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deleted1103055
The chief of Endocrinology at my state university medical school has stated he will not send Rxs to any compounding pharmacies because of their alleged substandard dosages for meds. If a patients needs an Rx, he requires that all be “FDA approved products” (i.e. not compounded) and dispensed at “regular retail pharmacies” (no compounding pharmacies). While Urologists, Dermatologists, OB/GYN and HIV physicians will utilize these compounding pharmacies for various injectables, creams and PO capsules, the Chief of Endocrinology is not persuaded with those outlets that register with the FDA as 503B outsourcing pharmacies, citing that those that are, often have a history of being issued Form FDA-483.
questions:
How reliable are compounded products as to guaranteeing their dosages/formulations vs “FDA approved” products? e.g. test cyp, tadaladil qd capsule, bimix, clindamycin gel for acne, tretinoin gel, etc?
What incentive exists for a compounding pharmacy to register as a 503B pharmacy? Why bother?
do the occasional issuance of Form FDA-483 reveal grave concerns or are they much ado about nothing?
Now I am doubting whether we should use compounding pharmacies since I assumed they were safe, reliable and their products were as trustworthy as “FDA approved“ products. OTOH, the cost savings to patients with compounding pharmacies can be significant with cash payments vs “covered insurance” with sizeable copayments
thanks
questions:
How reliable are compounded products as to guaranteeing their dosages/formulations vs “FDA approved” products? e.g. test cyp, tadaladil qd capsule, bimix, clindamycin gel for acne, tretinoin gel, etc?
What incentive exists for a compounding pharmacy to register as a 503B pharmacy? Why bother?
do the occasional issuance of Form FDA-483 reveal grave concerns or are they much ado about nothing?
Now I am doubting whether we should use compounding pharmacies since I assumed they were safe, reliable and their products were as trustworthy as “FDA approved“ products. OTOH, the cost savings to patients with compounding pharmacies can be significant with cash payments vs “covered insurance” with sizeable copayments
thanks