Compounding Pharmacy Bill Might Not Make Drugs Safer


NECC owner Barry Cadden was subpoenaed to appear before Congress a year ago, but he declined to answer questions, invoking his Fifth Amendment right against self-incrimination.

The FDA has issued more than 60 reports of compounding pharmacies that had one or more quality or sterility issues. Five compounding pharmacy testing labs received similar reports.

According to FDA records, there have been 22 compounding pharmacy recalls since last March. But there are no compounding pharmacy records in the database prior to that date going back five years -- though there may have been state recalls.

"I think the FDA realizes its own failure to act swiftly in the NECC case and that has elevated their scrutiny of compounding pharmacies to the point where [they] cannot -- [they] do not want to be put in the position of being accused of not taking swift action," said David Miller, president of the International Academy of Compounding Pharmacists, which had historically lobbied for looser oversight by the FDA in decades past, but last year blamed the FDA for not shutting down NECC.

Prior to the NECC outbreak, compounding pharmacies were regulated by state pharmacy boards, and the FDA said it didn't have the authority to properly regulate the industry. Its hope was that new legislation would change that.

Still, FDA officials said they are pleased with the new legislation.

"While this bill does not provide FDA with the additional authorities it sought, it provides a regulatory framework for certain compounders who register with the FDA," said FDA spokeswoman Erica Jefferson.

Compounding pharmacists who do not register with the FDA will be subject to the existing law, which is part of the Federal Food, Drug, and Cosmetic Act. This mandates that prescriptions be made for each patient individually, rather than in bulk, and has slightly less rigorous guidelines for quality and sterility testing.

Any compounding pharmacy that isn't compounding prescriptions for only individual patients would be acting illegally under the proposed law, but it doesn't provide a way for the FDA to figure out which pharmacies are misbehaving. That will still be up to state inspectors.

"The agency will continue enforcing the law to the full extent of its authority in order to protect public health," Jefferson said.

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