305.12 305.13 305.14 305.15 forms. Lost and stolen order forms. 305.16 Interim use of IRS order forms and requisitions. AUTHORITY: The provisions of this Part 305 issued under secs. 301, 308, 501 (b), 84 Stat. 1253, 1259, 1260, 1271; 21 U.S.C. 821, 828, 871(b). SOURCE: The provisions of this Part 305 appear at 36 F.R. 7796, Apr. 24, 1971, unless otherwise noted. 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 § 305.04 and § 305.06. (c) The term "supplier" means any registered person entitled to fill order forms pursuant to § 305.08. (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 §§ 301.02 and 302.02 of this chapter. § 305.03 Distributions requiring order forms. An order form (BND Form 222c) 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 § 316.04(d) 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 § 301.27 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 substances by the master of a vessel pursuant to § 301.28(a) (3) of this chapter: Provided, That the special order form provided by the U.S. Public Health Service as required by that section is used and preserved in the manner prescribed on this order form. § 305.04 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 schedules 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. § 305.05 Procedure for obtaining order forms. (a) Order forms are issued in books of six forms, each form containing an original, duplicate and triplicate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit of three books of forms will be furnished on any requisition, unless additional books are specifically requested and a reasonable need for such additional books 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 on BND Form 222d, which may be obtained from the Registration Branch of the Bureau. Any person already holding order forms may requisition additional forms only on BND Form 222b, which is contained in each book of order forms. All requisitions shall be submitted to the Registration Branch, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Post Office Box 28083, Central Station, Washington, D.C. 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 fər reregistration, or by any person authorized to obtain and execute order forms by a power of attorney pursuant to § 305.07. (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 Branch of the Bureau by returning the forms with notification of the error. [36 F.R. 7796, Apr. 24, 1971, as amended at 36 F.R. 18732, Sept. 21, 1971] (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 BND Form 222c. 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 five lines on each order form. If one order form is not sufficient to include all items in an order, additional forms shall be used. 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 3-milliliter 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 form. The catalogue number of the article may be included at the discretion of the purchaser. (d) The name and address of the supplier from whom the controlled substances are being ordered shall be entered on the form. Only one supplier may be listed on any one form. (e) Each order form shall be signed and dated by a person authorized to sign a requisition for order forms on behalf of the purchaser pursuant to § 305.05 (c). The name of the purchaser, if different from the individual signing the order form, shall also be inserted in the signature space. Unexecuted order forms may be kept and may be executed at a location other than the registered location printed on the form, provided that all unexecuted forms are delivered promptly to the registered location upon an inspection of such location by any officer authorized to make inspections, or to enforce, any Federal, State, or local law regarding controlled substances. [36 F.R. 7796, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971; 36 F.R. 18732, Sept. 21, 1971] Any purchaser may authorize one or more individuals, whether or not located at the registered location of the purchaser, to obtain and execute order forms on his behalf by filing a power of attorney on BND Form 231 for each such individual with the Registration Branch, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Post Office Box 28083, Central Station, Washington, D.C. 20005. The power of attorney shall be signed by the same person who signed the most recent application for registration or reregistration and shall contain the signature of the individual being authorized to obtain and execute order forms, which individual shall affirm his signature. Any power of attorney may be revoked at any time by filing a notice of revocation, signed by the person who signed the power of attorney, with the Registration Branch at the foregoing address. It shall be necessary to submit a new power of attorney upon the reregistration of a purchaser only if the application for reregistration was signed by a person different from the person who signed the existing power of attorney. § 305.08 Persons entitled to fill order forms. An order form may be filled only by a person registered as a manufacturer or distributor of controlled substances listed in schedules I or II under section 303 of the Act (21 U.S.C. 823) or as an importer of such substances under section 1008 