[Code of Federal Regulations] [Title 21, Volume 9] [Revised as of April 1, 2005] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR1305.16] [Page 72] TITLE 21-FOOD AND DRUGS CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE PART 1305_ORDER FORMS--Table of Contents Sec. 1305.16 Special procedure for filling certain order forms. (a) The purchaser of carfentanil etorphine hydrochloride or diprenorphine shall submit copy 1 and 2 of the order form to the supplier and retain copy 3 in his own files. (b) The supplier, if he/she determines that the purchaser is a veterinarian engaged in zoo and exotic animal practice, wildlife management programs and/or research and authorized by the Administrator to handle these substances shall fill the order in accordance with the procedures set forth in Sec. 1305.09 except that: (1) Order forms for carfentanil etorphine hydrochloride and diprenorphine shall only contain these substances in reasonable quantities and (2) The substances shall only be shipped to the purchaser at the location printed by the Administration upon the order form under secure conditions using substantial packaging material with no markings on the outside which would indicate the content. [39 FR 17839, May 21, 1974, as amended at 54 FR 33674, Aug. 16, 1989; 62 FR 13964, Mar. 24, 1997] Effective Date Note: At 70 FR 16911, Apr. 1, 2005, part 1305 was revised, effective May 31, 2005. For the convenience of the user, the revised text is set forth as follows: [Page 72-78] TITLE 21-FOOD AND DRUGS CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE PART 1305_ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES Subpart A_General Requirements Sec. 1305.01 Scope of part 1305. 1305.02 Definitions. 1305.03 Distributions requiring a Form 222 or digitally signed electronic order. 1305.04 Persons entitled to order Schedule I and II controlled substances. 1305.05 Power of attorney. 1305.06 Persons entitled to fill orders for Schedule I and II controlled substances. 1305.07 Special procedure for filling certain orders. Subpart B_DEA Form 222 1305.11 Procedure for obtaining DEA Forms 222. 1305.12 Procedure for executing DEA Forms 222. 1305.13 Procedure for filling DEA Forms 222. 1305.14 Procedure for endorsing DEA Forms 222. 1305.15 Unaccepted and defective DEA Forms 222. 1305.16 Lost and stolen DEA Forms 222. 1305.17 Preservation of DEA Forms 222. 1305.18 Return of unused DEA Forms 222. 1305.19 Cancellation and voiding of DEA Forms 222. Subpart C_Electronic Orders 1305.21 Requirements for electronic orders. 1305.22 Procedure for filling electronic orders. 1305.23 Endorsing electronic orders. 1305.24 Central processing of orders. 1305.25 Unaccepted and defective electronic orders. 1305.26 Lost electronic orders. 1305.27 Preservation of electronic orders. 1305.28 Canceling and voiding electronic orders. 1305.29 Reporting to DEA. Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted. [[Page 73]] Subpart A_General Requirements Sec. 1305.01 Scope of part 1305. Procedures governing the issuance, use, and preservation of orders for Schedule I and II controlled substances are set forth generally by section 308 of the Act (21 U.S.C. 828) and specifically by the sections of this part. Sec. 1305.02 Definitions. Any term contained in this part shall have the definition set forth in the Act or part 1300 of this chapter. Sec. 1305.03 Distributions requiring a Form 222 or a digitally signed electronic order. Either a DEA Form 222 or its electronic equivalent as set forth in subpart C of this part and Part 1311 of this chapter is required for each distribution of a Schedule I or II controlled substance except for the following: (a) Distributions to persons exempted from registration under Part 1301 of this chapter. (b) Exports from the United States that conform with the requirements of the Act. (c) Deliveries to a registered analytical laboratory or its agent approved by DEA. (d) Delivery from a central fill pharmacy, as defined in Sec. 1300.01(b)(44) of this chapter, to a retail pharmacy. Sec. 1305.04 Persons entitled to order Schedule I and II controlled substances. (a) Only persons who are registered with DEA under section 303 of the Act (21 U.S.C. 823) to handle Schedule I or II controlled substances, and persons who are registered with DEA under section 1008 of the Act (21 U.S.C. 958) to export these substances may obtain and use DEA Form 222 (order forms) or issue electronic orders for these substances. Persons not registered to handle Schedule I or II controlled substances and persons registered only to import controlled substances are not entitled to obtain Form 222 or issue electronic orders for these substances. (b) An order for Schedule I or II controlled substances may be executed only on behalf of the registrant named on the order and only if his or her registration for the substances being purchased has not