REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE MARKETED WITHOUT AN APPROVED DRUG APPLICATION.

SEC. 6508. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE MARKETED WITHOUT AN APPROVED DRUG APPLICATION. (a) Development Advice to Sponsors or Requestors.—Section 505G(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h(h)) is amended by striking “sponsors or requestors” and inserting “sponsors, requestors, or organizations nominated by sponsors or requestors to represent their interests in a proceeding”. (b) Technical Correction.—Section 505G(b)(2)(A)(iv)(III) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h(b)(2)(A)(iv)(III)) is amended by striking “requestors” and inserting “sponsors or requestors”.