Title 21—Food and Drugs (This book contains parts 300 to 499) Part CHAPTER I—Food and Drug Administration, Department of Health and Human Services (Continued) ........................... 300 1 VerDate Sep<11>2014 09:43 Aug 20, 2020 Jkt 250074 PO 00000 Frm 00011 Fmt 8008 Sfmt 8008 Y:\SGML\250074.XXX 250074 VerDate Sep<11>2014 09:43 Aug 20, 2020 Jkt 250074 PO 00000 Frm 00012 Fmt 8008 Sfmt 8008 Y:\SGML\250074.XXX 250074 CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) EDITORIAL NOTE: Nomenclature changes to chapter I appear at 59 FR 14366, Mar. 28, 1994, and 69 FR 13717, Mar. 24, 2004. SUBCHAPTER D—DRUGS FOR HUMAN USE Part Page 300 General .................................................................... 5 310 New drugs................................................................ 5 312 Investigational new drug application ..................... 52 314 Applications for FDA approval to market a new drug ...................................................................... 94 315 Diagnostic radiopharmaceuticals........................... 191 316 Orphan drugs........................................................... 193 317 Qualifying pathogens.............................................. 205 320 Bioavailability and bioequivalence requirements ... 206 328 Over-the-counter drug products intended for oral ingestion that contain alcohol ............................. 221 329 Nonprescription human drug products subject to section 760 of the Federal food, drug, and cos- metic act .............................................................. 222 330 Over-the-counter (OTC) human drugs which are generally recognized as safe and effective and not misbranded ..................................................... 223 331 Antacid products for over-the-counter (OTC) human use ............................................................ 243 332 Antiflatulent products for over-the-counter human use ........................................................................ 247 333 Topical antimicrobial drug products for over-the- counter human use ............................................... 248 335 Antidiarrheal drug products for over-the-counter human use ............................................................ 256 336 Antiemetic drug products for over-the-counter human use ............................................................ 258 338 Nighttime sleep-aid drug products for over-the- counter human use ............................................... 260 3 VerDate Sep<11>2014 09:43 Aug 20, 2020 Jkt 250074 PO 00000 Frm 00013 Fmt 8008 Sfmt 8008 Y:\SGML\250074.XXX 250074 21 CFR Ch. I (4–1–20 Edition) Part Page 340 Stimulant drug products for over-the-counter human use ............................................................ 261 341 Cold, cough, allergy, bronchodilator, and anti- asthmatic drug products for over-the-counter human use ............................................................ 262 343 Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use .... 286 344 Topical otic drug products for over-the-counter human use ............................................................ 293 346 Anorectal drug products for over-the-counter human use ............................................................ 295 347 Skin protectant drug products for over-the-counter human use ............................................................ 300 348 External analgesic drug products for over-the- counter human use ............................................... 308 349 Ophthalmic drug products for over-the-counter human use ............................................................ 309 350 Antiperspirant drug products for over-the-counter human use ............................................................ 315 352 Sunscreen drug products for over-the-counter human use [stayed indefinitely] ........................... 317 355 Anticaries drug products for over-the-counter human use ............................................................ 327 357 Miscellaneous internal drug products for over-the- counter human use ............................................... 332 358 Miscellaneous external drug products for over-the- counter human use ............................................... 336 361 Prescription drugs for human use generally recog- nized as safe and effective and not misbranded: Drugs used in research ......................................... 345 369 Interpretative statements re warnings on drugs and devices for over-the-counter sale ................... 