expired or been revoked or suspended. Sec. 1305.05 Power of attorney. (a) A registrant may authorize one or more individuals, whether or not located at his or her registered location, to issue orders for Schedule I and II controlled substances on the registrant's behalf by executing a power of attorney for each such individual, if the power of attorney is retained in the files, with executed Forms 222 where applicable, for the same period as any order bearing the signature of the attorney. The power of attorney must be available for inspection together with other order records. (b) A registrant may revoke any power of attorney at any time by executing a notice of revocation. (c) The power of attorney and notice of revocation must be similar to the following format: Power of Attorney for DEA Forms 222 and Electronic Orders ________________________________________________________________________ (Name of registrant) ________________________________________________________________________ (Address of registrant) ________________________________________________________________________ (DEA registration number) I, -------- (name of person granting power), the undersigned, who am authorized to sign the current application for registration of the above-named registrant under the Controlled Substances Act or Controlled Substances Import and Export Act, have made, constituted, and appointed, and by these presents, do make, constitute, and appoint -------- (name of attorney-in-fact), my true and lawful attorney for me in my name, place, and stead, to execute applications for Forms 222 and to sign orders for Schedule I and II controlled substances, whether these orders be on Form 222 or electronic, in accordance with 21 U.S.C. 828 and Part 1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and confirm all that said attorney must lawfully do or cause to be done by virtue hereof. ________________________________________________________________________ (Signature of person granting power) I, -------- (name of attorney-in-fact), hereby affirm that I am the person named herein as attorney-in-fact and that the signature affixed hereto is my signature. (signature of attorney-in-fact) Witnesses: 1. ------------ 2. ------------ Signed and dated on the -------- day of --------, (year), at -------- . Notice of Revocation The foregoing power of attorney is hereby revoked by the undersigned, who is authorized to sign the current application for registration of the above-named registrant under the Controlled Substances Act or the Controlled Substances Import and Export Act. Written notice of this revocation has been given to the attorney-in-fact -------- this same day. ________________________________________________________________________ (Signature of person revoking power) Witnesses: 1. ------------ 2. ------------ [[Page 74]] Signed and dated on the -------- day of -------- , (year), at -------- . (d) A power of attorney must be executed by the person who signed the most recent application for DEA registration or reregistration; the person to whom the power of attorney is being granted; and two witnesses. (e) A power of attorney must be revoked by the person who signed the most recent application for DEA registration or reregistration, and two witnesses. Sec. 1305.06 Persons entitled to fill orders for Schedule I and II controlled substances. An order for Schedule I and II controlled substances, whether on a DEA Form 222 or an electronic order, may be filled only by a person registered with DEA as a manufacturer or distributor of controlled substances listed in Schedule I or II pursuant to section 303 of the Act (21 U.S.C. 823) or as an importer of such substances pursuant to section 1008 of the Act (21 U.S.C. 958), except for the following: (a) A person registered with DEA to dispense the substances, or to export the substances, if he/she is discontinuing business or if his/her registration is expiring without reregistration, may dispose of any Schedule I or II controlled substances in his/her possession with a DEA Form 222 or an electronic order in accordance with Sec. 1301.52 of this chapter. (b) A purchaser who has obtained any Schedule I or II controlled substance by either a DEA Form 222 or an electronic order may return the substance to the supplier of the substance with either a DEA Form 222 or an electronic order from the supplier. (c) A person registered to dispense Schedule II substances may distribute the substances to another dispenser with either a DEA Form 222 or an electronic order only in the circumstances described in Sec. 1307.11 of this chapter. (d) A person registered or authorized to conduct chemical analysis or research with controlled substances may distribute a Schedule I or II controlled substance to another person registered or authorized to conduct chemical analysis, instructional activities, or