“HOW TO SURVIVE A DEA INSPECTION SERIES: UNDERSTANDING THE NEW DEA REGULATIONS ON PAPER DEA FORMS 222 AND THE USE OF THE POWER OF ATTORNEY AUTHORIZATION.” ©
(DISCLAIMER: PharmaDiversion LLC™ does not act or speak on behalf of DEA)
On September 30, 2019, the Diversion Control Division (Diversion) of the Drug Enforcement Administration (DEA) posted a federal register titled “Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222)”. The changes can be found in the following DEA Diversion link (https://www.deadiversion.usdoj.gov/fed_regs/rules/2019/fr0930.htm). The change can also be found in the DEA Diversion website (https://deadiversion.usdoj.gov).
The “FINAL RULE” will be effective October 30, 2019 which covers the modifications of regulations concerning paper DEA Forms 222 and the authorization of Power of Attorney (POA) letters for ordering Schedules I and II controlled substances. The changes in the final rule will modify Title 21, Code of Federal Regulations (21CFR) Sections 1305. The summary of the changes, noted in the final rule, are listed as the following.
Changes in the Final Rule
This final rule makes a number of substantive changes to the provisions of the proposed rule, as well as some non-substantive corrections and style edits to improve clarity. Regulatory text referring to registrants as “he or she,” “him or her,” or in similar ways has been updated to reflect that purchasers may be corporate entities. The substantive changes to the regulatory text are listed below.
As discussed in the comment analysis section, above, Sec. 1305.05(f) has been added to permit electronic signatures on POAs executed under that section. The witness requirement remains in place, but witnesses are permitted to sign a POA electronically.
This final rule also includes some non-substantive changes to Sec. 1305.05(d) to improve clarity.
As discussed in the comment analysis section, above, Sec. 1305.11(c) has been updated to reflect that registrants are not required to sign or date Form 222 requisition requests, or to provide their address with such requests.
As discussed in the comment analysis section, above, Sec. 1305.13(a) has been updated to make explicit that purchasers must make a copy of the original Form 222 for their records before forwarding the original to the supplier, and that purchasers may retain either paper or electronic copies of Forms 222 for their records.
As discussed in the comment responses, above, Sec. 1305.13(b) has been updated to not require ARCOS-reporting suppliers to create and fill out copies of Forms 222 in addition to the originals.
Section 1305.13(d) has been updated to remove fax as one of the options for submitting copies of completed Forms 222 to the DEA. On further review, the DEA believes the cost of providing this submission option would outweigh the marginal benefit to the few registrants who would submit copies by fax. Even if fax submission were permitted, the DEA believes that the vast majority of registrants would use the other options available–mail and email. Removing fax submissions as an option will simplify the processing of Form 222 copies for DEA, though excepted cost savings of this change are minimal.
As discussed in the comment responses, above, Sec. 1305.17(e) has been added in this final rule to clarify that the requirement to maintain copies of Forms 222 separately from all other records may be met, for electronic copies, by storing them in such a way that they are readily retrievable separately from all other records.
Additionally, newly added Sec. 1305.17(e) also includes a provision allowing electronic copies of Forms 222 to be stored at a location different from the registered location, provided such forms are readily retrievable at the registered location upon request. This will give purchasers more flexibility in utilizing electronic records systems while still ensuring the inspection process is not unduly hindered by complex recordkeeping arrangements.
Section 1305.18 has been updated to properly reflect the requirements of Sec. 1301.52(c), which directs registrants discontinuing business activities with respect to controlled substances to return all unexecuted Forms 222 to the Registration Section at DEA headquarters. Section 1305.18 currently states that unused Forms 222 should be returned to the nearest DEA office. This final rule resolves this conflict by updating Sec. 1305.18 to require registrants to return all unused Forms 222 to the Registration Section. The current mailing address for the Registration Section may be found in 21 CFR 1321.01.
Section 1305.20(h) has been updated to provide that unused triplicate Forms 222 should be returned to the Registration Section at DEA headquarters. This matches the new language in Sec. 1305.18, and resolves the conflict with Sec. 1301.52(c).
The introductory text to Sec. 1305.20 has been updated to make clear that even if registrants still have a supply of triplicate Forms 222 available after the two-year transition period, they must switch to using the new single-sheet Form 222 at that point.
THE INTERPRETATION OF THE CHANGES TO THE REGULATIONS
The interpretation is very clear. On October 31st when you order new paper DEA forms 222, DEA will mail you a single sheet paper DEA Form 222 and not the triplicate forms with the carbon paper. Why do you need them? Because if your DEA Controlled Substance Ordering System (CSOS) system goes down or your supplier close your CSOS account, you will need a paper DEA Form 222 to order a Schedule II controlled substance. If you don’t have them, we recommend you order them beginning November 1st.
The triplicate forms are still good but must be used for the next two years. Therefore, on October 30, 2021, your pharmacy will need to send in the existing triplicate copies of the DEA Form 222 to the Registration Section at the DEA Headquarters and use the new single sheet of a paper DEA Form 222.
The changes states that the pharmacy will need to be a copy of the new paper DEA Form 222 either as a hard copy or a copy maintained electronically but will need to be “readily retrievable” from other records. We recommend, that if you keep a hard copy, to staple it to the invoice. If you maintain them electronically, we recommend you maintain them on the cloud as a PDF copy. Either way, make sure you will in the require information to include the number of containers received and the date received by the pharmacy. Remember, for DEA purposes you need at least 2 years of records, but for some states, like New York, you will be required to maintain 5 years of records.
A change to 21CFR Section 1305.05 states that the POA letter can be authorized by the registrant, if an individual; a partner of the registrant, if a partnership; or an officer of the registrant, if a corporation, corporate division, association, a trust or other entity. Before the change, only the person identified on the initial DEA application and subsequent renewals was the only person who can authorized a POA letter. Generally, pharmacy owners would allow the pharmacy manager to sign the electronic initial DEA application and subsequent renewals which would make that person the registrant.
Another new change is the DEA Forms 222 you generally receive from a reverse distributor. Until a reverse distributor use all their triplicate order forms, you would receive Copy 1 and 2 of the paper DEA Forms 222. Copy 1 was your copy while Copy 2 you mailed to the local DEA office. Under the new regulation, when you receive the new single copy of a DEA Form 222, you will be required to make a copy and send it to the local DEA office. Make sure that the quantities of controlled substances shipped, and the date shipped are noted on the order forms.
There are many changes that pharmacy owners and pharmacy managers would need to understand. We recommend you read the new changes to the regulations.
Carlos M. Aquino