With the DEA and wholesalers cracking down on the dispensing of controlled substances and dangerous drug cocktails (see our July 2020 Newsline article Beware: DEA and Wholesalers are Cracking Down on Controlled Substance Dispensing for additional details), pharmacies might consider revising their controlled substance handling policy. In addition to resources provided by your State Board of Pharmacy or state pharmacy association, another valuable reference is the DEA Pharmacist’s Manual which was recently updated in 2020, and revised in 2022.
For those who have read the 2020 manual and are wondering what has changed, here is a summary of several major updates:
- Section III Registration Requirements – The DEA has updated several of their processes to be more electronic-based and less reliant on paper forms. DEA form 224 (registration of a new pharmacy) and renewal of a pharmacy license is now only available online. Renewal reminder notices will no longer be sent via US Mail, but pharmacies should receive electronic reminders 60, 45, 30, 15, and 5 days prior to expiration.
- Section IV Ordering Controlled Substances – Language about utilizing the DEA 222 triplicate form has been removed since the triplicate form was phased out and completely replaced with the single sheet DEA 222 form effective October 15, 2021. The manual does specify that old triplicate DEA 222 forms must still be maintained (separate from other records) and kept available for inspection for a minimum of two years.
- Section V Inventory Requirements – The 2022 manual added language regarding inventory (initial, biennial, etc.) record retention and spelled out the requirement more clearly that the registered location must maintain the complete and accurate accounting of the inventory in written, typewritten, or printed form for at least two years.
- Section XIII Combat Methamphetamine Epidemic Act of 2005 – This section discusses the sale of ephedrine, pseudoephedrine, and phenylpropanolamine (also known as “scheduled listed chemical products” or SLCPs). Here you will find language regarding the restriction of selling no more than 3.6 gm of the chemical (base) per calendar day. This language had not changed, however, the following has been added, “regulated sellers, including pharmacies, may not exceed this quantity limit of SLCP base, even if state law mandates that a prescription be issued for the product”. This is pursuant to 21 CFR 1314.20(a). Also added, “regulated sellers, including pharmacies, must maintain a logbook for sales of SLCPs even if state law mandates that the product only be sold by prescription”.
- Throughout the manual
- The word “abuse” has been replaced with “misuse” and the phrase “drug abusers” has been replaced with “those individuals seeking to fill fraudulent prescriptions”. This change seems to better encompass those individuals who are inappropriately obtaining, utilizing, and/or distributing controlled substances and not just those who are personally misusing the medication.
- DEA email addresses listed in the manual have been changed from an “@usdoj.gov” address to an “@dea.gov” address. If you are reaching out to the DEA, be sure to verify the email address you are utilizing is accurate.
Being familiar with the guidance provided in the current version of the DEA Pharmacist’s Manual is recommend for any pharmacy that dispenses controlled substances and the manual would be a great resource to utilize if you are revising or developing policies and procedures for the handling of controlled substances.
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