Do you distribute or manufacture pharmaceutical products regulated by the FDA? Do you need to report Electronic Product Code Information Services (EPCIS) transactions for regulatory compliance? If so, you are probably are aware of the Drug Supply Chain Security Act – the law that has been put in place to track these products individually. But did you know that Drug Supply Chain Security Act compliance is absolutely critical for your business? It therefore makes good business sense to be fully aware of the requirements.
Drug Supply Chain Security Act Compliance
These requirements went into effect on January 1, 2015. You should be familiar with these, because your company should already be doing these things.
- When ownership of a product is transferred, the company must provide the new owner with a transaction history, transaction information, and a transaction statement (as one document). Documentation of transaction history, transaction information, and transaction statement must be kept for 6 years.
- If information is requested by a Federal or State official, manufacturers must provide the applicable transaction information, transaction history, and transaction statement for the product no later than 1 business day (and not to exceed 48 hours) after the request.
- Manufacturers must only do business with authorized trading partners.
- If a product is suspect, manufacturers must have a process in place to quarantine the product and conduct a prompt investigation to determine whether the product is illegitimate. If it is found to be a legitimate product, the Secretary must be notified before distribution. Records of the investigation must be kept for 6 years.
- If a product is illegitimate, the manufacturer quarantine the product, disposition the product or assist a trading partner in control of the product to disposition it, and retain a sample of the product. The manufacturer must notify the Secretary of the illegitimate product. Records must be kept for 6 years.
These requirements go into effect this November. Familiarize yourself with what’s coming so you know how to prepare.
- Transaction information, transaction history, and transaction statements must be provided in electronic format (exception: a paper document may be provided to a licensed healthcare practitioner).
- Manufacturers must place a unique product identifier on each package of pharmaceutical products intended to be sold. These records must be kept for 6 years.
- If a request for verification is received by someone in control of the product, the manufacturer must respond within 24 hours with the unique product identifier information. If the information does not match, the product must be treated as suspect and investigated.
- Records must be kept in a secure electronic database.
- If a product is returned, the manufacturer must verify the unique product identifier on each sealed homogeneous case or package before reselling.
With so much coming down the line, do you know which products, services, and integration options are best for your organization? Our efficiency experts can help. With more than twenty years of experience under our belt, the Bar Code team helps logistics customers manage inventory, strengthen security, and increase production and labor inefficiencies. You can trust our expertise, knowledge, and experience to help your business comply with the DSCSA.