order form is not sufficient to include all items in an order, additional forms shall be used. Order forms for carfentanil etorphine hydrochloride and diprenorphine shall contain only these substances. The total number of items ordered shall be noted on that form in the space provided.

(c) An item shall consist of one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance; a separate item shall be made for each commercial or bulk container of different finished or bulk form, quantity or substance. For each item the form shall show the name of the article ordered, the finished or bulk form of the article (e.g., 10-milligram tablet, 10-milligram concentration per fluid ounce or milliliter, or U.S.P.), the number of units or volume in each commercial or bulk container (e.g., 100-tablet bottle or 3milliliter vial) or the quantity or volume of each bulk container (e.g., 10 kilograms), the number of commercial or bulk containers ordered, and the name and quantity per unit of the controlled substance or substances contained in the article if not in pure

« Previous Continue »

Books