The Healthcare Distribution Alliance (HDA) Traceability Seminar that was held back in early November was so packed with valuable information that I still have a number of topics queued up from that event for RxTrace essays in the future. Today I want to take a closer look at the results of the Saleable Returns Pilots conducted by the HDA last year to figure out the most efficient way to verify saleable returns. I discussed the overall project in my report of the Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”) but today I want to focus in on just two of the approaches piloted. These are:
- Manufacturer sends to wholesale distributor product identifiers for only the units purchased by that wholesale distributor, and,
- Verification Router Service (VRS).
Continue reading DSCSA: Saleable Returns Verification
Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain. Let me explain.
The text of the Drug Supply Chain Security Act (DSCSA) was developed last year by Congressional staff in consultation/negotiation with various lobbying organizations—primarily the Prescription Drug Security Alliance (PDSA). The effect of the legislation is to create a way of protecting the U.S. pharmaceutical supply chain that relies primarily on product identifier authentication (PIA) (see “Product Identifier Authentication” and “The Aggregation Hoax and PIA”) for at least the first 10 years and possibly beyond. Continue reading DSCSA: Congress Should Have Mandated Randomization
In my last essay I touched on the use of Product Identifier Authentication, or PIA, as an alternative to the collection and distribution of aggregation data to allow wholesale distributors and repackagers to meet the verification requirements of the Drug Supply Chain Security Act (DSCSA). Starting in November of 2018 for repackagers and in November of 2019 for wholesalers, the DSCSA will require these companies to verify that the standardized numerical identifier (SNI)—commonly referred to as “the serial number”—corresponds with one that the manufacturer originally applied to drugs that are found to be suspect, and for any returned drug that will be resold.
As I pointed out in my previous essay (see “The Aggregation Hoax and PIA”), manufacturers and repackagers may be able to choose to pass on aggregation information that would allow wholesale distributors to meet their requirements, or they might choose to offer a PIA service that would allow these companies to check the authenticity of one or more SNIs via a web service. Continue reading Product Identifier Authentication (PIA)
Pharmaceutical manufacturers should be aware that there is a lot of uninformed misinformation going around out there lately about the need for them to supply aggregation data to their trading partners to meet the Drug Supply Chain Security Act (DSCSA) (for more on aggregation, see “Pharma Aggregation: How Companies Are Achieving Perfection Today”, “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?”, and “Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…”). In my view, prior to 2023 you can collect aggregation data if you want to, but don’t let anyone tell you that the DSCSA requires you to. It doesn’t. And I also encourage you to be skeptical of any claims that wholesale distributors will not accept your product anytime soon unless you provide them with aggregation data. Feel free to Continue reading The Aggregation Hoax and PIA