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After discussing the difference between an FDA Form 483 and an FDA Warning Letter, it may perhaps be worthwhile to take a closer look at some of the most recent actions that have occurred (including new FDA 483 Forms and Warning Letters). Although perhaps a couple of months have already passed, but
Last month the The FDA (U.S. Food and Drug Administration) was extremely busy taking actions in regards to 503B outsourcing facilities and 503A compounding pharmacies. A review of many of these FDA 503 actions indicates an increased and aggressive program aimed at both outsourcing facilities and com
Many compounding pharmacies have been asking "what is the difference between an FDA Form 483 and an FDA Warning Letter?". The FDA (U.S. Food and Drug Administration) has been extremely busy and is dramatically stepping up their efforts at inspecting 503A compounding pharmacies across the nation. Off
GHRP is short for “Growth Hormone Releasing Peptide” and is in the category of drugs known as Growth Hormone Secretagogues (GHS). These peptides actually stimulate the body's natural release of the naturally occurring growth hormone (GH), primarily by stimulating the pituitary gland to produce more
Compounding pharmacies and 503A specialty pharmacies have been the center of FDA (U.S. Food & Drug Administration) focus ever since the tragic 64 deaths associated with the NECC (New England Compounding Center) occurred back in 2012. The 64 patients that died and the 750+ others that were injure
A lot of discussion about how FDA 503B inspections are having a huge impact on 503B outsourcing facilities and their operations. It's easy to see that being prepared with your 503B P&P manual up to date is the key to a successful inspection results and compliance audit outcomes. The Drug Quality
Specialty pharmacy startups are again at the forefront of discussions based on a recent article just released by HealthLeaders Magazine (a division of Simplify Compliance). The study states that commercial pharmacy spending in the USA has risen to a new rate that greatly exceeds the five year averag
The definition of a true consultant is an individual who is able to give you expert and professional advice. There comes a time in every business when an objective, qualified and experienced third party is necessary to help guide, direct or advise the owner or your management team. This is true for
Pharmacy Information Systems (PIS) have evolved over the years to become a core component of any successful pharmacy operation. Whether it's a hospital setting, a clinic or even a specialty pharmacy business, these complex and sophisticated computer software systems continue to evolve and their func
Why A Pharmacy Consulting Firm? In a traditional independent retail pharmacy setting, many pharmacy owners, Prescription Department Managers (PDM) and Pharmacists in Charge (PIC) ask themselves this question: "Perhaps I could use some expert advice on some of the business decisions that are being ma
Do you have Pharmacy HIPAA compliance policies and procedures at your pharmacy? Are your employees HIPAA certified? HIPAA (Health Insurance Portability and Accountability Act) is always a topic of discussion when patients start asking their pharmacists and physicians for the receipts of their medica
Dispensing errors in pharmacy are a fact of life. Even with the very best policies and procedures in place, an educated and well trained pharmacy staff performing the necessary steps to ensure safe Rx dispensing, plus an experienced pharmacist performing and overseeing the actual prescription dispen