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Compliance

DSCSA: Protecting Your Patients from Illegitimate Medication

We have been on a roll with DSCSA Blogs and Webinars over the past year. So, why not continue this trend by focusing on one of the main goals of DSCSA: protecting patients from medication that may be counterfeit, stolen, contaminated, or otherwise harmful. Why are we here? In 2013, the Drug Supply Chain Security Act (DSCSA) was passed by Congress to ensure the safety and security of the pharmaceutical supply chain in the United States. The main objectives of…

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DSCSA: When a Delay is Not a Delay

At the tail end of August, the FDA released the Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (Compliance Policies) Guidance Document, where they announced they did not plan to take action to enforce various aspects of the Enhanced Drug Distribution Security (EDDS) requirements (582(g)) of the DSCSA until 11/27/2024 (See Table 2 below for a list of these EDDS Requirements). This Guidance did not affect the existing requirements currently in place…

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Drilling Down into The Enhanced Drug Distribution System (EDDS) Requirements

In four months, the Enhanced Drug Distribution System (EDDS) requirements of the Drug Supply Chain Security Act (DSCSA) will go into effect. The EDDS changes the fundamentals of some existing DSCSA provisions that Pharmacies are required to comply with now, which we will discuss in addition to the upcoming EDDS requirements. Where are We Now with the DSCSA? Before moving into the new EDDS Requirements, let’s quickly discuss the existing requirements that Pharmacies should already comply with and have corresponding…

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DSCSA Update: HDA’s Letter To The FDA

Pharmacy Owners, Groups & Organizations, You may be hearing that in a letter dated June 2, 2023, the Healthcare Distribution Alliance (HDA), the trade organization that represents primary pharmaceutical distributors, recommended to the FDA a plan to phase in the last three components of DSCSA after the November 27, 2023 deadline to achieve the prescription drug traceability and security goals of DSCSA. HDA‘s series of recommendations are to address and acknowledge the fact that some wholesalers and manufacturers are not…

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DSCSA Requirements Now and Future

DSCSA REQUIREMENTS ARE ALREADY HERE The final requirements for DSCSA will go into effect on 11/27/2023, but did you know most DSCSA regulations are already in effect, and Pharmacies must follow them now? The Authorized Training Partners (ATP), Product Identifier, Product Tracing, and Verification sections of DSCSA are already in place and have many requirements for Pharmacy. The final requirement, Enhanced Drug Distribution Security (EDDS), will go into effect on 11/27/2023, bringing new requirements to the table and tweaking some…

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