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Amy Shank discusses what the final standard MOU, sent to the FDA from the White House Office of Management and Budget is, what it does, how it works and what it means for your pharmacy.
In November 2019, the FDA released the draft guidance Compounding Animal Drugs from Bulk Drug Substances: Guidance for Industry. PCCA's Amy Shank provides clarity on what that means for vets and how you can stand up for veterinary compounding
The FDA is allowing the temporary compounding of certain alcohol-based hand sanitizers. To assist pharmacists make hand sanitizer, PCCA wants to relay hand sanitizer compound formulas provided by the World Health Organization. Also, a video of how Steve Hoffart, PharmD, in Magnolia, Texas is assisting his community by donating hand sanitizer to his law enforcement departments during the coronavirus outbreak.
PCCA's Matt Martin and Melissa Merrell Rhoads provide an update on the FDA's decision to designate human chorionic gonadotropin (HCG) as a biologic product and what that means for compounders and for PCCA.
PCCA's Director of Formulation Development Melissa Merrell Rhoads, PharmD, provides part two in a set of posts detailing the upcoming changes to our formulas based upon the new USP guidelines. This particular section focuses on USP <797>.
PCCA's Director of Formulation Development Melissa Merrell Rhoads, PharmD, provides part one in a set of posts detailing the upcoming changes to our formulas based upon the new USP guidelines.
PCCA applauds the FDA for their decision and statement about Oxitriptan, which ensures that patients with BH4 deficiency can continue to receive the compounded medications they need.
Dylan Herr, RA/QA Development Manager at Eagle, understands that the revised USP <797> chapter for sterile compounding makes significant revisions to the old chapter. In this latest article, Dyan is happy to provide you with an overview of those changes and strategies for implementing them.
The only thing that stays the same is that everything changes. This is true even when it comes to nonsterile compounding and USP <795>. PCCA Clinical Compounding Pharmacist Matt Martin, PharmD, addresses notable changes of the new USP guidelines and provides some considerations regarding implementation.
Eagle's own Dylan Herr, discusses how the sanitary conditions for sterile and non-sterile drugs at compounding facilities are regulated and how those regulations can affect you.