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Electronic Code of Federal Regulations

e-CFR data is current as of April 2, 2020

Title 21Chapter IIPart 1305 → Subpart B


Title 21: Food and Drugs
PART 1305—ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES


Subpart B—DEA Form 222


Contents
§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.
§1305.20   Transition provisions allowing continued use of existing stocks of triplicate DEA Forms 222.

§1305.11   Procedure for obtaining DEA Forms 222.

(a) DEA Forms 222 are issued in mailing envelopes containing a predetermined number of forms based on the business activity of the registrant, each form consisting of one single-sheet. A limit, which is based on the business activity of the registrant, will be imposed on the number of DEA Forms 222 that will be furnished upon a requisition for order forms unless additional forms are specifically requested and a reasonable need for such additional forms is shown.

(b) Any person with an active registration that is authorized to order schedule I and II controlled substances is entitled to obtain a DEA Form 222, which will be supplied at any time after the DEA registration is granted. Any person holding a registration authorizing the person to obtain a DEA Form 222 may requisition the forms through a DEA secured network connection or by contacting any Division Office or the Registration Section of the Administration through the customer service center.

(c) Each requisition must show the name, address, and registration number of the registrant and the number of DEA Forms 222 desired.

(d) DEA Forms 222 will have an order form number and be 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; the registrant must report any errors to the local Division Office or the Registration Section of the Administration to modify the registration.

[84 FR 51374, Sept. 30, 2019]

§1305.12   Procedure for executing DEA Forms 222.

(a) A purchaser must prepare and execute a DEA Form 222 by use of a typewriter, computer printer, 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 §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.

[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51374, Sept. 30, 2019]

§1305.13   Procedure for filling DEA Forms 222.

(a) A purchaser must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier. The copy retained by the purchaser may be in paper or electronic form.

(b) A supplier may fill the order, if possible and if the supplier desires to do so, and must record on the original DEA Form 222 its DEA registration number and 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 the original DEA Form 222 for the supplier's files in accordance with §1305.17(c). Any supplier who is not required to report acquisition/disposition transactions to the Automation of Reports and Consolidated Orders System (ARCOS) under §1304.33(c) (such as a practitioner) must make and submit a copy of the original DEA Form 222 to DEA, either by mail to the Registration Section, or by email to DEA.Orderforms@usdoj.gov. The copy must be forwarded at the close of the month during which the order is filled. If an order is filled by partial shipments, the copy 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 its copy 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.

[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51374, Sept. 30, 2019]

§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 §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 in Part 3 on the original DEA Form 222) the DEA number of the second supplier, and must be signed and dated 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 §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.

[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019]

§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 the original DEA Form 222 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, the original DEA Form 222 and the statement must be retained in the files of the purchaser in accordance with §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.

[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019]

§1305.16   Lost and stolen DEA Forms 222.

(a) If a purchaser ascertains that an unfilled DEA Form 222 has been lost, the purchaser must execute another and attach a statement containing the order form 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. A copy of the second form and a copy of the statement must be retained with a copy of the DEA Form 222 first executed. A copy of the statement must be attached to a copy 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 the original DEA Form 222 to the purchaser, who must attach it to 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 any DEA Forms 222 are lost or stolen, and the purchaser is unable to state the order form numbers of the DEA Forms 222, the purchaser must report, in lieu of numbers of the forms, 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.

[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019]

§1305.17   Preservation of DEA Forms 222.

(a) The purchaser must retain a copy of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached.

(b) The supplier must retain the original of each DEA Form 222 that it has filled.

(c) DEA Forms 222 must be maintained separately from all other records of the registrant. DEA Forms 222 are required to be kept available for inspection for a period of two years. If a purchaser has several registered locations, the purchaser must retain a copy of the executed DEA Form 222 and any attached statements or other related documents (not including unexecuted DEA Forms 222, which may be kept elsewhere under §1305.12(e)), at the registered location printed on the DEA Form 222.

