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FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain, with phased-in obligations for the various trading partners over 10 years, beginning with the law’s passage in November 2013. Covered trading partners include manufacturers, repackagers, wholesale distributors, and dispensers, whose upcoming compliance obligations under the DSCSA are all addressed by FDA in the recently issued Compliance Policy guidance document. 

The subject of the Agency’s current enforcement discretion policy is the DSCSA’s requirement that, beginning November 27, 2017, manufacturers “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce.” According to the new Compliance Policy, FDA does not intend to enforce this product identifier requirement against manufacturers until November 27, 2018. That is, covered drugs introduced into commerce by the manufacturer between November 27, 2017, and November 26, 2018, that do not have a product identifier will not subject the company to potential liability under the law.  Downstream trading partners who purchase such non-serialized products also are being given comfort by FDA that they will not become the target of Agency enforcement efforts, as long as they meet the terms laid out in the guidance document and the drugs were initially introduced into commerce during this 1-year discretionary period being offered to manufacturers. Moreover, related requirements for manufacturers to verify product identifiers at the package level, either independently or based on a specific request from a trading partner, are also addressed in FDA’s new compliance policy.

As it explains in the document, FDA’s decision was spurred by comments and feedback from manufacturers and other trading partners expressing concern over industry-wide readiness of the product identifier requirements. The stakeholders’ concerns centered around: (1) the limited number of vendors that can provide the requisite IT solutions, and (2) the capabilities and readiness of contract facilities that perform manufacturing operations on behalf of manufacturers. The FDA decided to exercise its discretionary authority due to worries that these shortcomings could cause a disruption in the distribution of prescription drugs in the United States.

With respect to upcoming product identifier-related deadlines for downstream trading partners, the Agency states that it does not intend to take action against:

  • any repackager who, on or after November 27, 2018, accepts ownership of products lacking identifiers;

  • any wholesale distributor who, on or after November 27, 2019, engages in a transaction involving products without identifiers; or

  • any dispenser who, on or after November 27, 2020, engages in a transaction involving products without identifiers.

The terms laid out in the document are critical, so it is also important to emphasize what the new FDA Compliance Policy does not cover.  It makes no enforcement-related changes to any DSCSA requirement that has already gone into effect, including the product tracing obligations of all covered trading partners (provisions related to the so-called “3T information”) and their responsibilities to confirm that all trading partners are authorized to engage in prescription drug transactions (via state licensure, FDA registration, or otherwise).  And because prescription drug products without the required product identifier cannot be introduced by the manufacturer into commerce after November 26, 2018, the Agency recommends that downstream trading partners take concrete steps to determine that a product’s initial transaction date falls within the 1-year discretionary window. Other specific provisions of the DSCSA, such as its treatment of saleable, returned drugs, are also addressed by the Agency policy.

In 2015, trading partners expressed skepticism over their ability to satisfy the DSCSA’s first stage of product tracing requirements, which similarly led FDA to delay enforcement of those requirements. Although enforcement delays have been granted at multiple steps along this staggered implementation timeline, trading partners are still progressing towards the final goal of a national electronic, interoperable prescription drug tracing system. We will continue to follow any such developments on this blog.

Comments on the draft guidance are due by September 1, 2017 (60 days after notice of availability was published in the Federal Register).

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About this Author

Jordan T. Cohen Mintz Levin law firm Anti-Kickback Lawyer, HIPAA Attorney, Healthcare legal consutlant

Jordan provides clients in the healthcare industry with advice and counsel relating to federal health care law and regulations, including the Stark Law, the Anti-Kickback Law, the Anti-Markup Rule, as well as state health care laws and regulations.

Jordan also counsels clients on compliance with HIPAA’s Privacy Rule and Security Rule, including new requirements under the HITECH Act and 2013 Omnibus Regulations. In this capacity, Jordan has assisted in drafting policies and procedures for HIPAA compliance, business associate agreements, and...

Joanna Hawana, Mintz Levin, FDA Lawyer, Consumer Protection Attorney, Washington
Of Counsel

Joanne advises clients around the world in the food, drug, and biotechnology industries on issues ranging from prescription drug advertising to state licensing requirements for wholesale distribution. In particular, Joanne counsels clients on the business impact of new US federal and state actions that affect regulated products, such as drugs, foods, and medical devices.

Joanne is experienced in US federal drug regulations, including pre-market and post-market requirements, and restrictions on advertising and sampling. Joanne also has counseled clients on state regulation of prescription drug distribution and licensing requirements. She is well versed in advising clients on the regulatory considerations for marketing controlled substances, track-and-trace systems for prescription drugs, and the food safety and labeling requirements for human and animal food. Joanne also has counseled both pharmacies and practitioners on drug compounding regulatory matters.  In addition, she has worked with manufacturers and retailers to determine the regulatory status of certain medical devices, laboratory tests, and mobile medical applications.