HB170 Alabama 2017 Session

Summary

Primary Sponsor

Elaine Beech

Democrat

Session

Regular Session 2017

Title

Pharmacy, State Board of, practice of pharmacy further regulated, inspectors renamed investigators, maximum fees increased, frequency of drug supply chain registration increased, further regulation of entities within drug supply chain provided, resale of compound drug products prohibited, pharmacy technicians, licensure and regulation, Sec. 34-23-32.2 added; Secs. 34-23-152 to 34-23-157, inclusive, repealed; Secs. 20-2-9, 20-2-190, 34-23-1, 34-23-3, 34-23-9, 34-23-30, 34-23-32, 34-23-32.1, 34-23-33, 34-23-70, 34-23-92, 34-23-131, 34-23-159, 34-23-160, 34-23-162 am'd

Description

Under existing law, the Alabama State Board of Pharmacy is responsible for regulating the practice of pharmacy and the management and operation of pharmacies in the state.

This bill would rename drug inspectors employed by the board as drug investigators.

This bill would clarify that a pharmacist is a health care provider.

This bill would specify the qualifications a laboratory must satisfy for the board to use its product analysis data.

This bill would increase the maximum fee the board may charge for certain new pharmacy permit, permit renewal, and permit transfer applications and would specify fee ranges the board may charge for certain out-of-state pharmacy permit and permit renewal applications.

This bill would increase the frequency of registration for certain drug supply chain entities from biennially to annually, would add packagers, third party logistic providers, private label distributors, and other pharmacy businesses identified in the supply chain to those entities required to register, and would increase the fee range for a permit due to transfer of ownership.

This bill would prohibit any entity identified within a drug supply chain from shipping a legend drug or device into the state without a valid permit issued by the board and would provide a civil penalty for each violation.

This bill would require each holder of a permit to ship a legend drug or device into the state, upon request of the board, to provide a list of all trading partners.

This bill would authorize the board to discipline any pharmacist who obtains registration from the board by fraudulent means.

This bill would provide further for the initial and renewal registration process and fees for pharmacy technicians and continuing education requirements.

This bill would prohibit a prescriber from reselling a compound drug product administered in his or her office and would clarify that the board recognizes and enforces the provisions of the United States Pharmacopoeia or National Formulary relating to drug handling or compounding processes.

This bill would also authorize the board to permit any manufacturer, manufacturer affiliate, bottler, packager, repackager, third party logistic provider, wholesale drug distributor, private label distributor, or pharmacy business identified in the supply chain of any drugs, legend drugs, medicines, chemicals, or poisons for medicinal purposes and would clarify adherence to requirements established by the FDA Guidelines in the Drug Quality and Security Act.

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Subjects

Pharmacy, Alabama State Board of