Regulation Text
Authority
21 U.S.C. 321,331,351,352,355,360,360b,371,374,381,393;42 U.S.C. 262,264,271.
Related Guidelines (5)
Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide): Guidance for Industry (Status: Final)
→Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide (Status: Final)
→Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective: Guidance for Industry (Status: Final)
→FDA Oversight of PET Drug Products -- Questions and Answers (Status: Final)
→Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers (Status: Final)
→