Court says FDA can inspect compounding pharmacies

October 10, 2005

The Food & Drug Administration has the legal power to inspect a compounding pharmacy's facilities, drug products, and labeling, according to a federal appeals court ruling that upheld a lower court decision.

The Food & Drug Administration has the legal power to inspect a compounding pharmacy's facilities, drug products, and labeling, according to a federal appeals court ruling that upheld a lower court decision.

Not only can the FDA inspect compounding pharmacies, it can use a Compliance Policy Guide (CPG) the drug agency has held off implementing to determine whether a retail pharmacy is entitled to a limited exemption from inspections. The U.S. Court of Appeals for the Third Circuit also said that the FDA could use prescription volume to gauge a compounding pharmacy's eligibility for the exemption given to pharmacies that compound drugs in the normal course of their retail business.

Last month's ruling followed an appeal of a lower federal district court decision filed by Wedgewood Pharmacy, Swedesboro, N.J. The panel hearing the case included Judge Michael Chertoff, who resigned before the decision to become secretary of Homeland Security.

Malmberg is "disappointed" by the ruling, which he said sets a precedent that as a practical matter allows the FDA to inspect any state-licensed pharmacy for "any reason or no reasons at all. And if they determine there is probable cause, they can extend it to a records inspection. It's a little unclear, but I think the FDA has much broader latitude than prior to this decision. We find that disturbing since, historically, pharmacy has been a state-regulated profession."

The International Academy of Compounding Pharmacists was also "disappointed" with the ruling, said executive director L.D. King. He noted that the ruling was based on a "CPG that the FDA itself agreed needed to be changed, but here we have a court saying the FDA can use that CPG to determine whether a compounding pharmacy is entitled to a limited exemption." He added, "It's hard to know the effect of the ruling, but it certainly does clarify that the FDA can inspect, at least in a limited way, facilities, drug products, labeling, and so on. At what point the FDA has jurisdiction to inspect a pharmacy's entire records and books remains to be seen."

What also remains unanswered is what the FDA could legally do even if it were to conduct a full inspection of a compounding pharmacy, said King. "It's not clear what action the FDA can take legally after an inspection," he said. "That 'what then' is still a question mark, and there's still great disagreement between the FDA and pharmacy about the meaning of that 'what then.' "