Under Ala. Code Section 34-23-32 and Ala. Admin. Code Rule 680-X-2-.23, the Alabama State Board of Pharmacy (ALBOP) sets an annual facility permit for the drug and device supply chain, and both the designated-representative registration and the permit fees fall due on October 31, 2026. Out-of-state drug and device manufacturers shipping legend drugs or devices into Alabama, Alabama-licensed wholesale drug distributors, third-party logistics providers (3PLs) handling legend drugs in Alabama, repackagers and private label distributors in the Alabama drug supply chain, and Alabama pharmacies, reverse distributors, and retail medical oxygen suppliers in the drug supply chain must renew the annual ALBOP facility permit and register (or re-register) a designated representative by October 31, 2026, paying the permit fees and the designated-representative fee, or the permit is void if not renewed by December 31, 2026, with a $100 per-month delinquency penalty, and distributing drugs or devices in Alabama without a valid permit is unlicensed practice subject to ALBOP discipline.
FDA-registered outsourcing facilities are exempt from the designated-representative duty under Section 34-23-32(e), in force since January 1, 2024, and remain liable for the permit fee. The fee schedule is set by ALBOP rule under Section 34-23-92. The annual regime has been in force since August 1, 2017. No adopted act postpones October 31, 2026.
- Deadline : October 31, 2026, the annual permit and designated-representative obligations fall due (an unpaid permit is void on December 31, 2026)
- Who : Manufacturers, wholesalers, 3PLs, repackagers, private label distributors, pharmacies, reverse distributors, oxygen suppliers, and outsourcing facilities in the Alabama drug supply chain
- What : Register a designated representative with ALBOP (outsourcing facilities exempt) and pay the permit and designated-representative fees
- Otherwise : Permit void if not renewed by December 31, 2026, plus a $100 per-month delinquency penalty; distribution without a valid permit is unlicensed practice subject to ALBOP discipline
- Official source : Ala. Code Section 34-23-32
What is due on October 31, 2026
Two active obligations fall due on October 31, 2026: designated-representative registration for every permit holder except an FDA-registered outsourcing facility, and payment of the Rule 680-X-2-.23 fees by permit applicants and designated representatives. December 31, 2026 is the date an unpaid annual permit to distribute drugs or devices in Alabama becomes void.
Rule 680-X-2-.23 was filed on June 1, 1982, the annual permit commenced on August 1, 2017, designated-representative registration took effect on January 1, 2024, and on January 14, 2024 prior fee rule 680-X-2-.25 was repealed.
Who is covered
Coverage follows shipment into Alabama, not an Alabama domicile. Bottlers, packagers, and outsourcing facilities sit on the same list. Outsourcing facilities skip the designated representative and still pay the permit fee. Pure wholesale distributors are exempt from the on-premise pharmacist duty. Federal DSCSA tracing preempts inconsistent state wholesaler and 3PL standards.
What to do before October 31, 2026
- List every Alabama facility permit in the statutory chain, including manufacturer, wholesale distributor, 3PL, repackager, pharmacy, reverse distributor, retail medical oxygen supplier, and outsourcing facility.
- Renew the annual permit and pay the renewal fee of $250 to $1,000 (a new permit is $500 to $2,000; a transfer is $500 to $2,000).
- Register or re-register the designated representative and pay the fee of $100 or more, unless the site is an FDA-registered outsourcing facility.
- Confirm a full-time licensed pharmacist covers on-premise operations, unless the holder is a pure wholesale distributor.
- Record December 31, 2026 as the date an unpaid renewal makes the permit void, with a $100 per-month delinquency penalty.
What happens otherwise
An unpaid renewal is void on December 31, 2026, with a $100 per-month delinquency penalty. Distribution without a valid permit is unlicensed practice subject to Alabama State Board of Pharmacy discipline. The sources name no separate criminal fine. Continuous, per-jurisdiction monitoring surfaces a change to this ALBOP date the moment it is published.
