Although these changes were buried in the CARES Act and have just recently been brought to our attention, they still have a large impact on our industry.
BRANFORD, Conn. (PRWEB) January 05, 2021
Medical spa pioneer Francis X. Acunzo, founder and CEO of Acara Partners, is working to inform owners and physicians in the aesthetic medical industry about new regulations and limitations to the sale of over-the-counter (OTC) drugs containing hydroquinone, and how this will impact their businesses. Acunzo is owner and founder of Acara Partners, a full-service consultancy and marketing agency dedicated to the aesthetic medical industry.
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 on Sept. 23, 2020, when all OTC products containing hydroquinone had to be removed from the market. Currently, products containing hydroquinone can only be distributed if they are approved by the FDA through the new drug application process or if the compounds are patient-specific prescriptions. Physicians must comply with FDA regulations as well as state and local pharmacy regulations before dispensing products and prescriptions containing hydroquinone.
Acunzo is eager for physicians at aesthetic medical practices and medspas to become aware of these new regulations, as it may limit their ability to sell certain aesthetic medical skincare products. “Although these changes were buried in the CARES Act and have just recently been brought to our attention, they still have a large impact on our industry. Aesthetic medical practices and medspas should be aware of any and all regulatory changes proactively so as to avoid any potential punishment for simply not being aware,” he says.
Because hydroquinone is a compound commonly found in aesthetic medical skincare products, Acunzo reached out to Allyson Avila, a partner at Gordon Rees Scully Mansukhani, LLP and one of the country’s leading attorneys in the aesthetic medical industry, to better understand the impact these changes will have on aesthetic medical practices and medspas that use hydroquinone regularly in their practices.
Avila explained that although OTC hydroquinone products are no longer allowed to be sold or dispensed in the office, physicians can still prescribe compounded hydroquinone products that are patient-specific. She warned that misbranding drugs, such as changing labels to brand it as their own product, can create potential civil and criminal liability and is against FDA regulations.
Regulations regarding the dispensing of products containing hydroquinone are rapidly changing. For more details regarding the recent changes to the dispensing of hydroquinone, read the guest blog from Allyson Avila.
In the current difficult-to-maneuver landscape, Acara Partners is dedicated to supporting the aesthetic medical industry with regular updates. For industry updates from Acara Partners, including those on the Payment Protection Program, visit The Blog at Acara Partners.
About Francis X. Acunzo
Francis is a 25-year veteran of the spa, retail, corporate healthcare, hospitality, beauty, wellness and fitness industries. With his wife and business partner, Colleen, the couple is recognized as the founders of the medical spa movement in the United States.
Francis is known for his firsts in many industries. In 2010, he launched the digital division of Acara Partners, becoming the first full-service business consulting, marketing and digital agency focused on the cosmetic medical world. In 2005, he took the first corporate-owned chain of medical spas out of bankruptcy and sold it within 18 months. In 1999, Francis had the vision to create the industry’s first consolidation of day spas, aggregating almost $50M in annual revenue through the acquisition of 24 of the best spas in top U.S. markets. In 1996, he launched the country’s first medical spa.
Francis holds a bachelor’s degree in business administration from Providence College and resides on the Connecticut shoreline with his wife, Colleen, and their two sons. Outside of work, his passions are healthy cooking, running, boating and traveling.
About Acara Partners
Acara Partners is a full-service consultancy and marketing agency dedicated to the aesthetic medical industry. Their team of expert consultants and communications professionals make Acara the industry’s comprehensive business advisory, marketing, advertising and digital agency. Founded by husband-and-wife team Francis X. Acunzo and Colleen Acunzo in 2003, Acara has decades of experience in launching and developing aesthetic medical practices across the country. For further information about Acara Partners, go to https://acarapartners.com/.