What is serialization FDA?
As part of the FDA Drug Supply Chain Security Act’s (DSCSA) product tracing scheme, manufacturers and repackagers are required to place a unique product identifier, which is also known as serialization, on each package of human prescription drug product intended to be introduced into commerce.
Does Drug Supply Chain Security Act apply to OTC drugs?
In these cases, the FDA considers your drug to be Over-The-Counter (OTC), and therefore exempt. If your product is a device—even if the FDA requires your device to be dispensed only with a physician-issued prescription (“Rx Only”)—then it is not a prescription drug and therefore it is not covered by the DSCSA.
What products are not covered in the scope of the DSCSA?
What Transactions are Considered Exempt from the DSCSA?
- Intracompany distribution of any product between members of an affiliate or within a manufacturer.
- The distribution of product samples by a manufacturer or a licensed wholesale distributor.
- The distribution of over-the-counter (OTC) drugs.
What does DQSA stand for?
The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
Who is an authorized trading partner ATP )?
The DSCSA requires US pharmaceutical supply chain actors to prove that they only interact with trading partners that are “authorized”. Trading partners are “authorized” when they hold as a wholesaler a state license and as manufacturer a FDA Entity Identifier that is valid at the time of interaction.
Why the DSCSA was enacted?
Congress enacted the DSCSA in 2013. The act was crafted in response to the danger to patient safety of counterfeit drugs entering the U.S. prescription drug supply chain. Finally, the DSCSA establishes national licensure and licensing standards for drug wholesalers and third-party logistics providers.
What information does the product identifier contain DSCSA?
PRODUCT IDENTIFIERS UNDER THE DSCSA Therefore, each package and homogenous case of product intended to be introduced in a transaction into commerce must include the NDC, unique serial number, lot number, and expiration date in both human- and machine-readable formats.
Does DSCSA apply to veterinary medicine?
While the Drug Quality and Security Act (DQSA) provided a new regulatory framework for compounded medications for use in human medicine, it does not apply to veterinary compounded medications.
What are the different types of controlled substance?
Controlled substances include opioids, stimulants, depressants, hallucinogens, and anabolic steroids. Controlled substances with known medical use, such as morphine, Valium, and Ritalin, are available only by prescription from a licensed medical professional.