FDA plans new compounding pharmacy policy, agency head says

The head of the U.S. Food and Drug Administration said on Friday the agency is working on a new policy that would encourage more compounding pharmacies to register under a law enacted in the wake of a deadly 2012 meningitis outbreak linked to one such company.

The Underappreciated Risks of Hospital IV Compounding

A typical hospital room can be described as a patient lying in a bed with an IV drip bag hanging from a pole. But when you take a closer look at IV administration of fluids and medications, it is so much more than a common task. What can be viewed as an uneventful procedure, even by  health-care professionals, is too often accompanied by major errors.

Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase® (Alteplase)-100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is voluntarily recalling three lots of Activase® (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking.

A Process Capability-Derived Scale For Assessing The Risk Of Compound Carryover In Shared Facilities

By Andrew Walsh; David G. Dolan, Ph.D.; Andreas Flueckiger, M.D.; Igor Gorsky; Robert Kowal; Ester Lovsin Barle, Ph.D.; Mohammad Ovais; Osamu Shirokizawa; and Kelly Waldron

 

Part of the Cleaning Validation for the 21stCentury series

USP 800: A Primer for Community Pharmacists

In the evolving world of pharmacy practice, many are asking what is included in the key provisions of the United States Pharmacopeial Convention (USP) 800 when it comes to transport, storage, preparation, and compounding.

Aseptic Enclosures in Attendance of Pack Expo Las Vegas 2017

Aseptic Enclosures will be represented by Joe Skorcz, our new Project Engineer and Regional Manager.  Joe is directly responsible for Projects in our Northern Region, but will be available for requests concerning any region during the Pack Expo Las Vegas.

Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding: FDA Alert – Lack of Sterility Assurance

Vital Rx, doing business as Atlantic Pharmacy and Compounding, has issued a recall of all lots of all compounded injectable prescription medications to the consumer level.

Vital Rx, doing business as Atlantic Pharmacy and Compounding, has issued a recall of all lots of all compounded injectable prescription medications to the consumer level. FDA recently warned health care professionals and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx, dba Atlantic Pharmacy and Compounding, due to a lack of sterility assurance. An FDA inspection of Atlantic Pharmacy uncovered insanitary conditions, including poor sterile production practices, that raised concerns about the company’s ability to assure the sterility of the drug products it produces. Additional information about the recall is available here.

Viral Safety Approaches For Advanced Therapy Medicinal Products

FDA Links Naturopathic Turmeric Death To Contaminated Product

 

Jade Erick, 30, died in March 2017 after California naturopathic doctor, Kim Kelly, gave her an intravenous (IV) preparation of curcumin, a chemical constituent in the Indian spice turmeric that is over-hyped in alternative medicine. An FDA report released yesterday found that Imprimis Pharmaceuticals (NASDAQ:IMMY), a compounding pharmacy based in San Diego, California, mixed the curcumin emulsion product used in Ms. Erick’s treatment with ungraded castor oil that had a warning label stating, “CAUTION: For manufacturing or laboratory use only.”

Injections from Texas Pharmacy Linked to 43 Eye Injuries

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At least 43 people who had cataracts surgery in Texas developed severe eye problems after receiving injections of a drug that was compounded by Guardian Pharmacy Services in Dallas, Texas.