Are you ready for Butalbital/APAP combination products to become a Controlled Substance?
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Are you ready for Butalbital/APAP combination products to become a Controlled Substance?

On April 12, 2022, the Drug Enforcement Administration “DEA” published in the Federal Register a Notice of Proposed Rulemaking. The DEA proposed to revoke the exempted prescription product state for all butalbital products previously granted exemptions, namely Fioricet. (Federal Register :: Schedules of Controlled Substances; Exempted Prescription Products)

The DEA Diversion Control Division website has listed 189 prescription drug products that contain butalbital which was granted exempt status due to the quantity of acetaminophen (APAP) in the formulation, https://www.deadiversion.usdoj.gov/schedules/exempt/exempt_rx_list.pdf.

Butalbital and Butalbital/ASA containing products are already classified as a Schedule III. And almost certainly in the near future, the Butalbital/APAP products will also be reclassified from exempt to a CIII.

What does this mean for the pharmaceutical supply chain if the proposed rule is implemented?

If you already hold a DEA Registration for the handling of CIII products, by the effective date, you will need to:

  • Perform an opening inventory
  • Verify DEA registrations for suppliers and customers
  • Update SOP’s
  • Move the product to your cage
  • Update your Suspicious Order Monitoring program
  • Update manufacturing, receiving & shipping

How DEA Registrations Play a Part

If you hold a DEA registration but do not have CIII products listed on the registration, you will need to amend your registration to add CIII products and follow the above activities identified in the table.

If you do not hold any DEA Registrations because your company or site does not handle controlled substance, but you do handle Butalbital/APAP combination products, will need to do the following prior to the effective date:

  • Install a DEA approved cage
  • Obtain DEA registration
  • Write and train on SOP’s
  • Obtain resident state-controlled substance license
  • Obtain a Suspicious Order Monitoring program
  • Obtain non-resident state controlled substance licenses

By the effective date, the above must be obtained and you will need to perform an opening inventory and move the products too your cage.

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