Provider Demand to Drive Compounder Registration with FDA

FDA is moving fast to implement the drug compounding provisions of the new Drug Quality and Security Act (DQSA), issuing new guidance to spur registration by outsourcing facilities just days after President Obama signed the new bill into law. Because FDA cannot compel compounders to opt for agency regulation, implementation will rely largely on market pressures to encourage healthcare providers to purchase compounded products only from registered facilities, explained FDA commissioner Margaret Hamburg at a press briefing Dec. 2, 2013.

The law stops short of setting specific criteria for which compounders should register and pay fees to FDA, and it’s unclear how many operators will choose to do so. There may be somewhere between 700 and 1000 compounders that produce sterile products and ship across state lines-two key criteria for identifying those firms that the program is designed to cover. But FDA doesn’t know how many firms will identify themselves as “outsourcing facilities” that should register, acknowledged Jane Axelrad, associate director for policy in the Center for Drug Evaluation and Research (CDER).

FDA will post on its website the names and locations of registered outsourcers and the drugs they produce, which will promote the fact that they meet manufacturing quality standards and are regularly inspected by the agency. The hope is that hospitals and clinics will purchase more high-risk injectable medicines from such organizations. FDA also plans to talk to various stakeholders about what the program means and the benefits of FDA-reviewed products, Hamburg said. When the meningitis outbreak occurred last year, she noted, many providers were “disturbed that they didn’t have more information on where these products were coming from.” Payers and health plans, moreover, may make coverage and reimbursement decisions that favor those compounded products subject to FDA oversight.

To get the program moving, FDA issued draft guidance on Dec. 2, 2013 that briefly map out the process for registering outsourcing facilities and for listing the drugs they produce. FDA wants reports every six months on the active ingredients and strengths of compounded drugs, whether they are made from bulk ingredients or finished drugs, and if any address drug shortages. The agency is offering an abbreviated registration method for the “near term” to help compounders familiarize themselves with FDA systems. And firms that register before June 2, 2014 will get extra time to report full product information. Additional rules and policies will come in the future for compounding pharmacies that decide not to register with FDA. These firms will continue to be regulated by states, but FDA will step in if problems arise with operations or product quality. FDA will be updating its do-not-compound list of products found to be unsafe or not effective and will issue regulations for identifying products that are particularly difficult to compound.

FDA hopes that it will become the “standard of practice” for providers to look to registered outsourcers for high-risk injectable products. If purchasers decide to buy from registered facilities, then more compounders may sign up with FDA, Axelrad noted. And then, she added, there will be less need for providers to buy from unregistered facilities.