Bill includes voluntary oversight by FDA of outsourced compounded pharmaceuticals, national distributor licensure, and a timetable for serialization and drug tracking
Pharma track-and-trace, and tighter regulation of compounding pharmacies, is almost here.
In the middle of a high-tension day (Sept. 28) when the House spent hours debating the funding of the Affordable Health Care Act—and the government itself—the legislators paused to approve (by voice vote, indicating a non-controversial action) HR 3204, the Drug Quality and Safety Act. Earlier in the week, both Rep. Fred Upton’s (R-MI) Energy and Commerce Committee and Sen. Tom Harkin’s (D-IA) HELP Committee issued press releases acclaiming a bicameral, bipartisan breakthrough in getting House and Senate versions of the law unified. Sen. Harkin issued a statement applauding the passage, and urging full consideration by the Senate.
In retrospect, the Senate took a gamble, earlier this year, in combining bills addressing supply chain security and compounding pharmacy regulation. The former has been tossed back and forth for years (the so-called pedigree rules for tracking drugs go all the way back to the Prescription Drug Marketing Act of 1987, passed during the Reagan Administration), while the latter rose to public attention in the aftermath of the NECC compounding scandal, from last year, which has killed, at current count, 64 patients and sickened hundreds more. The House had passed a supply-chain security bill only (HR 1919) last spring, and subsequent hearings about including drug compounding had mixed reactions. But the gamble worked, and insofar as press statements are concerned, the compounding legislation carried the supply-chain legislation through to passage.
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The key decisions in HR 3204 for compounding:
- Voluntary federal registration as an “outsourcing facility” for compounding. The bill does not define how such a facility differs from the corner pharmacist (unregistered for the purposes of this law) who might be compounding individual doses for customers.
- Beginning in FY 2015, a registration fee of $15,000, and an additional $15,000 (inflation-adjusted) for inspections will be assessed on outsourcing facilities.
- A list will be developed of drugs for which compounding at an outsourcing facility is to be avoided.
- Compounded drugs from outsourced facilities will have a label saying “this is a compounded drug” or equivalent language.
- Enhanced communication is to occur between state boards of pharmacy and FDA for warnings or other compliance issues at outsourcing facilities.
Title II of the bill covers supply chain security:
- Manufacturers, wholesale distributors, repackagers and third-party logistics providers (a first for the latter) will have a federal registration process to undergo
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