Congress Moves Toward Passage of Compounding Oversight Bill

The Drug Quality and Security Act, designed to improve the safety of compounded medications and to keep counterfeit and stolen medications out of the nation’s drug supply, appears headed for passage by Congress. A bipartisan congressional committee reached agreement on the bill on September 25, 2013, the House of Representatives passed it on September 28, 2013, and the Senate is expected to follow suit.

The bill would create an “outsourcing facility” category of compounding pharmacy that would be overseen by the FDA, but would leave the choice of whether to join the category up to individual compounders. The logic is that those who purchase medications from large-scale compounding pharmacies would not want to do so unless they are subject to FDA oversight.

According to the bill, outsourcing facilities would need to register with the FDA, allow FDA inspectors into their plants for inspection, and alert authorities to problems with their products. Currently, the FDA needs a court order to force compounding pharmacies to allow them access to their books or to inspect their facilities.

The bill would also set up a system so that within 7 years, manufacturers, re-packagers, wholesale distributors, and dispensers will share records tracking each drug’s distribution history to prevent the distribution of counterfeit and stolen medications.