Pennsylvania is apparently another state that has specific requirements for cosmetic manufacturers. They’ve been on the books for a number of years (at least partially) but apparently haven’t been enforced much until just recently. The information available online is somewhat contradictory, but it does look like they do expect all cosmetic manufacturers to register.
Registrations are under the Pennsylvania Department of Health, Drug, Device, and Cosmetic Program. The home page of the program located here, says:
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 does say “medicated cosmetics” which is somewhat of an oxymoron. There’s no such thing as a “medicated cosmetic.” A product could be a cosmetic AND an over-the-counter drug or 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 registration form
The registration form is pretty straightforward. There’s a printed version can be downloaded and sent in (here). There’s also an online version which can be filled out and submitted (here). In order to submit the online version your business name must be registered with the Department of Corporations and you need to have a pin number already assigned.
All that’s 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, comply with labeling requirements.
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Second, good manufacturing practices. These include (very, very generally):
- Keeping batch and lot records
- Maintining 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.
Another shameless plug: If you need help with GMP, my book, Good Manufacturing Practices for Soap and Cosmetic Handcrafters (available at Amazon.com here), can help with getting things set up correctly.
Third, your business name (if other than your personal name) needs to be registered with the PA Department of Corporations.
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 not allowed and 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:
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:
§ 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.