E7-22984. New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222)

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The Drug Enforcement Administration (DEA) is proposing to amend its regulations to implement a new format for order forms (DEA Form 222) which are issued by DEA to DEA registrants to allow them to order schedule I and/or II controlled substances. The present format utilizes a three-part, carbon-copy form with Copies 2 and 3 replicating Copy 1. The proposed format will employ a single-sheet form. The new form will have enhanced security features and will be easier for DEA registrants to use.

DATES:

Written comments must be postmarked, and electronic comments must be sent, on or before January 28, 2008.

ADDRESSES:

To ensure proper handling of comments, please reference “Docket No. DEA-303P” on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be sent directly to DEA electronically by sending an electronic message to [e-mail]. Comments may also be sent electronically through http://www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http://www.regulations.gov Web site. DEA will accept electronic comments containing MS Word, WordPerfect, Adobe PDF, or Excel files only. DEA will not accept any file format other than those specifically listed here.

Posting of Public Comments: Please note that all comments received are considered part of the public record and made available for public inspection online at http://www.regulations.gov and in the Drug Enforcement Administration's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket.

Personal identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in the Drug Enforcement Administration's public docket file. If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.

FOR FURTHER INFORMATION CONTACT:

Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone [phone].

SUPPLEMENTARY INFORMATION:

Background

Legal Authority

The Drug Enforcement Administration (DEA) administers the Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.) as amended. DEA regulations implementing this statute are published in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1316. These regulations are designed to establish a framework for the legal distribution of controlled substances to ensure that there is a sufficient supply of these drugs for legitimate medical purposes while deterring their diversion to illegal purposes. Controlled substances are those substances listed in the schedules of the CSA and 21 CFR 1308.11-1308.15, and generally include narcotics, stimulants, depressants, hallucinogens, and anabolic steroids that have potential for abuse and physical and psychological dependence.

Controlled substances are divided into five schedules. Schedule I substances are drugs which have a high potential for abuse and no currently accepted medical use in treatment in the United States. They may be used only for research, chemical analysis, or manufacture of other drugs. Schedule II substances have legitimate medical uses, but a high potential for abuse and physical and psychological dependence, and are subject to more stringent controls than other legitimate controlled substances. Schedule III through V substances have legitimate medical uses; however, they have a lower potential for abuse and physical and psychological dependence than do schedule II controlled substances.

The CSA and DEA regulations require that persons involved in the manufacture, distribution, research, dispensing, import, and export of controlled substances register with DEA, keep track of all stocks of controlled substances, and maintain records to account for all controlled substances received, distributed, or otherwise disposed of. The overall goal of the CSA and its implementing regulations is to provide a closed distribution system so that a controlled substance is at all times under the legal control of a person registered, or specifically exempted from registration, by the Drug Enforcement Administration until it reaches the ultimate user or is destroyed. DEA achieves this goal by registering manufacturers, distributors, reverse distributors, dispensers, researchers, importers and exporters of controlled substances. Thus, any movement of controlled substances between these registered persons is covered by DEA regulations.

Order Forms

The CSA requires that schedule I and II controlled substances be distributed only pursuant to a written order made by the purchaser on a form issued by the Attorney General, (21 U.S.C. 828). This responsibility has been delegated to the Administrator of DEA (28 CFR 0.100) and redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (28 CFR 0.104; Appendix to Subpart R, § 7). DEA uses these order forms to allow better tracking of all distributions of schedule I and II controlled substances. As stated previously, order forms are required for schedule I and II controlled substances because they have a higher potential for abuse and physical and psychological dependence than schedule III through V controlled substances. The order forms are issued to DEA registrants to allow them to purchase controlled substances. The order forms are designated as DEA Form 222. The law and regulations require that DEA preprint certain information on these order forms including the name, address, and DEA number of the registrant, the authorized activity, and the schedules of the registrant (21 U.S.C. 828, 21 CFR 1305.11). Order forms are triplicate forms, printed on interleaved carbon sheets.

Whenever a DEA registrant wishes to acquire a schedule I and/or II controlled substance, that registrant must annotate on the order form the name and address of the supplying DEA registrant, the date requested, the number of packages of controlled substance ordered, the size of the package of the controlled substance ordered, and the name of the controlled substance ordered. The purchaser retains one copy (Copy 3) of the form and sends two copies to the supplier so that the order for a controlled substance can be filled. The supplier annotates the form by entering the actual number of packages of the controlled substance(s) shipped and the actual date shipped. The supplier retains one copy (Copy 1) of the order form sent to him/her by the purchaser, and sends the other copy (Copy 2) of the form to the DEA Special Agent in Charge in the area where the supplier is located. Upon receiving the controlled substances, the purchaser annotates on its copy of the order form the number of packages of the controlled substance(s) ordered which are actually received and the actual date received. Both the purchaser and the supplier are required to preserve their respective copy of the order form for two years and make it available to officials of the DEA for inspection, if requested.

