A customized Policy and Procedures (P & P) manual is no longer an option, it is truly a requirement. As we’ve previously discussed, every pharmacy is required to have and maintain a written Policy and Procedures manual on its premises. As noted by the NABP (the National Association of Boards of Pharmacy) each state has … Continue reading Customized Policy and Procedures
After discussing the FDA’s ongoing inspections of compounding pharmacies and cGMP, it seems logical to review some of the latest actions that have recently taken place (including new FDA 483 Forms and Warning Letters). Although the FDA has only published recent Warning Letters that were sent by August 31, 2019 (so any issued in September … Continue reading Recent FDA 483 Actions
The vast majority of compounding pharmacies that are currently operating within the United States are actually state licensed facilities that are classified as such under section 503A of the the United States Federal Food, Drug, and Cosmetic Act (sometimes referred to as either the FFDCA, FDCA, or FD&C). The FD&C is a group of federal … Continue reading FDA Inspections of Compounding Pharmacies
Pharmacy security has recently been a dominating topic in the news. As everyone already knows, pharmacies have always been a prime target for burglaries, theft, drug diversion and robberies.With an estimated 7,000 pharmacy break-ins occurring annually in the US, this is a possibility and a risk that everyone in our profession must face. Yet sometimes … Continue reading Pharmacy Security
Over a year ago a pharmacy audit in Colorado resulted in a payment of almost $64 million in a settlement by DaVita, Inc. DaVita is known for being a major provider in the dialysis field and in the treatment of patients with severe and chronic renal diseases. The company additionally owns a division that supplies … Continue reading Pharmacy Audits
Any new business venture, whether it may be the actual startup of an entirely new pharmacy operation, or simply the addition of a new service line to an already existing business, must begin with a well thought-out business plan. The plan is best developed through a process of careful and thorough consideration of the business’s … Continue reading Pharmacy Business Plans
Starting up and opening a new pharmacy business is really not that much different from starting up any other type of retail operation or business enterprise. Aside from the regulations and laws inherently involved in a new pharmacy startup being planned, built and opened, the basic business startup principles still all apply. Having opened up … Continue reading Opening a Successful New Pharmacy Business – What You Need To Know
Management of an in-house 340B pharmacy by a hospital is often times more complex and complicated than the hospital’s administrators may had initially anticipated. On the “surface” a hospital or healthcare system administrator can easily see the potential profitability that the specialty pharmacy can generate for them. Ever since the creation of the federal 340B … Continue reading 340B Pharmacy Consulting
Created all the way back in 1992 as a federal program, the 340B Drug Discount Program required that all drug manufacturers provided their medications and treatments on an outpatient level to eligible HCOs (Health Care Organizations) at appreciably reduced prices. Although many people don’t connect the two, the 340B Program was actually a section of … Continue reading 340B and Hospital Specialty Pharmacies
Exit strategies in any business are a critical requirement. Every business owner needs to think through and document exactly what their plan is regarding selling their business when it reaches a certain level or it’s perhaps time for them to finally retire. Perhaps this is even more critical to do if you own an independent … Continue reading Pharmacy Exit Strategy
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