Serialization affects all stages of the supply chain and with many companies, small and large, unprepared for the scope of regulations and data support required it leads to the question: what happens if you miss the serialization deadline? This blog is intended to shed light on what to be ready for and what consequences will take place if you do not make the November 27, 2017 deadline.
Q. What’s the difference between guidances and legal compliance?
A. Guidances are not laws. There is no requirement to follow them and no penalties if you don’t. The guidances issued since the Drug Supply Chain Security Act (DSCSA) was passed are mostly the “current thinking” by FDA on how to meet the requirements of the DSCSA. Guidances are non-binding as long as legal requirements are met.
The DSCSA was signed by President Obama and was an act of Congress, meaning that noncompliance will be penalized through legal action. The DSCSA states, “…upon conviction of violations of Federal, State, or local drug laws or regulations, may provide for fines, imprisonment, or civil penalties.”
Q. The DSCSA (Section 585 (b)(4)(C)) modifies Federal law (21 U.S.C. 331) to include noncompliance with aspects of the DSCSA as a “Prohibited Act.” What does the federal law 21 U.S.C. 333 specify as penalties for a prohibited act?
A. Specific penalties for a prohibited act include: Imprisonment for not more than one year and/or a fine of not more than $1,000; Imprisonment of not more than three years and/or a fine of not more than $10,000 for subsequent or intentional violations; Equitable remedies, such as restitution, disgorgement of profits and product seizure; The Federal Criminal Code also authorizes a general fine of up to $250,000 for individuals and $500,000 for entities.
Q. What other conditions need to be considered?
A. In addition to compliance dates and requirements for T3 documentation (Transaction History, Transaction Information and Transaction Statement) and serialization, prohibited acts will also include reselling or misbranding a product. Failing to report issues with shipments and/or suspect or illegitimate product within 48 hours is also prohibited.
The DSCSA also establishes the primacy of the FDA in regulating the pharmaceutical supply chain; the state will not control what penalties are faced under the DSCSA.
Q. Besides facing legal penalties, what does missing the deadline mean for your product and your patients who rely on the medication?
A. The products that are made are not saleable and could result in a drug shortage situation if serialization is not adhered to. This can put patient needs in jeopardy.
Q. Will your CDMOs continue to package non-serialized (non-compliant) product after the deadline?
A. Non-serialized product can continue to be packaged if it is not a commercial product meaning it’s a clinical and not for human use product. Otherwise, material must be serialized.
Q. Will distributors accept non-serialized (noncompliant) product post deadline?
A. Distributors are requiring serialized products in order to comply with the DSCSA November 27, 2017 deadline.
To learn more about serialization and what capabilities to look for in a CDMO for successful serialization outsourcing needs, be sure to download our white paper, “Guide to Pharmaceutical Serialization 2017: What You Need to Know When Partnering with Your CDMO.”
*Please note that since the original publication of this blog entry, the serialization deadline has been extended to November 27, 2018.