In January 2012, the US Pharmacopeial Convention (USP) proposed a set of recommended best practices to help ensure that medicines
can be traced back to their original manufacturer, are not adulterated or counterfeited, and are transported to their intended
destination with their quality intact. USP is seeking broad feedback on these recommendations on supply-chain integrity. The
new standard being proposed is not mandatory and is contained in the proposed USP General Chapter <1083> Good Distribution Practices—Supply Chain Integrity. The proposal is intended to serve as a central guidance document outlining the essential elements of an effective strategy.
"While individual pharmaceutical companies have their own approaches to addressing this issue, the size and sophistication
of companies and their suppliers vary widely, as do their quality systems and risk management approaches," noted USP in a
Jan. 4, 2012, press release in announcing the proposed standard. "Broad consensus around issues such as track-and-trace technology
does not exist, and smaller companies that may be relied upon for sourcing pharmaceutical ingredients may or may not have
security approaches comparable to their larger counterparts. Supply-chain integrity involves minimizing risks that arise anywhere
along the supply chain, from sourcing pharmaceutical raw materials to their manufacture and distribution," noted USP in its
"There is incentive for all players in the pharmaceutical industry—large and small companies, regulators and standards-setting
bodies—to come to some agreement on hot-button issues such as track-and- trace technology and, at the larger level, to codify
what constitutes a solid, universal approach to global supply-chain integrity," said Praveen Tyle, chief science officer for
USP, in the release. "USP has developed an initial proposal that we expect to evolve as industry, FDA and others weigh in.
Our role as an independent body provides an opportunity to convene all these parties and advance this critical issue. While
some pockets of information are available via FDA guidances, trade organizations and other sources, an overall approach is
lacking. USP can move forward something more concrete than a technical report, as part of a mechanism that can be regularly
updated to best meet the needs of all."
The proposed standard covers four main areas:
Importation—Details three primary initiatives importers should undertake to help prevent and detect potential risks: supply-chain risk
management, development of effective supplier partnerships and building a supply-chain quality system
Counterfeit drugs and medical devices—Documents types of counterfeit drugs, medical consequences, and distribution and extent of counterfeit drugs and devices
Best practices to combat counterfeit drug and medical devices—Covers topics including packaging technologies (tamper-evident designs, authentication technologies and serialization); drug
pedigrees; machine-readable data carriers (2D bar codes and RFID tags); repackaging guidance, information retention and security;
international standards; and best anticounterfeiting practices.
Diversion and theft—Addresses factors that raise the risk of theft of drug products, drug components and medical devices; security systems, devices
and procedures that should be implemented to reduce risk; and critical information to be gathered following discovery of a
USP envisions the general chapter will be of use to all organizations and individuals involved in the global supply chain,
including manufacturers; transportation companies involved in automobile, truck, rail, sea and air services; third-party logistics
providers, freight forwarders and consolidators; brokers, importers, and exporters; packaging and repackaging operations;
wholesalers and distributors; retail, mail-order, hospital, nursing home and other pharmacies; and mail distributors, including
the US Postal Service and other expedited shipping services.
DCAT Roundup: Podcast
The formal proposal will be published in Pharmacopeial Forum
38 (2), March–April 2012. This is the vehicle through which USP accepts public comment on its standards. The draft general chapter
and comments submitted to USP will be a central topic of a Supply Chain Integrity Workshop that USP is convening May 22–23,
2012, in Rockville, Maryland. This meeting will be a further opportunity to provide input, including whether additional information
needs to be included in the chapter.
Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072, firstname.lastname@example.org
1. FDA Statement, "FDA Notifies Healthcare Providers about the Risks of Purchasing Unapproved Injectable Cancer Medications
from Unlicensed Sources" (Rockville, MD, Jan. 13, 2012).
2. FDA Statement, "Counterfeit Version of Avastin in US Distribution" (Rockville, MD, Feb. 14, 2012).
3. Counterfeit Pharmaceutical Inter-Agency Working Group, "Counterfeit Pharmaceutical Inter-Agency Working Group Report to
the Vice-President of the United States and Congress (Washington, DC, March 2011).