Need for New Form

The proposed new format for DEA Form 222 will employ a single-sheet form. In executing a transaction of a schedule I and/or II controlled substance, a DEA registrant will process the new single-sheet form in a similar manner to the processing of the current three-part form. The change in processing will be that the single-sheet form will have to be copied rather than having the copies pre-printed. DEA will continue to preprint and issue the original form.

The new form is being initiated to improve security and to allow better ease in handling. The new form will have enhanced security features over the current three-part form. DEA will preprint the new form on sturdier paper with a special embedded watermark of the DEA emblem making it more difficult to copy for counterfeit purposes. If photocopied, the photocopy of the new form will display the DEA emblem and the statement “Copy” to hinder counterfeiting.

It is anticipated that the new form will be more convenient for DEA registrants to utilize. The old three-part form format was created more than thirty years ago and the processing of a transaction with carbon copies is an outdated concept. Today, new office technology exists such as laser printers and photocopiers which will allow DEA registrants greater ease in utilizing the single-sheet form.

The single-sheet form will be beneficial for DEA as well. The equipment used to print the interleaved carbon forms is old, and finding replacement parts and otherwise maintaining the equipment is costly, difficult, and time-consuming.

Transition From Old to New Format

If this regulation is finalized as proposed, once the new single-sheet form is in use, the current three-part form will be phased out, and eventually will no longer be issued by DEA. DEA registrants will be allowed to exhaust their supply of the old three-part forms as part of the transition. To effect a smooth transition, DEA registrants will be allowed to continue to order the current three-part form for at least one year once the new single-sheet form is introduced. Approximately two years after the establishment of the new single-sheet format, the old three-part form will be totally discontinued. Thus, business firms will have time to shift their processes to accommodate the new form.

Revision of DEA Regulations to Accommodate Single Sheet DEA Form 222

DEA proposes to amend its regulations pertaining to orders for schedule I and II controlled substances to allow for the transition from the three-part form to the single-sheet form of DEA Form 222. Initially, the new procedures for the single-sheet format will exist alongside the existing procedures for the three-part form. Eventually, in a later rulemaking, the procedures detailing the use of the three-part form will be deleted from the regulations.

DEA is amending its regulations to reflect the fact that only one original DEA Form 222 will be provided to purchasing registrants by DEA. Registrants purchasing schedule I and II controlled substances will now be required to make a copy of the form and send the original to their supplier for filling. It is important to note that the process for handling the DEA Form 222 remains unchanged. The only difference made by these proposed amendments is to require registrants to make photocopies of the form, rather than having DEA provide an original and two carbon copies.

Other Minor Regulatory Changes

In addition to the changes discussed above, DEA is proposing several minor regulatory changes as part of this rulemaking, as discussed below.

Currently, interleaved triplicate order forms are produced in books, with each book containing 7 order forms. The new single-sheet form will not be produced in books, giving DEA and registrants greater flexibility regarding the number of order forms to be requisitioned. Therefore, in § 1305.11, DEA is proposing to modify the language regarding the new single-sheet DEA Form 222 to indicate that a predetermined number of order forms, based on the business activity of the registrant, will be issued, rather than books of 7 order forms.

In § 1305.12, DEA is proposing to add to the list of acceptable methods for filling out a DEA Form 222 use of a computer printer, in addition to the existing typewriter, pen, or indelible pencil.

Regulatory Certifications

Regulatory Flexibility Act

The Deputy Assistant Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), and by approving it certifies that this regulation will not have a significant economic impact upon a substantial number of small entities. This rule proposes that DEA regulations be amended to implement a new format for order forms (DEA Form 222) which are issued by DEA to DEA registrants to allow them to order schedule I and/or II controlled substances. The present format utilizes a three-part, carbon-copy form with Copies 2 and 3 replicating Copy 1. The proposed format will employ a single-sheet form, which will incorporate additional security features and will be easier for DEA registrants to use.

Executive Order 12866

The Deputy Assistant Administrator further certifies that this rulemaking has been drafted in accordance with the principles of Executive Order 12866 Section 1(b). It has been determined that this is a significant regulatory action. Therefore, this action has been reviewed by the Office of Management and Budget.

Executive Order 12988

The Deputy Assistant Administrator further certifies that this regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988.

