US FDA tells industry how to exchange info to meet new drug tracing law
This article was originally published in SRA
The US Food and Drug Administration has released a draft guidance that explains how drug manufacturers, repackagers, wholesale distributors and dispensers should exchange transaction information, histories and statements when engaging in agreements involving certain prescription medicines to aid in tracing the products through the supply chain1.
The draft document is intended to address provisions of the new track-and-trace law, known as the Drug Supply Chain Security Act, part of the Drug Quality and Security Act (HR 3204), whose requirements go into effect on 1 January 2015 for manufacturers, repackagers and wholesale distributors and on 1 July 2015 for dispensers2.
The FDA, in consultation with stakeholders, was required to establish initial standards for the interoperable exchange of the product tracing information related to each transaction of certain human, finished, prescription drugs covered by the legislation.
Starting in 2015, trading partners are required to provide the subsequent purchaser with product tracing information for certain prescription drugs.
Trading partners also are required to capture and maintain the applicable product tracing information for not less than six years after the date of the transaction.
The FDA said it believes that "interoperability" encompasses the ability to exchange product tracing information accurately, efficiently and consistently among trading partners.
For any system, process or practice to be interoperable, the subsequent purchaser must be able to successfully capture and maintain the product tracing information, regardless of whether the information is provided in a paper or electronic format.
The FDA said it may revisit the application of interoperability as processes and capabilities that promote more standardization become available and as electronic systems evolve and are more widely accessible.
Regulators said trading partners could use current paper- or electronic-based methods for the interoperable exchange of data to provide product tracing information to subsequent purchasers as long as the selected methods allow information to be exchanged in a manner that complies with the track-and-trace law.
The FDA said email or Web-based platforms, such as portals, are acceptable means to transmit or access the product tracing information, as long as the information is captured, maintained and provided in compliance with the law.
The deadline for submitting comments on the draft guidance is 27 January 2015.
References
- DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information, November 2014, www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM424895.pdf
- Obama signs US compounding/track & trace billScrip Regulatory Affairs, 28 November 2013