350 370–499 [Reserved] 4 VerDate Sep<11>2014 09:43 Aug 20, 2020 Jkt 250074 PO 00000 Frm 00014 Fmt 8008 Sfmt 8008 Y:\SGML\250074.XXX 250074 SUBCHAPTER D—DRUGS FOR HUMAN USE PART 300—GENERAL presented for it, then formulation, la- beling, or dosage changes may be pro- Subpart A [Reserved] posed and any resulting formulation may meet the appropriate criteria list- Subpart B—Combination Drugs ed in paragraph (a) of this section. (c) A fixed-combination prescription Sec. 300.50 Fixed-combination prescription drugs drug for humans that has been deter- for humans. mined to be effective for labeled indica- tions by the Food and Drug Adminis- Subpart C—Substances Generally tration, based on evaluation of the Prohibited From Drugs NAS-NRC report on the combination, is considered to be in compliance with 300.100 Chlorofluorocarbon propellants. the requirements of this section. AUTHORITY: 21 U.S.C. 331, 351, 352, 355, 360b, 361, 371. [40 FR 13496, Mar. 27, 1975, as amended at 64 FR 401, Jan. 5, 1999] Subpart A [Reserved] Subpart C—Substances Generally Subpart B—Combination Drugs Prohibited From Drugs § 300.50 Fixed-combination prescrip- § 300.100 Chlorofluorocarbon propel- tion drugs for humans. lants. The Food and Drug Administration’s The use of chlorofluorocarbons in policy in administering the new-drug, human drugs as propellants in self- antibiotic, and other regulatory provi- pressurized containers is generally pro- sions of the Federal Food, Drug, and hibited except as provided by § 2.125 of Cosmetic Act regarding fixed combina- this chapter. tion dosage form prescription drugs for [43 FR 11317, Mar. 17, 1978] humans is as follows: (a) Two or more drugs may be com- bined in a single dosage form when PART 310—NEW DRUGS each component makes a contribution to the claimed effects and the dosage of Subpart A—General Provisions each component (amount, frequency, Sec. duration) is such that the combination 310.3 Definitions and interpretations. is safe and effective for a significant 310.4 Biologics; products subject to license patient population requiring such con- control. current therapy as defined in the label- 310.6 Applicability of ‘‘new drug’’ or safety ing for the drug. Special cases of this or effectiveness findings in drug efficacy general rule are where a component is study implementation notices and no- added: tices of opportunity for hearing to iden- (1) To enhance the safety or effec- tical, related, and similar drug products. tiveness of the principal active compo- Subpart B—Specific Administrative Rulings nent; and and Decisions (2) To minimize the potential for abuse of the principal active compo- 310.100 New drug status opinions; statement nent. of policy. (b) If a combination drug presently 310.103 New drug substances intended for the subject of an approved new-drug hypersensitivity testing. application has not been recognized as effective by the Commissioner of Food Subpart C—New Drugs Exempted From and Drugs based on his evaluation of Prescription-Dispensing Requirements the appropriate National Academy of 310.200 Prescription-exemption procedure. Sciences-National Research Council 310.201 Exemption for certain drugs limited panel report, or if substantial evidence by new drug applications to prescription of effectiveness has not otherwise been sale. 5 VerDate Sep<11>2014 09:43 Aug 20, 2020 Jkt 250074 PO 00000 Frm 00015 Fmt 8010 Sfmt 8010 Y:\SGML\250074.XXX 250074 § 310.3 21 CFR Ch. I (4–1–20 Edition) Subpart D—Records and Reports 310.537 Drug products containing active in- gredients offered over-the-counter (OTC) 310.303 Continuation of long-term studies, for oral administration for the treatment records, and reports on certain drugs for of fever blisters and cold sores. which new drug applications have been 310.538 Drug products containing active in- approved. gredients offered over-the-counter (OTC) 310.305 Records and reports concerning ad- for use for ingrown toenail relief. verse drug experiences on marketed pre- 310.540 Drug products containing active in- scription drugs for human use without gredients offered over-the-counter (OTC) approved new drug applications. for use as stomach acidifiers. 310.306 Notification of a permanent dis- 310.541 Over-the-counter (OTC) drug prod- continuance or an interruption in manu- ucts containing active ingredients of- facturing of marketed prescription drugs fered for use in the treatment of hypo- for human use without approved new phosphatemia. drug applications. 310.542 Over-the-counter (OTC) drug prod- ucts containing active ingredients of- Subpart E—Requirements for Specific New fered for use in the treatment of hyper- Drugs or Devices phosphatemia. 310.543 Drug products containing active in- 310.501 Patient package inserts for oral con- gredients offered over-the-counter (OTC) traceptives. for human use in exocrine pancreatic in- 310.502 Certain drugs accorded new drug sta- sufficiency. tus through rulemaking procedures. 310.544 Drug