In this edition of the Weekly Compliance Digest, we cover U.S. FDA requirements for pharmaceutical products in the supply chain that take effect later this month.
Title II of DQSA, the Drug Supply Chain Security Act (DSCSA)
What is it?
In November 2013, the U.S. Congress passed the Drug Quality and Security Act (DQSA). Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic system to identify and trace certain prescription drugs manufactured and distributed in the U.S. The objective of the system is to protect consumers from drugs that may be counterfeit, stolen, contaminated, or harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain, FDA says.
What are the provisions?
Major provisions of the Act include:
- Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.
- Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to provide information about a drug and who handled it each time it is sold in the U.S.
- Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.
- Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect.
- Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.
- Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database.
- Third-party logistics provider licensing: Third-party logistics providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.
What are the compliance dates?
Some requirements take effect on November 27, 2017, including:
- A manufacturer must provide the transaction information, transaction history, and transaction statement in electronic format each time a transaction takes place where ownership of a product is transferred.
- A manufacturer must respond within 24 hours to a request for verification from a repackager, wholesale distributor, or dispenser.
- When receiving a returned product that the manufacturer intends to further distribute, the manufacturer must verify the product identifier, including the standardized numerical identifier, for each product or case.
However, FDA is delaying enforcement of product identifier requirements to November 27, 2018. Product identifiers are for individual prescription drug packages and cases, and allow packages to be traced through the supply chain. An identifier includes the product’s lot number, expiration date, national drug code and a serial number.
FDA issued a draft guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. Although manufacturers are to begin including a product identifier on prescription drug packages and cases on November 27, 2017, FDA is delaying enforcement of those requirements until November 27, 2018. The policy applies only to products without a product identifier that are introduced into commerce between November 27, 2017 and November 26, 2018.
FDA has made available the following additional guidance documents:
- For serialization, i.e. the assignment of a unique serial number to each unit of a prescription product that is placed on the market: Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages
- For information, resources, best practices, processes and procedures designed to enhance global medical product quality and supply chain security: Supply Chain Security Toolkit for Medical Products
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