Month: April 2016

FDA Drafts Drug Compounding Guidance for Health-System Pharmacies

The FDA has issued 3 draft guidance documents that clarify how it intends to enforce the prescription requirement for drugs compounded by health-system pharmacies. Currently, under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), compounding pharmacies that aren’t registered outsourcing facilities must obtain a valid prescription order prior to compounding any drug products. If the …

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Bristol-Myers Squibb cancer drug receives expedited FDA status

Bristol-Myers Squibb Company BMY, -0.89% said early Monday that the Food and Drug Administration would expedite the development and review of its head and neck cancer drug Opdivo on the strength of its phase 3 trial results. Opdivo, which received the special status for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and …

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FDA Issues Guidance for Hospitals and Health Systems Engaged in Drug Compounding

If you read one thing… FDA interprets the FDCA not to permit compounding for “office use” under Section 503A; compounding pharmacies must receive a valid prescription for an individually identified patient before distributing compounded drugs to a hospital, clinic or other health care facility.   Hospitals and health care providers would generally be subject to …

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Robotic Compounding Of Medications Helps Improve Patient Safety

Using robotic systems for sterile IV therapies improves safety and compliance, reduces waste. IV compounding, particularly around chemotherapy drugs, poses a safety hazard to employees if ideal policies aren’t followed consistently. This is particularly difficult even as industry experts have yet to develop what these requirements should be. Automating this process simplifies workflows, minimizes employee …

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Three New FDA Draft Guidance Documents for Drug Compounders

On Friday, the US Food and Drug Administration (FDA) released three draft guidance documents for drug compounders. The guidance describes FDA’s interpretation of the prescription requirement in section 503A of the Food Drugs & Cosmetics Act (FD&C Act), how the agency intends to apply such a requirement to compounding for hospitals or health system pharmacies, and the …

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Safety issues at compounding pharmacy underscore oversight problems

In March FDA issued a health alert recommending that doctors and patients should toss sterile medicines made by the Texas compounder IV Specialty. The agency found numerous safety issues during an inspection earlier this year, but IV Specialty refused an agency recommendation to halt production or issue a recall until the problems were fixed. FDA, …

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The importance of first air in aseptic processing and sterile compounding

“First air is the last defense against contamination.” It can help guard against bad technique being utilized in upstream processes. The USP goes to great lengths to describe first air and unidirectional airflow. Significant testing and airflow characteristic patterning is also routinely done in the pharmaceutical manufacturing segment. It is tremendously important when set against …

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FDA: 2 Diabetes Drugs May Be Linked to Heart Failure Risk

(HealthDay News) — Diabetes drugs containing saxagliptin and alogliptin may raise the risk of heart failure, particularly in patients with heart or kidney disease, U.S. health officials warned Tuesday. Drugs containing these ingredients are Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin extended release), Nesina (alogliptin), Kazano (alogliptin and metformin) and Oseni (alogliptin and pioglitazone), the …

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FDA warns about sterile drug products from Medaus Pharmacy

A lack of sterility assurance has prompted FDA to warn patients and health care providers not to use unexpired drug products that are intended to be sterile from Medaus Pharmacy. A recent inspection of the Birmingham, AL company’s facility revealed insanitary conditions, including poor sterile production practices. A lack of sterility assurance has prompted FDA …

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FDA: Abortion pill can be used later in pregnancy

Prior guideline was to only use pill up to 49 days into pregnancy The new FDA-approved regime on the abortion pill was welcomed Wednesday by abortion rights groups who say the drug expands options for women but was criticized by opponents who assert serious risks remain. The FDA changes mean that drug Mifeprex, the brand …

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