Which of the following is not required of all non-sterile compounded products? (Select ALL that apply.) Answer A NDC numbers B FDA approval C Regulation by the Dietary Supplemental Health and Education Act (DSHEA) D Beyond use dates E Prepared under Current Good Manufacturing Practices (CGMPs)

BYD is required – doesn’t require all More test answers on https://studyhippo.com/non-sterile-compounding-and-sterile-compounding/

Which of the following statements concerning FDA approved manufactured drug products is/are correct? (Select ALL that apply.) Answer A FDA approved drugs must have an approved NDA. B They must be manufactured under Current Good Manufacturing Practices (CGMPs). C They must have a manufacturer’s expiration date on the bottle/package label. D They must each have an NDC number. E They include compounded preparations.

FDA approved drug products must have an approved NDA, be produced under Current Good Manufacturing Practices, and have an NDC number. They must also have a manufacturer’s expiration date on the bottle/package label. More test answers on https://studyhippo.com/non-sterile-compounding-and-sterile-compounding/

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Good Manufacturing Practices Flashcards, test questions and answers

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