regulations

Legal Issues: Compounded Care

The intended role and new classifications for compounding pharmacies.
MedEsthetics Jan/Feb 2018 Legal Issues

In 2012, 64 patients died and an additional 751 were injured due to contaminated compounded medications formulated and distributed by the New England Compounding Center. As a result, compounding pharmacies have become the subject of intense public and regulatory scrutiny, and the U.S. Food & Drug Administration (FDA) created a new two-tiered regulatory framework to improve oversight of these facilities.

OSHA and Medspas

A renewed focus on medspas combined with a new law that significantly increases penalties for OSHA violations means it’s time to review your workplace safety guidelines.
OSHA and Medspas

On the morning of October 20, 2015, Chelsea Ake-Salvacion was found dead inside a cryotherapy machine at Rejuvenice Cryotherapy, the medspa she managed in Henderson, Nevada. She had attempted to self-administer cryotherapy after the rest of her employees had gone home for the day. It was ruled that her death resulted from operator error. However, just because Ake-Salvacion was found to have been responsible for her own demise does not mean there won’t be consequences.

Spotlight on Sun Protection

New sunscreen actives may soon hit the U.S., but several consumer protection issues remain unresolved.
Spotlight on Sun Protection

There is something new under the sun! Late last year Congress enacted the Sunscreen Innovation Act, which the president signed into law on November 24. The Act amends the U.S. Food and Drug Administration’s time and extent application (TEA) program for sunscreen actives and imposes time limits on the ingredient review process. The TEA, finalized by the FDA in 2002, permits companies to apply for expedited approval for sunscreen ingredients that have been in continuous use for five or more years in a single country.