of the Act (21 U.S.C. 958), except for the following: (a) A person registered to dispense such substances under section 303 of the Act, or to export such substances under section 1008 of the Act, if he is discontinuing business or if his registration is expiring without reregistration, may dispose of any controlled substances listed in schedule I or II in his possession pursuant to order forms in accordance with § 307.14 of this chapter; (b) A person who has obtained any controlled substance in schedule I or II by order form may return such substance, or portion thereof, to the person from whom he obtained the substance or the manufacturer of the substance pursuant to the order form of the latter person; and (c) A person registered to dispense such substances may distribute such substances to another dispenser pursuant to, and only in the circumstances described in, § 307.11 of this chapter. [36 F.R. 7796, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971; 36 F.R. 18732, Sept. 21, 1971] its entirety, it may be filled in part and the balance supplied by additional shipments within 60 days following the date of the order form. No order form shall be valid more than 60 days after its execution by the purchaser, except as specified in paragraph (f) of this section. (c) The controlled substances shall only be shipped to the purchaser and at the location printed by the Bureau on the order form, except as specified in paragraph (f) of this section. (d) The supplier shall retain Copy 1 of the order form for his own files and forward Copy 2 to the Regional Director of the Bureau in the region in which the supplier is located. Copy 2 shall be forwarded at the close of the month during which the order is filled; if an order is filled by partial shipments, Copy 2 shall be forwarded at the close of the month during which the final shipment is made or during which the 60-day validity period expires. (e) The purchaser shall record on Copy 3 of the order form the number of commercial or bulk containers furnished on each item and the dates on which such containers are received by the purchaser. (f) Order forms submitted by registered procurement officers of the Defense Personnel Support Center of Defense Supply Agency for delivery to armed services establishments within the United States may be shipped to locations other than the location printed on the order form, and in partial shipments at different times not to exceed six months from the date of the order, as designated by the procurement officer when submitting the order. [36 F.R. 7796, Apr. 24, 1971, as amended at 36 F.R. 18732, Sept. 21, 1971] § 305.10 forms. Procedure for endorsing order (a) An order form made out to any supplier who cannot fill all or a part of the order within the time limitation set forth in § 305.09 may be endorsed to another supplier for filling. The endorsement shall be made only by the supplier to whom the order form was first made, shall state (in the spaces provided on the reverse sides of Copies 1 and 2 of the order form) the name and address of the second supplier, and shall be signed by a person authorized to obtain and execute order forms on behalf of the first supplier. The first supplier may not fill any part of an order on an endorsed form. The second supplier shall fill the order, if possible and if he desires to do so, in accordance with § 305.09 (b), (c), and (d), including shipping all substances directly to the purchaser. (b) Distributions made on endorsed order forms shall be reported by the second supplier in the same manner as all other distributions except that where the name of the supplier is requested on the reporting form, the second supplier shall record the name, address and registration number of the first supplier. § 305.11 Unaccepted and defective order forms. (a) No order form shall be filled if it: (1) Is not complete, legible, or properly prepared, executed or endorsed; or (2) Shows any alteration, erasure, or change of any description. (b) If an order form cannot be filled for any reason under this section, the supplier shall return Copies 1 and 2 to the purchaser with a statement as to the reason (e.g., illegible or altered). A supplier may for any reason refuse to accept any order and if a supplier refuses to accept the order, a statement that the order is not accepted shall be sufficient for purposes of this paragraph. (c) When received by the purchaser, Copies 1 and 2 of the order form and the statement shall be attached to Copy 3 and retained in the files of the purchaser in accordance with § 305.13. A defective order form may not be corrected; it must be replaced by a new order form in order for the order to be filled. § 305.12 Lost and stolen order forms. (a) If a purchaser ascertains that an unfilled order form has been lost, he shall execute another in triplicate and a statement containing the serial number and date of the lost form, and stating that the goods covered by the first order form were not received through loss of that order form. Copy 3 of the second form and a copy of the statement shall be retained with Copy 3 of the order form first executed. A copy of the statement shall be attached to Copies 1 and 2 of the second order form sent to the supplier. If the irst