How to Adhere to Pharmaceutical Waste Re...

Pharmaceutical Waste Compliance When considering how to properly manage pharmaceutical waste products, there are a few important areas of note. As of 2015, the Environmental Protection Agency has continued the process of outlining and proposing a new set of standards addressing how to handle both the management and disposal of pharmaceutical waste from healthcare facilities. This is meant to enhance the efforts proposed in 2008 when inclusion  of hazardous waste pharmaceuticals in the Universal Waste Program was proposed. Instead of finalizing that initial proposal, the...

Alameda County and Drug Disposal Regulat...

Drug manufacturers in the state of Florida – did you know you have to follow the Alameda County Safe Drug Disposal Ordinance if your products get into the state of California? If you have been paying attention to Pharma news over the past week you may have caught wind of a request for a lawsuit review denied by the U.S. Supreme Court filed by three industry trade groups against a drug take-back program based in Alameda County, California. The reason that this seemingly innocuous refusal to review a lawsuit is making waves has to do with it’s potential implications....

How to Spot a Counterfeit Prescription D...

Changes in Regulation Since 2013, The FDA has concentrated its efforts on tightening the regulations surrounding prescription drug supply chain management and compliance through such efforts as the DSCSA. The FDA has also launched initiatives meant to reduce the number of counterfeit prescription drug products through programs aimed at healthcare professionals and patients with campaigns like, “Know Your Source”.   What is the FDA Doing? Admittedly, complying with the new requirements for various drug entities based on the guidelines set forth in the Drug Quality and...

Florida Drug Entities and the new Federa...

  It seems as though every day I receive a call from yet another bewildered Prescription Drug Manufacturer, Wholesaler or third party logistics provider (3PL) somewhere in the country wanting to know how they are supposed to handle one or more of the confusing aspects of the Federal Drug Supply Chain and Security Act (DSCSA) also known as the Drug Quality and Security Act (DQSA).   As you can imagine I could write pages of guidance on who, what, where, when and why.  However, in lieu of confusing everyone even more I have a few key points to follow:   If...