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Is Your Pharmacy Ready for FDA's DSCSA 2015 Implementation?

The FDA Drug Supply Chain Security Act (DSCSA) has 4 areas of compliance for pharmacies and the first deadlines are January 1, 2015:

(1) Trading partners of a dispenser may be only authorized trading partners and

(2) Dispensers shall develop systems and processes to be able to comply with the verification requirements.

The remaining provisions on transaction documentation begin July 1, 2015 and we will see product serialization on packaging to meet package level traceability requirements over the next 10 years.

(3) Product tracing- dispensers shall not accept ownership of a product, unless the previous owner provides transaction history (TH), transaction information (TI), and a transaction statement (TS).In the event of a recall or for the purpose of investigating a suspect or an illegitimate product, a dispenser shall, not later than 2 business days after receiving the request or in another such reasonable time as determined by the Secretary, based on the circumstances of the request, provide the applicable TH, TI, TS which the dispenser received from the previous owner.

(4) Product identifier- Beginning not later than 7 years after the date of enactment of the Drug Supply Chain Security Act, a dispenser may engage in transactions involving a product only if such product is encoded with a product identifier.

Our colleague from rxtrace.com recently posted on the term “dispenser” in the DSCSA law that may cause confusion for healthcare providers when interpreting the requirements as applying to their trading partners only as well as the added confusion on the exception for health care professionals that does NOT exempt their procurement staff or supply chain colleagues.

As we have thousands of pharmacies in the US and are less than 70 days away, how are you and your trading partners intending to meet the detailed requirements? How can we utilize the enhanced product information for recall processes, supply chain efficiency and patient safety?  We look forward to your feedback and joining our next webinar for a review of the FDA’s Guidance due to be published by Nov 27th 2014.

The law intends to help protect consumers from exposure to counterfeit, stolen, contaminated, or otherwise harmful prescription drug products by building an electronic, interoperable system to identify and trace their distribution.  All trading partners are required to comply for products to move throughout the supply chain. Refer to our webinar archives http://www.usdm.com/webinars.html for DSCSA news to help you plan for future implementation deadlines now and over the next 10 years.

 

Compliance Deadlines

traceability deadlines

*Refer to the Act for definitions, data storage requirements, exceptions (direct purchase, drop ship, returns, 3rd party solutions, 3PLs, repackagers, effect on State laws) DQSA (H.R 3204) November 27, 2013 www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/

SNI= Standardized Numerical Identifier

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

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