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Committee advances bill aligning Arkansas with FDA guidance to allow specialty compounders to sell to pharmacies
Summary
House Bill 1801, as amended, would permit specialty compounding pharmacies to sell certain products to retail pharmacies when the FDA has deemed a product commercially unavailable or on the FDA shortage list; the committee passed the bill after adopting an amendment directing the Board of Pharmacy to promulgate labeling rules.
State Representative Kendra Moore (District 23) told the Senate committee that House Bill 1801 allows specialty compounding pharmacies—facilities that are licensed and regulated to meet higher manufacturing standards—to sell medications to retail pharmacies for patient dispensing when a product is not commercially available and appears on an FDA shortage list.
Moore said the FDA issued guidance last year allowing these specialty compounders to sell to pharmacies; HB1801 would bring the state into alignment with that guidance and allow constituents to obtain compounded medications when commercially available products are not on the market. She stated the bill applies only to products “not commercially available and on that FDA shortage list.”
The sponsor said the Arkansas Pharmacists Association, the National Community Pharmacy Association and the state Board of Pharmacy provided input incorporated into the bill. An amendment adopted in committee adds language directing the Board of Pharmacy to promulgate rules for labeling the contents of those compounded products.
No one signed up to testify for or against the bill. The committee voted by voice vote to pass HB1801 as amended.
Clarifying details from the hearing: The bill applies only when a product is not commercially available and is on the FDA shortage list; specialty compounders addressed by the bill are described as a class of compounders operating to current good manufacturing practice standards and regulated by federal authorities when applicable.
