NOTES FAILURE TO COMPLY WITH USP <797> AND STATE LAWS AND REGULATIONS BACKGROUND “Pharmacy Compounding†involves modifying commercially available products to meet the requirements of an individual patient based upon a prescription from a licensed provider. Within the State of Massachusetts, a total of 25 pharmacies meet … [Read more...]
NEW ENGLAND COMPOUNDING CENTER (NECC) POTENTIALLY CONTAMINATED MEDICATION: FUNGAL MENINGITIS OUTBREAK
Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. [UPDATED 10/06/2012] On October 4, 2012, the CDC and FDA recommended that all health care professionals cease use and remove from their pharmaceutical inventory any product produced by the New … [Read more...]
ASPERGILLUS CONTAMINATION FOUND AT NECC — IS USP 797 “PHARMACEUTICAL COMPOUNDING — STERILE PREPARATIONS” WORKING?
 SHOULD THE FDA BE DOING MORE? Recently the New England Compounding Center (NECC) was found to have dispensed a number of syringes containing methylprednisolone acetate to treat pain control and inflammation. Following a number of reports from various states, the FDA and CDC became involved in attempting to locate the source of … [Read more...]
FDA’S CDER SUMMARIZES TOP TEN 483 OBSERVATIONS AT PDA/FDA MEETING IN BALTIMORE (9/12)
COMMENT Each year CDER summarizes the number of significant Observations obtained from Form FDA 483s. At this year's PDA/FDA meetings which were held in Baltimore, MD, the FDA presented the totals calendar year to date. The Observations within the top ten usually do not change --- although their frequency may vary. Where a specific section is indicated, the Title indicates … [Read more...]
DPT LAKEWOOD, LLC LAKEWOOD, NJ RECEIVES FDA WARNING LETTER (08/27/12) FOR STERILITY FAILURES
DPT Lakewood, LLC was inspected between February 15 through March 7, 2012. During this audit the FDA found that Santyl Ointment to be adulterated and that the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, cGMP. Specific violations observed … [Read more...]
