The October 2012 news stories about cases of fungal meningitis have raised some concerns about compounding pharmacies, and the risk to patients receiving medications that do not come directly from the manufacturer.

• A pharmacy that mixes up a medication for patient use is called a ‘compounding pharmacy’;
• The compounding pharmacy involved in the case is called “The New England Compounding Pharmacy,” located in Massachusetts;
• They were actually producing the steroid medication by mixing powder they bought from a drug manufacturer along with liquid, and then selling the preparation to doctors and hospitals for various types of injections;
• The production of medication by drug companies is regulated by the Food and Drug Administration. Compounding pharmacies are registered as ‘pharmacies’ which fall under state rules;
• Compounding pharmacies can voluntarily apply for accreditation from the Pharmacy Compounding Accreditation Board (PCAB) to certify they meet the industry standards, which include verification of sterile procedures. This is not the same as FDA regulation, but is the best form of safety assurance available at this time.

The New England Compounding Pharmacy has never applied for accreditation by the PCAB, according to a report published in the New York Times.

About your Avastin injections:

• Avastin is manufactured by a company called Genentec;
• Genentec delivers Avastin directly to the compounding pharmacy we use which is named Avella, located in Arizona;
• Avella used to be named ‘The Apothecary Shop’, until it changed its name around June 2012. We have been using ‘The Apothecary Shop/Avella’ since May, 2009;
• The Avella lab transfers the Avastin from the vial they receive from Genentec directly into the syringe used to inject the medication into the eye;
• Avella does not mix the drug with anything, it is just transferred from the manufacturer’s vial into a syringe. (That is distinctly different from what was being done in the ‘New England Compounding Pharmacy’ for the steroid injections);
• This transfer is done under strict sterile procedures;
• The syringe is sealed in a packet which is marked with lot numbers and expiration dates, and sent directly to our office;
• Avella has received accreditation from the Pharmacy Compounding Accreditation Board;
• You can read about the PCAB and their process on their website: www.pcab.org