FDA Must Have New Authorities to Regulate Pharmacy Compounding

Ronen E

Just a person
Super Moderator
#2
Do you know anyone who might have been affected this time around?

http://www.fda.gov/Safety/Recalls/ucm345468.htm?source=govdelivery

ACETYLCYSTEINE OPHTHALMIC SOLUTION
ALPROSTADIL IN NS INJECTION
ATROPINE INJECTION
BACTERIOSTATIC WATER FOR INJECTION BIMIX INJECTION
BUPRENORPHINE HCL, VETERINARY INJECTION
CIDOFOVIR OPH SOLUTION
CYCLOSPORINE OPHTHALMIC
DIAZEPAM INJECTIBLE
DEXAMETHASONE PF
DMSO AQUEOUS IRRIGATION 50%
GENTAMICIN SULFATE IRRIGATION
HCG CHORIONIC GONADOTROPIN
HYDROXYPROGESTERONE CAPR. (G.S.)
METHYLCOBALAMIN - PF
MIC WITH B6 & B12
NANDROLONE DECANOATE INJECTIBLE
QUADMIX INJECTION
TACROLIMUS OPHTHALMIC
TESTOSTERONE CYPIONATE/TESTOSTERONE ENANTHATE INJECTION
TESTOSTERONE CYPIONATE/PROPIONATE INJECTION
TESTOSTERONE CYPIONATE INJECTION
TRIMIX INJECTION
VANCOMYCIN OPTHALMIC P.F.
VERAPAMIL INJECTION

Products were distributed directly to patients and/or physicians’ offices located in some or all of the following states: California, Connecticut, Florida, Georgia, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, and Wisconsin.

Users or recipients should discontinue use and return the recalled products...
 

paulag

Involved In Discussions
#9
dear all,

do you happen to know if there is any special licence needed for a contract manufacturer engaging in secondary packaging operations, when the drug is an opioid, eg. buprenorphine?

Thanks a lot!
 

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