The Drug Quality and Security Act, signed by President Obama, requires regular FDA inspection of compounding pharmacies, which alter ingredients in prescriptions to suit the specific needs of patients. The law will only impact pharmacies that voluntarily register with the FDA, however. Compounding pharmacies serve doctors, hospitals and other pharmacies by providing altered versions of commercial drugs that accommodate things like allergies and dosage levels.
The law came about in response to a fungal meningitis outbreak last year traced to tainted steroid injections from a Massachusetts-based compounder. The outbreak killed 64 people and sickened more than 750 across the country. Since then, many states have increased oversight of compounding pharmacies by writing new regulations enforced by their pharmacy boards. States have wide authority over licensing, professional credentialing, labeling, purity and other areas of the drug-making and distributing process within their borders.
In the United States compounding pharmacies are licensed and regulated by their respective states, like all other pharmacies. Recent state legislation has sought greater licensing authority and oversight of out-of-state compounders in particular, reflecting concerns about the lack of robust tracking and accountability in the system.
Allan Coukell, an expert on pharmaceuticals at the Pew Charitable Trusts, said the voluntary nature of new FDA rules means states will continue to play a dominant role in oversight, but the existence of even a voluntary federal system helps clarify what states should be doing to provide oversight.
“They could now look at their own standards and expectations to make sure they’re correctly aligned with federal law,” he said. “I don’t see anything here that stops what they’re doing and, if anything, it provides the impetus to do more.” Don Perdue, a pharmacist and West Virginia state lawmaker, also said he doesn’t think the new federal law cuts into state authority but in fact clarifies what states should be doing. “I think what you’re going to see is that states, once they see an overarching policy, will be able to operate within that in a much more effective manner,” he said.
At the same time, states may wait to see if the compounding pharmacies in their borders submit to the FDA before deciding they need to continue to toughen their own laws, Coukell said. While the regulations are voluntary, many compounders will agree to them out of pressure from their clients, who may insist upon doing business only with certified pharmacies.
One area where federal law will supersede state regulations for willing compounding pharmacies is in the area of pedigrees, or tracking systems that exist in about 20 states, Coukell said. Those pedigree laws give drugs serial numbers and determine how they’ll be tracked from transaction to transaction. “State boards of pharmacy will need to be able to look to this federal tracing standard when they’re investigating concerns about counterfeits or illegal prescription drug sales in their states,” he said. “The states continue to be responsible for oversight, but state pedigree laws go away.”
The National Association of Boards of Pharmacy, a trade group that supports uniform standards, backed the Senate version of the law because it made FDA rules a requirement. The group took no position on the law signed by President Obama. “It was voluntary for too many years and voluntary didn’t work,” said Carmen Catizone, the group’s executive director. “When people die, you have to go mandatory.” Lacking a mandatory system undermines attempts made by states to reign in compounding pharmacies, Catizone said. “In Massachusetts and Tennessee, (where lawmakers have passed tough new laws) there’s no control of what’s coming into their states unless the other states follow the same standards.”
