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.

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.

Lawfirm to File Lawsuit Against King’s Compounding Pharmacy

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The doctor prescribed a series of injections into the middle of her ear.

The lawsuit claims King’s Compounding Pharmacy improperly mixed the chemicals into a drug. The woman’s doctor then administered the drug to the woman in January of 2017.

Vet-Rx wary of new possible pharmacy regulations

Vet-Rx visit

Bill Soderlund Jr., left, talks about Food and Drug Administration regulations that Vet-Rx complies with, while Bill Soderlund Sr., center, and state Sen. Nick Frentz listen. (Nancy Madsen/St. Peter Herald)

 

 

Bill Soderlund Jr. says he loves regulation.

PCAB Launches USP 800-based Distinction in Hazardous Drug Handling (HDH)

Pharmacy Compounding Accreditation Board (PCAB), a service of Accreditation Commission for Health Care (ACHC), has released the compounding industry’s first Distinction in Hazardous Drug Handling (HDH).

Mom finds short-term solution in search for son’s life-saving drug

With only a few tablets left of a prescription drug that helps prevent a life-threatening allergic reaction, Lorrena Clee of Lower Sackville, N.S., got a call from her pharmacist Wednesday with some good news for her son.