[updated 26 July 2024]
In Pennsylvania, registration is required for cosmetic manufacturers.
Registrations are under the Pennsylvania Department of Health, Drug, Device, and Cosmetic Program. The home page of the program located here, says:
Directly from their website:
Any business in the Commonwealth of Pennsylvania who is manufacturing, distributing or retailing drugs, medical devices, and/or medicated cosmetics must register with the Department of Health unless otherwise noted as a designated exemption.
It says “medicated cosmetics,” which is an oxymoron. There’s no such thing as a “medicated cosmetic.” A product could be a cosmetic AND an over-the-counter drug or a prescribed drug.
However, it seems the statement is being interpreted to mean that all cosmetic manufacturers must register, regardless of whether the cosmetic is also a drug or not.
The online FAQ question regarding cosmetic registration says:
What is the definition of a Cosmetic and what are registration requirements for manufacturing or distributing cosmetics?
… Manufacturers, distributors, or wholesalers of cosmetics within the Commonwealth must register. Manufacturing includes producing, preparing, propagating, compounding, processing, repackaging, or relabeling. …
The registration form
The registration form is straightforward and is available online.
All that is really needed is to fill in the form with your business contact information, check off that you’re a cosmetic manufacturer and send in the $100. It doesn’t appear that any pre-approval or inspections are needed prior to issuing the approval.
Cosmetic manufacturer expectations
There are, however, some expectations of standards you should uphold as a cosmetic manufacturer.
First, business name registration. your business name (if other than your personal name) needs to be registered with the PA Department of Corporations.
Second, Labeling. You must comply with federal labeling requirements.
Third, MoCRA. You comply with federal MoCRA requirements regarding safety substantiation, and severe adverse reporting requirements. Depending on your business size or products, you may be required to register your facility and list your products with the FDA.
Fourth, good manufacturing practices. These include (very, very generally):
- Keeping batch and lot records
- Maintaining clean facilities free of dirt, debris, pets/animals, etc.
- Having appropriate written policies and procedures to ensure the safety of products and preventing the distribution of adulterated or misbranded products.
- Setting up recall procedures.
Inspections, including unannounced inspections
As part of the registration, you agree that your facility may be inspected by the Department of Health. They don’t have to announce that they are coming; the inspector could just show up at your door one day.
There isn’t any indication if, when, or why an inspection would take place. Unlike some other states, there is no indication that there is a fee for an inspection. (At least I didn’t find anything in the materials I looked at.)
Actual Laws & Regulations
The Pennsylvania LAW covering cosmetics is The Controlled Substances, Drugs, Device, and Cosmetic Act (here). It does cover some things about cosmetics (adulterated or misbranded cosmetics are not allowed, and specific color additives), but other than that it doesn’t actually mention cosmetics much. It doesn’t actually say that cosmetic manufacturers need to register. All the parts about registration have to do with drug and device manufacturers:
Directly from the regulations:
Section 6. Registration.-(a) No person shall operate within this Commonwealth as a manufacturer, distributor or retailer of controlled substances, other drugs and devices nor sell, offer for sale nor solicit the purchase of controlled substances, other drugs and devices nor hold them for sale or resale until such person has registered under this act with the Secretary.
The Pennsylvania REGULATIONS covering cosmetics are from the Pennsylvania Regulations (Title 28, Chapter 25), Controlled Substances, Drugs, Devices and Cosmetics (here). Again, it has some regulations specific to cosmetics, but the portions on registration all specify drugs and devices, not cosmetics:
Directly from the regulations:
§ 25.113. Requirements for registration.
(a) Every person who manufactures, distributes or retails drugs or devices within the Commonwealth or proposes to engage in the manufacture, distribution or retail sale of drugs or devices within the Commonwealth shall obtain annually a registration unless exempted under § 25.114 (relating to persons exempt from registration).
The bottom line
The officials of Pennsylvania Department of Health, Drug, Device, and Cosmetic Program have determined and implemented registration for cosmetic manufacturers in the state of Pennsylvania. The registration is fairly simple, doesn’t require advance approval, and only costs $100.
The expectations for a cosmetic manufacturer are reasonable, and in line with what you should be doing anyway (labeling, cleanliness, written procedures, etc.).
Whether they have expanded or exceeded the actual letter of the law is a question for another day.
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