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Part

Page

455

Certain other antibiotic drugs

968

460

Antibiotic drugs intended for use in laboratory di-
agnosis of disease

1019

461-499 [Reserved]

EDITORIAL NOTE: For nomenclature changes to chapter I see 59 FR 14366, Mar. 28, 1994.

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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]

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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.

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