On September 12, 2013, U.S. Representative Morgan Griffith (R-Va.) introduced H.R. 3089 ("the House Bill") [enhanced version available to lexis.com subscribers], which proposes a structure for federal oversight of compounding pharmacies. The House Bill is the latest federal proposal for regulating compounding. Unlike the Senate Bill, detailed in an earlier Duane Morris Alert, this House Bill takes smaller incremental steps toward federal regulation of compounding pharmacies.
The House Bill divides compounding practice into two categories: compounding performed at outsourcing facilities and traditional pharmacy compounding. Although the House Bill sets out requirements for all compounding for human use, the bill requires only outsourcing facilities to register with the U.S. Food and Drug Administration (FDA). State pharmacy boards would continue to maintain primary oversight over traditional pharmacy compounding practices. The House Bill would apply to drug products compounded for human use, but would not apply to drugs compounded for use in animals.
Under the House Bill, an outsourcing facility compounds sterile drug products without a patient-specific prescription and ships these compounds across state lines in a volume greater than five percent of the total drug products the facility dispenses in any given six-month period. In addition to registering with FDA, outsourcing facilities must comply with Current Good Manufacturing Practices (cGMPs), report adverse events to FDA and label their compounds in a special manner to demonstrate the drugs have been compounded. Outsourcing facilities would be subject to FDA inspections on a risk-based schedule and would be required to pay an annual establishment fee and fees for re-inspections. The House Bill criminalizes the intentional failure to register as an outsourcing facility.
The House Bill permits traditional pharmacy compounding when performed pursuant to a patient-specific prescription or, in limited quantities, when prepared pursuant to a non-patient-specific order for use in the physician's office. Traditional compounding for office use is permitted under limited circumstances. During any six-month period, no more than five percent of the total drug products the pharmacy dispenses may be compounded and shipped interstate for office use. Any pharmacy that goes over this limit is required to register with FDA as an outsourcing facility. The House Bill adds a reporting requirement when a pharmacy compounds for office use—the healthcare practitioner administering the compounded drug must provide the compounding pharmacist with a valid patient-specific prescription within seven business days after the compound is administered. Intentional falsification of prescriptions, purchase orders or patient names is subject to criminal penalties.
In addition to these proposed federal requirements, traditional compounding pharmacies would also be subject to state law. The House Bill permits states to enact laws that are more stringent than its requirements and encourages communication between FDA and the state boards. It aims to ensure better coordination and communication by implementing a notification system between the pharmacy boards and FDA.
The House Bill is the latest congressional attempt to expand federal oversight over compounding pharmacies, and it differs in significant ways from its Senate counterpart. It remains to be seen which, if any, of these proposals will be passed into law.
If you have any questions about this Alert or would like more information, please contact Rachael G. Pontikes, Patrick Gallagher, any of the attorneys in our Pharmaceutical, Medical Device, Pharmacy & Food group or the attorney in the firm with whom you are regularly in contact.
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