Up to date information in the field of Independent Pharmacy written by the PRS Pharmacy Consulting Experts and Pharmacists for Pharmacy Owners. Experience Matters.
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
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
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
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
6 Reasons PRS Pharmacy Services is the Best Resource for Selling a Pharmacy.
If you’re considering selling your pharmacy, PRS Pharmacy Services is the best resource for providing expert guidance and support throughout the entire process. Here are several reasons why PRS Pharmacy Services is the best resource for selling your pharmacy: 1.Experience and Expertise PRS Pharmacy Services has been providing pharmacy consulting services for over 40 years, making them one of the most experienced firms in the industry. Their team of experts has a deep understanding of the pharmacy industry, including the
What is an Authorized Trading Partner in DSCSA?
By now, you should be familiar with the Drug Supply Chain Security Act (DSCSA). It has been with us since 2013 and has, for the most part, already been in effect for pharmacies since 2015. And now we have the “last” phase of the law, Electronic Drug Distribution Security (EDDS) (see our Electronic Drug Distribution Security System Blog for information about EDDS), becoming effective on 11/24/2023. So in the next few blogs, I want to discuss some of the key
5 Myths About Pharmacy DSCSA Compliance
The Drug Supply Chain Security Act (DSCSA) is a federal law that was enacted in 2013 to protect the public from counterfeit, contaminated, and other potentially dangerous drugs in the pharmaceutical supply chain. The DSCSA requires pharmaceutical companies to implement enhanced security measures and traceability systems to ensure the authenticity and safety of prescription drugs. As part of this effort, the law requires Pharmacies or dispensers, as Pharmacies are referred to under DSCSA, to comply with certain requirements. Unfortunately, there