Legislation defines when FDA can take action against compounders

Allan Coukell, Senior Director, Drugs and Medical Devices, at The Pew Charitable Trusts

This week, Congress is expected to firm up FDA authority over compounding pharmacies like the one tied to last year's fatal outbreak of fungal meningitis. It will also give it stepped-up authority over those compounders that see enough market advantage that they volunteer to be regulated and pay a $15,000-a-year fee for the privilege.

"The question is, why would anybody ask for that? The answer is that 90% of hospitals outsource some of their compounding, and we hope that they will elect to buy from those facilities that operate under FDA oversight and those higher standards," explained Allan Coukell, a drug-policy expert at the Pew Charitable Trusts, which supports the legislation. "I think some will do it."

The Drug Quality and Security Act was passed by the U.S. House of Representatives Saturday and was expected to be passed by the U.S. Senate this week before the government shutdown complicated schedules. The new law clarifies the FDA's existing authority, which several court rulings had put into question, Coukell said. It does not allow the FDA carte blanche access to compounders' records, but it does allow the FDA to go in when it believes there is a safety or health concern. It gives the FDA authority to create a list of drugs that cannot be compounded. It also says compounders cannot make drugs without a prescription from a doctor except in limited quantities. It allows the FDA to investigate when it believes that is happening.

Traditionally, drug compounders have been small operations that made custom drugs for doctors and hospitals. But with drug shortages in recent years, some compounders, like New England Compounding Center (NECC), had begun manufacturing their products in larger quantities and selling them nationally. Last year, an NECC injected pain drug was tied to an outbreak of meningitis that sickened hundreds, dozens fatally. The FDA got called on the carpet by both the House and Senate to explain why the agency had not done a better job of protecting citizens against poor-quality drugs made by compounders.

Commissioner Margaret Hamburg told Congress FDA oversight was often fought by compounders and that the agency needed clearer authority. It had supported a Senate bill that would have given the agency the right to regularly inspect the largest compounders. The mandatory element of that bill, however, got lost in reconciling the House and Senate versions. But the FDA didn't wait for Congress to act before beginning inspections this year of the largest compounding pharmacies, getting many of them to recall drugs it believed had sterility issues.

Separately, the new bill also mandates establishment of a national track-and-trace system. The provisions will phase in over 10 years until it eventually provides unit-level tracking of drugs to fight counterfeit and stolen or diverted drugs from being introduced into the national supply chain.

- here's the bill (PDF)
- here's a backgrounder

Related Articles:
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Compounder issues nationwide recall of 45 products
Hamburg faces Senate as new compounding regulations progress
FDA now inspecting 'high risk' compounders