Medicines track-and-trace bill delayed until after recess

An updated version of a bill that aims to introduce a federal traceability system for medicines and new rules for compounding pharmacies in the US has been published.

There had been hopes that the Pharmaceutical Quality, Security and Accountability Act (S. 959) might make it to the Senate floor in July, but the time taken to incorporate amendments by the Health, Education, Labor, and Pensions Committee (HELP) committee means it will now be considered no earlier than September.

The PQSA would create a lot-level traceability system that within 10 years of adoption would be upgraded to full unit-level traceability of medicines based on the application of standard numerical identifiers (SNIs) to unit level packaging (see Senators clear medicine-tracking bill for floor debate).

Most of the amendments to the track-and-trace elements are relatively minor, according to summary documents provided by the HELP committee, although there are new provisions such as requiring transaction records be kept in electronic form only four years after enactment when manufactures are required to serialise product.

The amendments to the compounding section of the PQSA are more involved, including for example a provision to allow the US Food and Drug Administration (FDA) to draw up lists of drugs that are complex and should not be compounded at all, as well as bulk ingredients that must not be used in compounded products.

It also clarifies that traditional pharmacies - rather than the new category of "compounding manufacturers" that make sterile products without, or in advance of, a prescription and sell those products across state lines - may continue to compound a drug for a doctor to use in the office and would be overseen by state authorities.

What remains unclear is the path of the proposed legislation from now on.  SecuringIndustry.com understands the amendments do not have to return to the HELP committee for approval. Meanwhile, there have been suggestions that it could pass the Senate promptly as a request has been made it have the bill "hotlined" - a measure used to pass non-controversial legislation without a formal vote.

In order for a bill to be hotlined, the Senate Majority Leader and Minority Leader must agree to pass it by unanimous consent, without a roll-call vote, and - if no objections are registered - it is automatically passed.

With stakeholders lobbying against the bill - particularly from the compounding pharmacy sector - there is every possibility that objections may be raised to block the hotlining process.

[Ed. As this article went to press there were reports that the bid to hotline the bill had been shelved, but we have so far been unable to verify this.]

Even if S.959 is passed, Congress will still have to reconcile it with a House of Representatives bill (HR. 1919), which passed the House by a voice vote on June 3 (see House drug traceability bill makes stride forward) but had been criticised for setting a long timeframe before unit-level track-and-trace is required.

For the moment at least though it seems like some form of federal track-and-trace system that could avoid an unharmonised patchwork of state-level requirements is closer than ever before.