(d) The supplier of thiafentanil, carfentanil, etorphine hydrochloride, and diprenorphine must maintain DEA Forms 222 for these substances separately from all other DEA Forms 222 and records required to be maintained by the registrant.

(e) Electronic copies of DEA Forms 222 will be deemed to be maintained separately from all other records of the registrant, for the purposes of this section, if such copies are readily retrievable separately from all other records. Electronic copies of DEA Forms 222 may be stored on a system at a location different from the registered location, provided such copies are readily retrievable at the registered location.

[70 FR 16911, Apr. 1, 2005, as amended at 81 FR 58839, Aug. 26, 2016; 84 FR 51375, Sept. 30, 2019]

§1305.18   Return of unused DEA Forms 222.

If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser's registration) or is suspended or revoked under §1301.36 of this chapter for all Schedule I and II controlled substances for which the purchaser is registered, the purchaser must return all unused DEA Forms 222 to the Registration Section.

[84 FR 51375, Sept. 30, 2019]

§1305.19   Cancellation and voiding of DEA Forms 222.

(a) A purchaser may cancel part or all of an order on a DEA Form 222 by notifying the supplier in writing of the cancellation. The supplier must indicate the cancellation on the original DEA Form 222 sent by the purchaser by drawing a line through the canceled items and printing “canceled” in the space provided for the number of items shipped.

(b) A supplier may void part or all of an order on a DEA Form 222 by notifying the purchaser in writing of the voiding. The supplier must indicate the voiding in the manner prescribed for cancellation in paragraph (a) of this section.

[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019]

§1305.20   Transition provisions allowing continued use of existing stocks of triplicate DEA Forms 222.

Registrants may continue to use existing stocks of the triplicate DEA Form 222 until October 30, 2021. In any case, as soon as a registrant's supply of triplicate DEA Forms 222 is exhausted, the registrant must use the new single-sheet DEA Form 222. The provisions of this part are applicable to the use of triplicate forms, except for the specific rules as provided in this section.

(a) Procedure for obtaining triplicate DEA Forms 222. The DEA will no longer issue triplicate forms. Triplicate DEA Forms 222 will not be accepted after October 30, 2021.

(b) Procedure for executing triplicate DEA Forms 222. (1) A purchaser must prepare and execute a triplicate DEA Form 222 simultaneously by means of interleaved carbon sheets that are part of the triplicate DEA Form 222. Triplicate DEA Form 222 must be prepared by use of a typewriter, pen, or indelible pencil.

(2) 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. Triplicate DEA Forms 222 for carfentanil, etorphine hydrochloride, and diprenorphine must contain only these substances.

(3) 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.

(4) Each triplicate 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 DEA Form 222 under §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.

(5) 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.

(c) Procedure for filling triplicate DEA Forms 222. (1) A purchaser must submit Copy 1 and Copy 2 of the triplicate DEA Form 222 to the supplier and retain Copy 3 in the purchaser's files.

(2) 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 triplicate DEA Form 222. No triplicate DEA Form 222 is valid more than 60 days after its execution by the purchaser, except as specified in paragraph (c)(6) of this section.

(3) The controlled substances must be shipped only to the purchaser and the location printed by the Administration on the triplicate DEA Form 222, except as specified in paragraph (c)(6) of this section.

(4) The supplier must retain Copy 1 of the triplicate DEA Form 222 for his or her files in accordance with paragraph (g)(3) of this section 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.

(5) The purchaser must record on Copy 3 of the triplicate 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.

(6) DEA triplicate 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 triplicate 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.

(d) Procedure for endorsing triplicate DEA Forms 222. (1) A triplicate 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 paragraph (c) of this section, may be endorsed to another supplier for filling. The endorsement must be made only by the supplier to whom the triplicate DEA Form 222 was first made, must state (in the spaces provided on the reverse sides of Copies 1 and 2 of the triplicate DEA Form 222) the name and address of the second supplier, and must be signed by a person authorized to obtain and execute triplicate 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 paragraphs (c)(2) through (4) of this section, including shipping all substances directly to the purchaser.

