MoCRA GMP Final Rule: What to Expect and How to Prepare

MoCRA's GMP Authority

Section 606 of the Federal Food, Drug, and Cosmetic Act, as added by MoCRA, authorizes FDA to establish Good Manufacturing Practice regulations for cosmetics. This represents a historic shift — prior to MoCRA, FDA had no authority to mandate manufacturing standards for cosmetics. The cosmetics industry operated without enforceable GMP requirements for decades.

Under MoCRA, Congress directed FDA to align the cosmetics GMP regulations with ISO 22716:2007, the international standard for cosmetics Good Manufacturing Practices published by the International Organization for Standardization. This ensures global harmonization with the standard already adopted by the EU, ASEAN, and other major regulatory bodies.

The statute requires that FDA's cosmetics GMP regulations be "consistent with" ISO 22716, though FDA retains discretion to include additional requirements where necessary to protect public health. This means the final rule will likely follow ISO 22716's framework but may include FDA-specific additions.

As of early 2026, FDA has not yet published the proposed or final GMP rule. However, FDA has signaled through public meetings and guidance that rulemaking is underway, and companies should not wait for the final rule to begin preparation.

What Is ISO 22716 and Why It Matters

ISO 22716:2007 is an international standard that provides guidelines for the production, control, storage, and shipment of cosmetic products. It covers the entire manufacturing chain and addresses:

• Personnel: Training requirements, hygiene practices, defined responsibilities, and competency assessments for all staff involved in production
• Premises: Facility design, cleaning procedures, environmental controls, and pest management
• Equipment: Equipment design, installation, maintenance, calibration, and cleaning validation
• Raw materials and packaging: Supplier qualification, incoming inspection, identity testing, storage conditions, and traceability
• Production: Batch manufacturing records, in-process controls, process validation, and yield reconciliation
• Finished products: Final product testing, release procedures, stability testing, and storage conditions
• Quality control laboratory: Testing methods, reference standards, equipment qualification, and out-of-specification procedures
• Documentation: Batch records, specifications, SOPs, change control, and record retention
• Deviations, complaints, and recalls: Investigation procedures, CAPA (corrective and preventive action), and complaint handling

If your facility already follows ISO 22716, the transition to FDA GMP compliance should be relatively straightforward. If you don't, the gap analysis can be significant.

What FDA Inspectors Will Look For

Even before the final GMP rule is published, FDA has cosmetics inspection authority under MoCRA. FDA inspectors can already inspect cosmetics facilities and access records related to adverse event reporting and safety substantiation. Once GMP regulations are finalized, inspectors will have a formal checklist. Based on ISO 22716 and FDA inspection practices in other product categories, expect inspectors to examine:

• Written SOPs. Are standard operating procedures documented for every critical process — from receiving raw materials to final product release?
• Batch manufacturing records. Does every batch have a complete record showing ingredients, quantities, equipment used, in-process checks, and personnel involved?
• Cleaning and sanitation logs. Can you demonstrate that equipment and production areas are cleaned between batches according to validated procedures?
• Personnel training records. Have all production staff been trained on GMP requirements and their specific job functions? Are training records maintained?
• Complaint and deviation records. Do you have a system for documenting product complaints, investigating deviations, and implementing corrective actions?
• Raw material testing. Do you verify the identity and quality of incoming raw materials before use in production?
• Product release testing. Are finished products tested against specifications before release for distribution?

FDA will likely begin routine cosmetics GMP inspections once the rule is finalized. However, for-cause inspections based on adverse event reports or consumer complaints can happen at any time under existing MoCRA authority.

Small Business Considerations

MoCRA includes provisions that may affect how GMP requirements apply to small businesses:

• No blanket exemption. Unlike the MoCRA small business exemption for registration and listing (which expired December 29, 2025), there is no indication that small businesses will be exempt from GMP requirements. The statute applies GMP authority to all cosmetics facilities regardless of size.
• Possible extended compliance timelines. FDA may provide longer compliance timelines for small businesses in the final rule, similar to FSMA's tiered implementation approach.
• Proportional requirements. ISO 22716 itself notes that GMP implementation should be proportional to the facility's size and complexity. A small handmade soap company will have different documentation needs than a multinational manufacturer.

Regardless of size, every cosmetics company should begin documenting their manufacturing processes. Even basic SOPs, batch records, and cleaning logs will put you ahead of the curve when the final rule takes effect.

Steps to Prepare Now

While waiting for the final GMP rule, take these practical steps to prepare your facility:

1. Obtain a copy of ISO 22716:2007. Purchase the standard from ISO or your national standards body. Read it thoroughly — it is the blueprint for what FDA will require.
2. Conduct a gap analysis. Compare your current manufacturing practices against ISO 22716 requirements. Identify areas where you lack written procedures, testing protocols, or documentation.
3. Write your SOPs. Begin documenting standard operating procedures for critical processes: raw material receiving, batch manufacturing, equipment cleaning, quality control testing, and product release.
4. Implement batch records. If you don't already use batch manufacturing records, start now. Each batch should have a documented record linking ingredients, equipment, personnel, and quality checks.
5. Set up a complaint handling system. Under MoCRA, you already need to track adverse events. Expand this to include a general complaint handling and deviation investigation system.
6. Train your team. Conduct GMP training for all production personnel. Document the training with dates, topics covered, and attendee signatures.
7. Ensure your MoCRA registration and listing are current. GMP compliance will be linked to your registered facility. Make sure your Cosmetics Direct registration is up to date.