The MoCRA Good Manufacturing Practices Rule Coming Soon

Facility registration and product listing got most of the attention when MoCRA passed, but there's a second piece working its way through FDA's process that deserves just as much planning time: a formal Good Manufacturing Practices rule for cosmetics. It's not finalized, and we're not going to pretend to know the exact text before FDA publishes it. What we can talk about is the direction it's headed and why waiting for the final rule to start preparing is the wrong call.

Why MoCRA created this in the first place

Before MoCRA, US cosmetic manufacturing had no binding federal GMP requirement comparable to what drugs or even dietary supplements have long had. MoCRA changed that by directing FDA to establish GMP regulations for cosmetic facilities, aligning US practice more closely with how much of the rest of the world already operates. The EU has required a Product Information File and safety assessor sign-off for years. Canada expects sound manufacturing practice as part of not selling a product that's a danger to health. The US was the outlier without a codified standard, and MoCRA closes that gap.

What "GMP" tends to mean in this industry

Even without the US rule finalized, there's an existing international reference point: ISO 22716, the standard most of the cosmetics world already treats as the practical definition of good manufacturing practice. It covers things like:

• Personnel training and hygiene practices
• Premises and equipment maintenance
• Raw material and packaging control
• Production and in-process controls
• Finished product quality control
• Handling of deviations, complaints, and recalls
• Documentation and traceability

FDA's eventual rule doesn't have to mirror ISO 22716 exactly, but it's a reasonable working assumption that a US cosmetic GMP rule will land in the same neighborhood, since that's the standard most multinational brands already operate under globally and the one auditors already know how to assess against.

What small makers can do now, before the rule is final

You don't need to wait for a published rule to tighten up practices that are almost certainly going to be expected regardless of the final text.

1. Start a batch record habit. Note the date, lot numbers of raw materials, quantities, and who made each batch. This is the single most useful habit you can build early, and it costs nothing but a spreadsheet and discipline.
2. Track your raw material lots. If a supplier issues a recall or a customer has a reaction, you need to know which batches used which lot. Retroactively reconstructing this is miserable; recording it as you go is not.
3. Write down your process, even informally. A simple document describing how you make each product, in what order, at what temperatures or mixing times, becomes the backbone of what a GMP audit would eventually ask to see.
4. Keep your workspace and equipment maintenance simple but documented. Cleaning schedules, sanitizing steps between batches, and basic equipment checks are cheap to log and expensive to reconstruct after the fact.
5. Save your safety substantiation paperwork. MoCRA already requires safety substantiation and adverse event recordkeeping independent of the GMP rule, so if you're not already organizing this, that's the more urgent gap to close first.

The small business question

MoCRA includes exemptions from certain registration and listing requirements for some small businesses, and any future GMP rule will likely have its own scope decisions about which facilities it applies to in full versus in a scaled-down form. Don't assume you're automatically exempt from everything just because you're small. The safest approach is to check FDA's current guidance directly when the GMP rule is proposed and finalized, since exemption boundaries are exactly the kind of detail that gets refined during rulemaking.

Don't let "not final yet" become "not started"

The makers who struggle when a new compliance rule lands are almost always the ones who treated the proposal stage as a reason to wait. Batch records, lot tracking, and a written process are good practice regardless of what FDA's final GMP text says, and they're far easier to build habitually from day one than to reconstruct under deadline pressure. If your main filing headache right now is actually on the Canadian side, mapping ingredients to INCI names and CAS numbers for a Cosmetic Notification Form, Cosmetic Comply already handles that piece end to end, and its US listing support is on the way as MoCRA's requirements solidify.