The Arizona State Board of Pharmacy recently began interpreting its authority in a manner that implies that virtually every company that manufacturers or sells dietary supplements in the state will need to register as a nonprescription drug facility. If the board is successful and persistent in this approach, it could significantly disrupt dietary supplement business in the state.
The board is now communicating a position that companies selling dietary supplements in Arizona are required to register as either a resident or nonresident "wholesaler of nonprescription drugs" if any of their supplement products provide DSHEA-authorized statements of nutritional support. This new interpretation of the Arizona Pharmacy Act would apparently apply to all companies doing business in the state, whether located in Arizona or elsewhere. If applied consistently, this interpretation could also require each supplement manufacturer to register as a “drug manufacturer,” and every retailer in Arizona that sells supplements to register as a “nonprescription drug retailer.”
AHPA strongly opposes the Arizona State Board of Pharmacy's new interpretation of the Arizona Pharmacy Act. In a September 24, 2018 letter to the board, AHPA provided a thorough explanation of why this interpretation is incorrect and explained that the new purported registration requirements would place significant and unnecessary burdens on supplement companies, especially small businesses.
AHPA’s letter stressed that the new state requirements are inconsistent with longstanding and extensive federal requirements applicable to dietary supplements. If the board goes forward with its new interpretation, supplement companies would be put in the unreasonable position of representing that they are in compliance with Arizona and federal regulations applicable to the manufacture and/or wholesaling of drug products.
"This policy would set up an impossible situation for dietary supplement companies manufacturing or selling products in Arizona," said AHPA President Michael McGuffin. "AHPA requests the board recognize that supplements that make claims that are lawful under Federal regulation are not nonprescription drugs and cannot be regulated as drugs in Arizona."