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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter C - Drugs: General |
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Part 201 - Labeling |
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Subpart B - Labeling Requirements for Prescription Drugs and/or Insulin |
§ 201.59 - Effective date of 201.56, 201.57, 201.100(d)(3), and 201.100(e).
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Link to an amendment published at 71 FR 3996, Jan. 24, 2006. (a) On and after December 26, 1979, no person may initially introduce or initially deliver for introduction into interstate commerce any drug to which §§ 201.56, 201.57, 201.100(d)(3) apply unless the drug's labeling complies with the requirements set forth in the regulations, with the following exceptions:
(1) If the drug is a prescription drug that is not a biologic and not subject to section 505 of the act (21 U.S.C. 355), and was not subject to former section 507 of the act (21 U.S.C. 357, repealed 1997), §§ 201.56, 201.57, and 201.100(d)(3) are effective on April 10, 1981.
(2) If the drug is a prescription drug that on December 26, 1979 is (i) a licensed biologic, (ii) a new drug subject to an approved new drug application or abbreviated new drug application under section 505 of the act or (iii) an antibiotic drug subject to an approved antibiotic form, §§ 201.56, 201.57, and 201.100(d)(3) are effective on the date listed below for the class of drugs to which the drug belongs. Dates are also listed below for the submission of supplemental applications, amendments, and license changes.
(3) If the drug is approved after December 26, 1979 but is a duplicate of a drug approved on or before that date (for example, a drug approved under an abbreviated new drug application or an antibiotic form), §§ 201.56, 201.57, and 201.100(d)(3) are effective on the date listed below for the class of drugs to which the drug belongs. Dates are also listed below for the submission of supplemental applications, amendments, and license changes.
Effective Revised labeling due Drug class Mail routing code Biologics Nov. 1, 1982 Nov. 1, 1980 Bacterial vaccines and antigens with no U.S. standard of potency HFB-240 Do ......do Skin test antigens HFB-240 Nov. 1, 1982 1 Nov. 1, 1980 2 Bacteral vaccines and toxoids with standards of potency. HFB-240 Do ......do Viral and rickettsial vaccines HFB-240 Do ......do Allergenic extracts HFB-240 Do ......do Blood and blood derivatives HFB-240 New Drugs and Antibiotic Drugs Nov. 1, 1982 Nov. 1, 1980 Antiarrhythmics HFD-110 Do ......do Replenishers and regulators of electrolytes and water balance HFD-110, HFD-510, and HFD-160 Do ......do Anticonvulsants HFD-120 Do ......do Adrenal corticosteroids HFD-510 and HFD-150 Do ......do Aminoglycosides HFD-520 Do ......do Scabicides Do. Do ......do Pediculicides Do. Do ......do General anesthetics HFD-160 Dec. 1, 1982 Dec. 1, 1980 Antivirals HFD-520 Do ......do Dermatologics Do. Jan. 1, 1983 Jan. 1, 1981 Glaucoma ophthalmics HFD-520 Do ......do Topical otics Do. Feb. 1, 1983 Feb. 1, 1981 Antispasmodics HFD-110 Do ......do Anticholinergics Do. Do ......do Diuretics Do. Do ......do Narcotic antagonists HFD-120 Do ......do Alcohol antagonists Do. Do ......do Antipsychotics/antimanics Do. Do ......do Androgens HFD-510 Do ......do Anabolic steroids Do. Do ......do Hyperlipidemia Do. Do ......do Anthelmintics HFD-520 Do ......do Antigout HFD-150 Mar. 1, 1983 Mar. 1, 1981 Vaginal antibiotics HFD-520 Apr. 1, 1983 Apr. 1, 1981 Cephalosporins HFD-520 May 1, 1983 May 1, 1981 General analgesics HFD-120 Do ......do Anterior pituitary hormones HFD-510 Do ......do Hypothalamic hormones Do. Do ......do Progestins Do. Do ......do Mydriatic ophthalmics HFD-520 Do ......do