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STATE | ASPS Weighs in on Oregon Compounding Proposal

The Oregon Board of Pharmacy is the most recent state governmental entity to attempt to limit physician in-office compounding. The proposed changes to the state's compounding rule would require all compounders in Oregon to adhere to the United States Pharmacopeia (USP) Chapters 795 and 797 guidelines, as well as applicable chapters of USP and USP-NF related to compounding practices at any location. These new requirements for nonsterile compounding would place financial hardship on small practices without improving patient safety. Coupled with these onerous requirements are the proposed addition of recordkeeping requirements that would place further burdens on physicians. While the rule changes include these unwelcome aspects, the measure would provide physicians with flexibility to mix drugs when they are not commercially-available.

ASPS has commented on past efforts by state pharmacy boards in Florida, North Dakota, and Ohio that would have enacted similarly misguided policies. These proposals are the results of the legislative and regulatory backlash against in-office compounding following the contamination of compounded products produced by a compounding pharmacy in Massachusetts.