South Florida Hospital News
Sunday May 31, 2020

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May 2010 - Volume 6 - Issue 11




Where Do Your Prescription Drugs Come From?

When a physician writes a prescription or an order for a drug and gives it to the nurse or the patient, what happens next can be a very complicated chain of events.

Most prescription drugs in this country come from other countries with China and India probably being the leaders as manufacturers of the active pharmaceutical ingredients ("API") that make up our U.S. pharmaceuticals. The Food and Drug Administration ("FDA") does its best to regulate these foreign manufacturers as well as the U.S. manufacturers that import the API that is then put in capsules or shaped into tablets and sold into the U.S. stream of commerce.

Every state in the U.S. has their own drug regulations that they follow. Many states adopt the FDA guidelines, others, including Florida, adopt the FDA guidelines and then further set even higher standards that all companies that manufacture, sell or distribute prescription drugs in or into the State of Florida must follow. If you do business with Florida in the field of pharmaceuticals, you must be licensed by the State of Florida before doing so. With that said, there are many companies that do not comply with the rules of the State of Florida and continue to solicit doctorsí offices, hospitals and retail pharmacies through faxes, phone calls and sales representatives touting great deals and "specials" if you buy their FDA approved prescription products. It all sounds good. Just think you are getting those antibiotics at a price well below what your other vendor offered.

Donít be too quick to accept that good deal. Those products could be coming from a wholesaler or manufacturer not licensed to sell directly into the State of Florida, they could even be expired and relabeled, previously dispensed by other pharmacies and resold back into the market by patients, or even plain counterfeit. Take careful note when buying your drugs because if you are caught with an unlicensed or adulterated product, action will be taken again your license for buying prescription drugs from an unauthorized source. (1)

Sharon Roberts is a former State of Florida, Department of Health Inspector, and is now a practicing healthcare law attorney and pharmacist in Palm Beach County, FL, who specializes in healthcare and regulatory law practice with the law firm of Strawn & Monaghan, P.A. She can be reached at (561) 278-9400 or visit

(1) The Florida Food Drug and Cosmetic Act, F.S. Chapter 499; FAC 64F-12.

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