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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 C. DRUGS: GENERAL
  6. Part 201. LABELING
  7. Subpart A. General Labeling Provisions

21 CFR Subpart A - General Labeling Provisions

  • CFR
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  1. § 201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
  2. § 201.2 Drugs and devices; National Drug Code numbers.
  3. § 201.5 Drugs; adequate directions for use.
  4. § 201.6 Drugs; misleading statements.
  5. § 201.10 Drugs; statement of ingredients.
  6. § 201.15 Drugs; prominence of required label statements.
  7. § 201.16 Drugs; Spanish-language version of certain required statements.
  8. § 201.17 Drugs; location of expiration date.
  9. § 201.18 Drugs; significance of control numbers.
  10. § 201.19 Drugs; use of term “infant”.
  11. § 201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
  12. § 201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
  13. § 201.22 Prescription drugs containing sulfites; required warning statements.
  14. § 201.23 Required pediatric studies.
  15. § 201.24 Labeling for systemic antibacterial drug products.
  16. § 201.25 Bar code label requirements.
  17. § 201.26 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.

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