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doi: 10.1007/s15010-018-1178-5 84
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This means the vote did not: Immediately add the substances to the 503A Bulks List Authorize pharmacies to begin compounding them based only on the committee vote Complete the FDA drug approval process Establish that products containing the substances have undergone FDA review for safety, quality, or benefit Create a pathway for 503B outsourcing facilities to produce the substances for office use The scope of this meeting is specifically the Section 503A Bulks List
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