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Drug Supply Chain Security Act (DSCSA) 201 (Part 2): Pharmacy Advanced Overview FAQ

By Stacy Carson posted 22 days ago


Drug Supply Chain Security Act (DSCSA) 201 (Part 2): Pharmacy Advanced Overview FAQ

Authors: Sang Kit (Stephen) Wat, PharmD, MPH, MS, BCPS; Zachary Hagen, PharmD, MHA, BCSCP, 340B ACE

SAG: Operations and Automation; Workgroup: DSCSA

1.       Who does the DSCSA authorized trading partner requirement apply to?

a.       Manufacturers, repackagers, wholesale distributors, third-party logistics providers, dispensing pharmacies

2.       What are the requirements of becoming an authorized trading partner?

a.       Licensure – Trading partners must either be appropriately licensed or hold a valid registration

b.       Reporting – report licensure and other information to FDA annually (For Wholesale drug distributors and third-party logistics providers ONLY)

                                                                i.      Recommended submission timeframes are from January 1–March 31 annually

c.       Product tracing – provide, capture, and maintain information about transactions involving products distributed within the United States and the trading partners who engaged in such transactions of products

                                                                i.      Electronic-based approaches will be required to be used among all trading partners to meet the enhanced drug distribution security requirements, including electronic product tracing and verification of product at the package level

d.       Product Identifiers – add a product identifier to certain prescription drug packages and homogenous case of product intended to be introduced in a transaction into commerce

                                                                i.      Include the product’s national drug code (NDC), serial number, lot number, and expiration date in both human- and machine-readable form. The machine-readable form is generally a two-dimensional data matrix barcode for packages and in a linear or two-dimensional data matrix barcode for homogenous cases

3.       How would I verify if my trading partner met DSCSA requirements?

a.       To verify the below trading partners:

                                                                i.      Manufacturers or repackagersElectronic Drug Registration and Listing System (eDRLS) / FDA drug establishment registration database

                                                               ii.      Wholesale distributors (MUST be licensed in the United States)FDA annual reporting database (To annual reporting and requirements) AND state licensure website (verify the state the distributor is licensed in)

                                                             iii.      Third-party logistics providerFDA annual reporting database (To annual reporting and requirements) AND state licensure website (verify the state the distributor is licensed in)

                                                             iv.      Pharmacies/Dispensersstate licensure website (verify the state the distributor is licensed in)

4.       What are some steps of product verification?

a.       Manufacturers, repackagers, and wholesale distributors must create a system to respond to product verification requests and verification of returned saleable products

b.       For all authorized trading partners: MUST create process for

                                                                i.      Identifying suspected products

                                                               ii.      Investigate and quarantine suspect product

1.       in a physically separate area clearly identified for such use or through other procedures

2.       FDA encourages trading partners to use both physical and electronic quarantine, when possible, to ensure accurate record keeping

                                                             iii.      Establish systems and processes to promptly notify FDA when suspect product is determined not to be illegitimate

1.       Illegitimate product is defined as product in which there is credible evidence that shows the product is counterfeit, diverted, stolen, intentionally adulterated, subject of a fraudulent transaction or appears to be unfit for distribution as it would result in adverse health consequences or death

2.       The FDA’s CDER NextGen Portal (CDER NextGen) now includes a Drug Supply Chain Security Act (DSCSA) portal that enables the FDA and trading partners to communicate when the FDA requests information related to investigations of suspect or illegitimate products or during a recall

3.       Notify FDA within 24 hours

4.       Manufacturers are also required to notify FDA and appropriate trading partners within 24 hours after determining a product is at high risk for illegitimacy

5.       What if a product does not contain a unique barcode?

a.       Use this FDA published flowsheet

6.       What are some of the requirements for data retention and tracking? 

a.       Transaction information and transaction statements should be maintained for at least 6 years 

b.       Records of disposition of illegitimate product should be kept for at least 6 years 

7.       What are some DSCSA-specific tools and acronyms?

a.       EDI – electronic data interchange

b.       GS1 US – standardizes barcode used to allow track and trace

c.       GLNs – global location number provides businesses the ability to know who is involved in transactions and where things are located throughout the supply chain.

                                                                i.      Unique GLN per site/pharmacy

d.       DSCSA-exempted – An authorized trading partner may request a waiver if the requirements would result in an undue economic hardship or for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act

                                                                i.      A manufacturer or repackager may request an exception to the requirements relating to product identifiers if a product is packaged in a container too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with section 582 of the FD&C Act