Archives for April 2017

California Compounding Pharmacy Faces Civil Suit over Failure to Warn Consumer Regarding Dangers of Testosterone Cream

Great Earth Compounding Pharmacy, along with a pharmacist, integrative medicine center, and two doctors, all based in southern California, are being sued by a family for unspecified damages related to a compounded testosterone cream prescribed for plaintiff Andrew Simpson. The suit alleges that Simpson’s wife and two children have all suffered serious medical consequences due to their exposure to the compounded cream. The complaint alleges that the defendants failed to warn Simpson of the risks associated with the product should women or children come into physical contact with the cream.

NECC: Judge rules pharmacy board, FDA could be found liable

 

BOSTON – A Boston federal judge ruled the U.S. Food and Drug Administration and a state pharmacy board can be found at fault for the 2012 fungal meningitis outbreak that took the lives of some 77 patients, who had been injected with fungus contaminated drugs from a Framingham drug compounding company.

Countdown To The 2017 DSCSA Deadline: Serialization Strategies For Compliance

 

Pharmaceutical Product Serialization Regulations and Strategies for Compliance

Cleaning Compounding Aseptic Isolators

 

Using the right techniques and procedures can make cleaning sterile compounding areas a matter of routine.

USP 800 Mobile Cleanroom

Happy Easter Everyone!

 

Hi,

We would like to wish our valued customers and potential customers a Happy Easter! Wishing you a holiday celebration filled with family, friends, love and laughter.

 

Sincerely,

Aseptic Enclosures Team

Why Sterile Alcohol?

 

FDA reminder of safe non-sterile alcohol prep pad use

PCAB Collaborates on Consensus Statement on Handling of Hazardous Drugs per USP Chapter

Pharmacy Compounding Accreditation Board (PCAB), a service of Accreditation Commission for Health Care (ACHC), has collaborated with industry leaders to develop a consensus statement on the handling of hazardous drugs per USP Chapter guidelines.

FDA approves Sanofi and Regeneron’s New Eczema Drug

The US Food and Drug Administration (FDA) approved Sanofi and Regeneron’s Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis).

Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.