FDA unveils new drug pedigree requirements

August 10, 2014

Under the new law, duties of stakeholders in the pharmaceutical industry to investigate, quarantine, and report do not cease upon identifying a suspect or illegitimate pharmaceutical product. FDA requires that it be notified in a very short time frame of the existence of an illegitimate product. Reporting should be done electronically. However, equally important, immediate trading partners in the supply chain must also be notified of an illegitimate pharmaceutical product.

 

Mandatory reporting begins January 1, 2015

Title II of the Drug Quality and Security Act is composed of the Drug Supply Chain Security Act (DSCSA). The DSCSA modified Section 582 of the Federal Food, Drug, and Cosmetic Act to require pharmaceutical manufacturers, repackagers, wholesale distributors, as well as drug dispensers, who are not practitioners to notify the FDA and certain trading partners of products that are identified as illegitimate within 24 hours of making such determination.

Products that manufacturers, repackagers, wholesale distributors, and dispensers determine are suspect products must be quarantined and an investigation must be conducted to determine if the product is illegitimate. Suspect or illegitimate pharmaceutical products include those that are potentially counterfeit, diverted or stolen, may adversely affect humans, could be the subject of a fraudulent transaction, or are unfit for distribution.

It is expected that, in compliance with the modifications to the DSCSA, trading partners will develop secure electronic systems to verify the status of a pharmaceutical product and create processes to ensure the appropriate quarantine, investigation, and reporting requirements are met if a product is determined to be illegitimate or suspect. Concerns over improper pharmaceutical products entering commerce are not new. However, it does appear that the new mandates increase the attention required to protect the public and impose requirements on supply chain stakeholders to assist in identification of improper pharmaceutical products.. 

In an effort to provide specific recommendations, FDA recently published its draft Guidance for Industry Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification. (The agency has requested comments to the draft be submitted by August 11, 2014.) In that document, FDA identified numerous scenarios that should lead to scrutiny regarding the authenticity of pharmaceutical products. While not all inclusive, the specific examples provided in the guidance document are a helpful source as to how FDA views the issues.

Notification of suspect product

Under the new law, duties of stakeholders in the pharmaceutical industry to investigate, quarantine, and report do not cease upon identifying a suspect or illegitimate pharmaceutical product. FDA requires that it be notified in a very short time frame of the existence of an illegitimate product. Reporting should be done electronically. However, equally important, immediate trading partners in the supply chain must also be notified of an illegitimate pharmaceutical product. For suspect products, trading partners may be part of a coordinated investigation to determine if the product is, in fact, illegitimate. Manufacturers are further required to notify the FDA and trading partners if a product they distribute has a high risk of being an illegitimate product.

It is undisputed that problems exist within the supply chain. However, the recent draft guidance for the drug supply industry is a prediction of the changes and mandates that are occurring to make all in the supply chain a mandatory partner with the FDA.

Planning and preparation for compliance with the mandates that will be effective as of January 1, 2015, along with various informal guidance promulgated by the FDA, are already underway. The next several months will see additional feedback from the FDA as compliance with investigation and reporting of illegitimate products will be mandatory when the new requirements officially take effect January 1, 2015.

Ned Milenkovichis a partner and practice group manager of the health, drug and pharmacy legal practice at Roetzel and Andress LPA. He is also a member of the Illinois State Board of Pharmacy. Contact Ned at 312-582-1676 or at nmilenkovich@ralaw.com.

**PULL QUOTE**

The recent draft guidance for the drug supply industry is a prediction of the changes and mandates that are occurring to make all in the supply chain a mandatory partner with the FDA.