The United States House of Representatives’ Subcommittee on Health recently held a hearing examining the FDA’s ever-expanding role in ensuring the enforcement of the Compounding Quality Act. Against the backdrop of a fatal meningitis outbreak caused by a compounding pharmacy in Massachusetts which infected over 750 patients in 2012, Chairman Greg Walden (R-OR) emphasized that, with respect to 503B outsourcing facilities, the FDA “must ensure that outsourcing facilities do not compound products that are essentially copies of approved drugs” and that the FDA “must also guarantee that bulk drug substances are not used in compounding by outsourcing facilities, until there has been a final determination that there exists a clear clinical need to do so.” This has the potential to greatly impact outsourcing facilities and bulk chemical suppliers in many ways. Over the past few months, there has been a steady rise in pharmaceutical manufacturers taking legal action against compounders and other stakeholders, alleging that they are unlawfully producing copies of commercially available drugs. These policy statements will only serve to embolden those companies in continuing their efforts against outsourcing facilities and compounding pharmacies. Moreover, Congress’ statements on bulk drug substances used in the 503B may have substantial impact on the list and extent of bulk drug substances that may even be used by outsourcing facilities. Suppliers of bulk Active Pharmaceutical Ingredients (APIs) may face continued hurdles in causing their products to be placed on the list of acceptable bulk drug substances for use by 503B facilities.
Apart from just the focus on outsourcing facilities, the most heavily debated topic surrounding the hearing as well as in related witness statements was over the policy question of whether the FDA or individual state Boards of Pharmacy should predominantly regulate 503A compounding. As Congress is currently examining whether to expand the FDA’s enforcement authority over 503A compounding pharmacies through additional legislation, many industry commentators, including the National Community Pharmacists Association, urged Congress to draw the jurisdictional line by confining FDA oversight to 503B outsourcing facilities only, thereby leaving the regulation of 503A compounding pharmacies to the States.
For more information on how your business may be affected by these policy developments, contact Frier Levitt today.