research with the substances with either a DEA Form 222 or an electronic order, if the distribution is for the purpose of furthering the chemical analysis, instructional activities, or research. (e) A person registered as a compounder of narcotic substances for use at off-site locations in conjunction with a narcotic treatment program at the compounding location, who is authorized to handle Schedule II narcotics, is authorized to fill either a DEA Form 222 or an electronic order for distribution of narcotic drugs to off-site narcotic treatment programs only. Sec. 1305.07 Special procedure for filling certain orders. A supplier of carfentanil, etorphine hydrochloride, or diprenorphine, if he or she determines that the purchaser is a veterinarian engaged in zoo and exotic animal practice, wildlife management programs, or research, and is authorized by the Administrator to handle these substances, may fill the order in accordance with the procedures set forth in Sec. 1305.17 except that: (a) A DEA Form 222 or an electronic order for carfentanil, etorphine hydrochloride, and diprenorphine must contain only these substances in reasonable quantities. (b) The substances must be shipped, under secure conditions using substantial packaging material with no markings on the outside that would indicate the content, only to the purchaser's registered location. Subpart B_DEA Form 222 Sec. 1305.11 Procedure for obtaining DEA Forms 222. (a) DEA Forms 222 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 DEA Forms 222, 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 that would entitle him or her to obtain a DEA Form 222 may requisition the forms by so indicating on the application form; a DEA Form 222 will be supplied upon the registration of the applicant. Any person holding a registration entitling him or her to obtain a DEA Form 222 may requisition the forms for the first time by contacting any Division Office or the Registration Section of the Administration. Any person already holding a DEA Form 222 may requisition additional forms on DEA Form 222a, which is mailed to a registrant approximately 30 days after each shipment of DEA Forms 222 to that registrant, or by contacting any Division Office or the Registration Section of the Administration. All requisition forms (DEA Form 222a) must be submitted to the DEA Registration Section. (c) Each requisition must show the name, address, and registration number of the registrant and the number of books of DEA Forms 222 desired. Each requisition must 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 DEA Forms 222 by a power of attorney under Sec. 1305.05. [[Page 75]] (d) DEA Forms 222 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 Section of the Administration by returning the forms with notification of the error. Sec. 1305.12 Procedure for executing DEA Forms 222. (a) A purchaser must prepare and execute a DEA Form 222 simultaneously in triplicate by means of interleaved carbon sheets that are part of the DEA Form 222. DEA Form 222 must be prepared by use of a typewriter, pen, or indelible pencil. (b) Only one item may be entered on each numbered line. An item must consist of one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance. The number of lines completed must be noted on that form at the bottom of the form, in the space provided. DEA Forms 222 for carfentanil, etorphine hydrochloride, and diprenorphine must contain only these substances. (c) The name and address of the supplier from whom the controlled substances are being ordered must be entered on the form. Only one supplier may be listed on any form. (d) Each DEA Form 222 must be signed and dated by a person authorized to sign an application for registration or a person granted power of attorney to sign a Form 222 under Sec. 1305.05. The name of the purchaser, if different from the individual signing the DEA Form 222, must also be inserted in the signature space. (e) Unexecuted DEA Forms 222 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 the location by any officer authorized to make inspections, or to enforce, any Federal, State, or local law regarding controlled substances. Sec. 1305.13 Procedure for filling DEA Forms 222. (a) A purchaser must submit Copy 1 and Copy 2 of the DEA Form 222 to the supplier and retain Copy 3 in the purchaser's files. (b) A supplier may fill the order, if possible and if the supplier desires to do so, and must record on Copies 1 and 2 the number of commercial or bulk containers furnished on each item and the date on which the containers are shipped to the purchaser. If an order cannot be filled in its entirety, it may be filled in part and the balance supplied by additional shipments within 60 days following the date of the DEA Form 222. No DEA Form 222 is valid more than 60 days after its execution by the purchaser, except as specified in paragraph (f) of