Executive Order 13132

This rulemaking does not preempt or modify any provision of State law; nor does it impose enforcement responsibilities on any State; nor does it diminish the power of any State to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

Paperwork Reduction Act

Although this rule establishes a new DEA Form 222, it does not affect the time necessary to complete the collection of information nor the persons required to use DEA Form 222 in the ordering of schedule I and II controlled substances. Nor does the revision of the design of the form—use of triplicate interleaved sheets versus single sheet—revise the fields contained on the form. The new form does not collect any new information or modify any existing information being collected. Accordingly, revisions to the DEA information collection entitled “U.S. Official Order Forms for Schedule I and II Controlled Substances (Accountable Forms), Order Form Requisition” (OMB approval number 1117-0010) are not necessary.

Congressional Review Act

This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

List of Subjects in 21 CFR Part 1305

• Drug traffic control
• Reporting requirements

For the reasons set forth above, 21 CFR part 1305 is proposed to be amended as follows:

PART 1305—ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES [AMENDED]

1. The authority citation for part 1305 continues to read as follows:

Authority: 21 U.S.C. 821, 828, and 871, unless otherwise noted.

2. Section 1305.11 is amended by revising paragraphs (a) and (b) to read as follows:

§ 1305.11

Procedure for obtaining DEA Forms 222.

(a)(1) Except as provided in paragraph (a)(2) of this section, DEA Forms 222 are issued in mailing envelopes containing seven forms, each form containing an original, duplicate, and triplicate copy (respectively, Copy 1, Copy 2, and Copy 3) (hereafter referred to as the “triplicate” form). 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.

(2) 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 (hereafter referred to as the “single sheet” form). 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 or renewal 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 by contacting any Division Office or the Registration Section of the Administration.

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3. Section 1305.12 is amended by revising paragraph (a) to read as follows:

§ 1305.12

Procedure for executing DEA Forms 222.

(a)(1) A purchaser must prepare and execute a triplicate 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, computer printer, pen, or indelible pencil.

(2) A purchaser must prepare a single sheet DEA Form 222 by use of a typewriter, computer printer, pen, or indelible pencil.

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4. Section 1305.13 is amended by revising paragraphs (a), (b), (d), and (e) to read as follows:

§ 1305.13

Procedure for filling DEA Forms 222.

(a)(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 purchaser must submit the original of the single sheet DEA Form 222 to the supplier and retain a copy in the purchaser's files.

(b)(1) For the triplicate DEA Form 222, 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.

(2) For the single sheet DEA Form 222, a supplier may fill the order, if possible and if the supplier desires to do so, and must record on the original and a copy 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.

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(d)(1) The supplier must retain Copy 1 of the triplicate 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.

(2) The supplier must retain the original of the single sheet DEA Form 222 for his or her files and forward a copy to the Special Agent in Charge of the Drug Enforcement Administration in the area in which the supplier is located. 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)(1) 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.

(2) The purchaser must record on its copy of the single sheet 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.

* * * * *

5. Section 1305.14 is amended by revising paragraph (a) to read as follows:

§ 1305.14

Procedure for endorsing DEA Forms 222.

(a)(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 § 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 triplicate 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 § 1305.13(b), (c), and (d), including shipping all substances directly to the purchaser.

(2) A single-sheet 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 2 on the original DEA Form 222 and on the copy to be sent to DEA) 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 § 1305.13(b), (c), (d), including shipping all substances directly to the purchaser.

* * * * *

6. Section 1305.15 is amended by revising paragraphs (b) and (d) to read as follows:

§ 1305.15

Unaccepted and defective DEA Forms 222.

* * * * *

(b)(1) 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).

(2) If a single-sheet DEA Form 222 cannot be filled for any reason under this section, the supplier must return the original copy to the purchaser with a statement as to the reason (e.g. illegible or altered).

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(d)(1) 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 § 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.

(2) When a purchaser receives an unaccepted order, the original of the single-sheet 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.

7. Section 1305.16 is amended by revising paragraph (a) to read as follows:

§ 1305.16

Lost and stolen DEA Forms 222.

(a)(1) If a purchaser ascertains that an unfilled triplicate 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.

(2) If a purchaser ascertains that an unfilled single-sheet DEA Form 222 has been lost, he or she must execute another 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. 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 it (“the original”) to the purchaser, who must attach it to the statement.

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8. Section 1305.17 is amended by revising paragraphs (a), (b), and (c) to read as follows:

§ 1305.17

Preservation of DEA Forms 222.

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

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

(2) The supplier must retain the original of each single-sheet DEA Form 222 that it has filled.

(c)(1) Triplicate 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 Copy 3 of the executed triplicate 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.

(2) Single-sheet 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 single-sheet 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.

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9. Section 1305.19 is revised to read as follows:

§ 1305.19

Cancellation and voiding of DEA Forms 222.

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

(b)(1) 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 (a)(1) of this section.

(2) A supplier may void part or all of an order on a single-sheet 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)(2) of this section.

Dated: November 17, 2007.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control.