September 19, 2018
“Patients should expect safe and high-quality drugs. And the manufacturers who develop and ship these products should expect a secure supply chain that guarantees the custody of these medicines. That means accountability throughout the supply chain. However, given the breadth and complexity of our U.S. drug supply chain and its continued expansion and diversification, we recognize the need to ensure greater accountability for manufacturers, repackagers and other intermediaries in the supply chain. This includes those involved in the distribution and delivery of medicines,” said FDA Commissioner Scott Gottlieb, M.D. “We’re committed to using increasing tracing of drugs to protect patients at every point in the supply chain. This includes protecting patients from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. By creating a tighter, closed system, we’ll be able to better prevent the introduction of illegitimate products, better detect the introduction of illegitimate products, and enable stakeholders and the FDA to respond rapidly when such products are found. The three guidances we’re issuing today will help bring us towards a more secure supply chain to help avoid these types of issues going forward. These policies are part of a continuing effort to protect American patients.”
Today, the FDA is finalizing two guidance documents and making available one draft guidance to help ensure that prescription drug products are identified and traced properly as they move through the supply chain in compliance with federal law. The goal of these documents laying out the FDA’s policies is to clarify for the pharmaceutical industry timing related to product identification, and verification, to reduce confusion in the supply chain and ensure compliance.
As part of the Drug Supply Chain Security Act (DSCSA), manufacturers and repackagers are required to use unique product identifiers. These product identifiers include the product national drug code (NDC), a serial number, lot number, and an expiration date on each package and case of product in human- and machine-readable form. Industry questions are addressed in the draft guidance, Product Identifiers Under the Drug Supply Chain Security Act, Questions and Answers.
Additionally, the final guidance Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy addresses industry-wide readiness for implementation of the new requirements aimed at enhancing the security of the drug supply chain. This guidance document specifies the FDA’s one-year delay in enforcement of manufacturers’ requirement to include product identifier on package or case of product to November 27, 2018; as the agency continues to work with stakeholders to ensure proper implementation of the law.
In conjunction with the guidance on product identifier compliance policy, the final guidance Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier outlines the circumstances in which packages and cases of product that were in the supply chain before the November 2018 product identifier requirement are considered grandfathered. The grandfathering policy describes the circumstances under which products already in the supply chain can remain in distribution without being relabeled with a product identifier. These guidances will help ensure there are no disruptions in the supply chain as manufacturers and repackagers include a product identifier on the package or case.
In the weeks ahead, to continue the implementation of this framework, the agency will issue another draft guidance, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs. This additional guidance document will address the verification systems that manufacturers, repackagers, wholesale distributors and dispensers must have in place under the DSCSA to quarantine and investigate suspect and illegitimate products.
The Drug Supply Chain Security Act was enacted by Congress on November 27, 2013. DSCSA outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.