FDA unveils new drug pedigree requirements

Ned MilenkovichTitle 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, and drug dispensers who are not practitioners to notify 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 must be quarantined and an investigation must be conducted to determine whether the products are illegitimate. Suspect or illegitimate pharmaceutical products include those that are potentially counterfeit, diverted, or stolen; capable of adversely affecting human beings; possible subjects of fraudulent transactions; or unfit for distribution.

Verification systems

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 that 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.

Draft guidance

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 that comments to the draft be submitted by August 11, 2014.

In the 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 demonstration of how FDA views the issues.

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 expects to be notified quickly of the existence of an illegitimate product. Reports should be made electronically.

It will be equally important to notify immediate trading partners in the supply chain of an illegitimate pharmaceutical product. For suspect products, trading partners may be part of a coordinated investigation to determine whether 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.

Changes and mandates

It is undisputed that problems exist within the supply chain. However, the recent draft guidance for the drug supply industry is a sign of the changes and mandates that are moving all in the supply chain toward becoming mandatory partners with the FDA.

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

Ned Milenkovichis a partner and head of the healthcare, 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 atnmilenkovich@ralaw.com.