EDITORIAL NOTE: The Food and Drug Administration published a document at 49 FR 41019, Oct. 19, 1984, establishing July 1, 1987, as a uniform effective date for compliance for regula- tions affecting the labeling of food products. At 51 FR 34085, Sept. 25, 1986, FDA established January 1, 1989, as a new uniform effective date for compliance. The new uniform effective date will apply only to final FDA food labeling regulations published after July 1, 1986, and before January 1, 1988. At 55 FR 276, Jan. 4, 1990, FDA established January 1, 1993 as a new uniform effective date for compliance. The new uniform effective date will apply only to final FDA food labeling regulations published after January 1, 1990 and before January 1, 1992. Cold, cough, allergy, bronchodilator, and anti- asthmatic drug products for over-the-counter Interpretative statements re warnings on drugs and devices for over-the-counter sale ..... Part Page 455 Certain other antibiotic drugs 968 460 Antibiotic drugs intended for use in laboratory di- 1019 461-499 [Reserved] EDITORIAL NOTE: For nomenclature changes to chapter I see 59 FR 14366, Mar. 28, 1994. The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows: (a) Two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug. Special cases of this general rule are where a component is added: (1) To enhance the safety or effectiveness of the principal active component; and (2) To minimize the potential for abuse of the principal active component. (b) If a combination drug presently the subject of an approved new-drug application or antibiotic monograph has not been recognized as effective by the Commissioner of Food and Drugs based on his evaluation of the appropriate National Academy of SciencesNational Research Council panel report, or if substantial evidence of effec tiveness has not otherwise been presented for it, then formulation, labeling, or dosage changes may be proposed and any resulting formulation may meet the appropriate criteria listed in paragraph (a) of this section. (c) A fixed-combination prescription drug for humans that has been determined to be effective for labeled indications by the Food and Drug Administration, based on evaluation of the NAS-NRC report on the combination, is considered to be in compliance with the requirements of this section.0 [40 FR 13496, Mar. 27, 1975] 310.3 Definitions and interpretations. 310.4 Biologics; products subject to license control. 310.6 Applicability of “new drug" or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products. Subpart B-Specific Administrative Rulings and Decisions 310.100 New drug status opinions; statement of policy. 310.103 New drug substances intended for hypersensitivity testing. Subpart C-New Drugs Exempted From Prescription-Dispensing Requirements 310.200 Prescription-exemption procedure. 310.201 Exemption for certain drugs limited by new drug applications to prescription sale. |