(2) Distributions made on endorsed triplicate DEA Forms 222 must be reported by the second supplier in the same manner as all other distributions.

(e) Unaccepted and defective triplicate DEA Forms 222. (1) A triplicate DEA Form 222 must not be filled if either of the following apply:

(i) The order is not complete, legible, or properly prepared, executed, or endorsed.

(ii) The order shows any alteration, erasure, or change of any description.

(2) If a triplicate 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).

(3) 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.

(4) When a purchaser receives an unaccepted order, Copies 1 and 2 of the triplicate DEA Form 222 and the statement must be attached to Copy 3 and retained in the files of the purchaser in accordance with paragraph (g) of this section. A defective triplicate DEA Form 222 may not be corrected; it must be replaced by a new triplicate DEA Form 222 for the order to be filled.

(f) Lost and stolen triplicate DEA Forms 222. (1) If a purchaser ascertains that an unfilled triplicate DEA Form 222 has been lost, the purchaser 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 triplicate DEA Form 222 were not received through loss of that triplicate DEA Form 222. Copy 3 of the second form and a copy of the statement must be retained with Copy 3 of the triplicate DEA Form 222 first executed. A copy of the statement must be attached to Copies 1 and 2 of the second triplicate DEA Form 222 sent to the supplier. If the first triplicate 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. However, if the registrant no longer can use triplicate forms, then the registrant shall proceed by issuing a new single-sheet form in accordance with §1305.16.

(2) Whenever any used or unused triplicate 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.

(3) If the theft or loss includes any original triplicate DEA Forms 222 received from purchasers and the supplier is unable to state the serial numbers of the triplicate DEA Forms 222, the supplier must report the date or approximate date of receipt and the names and addresses of the purchasers.

(4) If an entire book of triplicate DEA Forms 222 is lost or stolen, and the purchaser is unable to state the serial numbers of the triplicate 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.

(5) If any unused triplicate 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.

(g) Preservation of triplicate DEA Forms 222. (1) The purchaser must retain Copy 3 of each executed triplicate DEA Form 222 and all copies of unaccepted or defective forms with each statement attached.

(2) The supplier must retain Copy 1 of each triplicate DEA Form 222 that it has filled.

(3) Triplicate DEA Forms 222 must be maintained separately from all other records of the registrant. Triplicate DEA Forms 222 are required to be kept available for inspection for a period of two years. If a purchaser has several registered locations, the purchaser must retain Copy 3 of the executed triplicate DEA Form 222 and any attached statements or other related documents (not including unexecuted triplicate DEA Forms 222, which may be kept elsewhere under paragraph (b)(5) of this section), at the registered location printed on the triplicate DEA Form 222.

(4) The supplier of thiafentanil, carfentanil, etorphine hydrochloride, and diprenorphine must maintain triplicate DEA Forms 222 for these substances separately from all other DEA triplicate Forms 222 and records required to be maintained by the registrant.

(h) Return of unused triplicate DEA Forms 222. If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser's registration) or is suspended or revoked under §1301.36 of this chapter for all schedule I and II controlled substances for which the purchaser is registered, the purchaser must return all unused triplicate DEA Forms 222 to the Registration Section.

(i) Cancellation and voiding of triplicate DEA Forms 222. (1) A purchaser may cancel part or all of an order on a triplicate DEA Form 222 by notifying the supplier in writing of the cancellation. The supplier must indicate the cancellation on Copies 1 and 2 of the triplicate DEA Form 222 by drawing a line through the canceled items and printing “canceled” in the space provided for the number of items shipped.

(2) A supplier may void part or all of an order on a triplicate DEA Form 222 by notifying the purchaser in writing of the voiding. The supplier must indicate the voiding in the manner prescribed for cancellation in paragraph (i)(1) of this section.

[84 FR 51375, Sept. 30, 2019]

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