Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Volume 90 Issue 52 | p. 35 Issue Date:
December 24, 2012
Congress made it a top priority this year to pass the FDA Safety &
Innovation Act (S. 3187), a bill that reauthorizes FDA to collect fees from the
pharmaceutical and medical device industries to help accelerate the review of
new drugs and devices. After numerous hearings this year, the bill cleared both
the House of Representatives and Senate in June and was then signed into law by
President Barack Obama.
The legislation allows FDA to collect user fees from industry for five years,
beginning in fiscal 2013. Such fees provide about 60% of FDA’s drug review
budget and 20% of its device center budget. The bill also authorizes, for the
first time, user-fee programs for generic drugs and biosimilars—the generic
equivalents of biologic drugs. In addition, it permanently authorizes two
programs aimed at increasing the safety and effectiveness of drugs and medical
devices for children.
Also part of the user-fee law is a provision that criminalizes a host of designer drugs. The law bans virtually all synthetic marijuana
compounds, two stimulants sold as bath salts, and nine hallucinogens called 2C
substances for the two-carbon bridge that links a benzene ring and an amino
group in these compounds.
FDA was on the congressional radar again this fall because of a multistate outbreak of fungal meningitis, linked to a
Massachusetts-based compounding pharmacy that produced injectable steroids.
Lawmakers questioned whether the agency has sufficient oversight of compounding
pharmacies. Such pharmacies typically mix small batches of drugs and are
regulated at the state level, whereas large-scale drug manufacturers are
regulated by FDA.
Lawmakers believe that the pharmacy responsible for the meningitis outbreak,
the New England Compounding Center, was operating as a drug manufacturer under
the guise of a compounding pharmacy.
Hearings related to FDA oversight of compounding pharmacies were held in both
the Senate and House after news of the outbreak. In addition, last month Rep.
Edward J. Markey (D-Mass.) introduced H.R. 6584. The bill would preserve state
regulatory authority for small compounding activities and ensure that pharmacies
operating as drug manufacturers are regulated by FDA.
Earlier this month, House lawmakers sent a letter to the International
Association of Compounding Pharmacies, questioning whether the industry group
has a history of encouraging compounding pharmacies to impede FDA from
evaluating their products.