H e l p I n g H e a l t h c a r e C a r e. U.S. Drug Supply Chain Security Act (DSCSA) Product Specifications Overview

Transcription

1 U.S. Drug Supply Chain Security Act (DSCSA) Product Specifications Overview

2 Agenda Systems, Notification and Disposition What is a Suspect Product? What is an Illegitimate Product? Investigations Product Identifiers Product Definition What It Includes Product Definition What It Does NOT Include 2

3 Systems, Notification and Disposition As of January 1, 2015: Trade partners (manufacturers, repackagers, wholesale distributors, and dispensers) must maintain systems and processes for investigating and quarantining products that are suspect or illegitimate. If a product is determined to be illegitimate, the partner must notify the U.S. Department of Health & Human Services (HHS) Secretary and its trading partners, take steps to disposition the product, and, if requested by an appropriate government official, to retain a sample. Manufacturers, wholesale distributors, dispensers, and repackagers must only utilize authorized trading partners. 3

4 What is a Suspect Product? A product for which there is reason to believe that such product: Is potentially counterfeit, diverted, or stolen Is potentially intentionally contaminated such that usage of the product would result in serious adverse health consequences or death to humans Is potentially the subject of a fraudulent transaction Appears otherwise unfit for distribution 4

5 What is an Illegitimate Product? A product for which credible evidence shows that the product: Is counterfeit, diverted, or stolen Is intentionally adulterated such that usage of the product would result in serious adverse health consequences or death to humans Is the subject of a fraudulent transaction Appears otherwise unfit for distribution 5

6 Investigations As requested by the HHS Secretary, (or other appropriate federal or state official) trade partners must provide the transaction information (TI), transaction history (TH), and transaction statement (TS) to the official as part of a recall or investigation of a product that is suspect or illegitimate. Manufacturers, wholesale distributors, and repackagers must respond to these requests within one (1) business day, but not more than 48 hours. Dispensers must respond within two (2) business days. Some of what an entity is required or able to produce may depend on the current requirements and timelines. 6

7 Product Identifiers A product identifier is a standardized graphic that carries the product s standardized numerical identifier (SNI), lot number, and expiration date in both human-and machine-readable format. Manufacturers Repackagers Beginning November 27, 2017, manufacturers must affix a product identifier to each individual package and homogenous case of product. Beginning November 27, 2018, Repackagers must affix product identifiers. 7

8 Product Definition What It Includes In general, a product is a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing, i.e.: Capsules Tablets Lyophilized products before reconstitution 8

9 Product Definition What It Does NOT Include The definition of product does NOT include: Blood or blood components intended for transfusion Certain radioactive drugs or radioactive biological products Imaging drugs The following intravenous products: the distribution of an intravenous product that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids); the distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions; the distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection; Certain medical gases Homeopathic drugs marketed in accordance with applicable guidance under the FD&C Act Drugs compounded in compliance with section 503A 9