DEA Yanks Registration from Opioid-Rule-Breaking Pharmacy
Published Date: 4/2/2025
Notice
Summary
Prescript Pharmaceuticals got their DEA registration suspended and revoked because they ordered powerful opioids without proper approval between 2020 and 2023. This affects the company directly and means they can’t legally handle these drugs anymore, protecting public health. The decision is final and signals serious consequences for companies that don’t follow drug safety rules.
Analyzed Economic Effects
5 provisions identified: 0 benefits, 5 costs, 0 mixed.
DEA Registration Revoked for Prescript
The DEA revoked Prescript Pharmaceuticals' Certificate of Registration No. RP0177798, effective May 2, 2025. The agency found that Prescript ordered Schedule II opioids (hydrocodone and oxycodone) from 2020 through 2023 without requesting or receiving procurement quota as required by 21 CFR 1303.12(b), so the company can no longer lawfully handle those controlled substances.
Pending Renewal and New Applications Denied
The Order denies any pending applications of Prescript Pharmaceuticals to renew or modify Certificate No. RP0177798 and denies any other pending application for additional registration in California. That denial takes effect with the Order effective May 2, 2025.
DEA May Adjudicate Expired Registrations
The Agency states it has jurisdiction to adjudicate a registrant's conduct to finality even if the registrant's DEA registration has expired. The Order explains the Agency's jurisdiction is over the registrant (not the registration) and that final orders may be issued after a registration expires.
Final Order Clarifies Seized Inventory Disposition
The Order notes that controlled substances seized from Prescript when the OSC/ISO was served remain outstanding and that issuing a final order will clarify the disposition of those seized assets. The record shows Prescript's registration expired on March 31, 2024, but the disposition of seized controlled substances is unresolved.
Order Sends Strong Deterrent Message
The Agency explains that revocation is intended to serve both specific and general deterrence, warning other registrants that repeatedly ignoring quota rules can lead to revocation. The decision emphasizes that allowing Prescript to retain registration would signal that registrants may choose which rules apply to them.
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