Pharmacy Associations Testify on Compounding Regulation at House Subcommittee Hearing
A July 16 hearing on regulation of pharmacy compounding held by a United States House of Representatives health subcommittee featured testimony by representatives of several pharmacy associations.
In its testimony, the National Association of Chain Drug Stores argued that state boards of pharmacy should retain sole jurisdiction over traditional compounding pharmacies and that collaboration between the FDA and state regulators should be increased in order to identify and bring to account rogue compounders who are trying to avoid federal oversight.
The National Community Pharmacists Association (NCPA) agreed with these points and urged that anticipatory compounding and office use of compounded drugs should continue to be permitted where state law allows. The NCPA also expressed concern about proposals that would give the FDA authority to develop a list of medications that cannot be compounded, require pharmacies to notify the FDA when compounded medications are in short supply, and exempt health systems from new compounding regulations.
The American Society of Health-System Pharmacists, however, expressed support for provisions in a bill approved by a US Senate committee in May that would allow the FDA to regulate “compounding manufacturers” while keeping traditional compounders under the jurisdiction of state boards of pharmacy. (Compounding manufacturers would be defined as pharmacies that compound sterile drugs in advance of a prescription and ship them across state lines.)