US FDA Clarifies Compounding Policies On Interstate Distribution, Drug Shortages
The US FDA clarifies that drugs in shortage are not considered “essentially a copy” of an approved drug and can be compounded by traditional pharmacies and outsourcing facilities. This clarification is one of several recently announced by the agency.
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Hospital shortages of critical FDA-approved drugs used for treating COVID-19 patients has prompted the US FDA to loosen restrictions against compounding these drugs. In a related action, the FDA will now allow outsourcing facilities and compounding pharmacies to repackage propofol, also in short supply.
In less than three weeks, the number of clinical trials for potential treatments has jumped to 72, according to the FDA’s Coronavirus Treatment Acceleration Program.
Vials arrive in fits and starts, often in wrong sizes, as allocation quotas, quality issues and difficulty anticipating surges wreak havoc in pharmaceutical supply chain.