SB32 Summary

• Adds "outsourcing facility" as a defined term in Alabama pharmacy law, meaning a facility at one geographic location engaged in compounding sterile drugs that has registered with the federal Food and Drug Administration under Section 503B(d)(4)(A) of the federal Food, Drug, and Cosmetic Act.

• Requires outsourcing facilities to annually register with the Alabama State Board of Pharmacy by application for a permit, effective August 1, 2017.

• Sets permit fees for outsourcing facilities at $500-$2,000 for new establishments, $250-$1,000 for renewals, and $500-$2,000 for ownership transfers, with fees determined by the board.

• Establishes that permit holders must employ a full-time licensed pharmacist for on-premise pharmaceutical operations, though wholesale drug distributors limiting operations to distribution only are exempt from this requirement.

• Imposes a $4,000 civil penalty for any manufacturer, distributor, or outsourcing facility shipping legend drugs into Alabama without a valid permit.