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DEPARTMENT OF HEALTH AND HUMAN

SERVICES—Continued

(Parts 300 to 499)

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

iform 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.

Nighttime sleep-aid drug products for over-the-

counter human use

Stimulant drug products for over-the-counter

human use

Cold, cough, allergy, bronchodilator, and anti-

asthmatic drug products for over-the-counter

human use

Topical OTIC drug products for over-the-counter

human use

Anorectal drug products for over-the-counter

human use

Skin protectant drug products for over-the-

counter human use ....

External analgesic drug products for over-the

counter human use

Ophthalmic drug products for over-the-counter

human use

Anticaries drug products for over-the-counter

human use

Miscellaneous internal drug products for over-the-

counter human use

Miscellaneous external drug products for over-the-

counter human use

Prescription drugs for human use generally recog-

nized as safe and effective and not misbranded:

Drugs used in research

Interpretative statements re warnings on drugs

and devices for over-the-counter sale ....

Drugs composed wholly or partly of insulin

Antibiotic drugs; general

Certification of antibiotic drugs

Packaging and labeling of antibiotic drugs

Exemptions from antibiotic certification and la-

beling requirements ...

Tests and methods of assay of antibiotic and anti-

biotic-containing drugs

Penicillin antibiotic drugs

Penem antibiotic drugs

Cepha antibiotic drugs ...

Carbacephem antibiotic drugs

Oligosaccharide antibiotic drugs

Tetracycline antibiotic drugs

Peptide antibiotic drugs

Antifungal antibiotic drugs

Antitumor antibiotic drugs

Macrolide antibiotic drugs

Lincomycin antibiotic drugs

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Page 968

Part
455 Certain other antibiotic drugs
460 Antibiotic drugs intended for use in laboratory di-

agnosis of disease 461-499 [Reserved]

1019

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

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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

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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