Compliance

Drug Supply Chain Security Act in Pharmacy: Today and Tomorrow

The Drug Supply Chain Security Act (DSCSA) has been with us for almost nine years as part of the FDA’s Plan to protect the U.S. drug supply chain. The culmination of the Drug Supply Chain Security Act will reach its final implementation goal in November 2023. On 11/27/2023, all trading partners (Manufacturers, Wholesalers, and Dispensers (including Pharmacies) will need to begin using an “Enhanced Drug Distribution Security System.” However, before we talk about that, let’s talk about what you need…

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HIPAA Is Not Just About Training

PRS still receives many questions from non HIPAATrack Members about whether written (or electronic) Policies and Procedures are required for their Pharmacy business. These questions have typically come from Pharmacies that have purchased a Training Program or Continuing Education, or they may have received a “free” “HIPAA Program” from their wholesaler or other entity. These Training Programs,  CEs and “free” Programs typically do not include actual Policies and Procedures to implement by the Pharmacy, making them effectively useless as far…

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Red Flags and Controlled Drugs

The vast majority of Pharmacies are dispensing controlled substances in compliance with the DEA and State Regulations. However, we regularly hear about a Pharmacy, prescriber, wholesaler, or manufacturer in the news breaking those regulations and trying to circumvent public safety for profit. Now that the COVID-19 pandemic is winding down [fingers crossed], we are once again starting to see a focus on the public health emergency of drug addiction and abuse. Here at PRS, we get questions from Pharmacy Owners…

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The POCT Opportunity in Pharmacy

Another winter is quickly approaching, and Pharmacies have the opportunity to help their communities by becoming credentialed to provide CLIA-waived testing. As we already know, Pharmacies are the most accessible health care providers, with some patients already coming to us several times a month for prescriptions, over-the-counter medication, and vaccination needs. The next step is to provide point of care testing (POCT), whether for Flu and Strep or an entire testing suite. With that in mind and holidays approaching, this…

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pharmacy compliance, pharmacy cyber security

Things to Think About When It Comes to Protecting Your Pharmacy Infrastructure

You cannot go more than a day or two without hearing about another cyber attack in the United States. More importantly for pharmacy owners, Health Care has become a frequent target for phishing and ransomware attacks.  These can devastate an organization, so protecting your pharmacy infrastructure is critical, but have you ever stopped to think about what that protection encompasses?   In this blog, we want to cover some essential areas that need to be addressed to ensure your compliance with…

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