Regulatory Focus™ > News Articles > Modified Senate Legislation Emerges, Would Reform Compounding Regulation, Track and Trace

Modified Senate Legislation Emerges, Would Reform Compounding Regulation, Track and Trace

Posted 26 July 2013 | By Alexander Gaffney, RAC

The US Senate's Health, Education, Labor and Pensions (HELP) Committee has released an updated version of legislation meant to enact a track and trace system for pharmaceuticals, as well as new regulations to crack down on deficient pharmaceutical compounding practices that resulted in a massive outbreak of fungal meningitis in late 2012.


Both the Senate and House of Representatives have been working independently of one another to push forward measures on both compounding and track and trace. On the Senate side, the two measures have been combined into a single bill, the Pharmaceutical Quality, Security and Accountability Act (PQSA Act), while on the House side the measures are proceeding separately.

The HELP Committee had previously passed separate iterations of the bill, the Pharmacy Compounding Quality and Accountability Act and the Drug Supply Chain Security Act, on 22 May 2013 with unanimous consent, saying the bills would help give FDA new regulatory authority with which it could use to better inspect compounding facilities and their products and keep track of the pharmaceutical supply chain.

[For an explanation of both bills, please see our 23 May 2013 bill, "Senate Advances Compounding, Track and Trace Legislation with an Eye on July Passage."]

New Changes

In the meantime, however, HELP Committee members have gone back to the legislative drawing board to make changes to the bills, the most notable of which is to combine them into a single entity.

The new bill makes minor changes to each respective part of the legislation. For example, FDA will be allowed to designate a list of drugs that cannot be compounded-authority the agency had lobbied for vigorously-but FDA would be required to show a reasonable likelihood that compounding the drug would lead to adverse events or other safety/efficacy issues. FDA would also be required to take into account the historical use of the drug, as well as other to-be-defined criteria. This measure seemed to be aimed at placating critics of the legislation, such as community pharmacy groups, which fear the legislation could make a wide range of drugs unavailable. The new measure would slow down any attempt by FDA to ban a drug from being compounded by requiring various criteria to be met, presumably giving groups more time to respond.

Another change would vastly reduce the number of drugs capable of being compounded. "To help preserve incentives to go through the FDA approval process, compounding manufacturers will only be able to compound non-sterile drugs included on a list developed by FDA," legislators wrote. This would presumably help companies like Roche and KV Pharmaceutical, whose drugs have been subject to large amounts of competition from compounders, eroding their market share (and in the case of the latter, leading to bankruptcy).

The drug supply chain provisions, however, have stayed almost entirely the same, with only one modification: Manufacturers will now be required to provide transaction information, transaction history, and transaction statements in electronic form to their trading partners. This requirement will go into effect four years after the date when serialization requirements do.

The bill now needs to pass the HELP Committee, after which time it would be voted on by the full Senate. Assuming passage, it would then await a vote in the House. The House, however, may opt to wait until its own legislation on the measures is completed before voting, in which case the likely result is a Conference Committee that would work to combine the two bills into a single piece of legislation capable of passing both the House and Senate.

The legislation may be found here.

The Pharmaceutical Quality, Security and Accountability Act

PQSA Summary

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