Regulation of Compounding Pharmacies Continues to Evolve with House Passage of "Drug Quality and Security Act" 10/9/2013

In the current environment it seems that few, if any, pieces of legislation are moving through Capitol Hill. However, there is one area that has seen significant activity: the regulation of compounding pharmacies. Specifically, there has been bipartisan support for legislation intended to bolster the Food and Drug Administration's (FDA) oversight of compounding pharmacies in light of last year's unfortunate incidents involving compounded medications and meningitis. For example, H.R. 3089, also referred to as the "Compounding Clarity Act of 2013," received significant support from Representatives on both sides of the aisle when it was introduced on September 12, 2013. This led to the passage of the "Drug Quality andSecurity Act," H.R. 3204, which, according to the bill's sponsor, Rep. Fred Upton (R-Mich.), Chair of the House Energy and Commerce Committee, builds on the provisions of H.R. 3089 by eliminating the unconstitutional provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) that created uncertainty surrounding compounding laws, requiring the FDA to engage in two-way communication with state regulators and permitting entities that engage in pharmacy compounding to voluntarily register as "outsourcing facilities," making them subject to FDA current good manufacturing practices (cGMPs), risk based inspection provisions and other standards. The bill also includes provisions addressing drug supply chain security.

Voluntary Outsourcing Facilities

In contrast to H.R. 3089, which differentiated between traditional pharmacy compounding and "outsourcing" facilities based on the percentage of the facility's total compounded sterile drug products dispensed and shipped interstate, H.R. 3204 allows compounding pharmacies to voluntarily register with the FDA. The bill specifically states that an outsourcing facility is not required to be a licensed pharmacy and is not required to obtain prescriptions for identified patients, thus allowing outsourcing facilities to compound drugs pursuant to non-patient-specific purchase orders. Pharmacies that do not register as outsourcing facilities may be prohibited from compounding drug products without a valid prescription, and this could create an incentive for facilities to register as outsourcing facilities. Drugs compounded by a licensed pharmacist at registered outsourcing facilities would be exempt from FDA adequate directions for use, new drug application and approval and drug supply chain security requirements, so long as the following conditions are met:

• Registration. Outsourcing facilities that elect to register with the FDA must pay an annual registration fee of $15,000.
• Compounding Limitations. Registered outsourcing facilities are prohibited from compounding certain drugs, such as drugs that have had their approval withdrawn for safety reasons or drugs included on a newly created list maintained by the FDA of drugs or categories of drugs that are reasonably likely to lead to adverse effects.
• continue to read here