this section. (c) The controlled substances must be shipped only to the purchaser and the location printed by the Administration on the DEA Form 222, except as specified in paragraph (f) of this section. (d) The supplier must retain Copy 1 of the DEA Form 222 for his or her files and forward Copy 2 to the Special Agent in Charge of the Drug Enforcement Administration in the area in which the supplier is located. Copy 2 must be forwarded at the close of the month during which the order is filled. If an order is filled by partial shipments, Copy 2 must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period expires. (e) The purchaser must record on Copy 3 of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser. (f) DEA Forms 222 submitted by registered procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed services establishments within the United States may be shipped to locations other than the location printed on the DEA Form 222, 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. Sec. 1305.14 Procedure for endorsing DEA Forms 222. (a) A DEA Form 222, made out to any supplier who cannot fill all or a part of the order within the time limitation set forth in Sec. 1305.13, may be endorsed to another supplier for filling. The endorsement must be made only by the supplier to whom the DEA Form 222 was first made, must state (in the spaces provided on the reverse sides of Copies 1 and 2 of the DEA Form 222) the name and address of the second supplier, and must be signed by a person authorized to obtain and execute DEA Forms 222 on behalf of the first supplier. The first supplier may not fill any part of an order on an endorsed form. The second supplier may fill the order, if possible and if the supplier desires to do so, in accordance with Sec. 1305.13(b), (c), and (d), including shipping all substances directly to the purchaser. (b) Distributions made on endorsed DEA Forms 222 must 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 must record the name, address, and registration number of the first supplier. [[Page 76]] Sec. 1305.15 Unaccepted and defective DEA Forms 222. (a) A DEA Form 222 must not be filled if either of the following apply: (1) The order is not complete, legible, or properly prepared, executed, or endorsed. (2) The order shows any alteration, erasure, or change of any description. (b) If a DEA Form 222 cannot be filled for any reason under this section, the supplier must return Copies 1 and 2 to the purchaser with a statement as to the reason (e.g., illegible or altered). (c) 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 is sufficient for purposes of this paragraph. (d) When a purchaser receives an unaccepted order, Copies 1 and 2 of the DEA Form 222 and the statement must be attached to Copy 3 and retained in the files of the purchaser in accordance with Sec. 1305.17. A defective DEA Form 222 may not be corrected; it must be replaced by a new DEA Form 222 for the order to be filled. Sec. 1305.16 Lost and stolen DEA Forms 222. (a) If a purchaser ascertains that an unfilled DEA Form 222 has been lost, he or she must execute another in triplicate and attach a statement containing the serial number and date of the lost form, and stating that the goods covered by the first DEA Form 222 were not received through loss of that DEA Form 222. Copy 3 of the second form and a copy of the statement must be retained with Copy 3 of the DEA Form 222 first executed. A copy of the statement must be attached to Copies 1 and 2 of the second DEA Form 222 sent to the supplier. If the first DEA Form 222 is subsequently received by the supplier to whom it was directed, the supplier must mark upon the face ``Not accepted'' and return Copies 1 and 2 to the purchaser, who must attach it to Copy 3 and the statement. (b) Whenever any used or unused DEA Forms 222 are stolen or lost (other than in the course of transmission) by any purchaser or supplier, the purchaser or supplier must immediately upon discovery of the theft or loss, report the theft or loss to the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located, stating the serial number of each form stolen or lost. (c) If the theft or loss includes any original DEA Forms 222 received from purchasers and the supplier is unable to state the serial numbers of the DEA Forms 222, the supplier must report the date or approximate date of receipt and the names and addresses of the purchasers. (d) If an entire book of DEA Forms 222 is lost or stolen, and the purchaser is unable to state the serial numbers of the DEA Forms 222 in the book, the purchaser must report, in lieu of the numbers of the forms contained in the book, the date or approximate date of issuance. (e) If any unused DEA Form 222 reported stolen or lost is subsequently recovered or found, the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located must immediately be notified.