FDA Releases DSCSA Guidance Plan for 2016

FDA Releases DSCSA Guidance Plan for 201...

The U S Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) recently released insights regarding off-label communications, generics products, and pharmaceutical quality. More importantly, the FDA released the Drug Supply Chain Security Act (DSCSA) guidance plan for 2016. There are 15 categories of guidance documents planned for 2016. Included: advertising, biopharmaceutics, biosimilarity, clinical/antimicrobial, clinical/medical, clinical pharmacology, clinical/statistical, drug safety, electronic submissions, generics, labeling,...
FDA’s MedWatch Program Facilitates Reporting on Suspected, Identified Problems

FDA’s MedWatch Program Facilitates Repor...

FDA pharmacist Captain Catherine Chew recently appeared in a video that advertised the importance of being vocal about problems with medicines during clinical use. On behalf of the FDA, she asked that professionals and patients utilize MedWatch if they suspect or identify issues with medical products within a clinical setting. FDA’s MedWatch program is a tool that will be essential for reporting these serious allegations and issues. “When you report adverse events to the FDA’s MedWatch program, you provide a vital source of information to the FDA. Today, resources are...

New Software Injects New Life into Pharm...

SAP, the largest global provider of Enterprise Application Software recently announced their newest software module currently called, “SAP Advanced Track and Trace for Pharmaceuticals”. Also known as ATTP, this new module from SAP is an enterprising new competitor to third party solutions that allow companies to serialize their products in a way that complies with global serialization and tracing regulations for pharma products. Currently, drug companies utilize a system that incorporates multiple modes of serialization and tracking products, and often requires these...

What’s in a Name? Medical Spas and the L...

Generally speaking, people consider a medical spa to be a facility that operates under the supervision of a licensed healthcare professional during business hours. This healthcare professional must be operating under the scope set forth by his or her license, and must be available on-site. Furthermore, the other staff members must also be working within the scope of practice as set forth by their licensing board. While this definition seems simple enough in understanding a medical spa or “med spa”, there are certain considerations that potential clients should be aware of...

Domestic Sugar Wars

While my site tends to focus strictly on information regarding pharmaceutical compliance based in Florida, the FDA has recently made headlines for proposed changes to how added sugars are labeled in processed foods that we consume. While food labeling and drug labeling are different processes, it is interesting to observe the process and the reaction of the public on a non-pharma product. The new proposed changes to the Nutrition Facts label began in March of 2014 and the supplemental rules were proposed in the July update of 2015. ONe of the points in particular of this...

The Right to Try in Florida

Over the past year or so, Right-to-Try laws have become increasingly popular throughout the United States. These laws allow patients who are terminally ill to access experimental drugs, biologics and devices that have not yet secured the approvals necessary to be distributed widely. Florida recently approved a Right-to-try law for eligible patients.   Currently, the Right To Try is limited to patients afflicted with a terminal disease who have already tried the traditional treatments but are unable to enroll in a clinical trial. Essentially this is the last option...

$16 Million in FL Pharma Drugs Gone Wron...

In April of this year, the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Florida requested that U.S. Marshals seize over $16 million dollars worth of prescription drug products that had not yet been approved from Stratus Pharmaceuticals, Inc., of Miami, Florida. These prescription drug products had been marketed and distributed in spite of their lack of approval, which is what prompted this large-scale seizure. The products removed during this operation included topical treatments including; antibiotic skin cleansers, ointments for...

How to Reduce Pharma Drug Waste in Flori...

According to the Florida Department of Environmental Protection, properly managing pharmaceutical waste products produced by different types of medical facilities can pose a real challenge. Not only do medical facilities need to comply with all required hazardous and solid waste regulations, but they must also ensure compliance with regulations from the Department of Health and the Board of Pharmacy, the Department of Transportation ( with particular attention to the Pipeline and Hazardous Materials Safety Administration). This particular waste stream also needs to...