The Senate has moved toward passage of a bill to provide federal regulation of compounding pharmacies.

compounding pharmacies, Drug Quality and Security Act, H.R. 3204, New England Compounding Center, state pharmacy boards, drug safety, Margaret Hamburg, FDA, track-and-trace legislation, pharmaceutical supply chain, Tom Harkin

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Rx compounding, supply chain bill advances in Senate

November 25th, 2013

WASHINGTON – The Senate has moved toward passage of a bill to provide federal regulation of compounding pharmacies.

Titled the Drug Quality and Security Act (DQSA), or H.R. 3204, the legislation was approved by the House in late September and by the Senate in a 97-1 preliminary vote on November 12. Final passage was expected in days.

The bill was inspired by an outbreak of meningitis that has killed 64 people and sickened more than 750 others. The outbreak was traced to a compounding pharmacy, the New England Compounding Center, that has since been closed.

The new legislation attempts to clarify Food and Drug Administration regulation of compounding pharmacies, which had been able to operate in the gaps between federal rules and patchwork state regulations.

Under the bill, pharmacies operating as traditional compounders to fill doctors’ prescriptions will continue to be regulated by state pharmacy boards. Large-scale compounders that produce compounded medications without prescriptions can register voluntarily with the FDA as outsourcing facilities and submit to federal inspections and quality standards.

The fact that registration is voluntary and not required has drawn fire from drug safety advocates and lobbyists for the compounding industry. Public Citizen, a consumer advocacy group, said compounded drugs should be required to carry labels warning that they have not been approved by the FDA.

FDA Commissioner Margaret Hamburg was lukewarm in her recent endorsement of the legislation, calling the measure a “step in the right direction” but expressing doubt that it would be as comprehensive as the agency had hoped.

In addition to its compounding provisions, DQSA provides for the development of track-and-trace legislation that will enhance the safety of the pharmaceutical supply chain.

“The bill establishes a clear pathway to unit-level tracing in a decade,” Sen. Tom Harkin (D., Iowa), chairman of the Senate Health, Education Labor and Pensions Committee, said in a statement. “This legislation will help to root out counterfeit and adulterated products before they make their way into the medicine cabinets of American patients.”