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e-CFR data is current as of August 7, 2020

Title 21Chapter ISubchapter DPart 330


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER D—DRUGS FOR HUMAN USE

PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

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Subpart A—GENERAL PROVISIONS

§330.1
General conditions for general recognition as safe, effective and not misbranded.
§330.2
Pregnancy-nursing warning.
§330.3
Imprinting of solid oral dosage form drug products.
§330.5
Drug categories.
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Subpart B—ADMINISTRATIVE PROCEDURES

§330.10
Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.
§330.11
NDA deviations from applicable monograph.
§330.12
Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).
§330.13
Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.
§330.14
Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.
§330.15
Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions.

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