Pharmacies Selling PSE: Remember to Train Employees and Self-Certify

Last week the U.S. Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”).  Austin Pharmacy to Pay $200,000 in Civil Penalties for Alleged Violations of the Controlled Substances Act, Aug. 16, 2023 (DOJ Press Release).  During a routine inspection in June 2022, Drug Enforcement Administration (“DEA”) diversion investigators determined that People’s Rx pharmacy violated recordkeeping requirements, improperly dispensed controlled substances to practitioners for office stock and issued prescriptions without authorization.  Id.  Investigators also found that the pharmacy sold pseudoephedrine (“PSE”) products but failed to self-certify in violation of the Combat Methamphetamine Act of 2005 (“CMEA”).  Id.

We note that in December 2020, the same U.S. Attorney’s Office announced that another pharmacy paid $320,000 to resolve allegations that in addition to violating recordkeeping provisions, it had also sold PSE and ephedrine products without self-certifying with DEA.  Odessa Pharmacy and Owner to Pay $320,000 in Civil Penalties for Alleged Violations of the Controlled Substances Act and the Combat Methamphetamine Epidemic Act of 2005, Dec. 2, 2020 (DOJ Press Release).

These settlements provide powerful reminders for “regulated sellers” of PSE, ephedrine and phenylpropanolamine.  “Regulated sellers” (retail distributors including pharmacies, grocery stores, general merchandise stores and mobile vendors) selling “scheduled listed chemical products” (“SCLPs”) (products containing ephedrine, PSE and phenylpropanolamine that may be marketed in the U.S. as non-prescription drugs) directly to walk-in customers or in face-to-face transactions by direct sales must self-certify with DEA that their employees have been trained on SCLP sales requirements.  21 U.S.C. § 830(e)(1)(B)(i).  Regulated sellers must renew their self-certification annually for each place of business where they sell SCLPs.  21 C.F.R. § 1314.40(b).  Mail-order distributors of SCLPs must also self-certify.  21 C.F.R. § 1314.102(a).

Regulated sellers must train employees responsible for delivering SCLPs into the custody of purchasers or who deal directly with purchasers by obtaining payment for the SCLPs then self-certify that they have done so.  21 U.S.C. § 830(e)(1)(A)(vii).

Regulated sellers must limit daily sales of SCLPs to 3.6 grams and 30-day limits to 9 grams, verify each customer’s identification, maintain records of each sale and keep products behind the counter or in a locked cabinet away from customer access.  Before they can sell SCLPs, regulated sellers must certify their employees have been trained on these requirements.  21 C.F.R. § 1314.35(a).  Certification must also include a statement that the regulated seller understands the requirements for selling SCLPs and will comply with those requirements.  21 C.F.R. § 1314.40(a).

Regulated sellers must train employees on SCLP sales requirement content developed by DEA and listed on the DEA website provided at the Diversion Control Division Retail Training Page.  DEA has developed two sets of training materials: one for regulated sellers who are not mobile retail vendors, and a second set for mobile retail vendors.

After employees have been trained, regulated sellers must self-certify through the DEA website provided at the Diversion Control Division Self-Certification Page.  Regulated sellers must print out and maintain a copy of their self-certification certificate.  In the unlikely event a regulated seller cannot recall whether they have self-certified, they can consult DEA’s monthly self-certification list of all who have current self-certifications found at the Diversion Control Division CMEA Monthly List.

Self-certification fees are waived for DEA-registered regulated sellers but the fee for initial self-certification and renewal for regulated sellers who are not DEA registrants is $21.00.  Id. at 21 C.F.R. §1314.42(a), (b).