1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter C - DRUGS: GENERAL
  5. Part 207 - REQUIREMENTS FOR FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS, AND THE NATIONAL DRUG CODE
  6. Subpart A - General
  7. 21 CFR § 207.3
21 CFR § 207.3
Bulk drug substance
June 25, 2020
CFR

Bulk drug substance, as referenced in sections 503A(b)(1)(A) and 503B(a)(2) of the Federal Food, Drug, and Cosmetic Act, previously defined in §207.3(a)(4), means the same as “active pharmaceutical ingredient” as defined in §207.1(b).

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§ 207.1 What definitions and interpretations of terms apply to this part?
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§ 207.5 What is the purpose of this part?

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