“The assessment shall be performed before July 1 of every odd-numbered year. The self-assessment forms must remain on-site at the facility. Only submit the form to the board if requested by board staff. The board is in the process of updating the Self-Assessment forms through a formal rulemaking. The updates include references to statutory and regulatory changes that occurred between 2014 and 2016. The last time the forms were formally updated was 2014.Current regulation requires a pharmacy or wholesaler to complete the 2014 version of the Self-Assessment form. Please be advised, however, the board will accept completion of either the 2014 version OR the 2016 version. The latter version is likely to be a more helpful assessment to the pharmacy or wholesaler completing it.”
“Specifically, how to mark pharmaceutical products with a National Drug Code (NDC), serial number, lot number, and expiration date in both machine-readable and human-readable format will be covered, as will the use of GS1 identifiers, application identifiers, and data carriers.”
The Florida Department of Business and Professional Regulation (DBPR) – Division of Drugs, Devices, & Cosmetics (DDDC) maintains a webpage full of commonly posed questions. Many of the questions are related to the Florida Certified Designated Representative (CDR) license: FL DBPR DDDC Permitting FAQs
“Some companies need more than one designated representative. That is because every moment that the business is operating, at least one rep must be there. So with vacations and days off and maybe multiple shifts, it’s not possible in many cases for one of these wholesale drug or device companies to fulfill their requirements with only one designated rep.”
“A successful marketing plan is based on what you did in 2016—what worked and what didn’t—and what you want to make sure you do again. If you don’t think about each of these items, you may be doomed for failure—you don’t want to be responsible for helping your competition have their best year in 2017. Plan now, and make the success all yours!”
It’s hard to believe that the year is coming to an end. It means it’s time to get a jump on planning for the new year. This article is full of great thought provoking ideas and tips on how to move your marketing efforts to a higher level. Full of great advice!
“For 10 years, the government waged a behind-the-scenes war against pharmaceutical companies that hardly anyone knows: wholesale distributors of prescription narcotics that ship drugs from manufacturers to consumers.”
“The stepped-up oversight was hastened by a new law that bolstered FDA authority. But compounders say the get-tough approach is a double-edged sword. Hospitals, doctors and patients may eventually have more confidence in compounded’ medicines, but in the meantime costs and red tape have increased. And a new batch of proposed guidelines issued by the FDA last week has set off another round of anguish.
The FDA maintains the guidelines are “critical to protecting public health.” But Scott Karolchyk of QmedRx, a compounder based in Maitland, Florida, argues “the FDA is trying to punish success. If these [guidelines] go into effect, a lot of pharmacies face onerous restrictions. And limiting good compounding pharmacies only hurts patients and their access to medications.””