HB61 Summary

• Adds "outsourcing facility" definition to Alabama pharmacy law: 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.

• Establishes permit fees for outsourcing facilities ranging from $500-$2,000 for new establishments, $250-$1,000 for renewals, and $500-$2,000 for ownership transfers.

• Prohibits outsourcing facilities from shipping legend drugs into the state without a valid board permit; violation carries a civil penalty of $4,000 per violation.

• Effective on the first day of the third month following passage and approval by the Governor.