Microbial Examination of Nonsterile Products: Microbial Enumeration Tests USP <61> Q. Can I use strains other than those that are cited in the USP? A. You should use the strains that are cited in this chapter or equivalent strains from other culture collections. For example, if Pseudomonas aeruginosa ATCC 9027 is indicated, you should use this strain or strains … [Read more...]
FRANCK’S PHARMACY RECALLS ALL STERILE HUMAN AND VETERINARY PRESCRIPTIONS FROM NOV 21, 2011 TO MAY 21, 2012
ENVIRONMENTAL SAMPLING OF CLEAN ROOM REVEALED PRESENCE OF MICROORGANISMS AND FUNGAL GROWTH BY FDA. WHAT HAPPENED TO USP <797>? Franck's Pharmacy, Ocala, Florida initiated a recall of all sterile human and veterinary prescriptions from November 21, 2011 through May 21, 2012. This recall follows an earlier recall (May 2, 2011 Notice of Recall, … [Read more...]
HOSPIRA – WHEN IS A DRUG RECALL AN ALERT
 FDA RECOMMENDS ALERT TO AVOID DRUG SHORTAGES In a previous Blog (May 24, 2012) the issue of Warning Letters and how the FDA now on a routine basis is asking their Clients to advise them if the Warning Letter and its consequences will result in shortages was discussed. In this Blog, the FDA is using “Risk Management†… [Read more...]
NEW ADDITION TO WARNING LETTERS’ “BOILERPLATE” PARAGRAPHS
CDER RESPONDS TO MANAGEMENT OF LACK OF AVAILABILITY OF FINISHED DRUG PRODUCT OR API Recently the FDA has added a new standardized paragraph to each of its Warning Letters for both Finished Drug Products and for Active Pharmaceutical Ingredients. Please review how the FDA desires you to respond. "If, as a result of receiving this Warning Letter or in general, you … [Read more...]
FDA CBER STERILITY TESTING REQUIREMENTS (610.12) AMENDED (06/04/12)
ELIMINATES SPECIFIED STERILITY TEST METHODS, CULTURE MEDIA FORMULAE, AND CULTURE MEDIA TEST REQUIREMENTS -- CLARITY OR CONFUSION? Summary (Effective June 4, 2012) The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages … [Read more...]