Cycloplegic ophthalmics Do. Do ......do Radiopharmaceuticals, diagnostic HFD-150 Do ......do Radiopharmaceuticals, therapeutic Do. Do ......do Contrast agents diagnostic radiopaque Do. Do ......do Local anesthetics HFD-160 Do ......do Antihistamines Do. June 1, 1983 June 1, 1981 Antifungals HFD-520 July 1, 1983 July 1, 1981 Antidiarrheals HFD-110 Do ......do Cardiac glycosides Do. Do ......do Sedatives HFD-120 Do ......do Hypnotics Do. Do ......do Tetracyclines HFD-520 Aug. 1, 1983 Aug. 1, 1981 Calcium metabolism HFD-510 Do ......do Vitamins and minerals Do. Do ......do Antiinfective ophthalmics HFD-520 Do ......do Antiinflammatory ophthalmics Do. Sept. 1, 1983 Sept. 1, 1981 Antihypertensives HFD-110 Do ......do Drugs indicated for extrapyramidal movement disorders HFD-120 Do ......do Antiprotozoals HFD-520 Oct. 1, 1983 Oct. 1, 1981 Penicillins HFD-520 Nov. 1, 1983 Nov. 1, 1981 Blood glucose regulators (except sulfonylureas) HFD-510 Oct. 9, 1984 July 10, 1984 Sulfonylurea blood glucose regulators HFN-130 Nov. 1, 1983 Nov. 1, 1981 Drugs indicated for parenteral nutrition HFD-510 and HFD-160 Do ......do Drugs indicated for enteral nutrition Do. Do ......do Miscellaneous ophthalmics HFD-520 Do ......do Immunomodulators HFD-150 Dec. 1, 1983 Dec. 1, 1981 Anticoagulants HFD-110 Do ......do Thrombolytics Do. Do ......do Drugs indicated for acid peptic disorders Do. Do ......do Antidepressants HFD-120 Do ......do Drugs indicated for skeletal muscle hyperactivity Do. Do ......do Sulfonamides and related sulfa compounds HFD-520 Do ......do Dental preparations HFD-160 Jan. 1, 1984 Jan. 1, 1982 Miscellaneous antibacterials HFD-520 Feb. 1, 1984 Feb. 1, 1982 Drugs indicated for infertility HFD-510 Do ......do Thyroids Do. Do ......do Antithyroids Do. Do ......do Polymyxins HFD-520 Do ......do Antineoplastics HFD-150 Mar. 1, 1984 Mar. 1, 1982 Urinary tract stimulants HFD-110 Do ......do Urinary tract relaxants Do. Do ......do Antimigraine HFD-120 Antimycobacterials (including antileprosy) HFD-520 Do ......do Adjuncts to anethesia HFD-160 Apr. 1, 1984 Apr. 1, 1982 Antianginals HFD-110 Do ......do Laxatives Do. Do ......do CNS stimulants HFD-120 Do ......do Anorexiants Do. Do ......do Chloramphenicol and derivatives HFD-520 May 1, 1984 May 1, 1982 Drugs indicated for vertigo/motion sickness/vomiting HFD-120 Do ......do Antidiuretics HFD-510 Do ......do Contraceptives Do. Do ......do Macrolides HFD-520 Do ......do Lincosamides Do. Do ......do Antiarthritics HFD-150 Do ......do Antitussives HFD-160 Do ......do Expectorants Do. Do ......do Inhalants Do. June 1, 1984 June 1, 1982 Urinary tract antiseptics HFD-520 July 1, 1984 July 1, 1982 Chelating agents/heavy metal antagonists HFD-110 Do ......do All other gastrointestinal drugs HFD-110 Do ......do Antianxiety HFD-120 Do ......do Drugs indicated for myasthenia gravis HFD-120 Do ......do All other antiinfective drugs HFD-520 Do ......do Bronchodilators/antiasthmatics HFD-160 Aug. 1, 1984 Aug. 1, 1982 Estrogens HFD-510 Do ......do Uterine stimulants HFD-510 Do ......do Uterine relaxants Do. Sept. 1, 1984 Sept. 1, 1982 Drugs indicated for hypotension and shock HFD-110 Oct. 1, 1984 Oct. 1, 1982 All other cardiac drugs HFD-110 Do ......do Nasal decongestants HFD-160 Nov. 1, 1984 Nov. 1, 1982 All other prescription drugs 1 Except the effective date for all biological products reviewed generically by the advisory panel is 30 months after a final order is published under 21 CFR 601.25(g).2 Except the due date for all biological products reviewed generically by the advisory panel is 6 months after a final order is published under 21 CFR 601.25(g).(b) Section 201.100(e) is effective April 10, 1981.
Effective Date Note: At 71 FR 3996, Jan. 24, 2006, § 201.59 was removed, effective June 30, 2006.