Monday, October 22, 2012

Compounding Pharmacies

The tragic news of deaths related to contaminated injectables goes beyond the personal responsibility that every healthcare professional shares.  The “compounding” pharmacy involved is obviously not a compounding pharmacy but a manufacturer.  The production of 17,700 vials of product is not compounding.  Compounding is where a pharmacy combines ingredients that are not commercially available for a specific patient.  Pharmacists are allowed to compound stock for anticipated prescriptions.  I provided sterile compounding from 1983 to about 2002 and actually made the product in question.  However, after each batch was compounded, a sample was sent to an independent lab for testing to confirm potency and sterility before any product was dispensed.  This was not a requirement but just good procedure.  This is now a current “standard” according to USP guidelines.  The manufacturer in question was obviously not following current compounding guidelines or what is known as FDA good manufacturing practices.

Dr. John Carr has a more detailed blog about compounding pharmacies at his Holy Hormones blog spot.

1 comment:

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