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Whitepapers

Serialization Implementation and Operations for DSCSA Compliance (updated July 2018)

SUMMARY With the stroke of a pen in 2013, the pharmaceutical industry mobilized in order to comply with sweeping changes enacted by the Drug Quality and Security Act. The law includes the Drug Supply Chain Security Act (“DSCSA”), written to increase patient safety by minimizing risk from unauthorized pharmaceutical drug products entering the marketplace.   The Food and Drug Administration, charged with enforcing the Act, set deadlines for the industry to comply with this law. The law requi...

Serialization Solutions For DSCSA-Challenged Manufacturers

In recent years, the pharmaceutical industry has acted like a student who is not sure whether he or she has studied the proper material for an upcoming exam.  The deadline for the next phase of DSCSA serialization compliance passes on November 27, 2017.  It’s too late to cram for the test. HIDDEN HEROES Manufacturers that delayed studying up till now won’t catch up no matter how many all-nighters they put in until November, unless they get a study partner to help achieve serialization.  T...

Hope Is Not A Disaster Plan: Risk Management Within The Pharmaceutical Supply Chain – Insights Of A Third Party Logistics Provider

    OVERVIEW Third party logistics providers play an important role in assuring pharmaceutical drug products move efficiently within the supply chain from their point of manufacture to their final dispenser. That’s a big responsibility.  According to the Healthcare Distribution Alliance (HDA), a healthcare industry trade group, 4.3 billion prescriptions were filled in the United States during 2015, the latest year figures are available.  The quantity of prescriptions filled has inc...

White Paper – DSCSA Implementation for Pharmaceutical 3PL Providers

Download PDF Version SUMMARY With the stroke of a pen in 2013, the pharmaceutical industry mobilized in order to comply with sweeping changes enacted by the Drug Quality and Safety Act. The law includes the Drug Supply Chain Security Act (“DSCSA”), written to increase patient safety by minimizing risk from unauthorized pharmaceutical drug products entering the marketplace.   The Federal Drug Administration, charged with enforcing the Act, set deadlines for the industry to comply with this ...

Are any Controlled Substances (CII) included in your return? If so, please press "Yes" and complete the DEA 222 Request Form. You can also contact Jason Solomon at jsolomon@wdsrx.com or (561) 998-3885 x316.