Using Aleph's MoCRA pages

The MoCRA page has three tabs: Products, Facilities and Company details. Start with Company details, then add your facilities, then open each product.

Company details (asked once; every cosmetic product uses it)

• Responsible person — the manufacturer, packer or distributor whose name appears on your product labels.
• Label contact — the US address, US phone number or electronic contact (such as a website) printed on your labels, where the responsible person can receive adverse event reports.
• Small business — whether your company declares that it is a small business under MoCRA. Aleph does not check this or decide it for you. If you answer Yes, facility registration and product listing show as not required and are left out of counts and alerts. Each product then asks the law's four product questions; one Yes on any product means the declaration is not applied.

Only an owner or manager can change these. Click Save company details when you are done.

Facilities

Click Add Facility for each place where your products are manufactured or processed: facility name, FEI number, registration status, the date it was registered (needed when you mark it Registered), and for a foreign facility its US agent and contact. Aleph shows each facility's Biennial renewal due date.

Each product's MoCRA records

A cosmetic product is listed with FDA separately from registering the facility that makes it, and listing updates are submitted annually (21 U.S.C. 364c(c)). On the Products tab, select a product to open its MoCRA records on the product's Compliance tab. There you record the Listing number and Listing date, the cosmetic product category and the facility where it is made, and upload its safety records. The box Needed before you can submit this listing lists anything still blank; Information FDA asks for shows what you have entered. Download audit package gathers the product's MoCRA records in one file.

The MoCRA records list on a product

At the top of a cosmetic product's MoCRA records, seven lines say what is written down in Aleph — never what FDA has or has not done:

• Facility marked as registered and Facility renewal date not passed — from the facility you chose for the product
• Safety records on file — the product's safety substantiation records
• Responsible person on file and Label contact on file — from Company details
• Listing number and date on file and Listing update date not passed — from the product's listing

These are separate from the Required records checklist beside them, which covers the requirements on each product — safety substantiation, adverse event records and the label rows. Registration and listing are tracked here instead.

Submitting: FDA takes registrations and listings through its Cosmetics Direct electronic submission portal. Use the facts under Information FDA asks for, then record the listing number and date here.

INFO: Aleph does not file with FDA. Submit registrations and listings on FDA's own system, then record the numbers and dates here so your records and dates stay in one place.