Recently, changes to the sale of Over-the-Counter (OTC) products containing hydroquinone, a compound commonly found in aesthetic medical skincare products, have come to our attention here at Acara Partners. Wanting to know more, we reached out to Allyson Avila, a partner at Gordon Rees Scully Mansukhani, LLP and one of the country’s leading lawyers for the aesthetic medical industry, for clarity on what has been changed and how the changes will impact the sale of OTC products containing hydroquinone in the aesthetic medical field.
As part of the passage of the CARES act on March 27, 2020, Congress made significant changes to how OTC products containing hydroquinone are regulated and dispensed. These changes became effective September 23, 2020, when all OTC products containing hydroquinone had to be removed from the market. Currently, products containing hydroquinone can only be distributed if (1) they are approved by the FDA through the new drug application process or (2) the compounds are patient-specific prescriptions.
As of July 30, 2020 (most recent update) hydroquinone remains a category 1 substance on the FDA “503B Bulk Drug Substances List”. Items that fall under Category 1 substances are under evaluation. Therefore, compounds that come from 503B facilities are not allowed to be dispensed at this time unless they are FDA approved. If these compounds are patient-specific prescriptions, they can be dispensed from either 503A or 503B facilities. Additionally, each state has slightly different pharmacy regulations that go along with FDA guidelines. Physicians must comply with FDA regulations along with State and Local pharmacy regulations before dispensing products and prescriptions containing Hydroquinone.
What are potential implications for physicians, aesthetic medical practices and medspas?
Physicians need to be aware of the new regulations regarding hydroquinone. OTC hydroquinone products are no longer allowed to be sold or dispensed in the office. This includes aesthetic medical skincare products found in aesthetic medical practices and medspas. Physicians can still prescribe compounded Hydroquinone products that are patient-specific. Misbranding drugs, such as changing the labels to brand it as their own product, can create potential civil and criminal liability. If a physician mislabels drugs, it creates an unapproved drug, which is against FDA regulations.
What is Compounding?
Compounding is generally a practice in which a licensed pharmacist, a licensed physician or in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.
What is a 503A Compounding Pharmacy?
503A compounding pharmacies are what you know as ‘traditional’ patient-focused compounding facilities in that they:
1.) Fulfill individual patient-specific prescriptions approved by a prescribing practitioner.
2.) Are staffed by a licensed pharmacist with additional training in compounding in a licensed facility.
3.) All acts of compounding must be performed by a licensed pharmacist and in a licensed pharmacy (or Federal facility).
4.) Comply with state boards of pharmacy regulations.
5.) Produce compounds in compliance with United States Pharmacopeia (USP) chapters or the National Formulary (NF) monograph. These compliance standards ensure patient safety, and maintain drug quality and purity. For human sterile medications these chapters are called USP <797> and <795>.
6.) Each and every bulk substance (i.e. active pharmaceutical ingredient) used for the compounding process must be:
Made at an FDA-registered facility
Accompanied by a valid Certificate of Analysis (COA)
7.) Do not compound drugs that have been withdrawn or removed from the market or have been otherwise proven to be unsafe or ineffective by FDA.
What is a 503B Outsourcing Facility?
503B facilities are designated as “outsourcing facilities” which allows the facility to produce large batches of compounded drugs with or without prescriptions to be sold to healthcare facilities as office use only.
All 503B pharmacies must adhere to the same rules and regulations as a 503A pharmacy and must also comply with additional CGMP requirements.
503B pharmacy facilities are unable to collaborate with physicians on customized formulas due to the FDA’s requirement that all new compounds be submitted for testing and stability studies.
503B pharmacies are required to report any adverse effects and are required to register with each state board of pharmacy, DEA and FDA.
All 503B pharmacies must have an independent quality assurance department in place and be subjected to FDA inspections.
Regulations regarding the dispensing of products containing hydroquinone are rapidly changing. Acara Partners is committed to staying up to date with all new regulations and changes to the aesthetic medical industry. If you would like further information or questions about specific regulations, Gordon & Rees can provide legal counsel.