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Regulatory Focus™ > News Articles > New Legislation Aims to Provide FDA with New Authority to Regulate Compounders

New Legislation Aims to Provide FDA with New Authority to Regulate Compounders

Posted 05 November 2012 | By Alexander Gaffney, RAC

US Rep. Ed Markey (D-MA) plans to introduce a new piece of legislation he says will give the US Food and Drug Administration (FDA) new authority to regulate compounding pharmacies while still preserving state-level oversight authority.

Markey's bill, the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012, is an attempt to rectify a "regulatory black hole" responsible for letting through dangerous products that have killed dozens of patients and made ill hundreds of others in the last two months. (For background information, please see Regulatory Focus' page on the New England Compounding Pharmacy.)

FDA has for years operated in a legal gray area, asserting the right to regulate and inspect compounding facilities and hold them to current good manufacturing practice (cGMP) standards despite having much of that authority struck down by federal courts.

Markey's bill would enshrine into law a distinction FDA has long argued: Compounding taking place on a large scale without regard to individual prescriptions places the facility's operations under the regulatory authority of FDA.

Facilities would, under Section 3 of the law, be required to register with FDA if they exceed certain manufacturing thresholds set by FDA for sale across state lines, the quantity of compounded products sold and "other factors." Such pharmacies would also be subject to FDA inspections.

FDA would need to promulgate those requirements within a year of the act's passage.

Other various requirements of the bill aim to boost FDA's authority to inspect pharmacies and the safety of compounded products. Compounding pharmacies would be subject to adverse event reporting requirements, required reporting to FDA regarding potential microbial contamination or need for a recall, and new labeling requirements.

All compounded products would be required to include a statement on their labeling that, "This drug has not been tested for safety and effectiveness and is not approved by the FDA. Serious adverse reactions to this drug should be reported to the pharmacy where it was received and [to] the FDA."

A 'Do-Not-Compound' List and Other Measures

The legislation also includes a number of other provisions aimed at plugging gaps in the way products are currently regulated.

FDA will be also charged with developing and maintaining a list of drug products that should not be compounded, as well as specific dosages, forms, ingredients or categories that should be avoided and the reason for the product's inclusion-a sort of "do-not-compound" list.

Another provision in the legislation would allow FDA to use compounding pharmacies to address drug shortages. In the wake of some federally regulated facilities being shut down for quality deficiencies, compounding pharmacies have picked up some of the slack by manufacturing equivalent medications. But instituting new requirements-or even enforcing existing ones-has left some officials nervous that shortages could be left worse than ever. A 1 November 2012 statement by FDA indicated that the shutdown of just one compounding pharmacy, Ameridose, could leave several drug products in short supply.

Markey's legislation gets around this, in part, by allowing FDA to issue waivers to allow bulk compounding if it determines that either a public health crisis or drug shortage situation exist. That waiver would automatically expire after one year, with extensions permitted. State governments would not be allowed to issue such waivers unless explicitly authorized by FDA, and they would only be allowed to be issued to registered pharmacies operating under a license.

Markey's legislation also preserves much of the existing system, particularly as it relates to local regulation of compounders. Small-scale hospital compounders that do not produce products for out-of-state export-or even outside of their local hospital-would continue to be regulated by the state boards of pharmacy.

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