The Congressional approval of the Drug Quality and Security Act (H.R. 3204) is intended to clarify and strengthen the regulatory framework for compounding pharmacies. Compounding pharmacies deliver personalized medicines that meet unique needs of an individual patient when commercially available drugs do not meet such needs.
The October 2012 outbreak of fungal meningitis, caused by contaminated steroid injections from New England Compounding Center, turned the industry's attention to a what could be a dangerous regulatory gap.
The Massachusetts Health Department’s report from the NECC recall stated, “Manufacturing and distributing sterile products in bulk was not allowed under the terms of its state pharmacy license." It went on to state, "If NECC was appropriately licensed as a manufacturer with the FDA, the company would have been subject to additional levels of scrutiny.”
This report touches on two very good points, both of which are at the center of the debate surrounding the passage of the Drug Quality and Security Act:
1) Compounders are not licensed to distribute products in bulk
2) Drug manufactureres and compounders are subject to different quality standards and practices
The Drug Quality and Security Act, which must be signed into law by President Obama, is intended to address several concerns about compounding pharmacies. The full summary is here. The highlights:
• A pharmacy engaged in preparing sterile compounded drug formulations may voluntarily elect to register as an "outsourcing facility."
• The bill exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements. Those registered as outsourcing facilities are permitted to compound large quantities of drug formulations on the FDA's drug shortage list, and other formulations compounded with drug substances that are on a "clinical need" list to be established by the FDA, without a prescription, as well as distribute these formulations out of state without limitation.
• The bill requires a facility to report biannually to the Secretary of Health and Human Services on what drugs are compounded in the facility and to submit adverse event reports.
• Registered facilities are subjected to a risk-based inspection schedule.
The conflict, as outlined in a story by ABC news and numerous other consumer media sites, is as follows:
Prior to the NECC outbreak, compounding pharmacies were regulated by state pharmacy boards, and the FDA claimed it didn't have the authority to properly regulate the industry. The Drug Quality and Security Act was designed to address these concerns.
However, critics claim that the new bill will do the opposite, instead allowing compounding pharmacies to function as large scale drug manufacturers, but without being subjected to the same regulatory scrutiny.
"It makes what is now illegal legal," said Dr. Michael Carome, Director, Public Citizen’s Health Research Group. "It has misleadingly been presented to the American public as something that improves federal oversight over compounding pharmacies."
Registration as an outsourcing facility is optional, and critics point out that compounders won't register unless it's mandatory. Supporters of the Drug Quality and Security Act hope that compounding pharmacists will seek FDA registration because doctors will prefer to use compounding pharmacists perceived as safer.
Opponents suggest that the industry would be better served if the FDA was more aggressive in enforcing existing law, rather than passing a new one.