The International Academy of Compounding Pharmacists, the industry’s largest trade group, is asking for federal and state legislation that would require compounders to adhere to guidelines that are currently voluntary. The guidelines run more than 400 pages long and were developed by pharmacists, doctors and nurses.
“We believe they need to be mandated by law,” said David G. Miller, IACP’s executive vice president.
Miller said he told congressional staffers that he still wants state inspectors to retain the authority to enforce the standards for most compounding pharmacists. Last month, Miller reversed course on his long-held position that all compounders should be regulated by state boards of pharmacy, saying manufacturing-style firms that market and sell products without patient-specific prescriptions should register with the FDA and be inspected by the agency.
The shift in IACP’s position followed a Washington Post investigation that showed 15 of the nation’s largest compounding pharmacies mass produce medications, often shipping them across state lines without patient prescriptions. The Post also reported that shoddy equipment and unsanitary conditions at some of these firms had caused patient illnesses and deaths long before this fall’s deadly outbreak but that the firms rarely were penalized.
IACP and other groups are squaring off over which pharmacies would fall into the new category and face stepped-up FDA enforcement.
Many compounding experts and drugmakers maintain that size is the key factor for defining this new category. Express Scripts, a company that has a compounding arm that makes fertility drugs, is telling Congress that even though it ships to all 50 states, it does not belong in this new group, since it makes medications for individual patients.
Among those most affected are large hospitals, which often compound medications in-house. They want to be excluded from increased federal scrutiny, arguing that they make drugs only for their individual patients.
Many smaller community hospitals do not have the resources to mix their own medications. If they cannot buy the medications from drug manufacturers, these hospitals often rely on large compounding pharmacies to supply pain medication, anesthetics, and drugs commonly used in labor and delivery. Lobbyists for smaller hospitals say they want more oversight of compounded products.
Alice R. Crites contributed to this report.