order form is subsequently received by the supplier to whom it was directed, the supplier shall mark upon the face thereof "Not accepted" and return Copies 1 and 2 to the purchaser, who shall attach it to Copy 3 and the statement. (b) Whenever any used or unused order forms are stolen from or lost (otherwise than in the course of transmission) by any purchaser or supplier, he shall immediately upon discovery of such theft or loss, report the same to the Registration Branch, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Post Office Box 28083, Central Station, Washington, D.C. 20005, stating the serial number of each form stolen or lost. If the theft or loss includes any original order forms received from purchasers and the supplier is unable to state the serial numbers of such order forms, he shall report the date or approximate date of receipt thereof and the names and addresses of the purchasers. If an entire book of order forms is lost or stolen, and the purchaser is unable to state the serial numbers of the order forms contained therein, he shall report, in lieu of the numbers of the forms contained in such book, the date or approximate date of issuance thereof. If any unused order form reported stolen or lost is subsequently recovered or found, the Registration Branch of the Bureau shall immediately be notified. [36 F.R. 7796, Apr. 24, 1971, as amended at 36 F.R. 13386, July 21, 1971] § 305.13 Preservation of order forms. (a) The purchaser shall retain Copy 3 of each order form which has been filled. He shall also retain in his files all copies of each unaccepted or defective order form and each statement attached thereto. (b) The supplier shall retain Copy 1 of each order form which he has filled. (c) Order forms must be maintained separately from all other records of the registrant. Order forms are required to be kept available for inspection for a period of 2 years. If a purchaser has several registered locations, he must retain Copy 3 of the executed order forms and any attached statements or other related documents (not including unexecuted order forms which may be kept elsewhere pursuant to § 305.06 (e)) at the registered location printed on the order form. § 305.14 Return of unused order forms. If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes his name or address as shown on his registration) or is suspended or revoked pursuant to §§ 301.45 or 301.46 of this chapter as to all controlled substances listed in schedules I and II for which he is registered, he shall return all unused order forms for such substance to the nearest office of the Bureau. [36 F.R. 7796, Apr. 24, 1971, as amended at 36 F.R. 18732, Sept. 21, 1971] § 305.15 Cancellation and voiding of order forms. (a) A purchaser may cancel part or all of an order on an order form by notifying the supplier in writing of such cancellation. The supplier shall indicate the cancellation on Copies 1 and 2 of the order form by drawing a line through the canceled items and printing "canceled" in the space provided for number of items shipped. (b) A supplier may void part or all of an order on an order form by notifying the purchaser in writing of such voiding. The supplier shall indicate the voiding in the manner prescribed for cancellation in paragraph (a) of this section. (c) No cancellation or voiding permitted by this section shall affect in any way contract rights of either the purchaser or the supplier. 306.24 (a) Existing order forms (IRS Form 2513) will be valid until April 30, 1972, for transactions of controlled substances listed in schedule I and II. Purchasers using existing IRS Forms 2513 after April 30, 1971, must place the registration number assigned by the Bureau on the form in the block which contains the name, address, old IRS registration, and class of registration. Registrants who obtain BND Form 222c, but still possess IRS order forms, should not discard the IRS Forms, but instead draw a line thru the unused forms and print "Void" across the line. Voided forms must be maintained for at least 2 years in the manner prescribed in § 305.13. (b) Effective May 1, 1971, only the Bureau will issue order forms. A purchaser desiring order forms (BND Form 222c) may obtain them by using IRS Form 679 found in the back of his current IRS order from book. In utilizing IRS Form 679, the registration number assigned by the Bureau must be placed in section 8 of the requisition form and the requisition forwarded to Registration Branch, Bureau of Narcotics and Dangerous 306.31 Filing of prescriptions. SCHEDULE III AND IV Requirement of prescription. Refilling of prescriptions. Labeling of substances. CONTROLLED SUBSTANCES LISTED IN Requirement of prescription. 306.32 Dispensing without prescription. AUTHORITY: The provisions of this Part 306 issued under secs. 301, 309, 501(b), 84 Stat. 1253, 1260, 1271; 21 U.S.C. 821, 829, 871(b). SOURCE: The provisions of this Part 306 appear at 36 F.R. 7799, Apr. 24, 1971; 36 F.R. 13386, July 21, 1971, unless otherwise noted. GENERAL INFORMATION § 306.01 Scope of Part 306. Rules governing the issuance, filling and filing of prescriptions pursuant to section 309 of the Act (21 U.S.C. 829) are set forth generally in that section and specifically by the sections of this part. |