id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-303865-vd3qr32o	Gianturco, Stephanie L.	Outsourcing facilities and their place in the U.S. drug supply chain	2020-08-28		.txt	text/plain	2840	140	49	Although it is preferable for providers to use Food and Drug Administration (FDA)eapproved, commercially available drug products, there are times when drug products need to be compounded to meet a patient-specific need. 4 FDA does not intend to take action against outsourcing facilities that compound drug products using bulk drug substances in category 1, in which information supports their clinical use or need, and FDA was unable to identify significant safety risks. Outsourcing facilities can provide hospitals and independent practices with ready-to-use sterile drug products because they can compound drug products on a larger scale and are not limited by the requirement of a patient-specific prescription. Challenges that limit the use of outsourcing facilities in the U.S. drug supply chain include a lack of a finalized 503B Bulks List, inconsistences in the inspection process, and lack of transparency in compliance status.	./cache/cord-303865-vd3qr32o.txt	./txt/cord-303865-vd3qr32o.txt