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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER A—GENERAL
  6. PART 4—REGULATION OF COMBINATION PRODUCTS
  7. Subpart A—Current Good Manufacturing Practice Requirements for Combination Products

21 CFR Part 4 - Subpart A - Current Good Manufacturing Practice Requirements for Combination Products

  • CFR
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  1. § 4.1 What is the scope of this subpart?
  2. § 4.2 How does FDA define key terms and phrases in this subpart?
  3. § 4.3 What current good manufacturing practice requirements apply to my combination product?
  4. § 4.4 How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?

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