Back to the drawing board for USP , Good Distribution Practices

At the Global Cold Chain Forum (Boston, Oct. 5-9), Mary Foster, PharmD, chair of the Packaging and Distribution Expert Committee at US Pharmacopeia (Bethesda, MD) gave an update on the organization’s plans for revising USP <1083>--the gist of which is, USP is reducing its involvement in distribution practices per se. The Expert Committee will continue work on materials of construction for packaging (presumably including the tertiary packaging which constitutes temperature-controlled shipping), and it will continue to develop at least one part of <1083> pertaining to quality systems in distribution management. But subchapters on other topics may be reduced or eliminated.

USP (which has a federal recognition dating back nearly two centuries) is a private non-profit whose deliberations become enforceable regulations by FDA in some cases, and useful guidance in others. USP <1083> work began some three years ago, and the original vision was to have a guidance chapter that would include subchapters on quality systems, good import/export practices, supply chain integrity and related topics. In a generalized fashion, the USP work paralleled that of the European Union’s adoption of Good Distribution Practices (GDPs), which are now in force in some parts of European pharma distribution, and are a model of best practices for many nations.

Now, apparently, the EU’s GDPs will be the guidance for US practices as well, at least in private industry. A number of changes have taken place in US distribution practices since the <1083> work began, notably passage of the Drug Supply Chain Security Act in 2013, which provides specific requirements for FDA to enforce. According to Foster, stakeholders in USP deliberations (likely to be FDA, academics and private industry) recommended not delving too deeply into distribution practices themselves. A possible reason would be that USP’s work would simply be redundant to what’s going on elsewhere.

Does any of this matter? Yes and no. Whether codified and approved or not, these USP “general chapters” are recommendations and guidance, not requirements to be enforced under law. What goes on in pharma distribution in the US has generally had a lower priority for FDA, although agreements between manufacturers (whose products are being shipped around) and logistics providers (who do the transporting and storage) could certainly affect overall performance. It’s also true that FDA has oversight over only parts of pharma distribution; “No one regulatory agency can secure the pharma supply chain,” noted Foster. An update on USP deliberations will be published in an upcoming issue of Pharmacopeial Forum, USP’s open-access report.