21 C.F.R. PART 330--OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
Subpart A--GENERAL PROVISIONS
|
|
| General conditions for general recognition as safe, effective and not misbranded.
|
|
|
|
| Pregnancy-nursing warning.
|
|
|
|
| Imprinting of solid oral dosage form drug products.
|
|
Subpart B--ADMINISTRATIVE PROCEDURES
|
|
| Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.
|
|
|
|
| NDA deviations from applicable monograph.
|
|
|
|
| Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).
|
|
|
|
| Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.
|
|
|
|
| Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.
|
|
