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Part 4: Regulatory Considerations
We are continuing our series on "Compounding Cosmetics for Special Populations and for Use as Compounding Vehicles." Many compounding pharmacists are already involved in this area, and there are many opportunities available as follows:
- Compounding cosmetics for ingredient-sensitive patients,
- Compounding special vehicles to meet patient-specific needs, and
- Compounding cosmeceuticals, as appropriate.
This week, we will look at regulatory issues.
Regulatory Issues
Section 201(i) of the 1938 Food, Drug, and Cosmetic Act defines cosmetics as "(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap..."
The FDA requirements governing the sale of cosmetics are not as stringent as those that apply to other FDA-regulated products. The FDA is able to regulate cosmetics only after products are released to the marketplace. Neither cosmetic products nor cosmetic ingredients are reviewed or approved by the FDA before being sold to the public. The FDA cannot require companies to test their cosmetic products for safety before marketing. If the safety of a cosmetic product has not been substantiated, however, the product's label must read: "Warning: The safety of this product has not been determined."
The FDA can inspect cosmetics-manufacturing facilities, collect samples for examination, and take action through the U.S. Department of Justice to remove adulterated and misbranded cosmetics from the market. However, the FDA does not have the authority to require manufacturers to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries. The agency does maintain a voluntary data collection program; cosmetic companies that wish to participate forward data to the FDA. Fortunately, serious injury from makeup is a rare event. Consumers can report adverse reactions to cosmetics to the FDA.
The regulatory category occupied by a product clearly has a great effect on the marketing of that product. As explained previously, intended use is determined principally, but not solely, by the claims that are made on product labeling.
Disallowed Ingredients
Distribution of cosmetics containing substances that are poisonous or that might injure users under normal conditions is illegal. Ingredients that are prohibited in cosmetics include bithionol, chloroform, halogenated salicylanilides, hexachlorophene, mercury compounds (except under certain conditions as preservatives in eye cosmetics), methylene chloride, methyl methacrylate monomer in nail products, vinyl chloride and zirconium salts in aerosol products, and zirconium complexes in aerosol cosmetics. Also, color additives must be tested for safety and FDA approval obtained for their intended use before they can be manufactured.
Labeling
Cosmetics sold to consumers must have labels that list ingredients in descending order of predominance, with the exception of trade secrets (as defined by the FDA) and the ingredients of flavors and fragrances. The ingredient list is a consumer's only readily accessible source of information about what he or she is buying. Regulations concerning ingredient lists apply only to retail products intended for home use, not to those used exclusively by beauticians in salons. However, the product must state the distributor, list the content's quantity, and include all the necessary warning statements.
Expiration Dating and Beyond-use Dating
There are no absolute dates for discarding various cosmetic products. Current U.S. law contains no requirement for cosmetic manufacturers to print expiration dates on the labels of their products. Nevertheless, manufacturers must determine the shelf life for products as a part of their overall responsibility to substantiate product safety. Products that contain so-called "all natural" ingredients that are plant-derived substances may be more conducive to microbial growth, so a shorter shelf life would be indicated. Expiration dates on cosmetics are simply "rules of thumb." However, if an active ingredient has been added during compounding, the State Board of Pharmacy regulations regarding beyond-use dates must be followed.
Categories of Cosmetics
The FDA has classified cosmetics into 13 categories according to 21 CFR 720.4:
- Skin care (creams, lotions, powders, sprays)
- Fragrances
- Eye makeup
- Manicure products
- Makeup other than for the eye (e.g., lipstick, foundation, blush)
- Hair-coloring preparations
- Shampoos, permanent waves, and other hair products
- Deodorants
- Shaving products
- Baby products (e.g., shampoos, lotions, powders)
- Bath oils and bubble baths
- Mouthwashes
- Tanning products
Of this list, pharmacists may be involved in compounding cosmetics for patients with specific needs or incorporating active drugs in deodorants, lipsticks or medication sticks, mouthwashes, shampoos, shaving products, and skin-care preparations (creams, lotions, powders, and sprays). Some basic formulas for these preparations are provided later in this chapter; they can be easily modified to meet the needs of specific patients or to incorporate active drugs. When the formulas include preservatives or perfumes, a patient's sensitivities and requests should be considered. If a patient has a lanolin allergy, that ingredient can be omitted and possibly replaced by an equal quantity of Hydrophilic Petrolatum USP (Aquaphor, Aquabase).
Next week "Quality Control of Compounded Cosmetics."
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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