OTC Drugs

21 CFR PARTS 210 AND 211 AND OTC MONOGRAPH COMPLIANCE SUPPORT FOR DRUG MANUFACTURERS

Clear, Guided OTC cGMP Compliance

cGMP Consulting provides engineering, validation and consulting to over-the-counter (OTC) drug manufacturers, packers and brands to help them meet FDA cGMP requirements under 21 CFR Parts 210 and 211. OTC drugs are held to the same cGMP standards as prescription drugs and the CARES Act of 2020 introduced significant changes to how OTC monograph drugs are regulated.

We help you build regulatory compliance into your everyday operations without adding unnecessary complexity.

How Our Services Support OTC Manufacturers

  • Make FDA requirements work within your operations. We help you meet regulatory requirements in ways that fit your manufacturing processes.
  • Get your facilities and equipment ready for production. Our engineering and CQV services help ensure facilities, utilities, and equipment are properly designed, installed, and qualified for their intended use.
  • Build reliable, repeatable manufacturing processes. We develop and execute validation protocols that demonstrate your processes perform consistently and produce products that meet established quality standards.
  • Find opportunities to improve how you operate. We evaluate manufacturing processes, identify gaps, and recommend practical improvements that strengthen efficiency, consistency, and GMP compliance.
  • Be better prepared for audits and inspections. We assess manufacturing operations, review quality systems, and help resolve deficiencies with practical solutions tailored to your facility.

Common Challenges in the OTC Drug Industry

OTC drug manufacturers face a wide range of regulatory and operational challenges. Even organizations with experienced quality teams may lack the specialized expertise or internal resources to address every requirement while managing day-to-day operations.

Common challenges:

  • Understanding and applying overlapping cGMP requirements, OTC monographs, and changes introduced through OTC Monograph Reform
  • Managing drug establishment registration and product listing requirements
  • Understanding and meeting applicable OTC Monograph User Fee (OMUFA) obligations
  • Developing, implementing, and maintaining compliant quality systems
  • Ensuring Drug Facts labeling and product claims meet FDA requirements
  • Identifying compliance gaps and responding effectively to FDA inspection findings and enforcement actions

Our OTC Drug Services

GMP Gap Assessments

GMP Gap Assessments

Evaluate manufacturing operations, facilities, and quality systems against 21 CFR Parts 210 and 211 to identify compliance gaps and prioritize improvements.

Engineering Support

project engineers working around office table

Provide technical expertise for facility and equipment design, upgrades, troubleshooting, and manufacturing improvements to support efficient, compliant operations.

Commissioning, Qualification and Validation (CQV)

Safety Substantiation

Support facility, utility, and equipment qualification, as well as manufacturing process validation, through practical strategies, protocol development, execution, and documentation.

Quality System Development

Labeling Support

Establish and improve GMP procedures, documentation, change control, deviation management, CAPA, and other essential quality processes.

Inspection Readiness and FDA Response

Adverse Events Reporting

Evaluate inspection readiness, address compliance deficiencies, and support responses and remediation related to FDA Form 483 observations and Warning Letters.

GMP Audits and Training

Customized GMP

Conduct GMP audits and provide practical training to strengthen employee understanding, improve compliance practices, and support ongoing inspection readiness.

FREQUENTLY ASKED QUESTIONS

Do OTC drugs have to follow cGMP?

Yes. Over-the-counter (OTC) drugs must comply with current Good Manufacturing Practice (cGMP) requirements under 21 CFR Parts 210 and 211, the same standards that apply to prescription drugs.

An OTC monograph is the FDA rulebook that defines the acceptable active ingredients, doses, formulations, and labeling for a category of OTC drugs. Products that conform to an applicable monograph may be marketed without a pre-market approval application.

An Over-the-Counter Monograph Order Request (OMOR) is the mechanism created by the OTC Monograph Reform (CARES Act of 2020) for requesting changes to a monograph, replacing the former rulemaking process.

Yes. OTC drug establishments must register with the FDA and list their products, and many monograph facilities owe annual OTC Monograph User Fee (OMUFA) facility fees.

We provide GMP gap assessments, validation services, project management, quality system development, FDA inspection readiness, and more. Contact us to get started.

Woman inspecting an over the counter drug label

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