HB61 Alabama 2018 Session

Updated Feb 24, 2026

Summary

Primary Sponsor: Elaine Beech
Democrat
Session: Regular Session 2018
Title: Pharmacy, State Board of, outsourcing facilities, annual permit required, Secs. 34-23-1, 34-23-32 am'd
Summary: HB 61 would require outsourcing facilities that compound sterile drugs to obtain an annual permit from the Alabama State Board of Pharmacy and register with the state.
What This Bill Does
The bill adds a requirement for outsourcing facilities to register annually with the State Board of Pharmacy and obtain a state permit. It sets permit fees for new establishments, renewals, and transfers, and requires permit holders to employ a full-time licensed pharmacist on site. It also strengthens rules on shipping legend drugs, allowing the board to request partner lists and imposing penalties for violations; physicians are exempt from these permit requirements. The changes become effective a few months after the Governor signs the bill into law.

Who It Affects
Outsourcing facilities that compound sterile drugs would must register annually with the Board, obtain a state permit, and comply with on-site pharmacist employment rules and related oversight.
Other entities in the drug supply chain in Alabama—including manufacturers, bottlers, packagers, repackagers, third-party logistics providers, wholesale drug distributors, private label distributors, and pharmacies—would also be subject to annual permit registration and associated fees under the board's oversight.

Key Provisions
Outsourcing facility is defined as a facility at one location engaged in sterile drug compounding that is registered with the FDA as an outsourcing facility under 503B and complies with relevant federal law.
Annual permit registration with the Alabama State Board of Pharmacy is required for outsourcing facilities and other supply-chain entities, with fees: new establishment $500-$2,000; renewal $250-$1,000; transfer $500-$2,000.
Permit holders must employ a full-time licensed pharmacist on-site for pharmaceutical operations; wholesale distributors that only distribute drugs may be exempt from this requirement.
Shipping legend drugs into Alabama requires a valid permit; civil penalty for violations is $4,000 per violation.
Permit holders may be required to provide a list of trading partners to the board upon request; violators can face additional penalties.
Permits are due Oct. 31 and become null if not paid by Dec. 31; renewals must be completed by Dec. 31 with a $100 per overdue month penalty; the act becomes effective on the first day of the third month after Governor approval.

AI-generated summary using openai/gpt-5-nano on Feb 24, 2026. May contain errors — refer to the official bill text for accuracy.
Subjects: Pharmacies and Pharmacists