Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Proposed Rule

16 organizations filed 19 public comments on Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Proposed Rule, at the Food and Drug Administration. The comment window closed 1341d ago.

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an ACNU that an applicant must implement to ensure appropriate self selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The proposed rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.

Commenters (16)

• American Society of Consultant Pharmaciststrade assoc.

  2 filings · confidence 85%
• Consumer Healthcare Products Associationtrade assoc.

  2 filings · confidence 97%
• National Community Pharmacists Associationtrade assoc.

  2 filings · confidence 97%
• American Heart Associationtrade assoc.

  1 filing · confidence 85%
• American Pharmacists Association (APhA)trade assoc.

  1 filing · confidence 97%
• American Society of Health-System Pharmaciststrade assoc.

  1 filing · confidence 85%
• American Well Corporationunverified attribution

  1 filing · confidence 70%
• Association for Accessible Medicinestrade assoc.

  1 filing · confidence 97%
• Association of Women's Healthtrade assoc.

  1 filing · confidence 85%
• Dry Eye Foundationtrade assoc.

  1 filing · confidence 85%
• Guttmacher Institutetrade assoc.

  1 filing · confidence 85%
• Members of the Free the Pill coalitiontrade assoc.

  1 filing · confidence 85%
• National Alliance of State Pharmacy Associationstrade assoc.

  1 filing · confidence 85%
• National Association of Chain Drug Storestrade assoc.

  1 filing · confidence 97%
• New Jersey Pharmacists Associationtrade assoc.

  1 filing · confidence 85%
• The Naloxone Policy Section of the Justice Roundtable’s Harm Reduction Working Grouptrade assoc.

  1 filing · confidence 85%