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DEPARTMENT OF HEALTH AND HUMAN
(Parts 300 to 499)
EDITORIAL NOTE: The Food and Drug Administration published a document at 49 FR 41019,
agnosis of disease 461-499 [Reserved]
EDITORIAL NOTE: For nomenclature changes to chapter I see 59 FR 14366, Mar. 28, 1994.
Subpart C-Substances Generally
Prohibited From Drugs
$ 300.100 Chlorofluorocarbon propel
lants. The use of chlorofluorocarbons in human drugs as propellants in selfpressurized containers is generally prohibited except as provided by $2.125 of this chapter.
(43 FR 11317, Mar. 17, 1978)
PART 310-NEW DRUGS
Subpart A-General Provisions
Subpart B-Combination Drugs $ 300.50 Fixed-combination prescrip
tion drugs for humans. 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
Sec. 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 90tices of opportunity for hearing to identical, related, and similar drug products.
Subpart B-Specific Administrative Rulings
310.100 New drug status opinions; statement
of policy. 310.103 New drug substances intended for
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.