Prior registration and inspection by FDA required for certain outsourcing facilities.

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36-11A-4.2. Prior registration and inspection by FDA required for certain outsourcing facilities.

No outsourcing facility engaged in compounding of nonpatient specific sterile and nonsterile drugs may become licensed by the board without first obtaining a registration and inspection by the United States Food and Drug Administration, and paying the license fee set by the board in rules promulgated pursuant to chapter 1-26. The fee may not exceed two hundred dollars.

Source: SL 2017, ch 174, §8.


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