OTC Medicines

In general, CHPA supports FDA's intent to harmonize the requirements for Rx and OTC products and make them consistent with long-standing Agency policy.

Comments regarding guidance for industry pertaining to sunscreen ingredients requesting inclusion into the OTC sunscreen monograph.

Enclosed herein are comments on "Guidance for Industry; Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process."

Enclosed herein are comments on "Guidance for Industry; Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request", published as Draft Guidance.

Enclosed herein are comments on "Guidance for Industry; Nonprescription Sunscreen Drug Products - Content and Format of Data Submissions to Support a GRASE determination Under the Sunscreen Innovation Act."

CHPA supports EPA's efforts to streamline regulations under RCRA. CHPA has two central comments on the proposal.

CHPA supports improving the compendial test methods and establishing product standards for the variety of dosage forms, which can provide an additional measure of safety for OTC products.

Comments regarding the Agency’s goals behind the proposed quality metrics program.

CHPA appreciates the opportunity to provide information relevant to the assessment of the evidence of the potential developmental neurotoxicity of fluoride.