[Code of Federal Regulations] [Title 21, Volume 4] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR201.59] [Page 31-33] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 201--LABELING--Table of Contents Subpart B--Labeling Requirements for Prescription Drugs and/or Insulin Sec. 201.59 Effective date of Secs. 201.56, 201.57, 201.100(d)(3), and 201.100(e). (a) On and after December 26, 1979, no person may initially introduce or initially deliver for introduction into interstate commerce any drug to which Secs. 201.56, 201.57, 201.100(d)(3) apply unless the drug's labeling complies with the [[Page 32]] 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subject to section 505 of the act (21 U.S.C. 355), and was not subject to former section 507 of the act (21 U.S.C. 357, repealed 1997), Secs. 201.56, 201.57, and 201.100(d)(3) are effective on April 10, 1981.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, Secs. 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), Secs. 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 HFB-240 antigens with no U.S. standard of potency. Do................ ......do.............. Skin test antigens.......... HFB-240 Nov. 1, 1982 \1\...... Nov. 1,1980 \2\....... Bacteral vaccines and HFB-240 toxoids with standards of potency.. Do................ ......do.............. Viral and rickettsial HFB-240 vaccines. 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 HFD-110, HFD-510, and HFD-160 of electrolytes and water balance. 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, HFD-150 diagnostic. Do................ ......do.............. Radiopharmaceuticals, Do. therapeutic. Do................ ......do.............. Contrast agents diagnostic Do. radiopaque. Do................ ......do.............. Local anesthetics........... HFD-160 Do................ ......do.............. Antihistamines.............. Do. June 1, 1983.......... June 1, 1981.......... Antifungals................. HFD-520 [[Page 33]] 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 HFD-120 extrapyramidal movement disorders. Do................ ......do.............. Antiprotozoals.............. HFD-520 Oct. 1, 1983.......... Oct. 1, 1981.......... Penicillins................. HFD-520 Nov. 1, 1983.......... Nov. 1, 1981.......... Blood glucose regulators HFD-510 (except sulfonylureas). Oct. 9, 1984.......... July 10, 1984......... Sulfonylurea blood glucose HFN-130 regulators. Nov. 1, 1983.......... Nov. 1, 1981.......... Drugs indicated for HFD-510 and HFD-160 parenteral nutrition. Do................ ......do.............. Drugs indicated for enteral Do. nutrition. 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 Do. peptic disorders. Do................ ......do.............. Antidepressants............. HFD-120 Do................ ......do.............. Drugs indicated for skeletal Do. muscle hyperactivity. Do................ ......do.............. Sulfonamides and related HFD-520 sulfa compounds. 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 HFD-510 infertility. 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 HFD-520 (including antileprosy). 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 HFD-520 derivatives. May 1, 1984........... May 1, 1982........... Drugs indicated for vertigo/ HFD-120 motion sickness/vomiting. 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 HFD-110 antagonists. Do................ ......do.............. All other gastrointestinal HFD-110 drugs. Do................ ......do.............. Antianxiety................. HFD-120 Do................ ......do.............. Drugs indicated for HFD-120 myasthenia gravis. Do................ ......do.............. All other antiinfective HFD-520 drugs. Do................ ......do.............. Bronchodilators/ HFD-160 antiasthmatics. 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 HFD-110 hypotension and shock. 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). [45 FR 32552, May 16, 1980, as amended at 46 FR 7272, Jan. 23, 1981; 49 FR 14331, Apr. 11, 1984; 50 FR 8995, Mar. 6, 1985; 55 FR 11576, Mar. 29, 1990; 64 FR 400, Jan. 5, 1999] [[Page 34]]