DSCSA: What Wholesalers Want

March 8, 2019 Dirk Rodgers

Last November pharma manufacturers selling into the U.S. market had to meet a big serialization and verification deadline under the Drug Supply Chain Security Act (DSCSA). Now, pharma wholesale distributors in the United States are facing their own important deadline this coming November. Remember how manufacturers had to scramble and go through a lot of pain to achieve compliance in time? Your friendly neighborhood wholesale distributors—big and small—are going through that now. And the problem is…they can’t do what they need on their own. They need all drug manufacturers to do something so that they can be compliant with the DSCSA in November.

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DSCSA, Interoperability

DSCSA: Interoperable Data Exchange In 2023

March 4, 2019 Dirk Rodgers 1 Comment

Lots of people have been talking lately about what interoperable data exchange in the US pharma supply chain will look like after the Enhance Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) takes effect in November 2023 (see “Does Interoperability Change In 2023?”, “5 Myths About The DSCSA In 2023” and “Interoperability And The DSCSA”).

Increasingly, I’ve heard the opinion expressed that there will surely be multiple approaches adopted for exchanging data, and so it will be necessary for all of those approaches to be made interoperable with each other. Proponents of this idea claim it is unrealistic to expect a single approach to be accepted by all companies in the supply chain and therefore, having to deal with multiple approaches is inevitable. This kind of talk makes me nervous. Here’s why.

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India

Barcoding Regulation For India’s Domestic Drug Supply

February 25, 2019 Dirk Rodgers

India has recently made moves to impose a new barcoding requirement for all drugs procured by state and federal governments for domestic public consumption. The new requirements are part of the preference to “Make In India” program that is intended to “…promote manufacturing and production of goods and services in India with a view to enhancing income and employment.”

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DSCSA

FDA Hammer Comes Down On McKesson For DSCSA Violations

February 18, 2019 Dirk Rodgers

The internet lit up last week on the publication of an official warning letter from Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, to John H. Hammergren, CEO of McKesson Corporation, for violations of the Drug Supply Chain Security Act (DSCSA). I’ve written about this situation before, back when the original FDA 483, notice of “inspectional observations”, was originally published (see “McKesson’s DSCSA 483 Explained”), but this new letter provides many more details of the incidents that led to that original notice, including some details of McKesson’s follow-up communications regarding the situation.

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DSCSA, Verification

HDA Makes A Strong Case For ‘Reframing’ Of FDA’s Draft Guidance On DSCSA Verification Systems

February 11, 2019 Dirk Rodgers

Last October the FDA published a draft guidance called “Verification Systems Under the Drug Supply Chain Security Act (DSCSA) for Certain Prescription Drugs” (see “DSCSA: Verification Systems Draft Guidance”). Near the end of the comment period in December, the Healthcare Distribution Alliance (HDA) submitted comments containing proposed changes. Like other comments submitted by the HDA for other FDA DSCSA guidance, these are well worth reading. Once again, the HDA demonstrates their thorough understanding of the DSCSA and their ability to clearly and crisply explain where the FDA’s draft language fails to reflect the language in the original law.

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DSCSA

FDA Announces Start Of DSCSA Voluntary Piloting Program

February 7, 2019 Dirk Rodgers

Starting tomorrow companies in the US supply chain wishing to volunteer to participate in FDA-sanctioned Drug Supply Chain Security Act (DSCSA) pilots will have just 30 days to apply. Applicants are asked to propose pilots aimed at the goals of the FDA program. These include:

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DSCSA

Most Companies Will Do DSCSA Verification Wrong

February 4, 2019 Dirk Rodgers

A lot has been written about the concept of “verification”, here in RxTrace and elsewhere. It’s all good, but I still don’t think the critical point has been made yet by anyone—including me (see “What’s So Hard About Unique Identifier Verification?”)—and until it is, companies are going to do it wrong. Less than an hour after I posted my essay last Wednesday (see “GS1’s Messaging Standard For Verification Of Product Identifiers”) I received an email from a subscriber who had questions about it, the essay was referenced in a post on LinkedIn by a reader in Europe, and I found a great link to a brand new essay about verification by Scott Pugh that had just been posted about the same time. So here is my new take on why most companies are going to get it wrong.

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Verification

GS1’s Messaging Standard For Verification Of Product Identifiers

January 30, 2019 Dirk Rodgers

For companies in the US pharma supply chain, 2019 is going to be the year of an important milestone of the Drug Supply Chain Security Act (DSCSA). In November, wholesale distributors will be required to begin issuing verification requests to manufacturers, at the Standardized Numerical Identifier (SNI) level, for any returned drug that is still saleable, before they resell it. I’ve written a lot about this change in the past.

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