News & Blog
Read below for some new legal developments and some things to think about if you’re part of a new business.
Understanding the Important Relationship Between Your Medical Spa and its Medical Director: Key Considerations for Medical Spas in North Carolina
In North Carolina’s fast-growing medical spa industry, ensuring compliance with regulations is crucial to the continued success and safety of operations. Many medical spas rely on supervisory relationships with physicians who oversee Advanced Practice Providers (APPs)...
FDA Reconsiders Decision on Tirzepatide Shortage: A Win for Prescribers, Patients, and Compounding Pharmacies
In a surprising turn of events, the U.S. Food and Drug Administration (FDA) has agreed to reconsider its decision to remove tirzepatide, the active ingredient in Eli Lilly’s diabetes therapy Mounjaro and weight loss therapy Zepbound, from its drug shortage list. This...
The Legal Battle Over Tirzepatide: Compounders Sue the FDA
The pharmaceutical landscape is once again at the center of a legal battle. This time, the battle involves the popular drug tirzepatide, manufactured by Eli Lilly under the brand name Mounjaro. Compounders, the small but crucial segment of the pharmaceutical world,...
Tirzepatide Is No Longer On FDA’s Shortage List: Implications for Healthcare Practices and Compounding Pharmacies
Recent developments regarding weight loss drugs and the FDA's policies on compounding pharmacies have sparked significant changes in the healthcare and wellness sectors. With the FDA announcing that Eli Lilly’s popular weight loss drug, Tirzepatide, is no longer in...
Governor Vetoes AB 3129: Analyzing the Impact on Private Equity and Healthcare Regulation in California
On September 28, 2024, California Governor Gavin Newsom vetoed Assembly Bill 3129, a proposed piece of legislation that would have imposed new stringent regulatory requirements on private equity groups and hedge funds regarding their investments in the healthcare...
Common Type of Office Action: Suspension Letter—What It Means for Your Trademark Application
Navigating the trademark application process can often feel like a series of hurdles, with various steps that may require attention and action. One of the communications you may receive from the United States Patent and Trademark Office (USPTO) is a Suspension Letter....
Common Type of Trademark Office Action: Suspension Inquiry—How to Respond
When navigating the trademark application process, there are several steps along the way where the United States Patent and Trademark Office (USPTO) may reach out to you for additional information or clarification. One of these instances is when you receive a...
Navigating DEA License Requirements: Do You Need a Separate Registration for Each Location?
For healthcare providers who administer, prescribe, or dispense controlled substances, registering with the U.S. Drug Enforcement Administration (DEA) is an essential legal step. DEA registration ensures that providers are compliant with federal regulations...
How to Position Your Medical Spa for Sale: Key Insights from Lengea Law and Pacific Reliance Medical M&A Advisors
Are you considering selling your medical spa in the near or distant future? Whether you’re planning a sale within the next year or years down the line, now is the time to prepare. Today, Sara Shikhman, managing partner of Lengea Law, joins forces with Jerry Deza of...
How to Reply To a Common Type of Trademark Office Action: Notice of Incomplete Response
A Notice of Incomplete Response from the United States Patent and Trademark Office (USPTO) indicates that the response to a prior office action was not sufficient to meet USPTO’s requirements. Typically, the most common issue is that the response was not signed by...
Common Type of Office Action: Suspension Letter
Understanding Trademark Application Holds A Suspension Letter informs you that your trademark application has been temporarily placed on hold. This happens when the examining attorney is waiting for an external factor to resolve, such as the assignment of ownership or...
What is a Trademark Office Action and How to Reply To It
The trademark application process can be complex, and one common hurdle businesses face is receiving an Office Action from the United States Patent and Trademark Office (USPTO). If you and your attorney recently applied for a trademark, you may receive a communication...
Can Registered Nurses Inject Botox and Fillers in Florida?
As the popularity of Med Spas and aesthetic procedures continues to grow, questions about who can legally perform these treatments have become increasingly important. Botox and dermal fillers are two of the most sought-after treatments, but in Florida, the rules...
What Licenses Are Required for a Medical Spa? A Guide for Aspiring Owners
Opening a medical spa, or med spa, is an exciting and rewarding business venture, but it comes with its own set of challenges, particularly around legal requirements. Med spas operate at the intersection of medical care and beauty, meaning medical and business...
Navigating the Critical Relationship Between Your Medical Spa and Medical Director in North Carolina
In North Carolina’s fast-growing medical spa industry, ensuring compliance with regulations is crucial to the continued success and safety of operations. Many medical spas rely on supervisory relationships with physicians who oversee Advanced Practice Providers (APPs)...
How Often Should Consents Be Signed By Patients: Navigating Informed Consent Requirements
What is Informed Consent? When patients at medical spas consent to treatments, they entrust their well-being to the medical providers providing care. Providers must be transparent and comprehensive in their communication about these treatments. This is known as...
Breaking News: FTC’s Ban on Non-Compete Agreements Overturned
August 21, 2024 In a landmark decision, Judge Ada Brown of the United States District Court for the Northern District of Texas has overruled the Federal Trade Commission's (FTC) sweeping ban on non-compete agreements. This ruling marks a significant development in the...
Overview of Tattoo Removal Methods and Associated Risks
Tattoo removal typically involves the use of laser technology, though alternative methods like dermabrasion (which sands off the top layers of skin) and surgical excision (cutting out the tattooed skin) are also used. Laser removal is the most common method, utilizing...
Key Legal Considerations for Dental Service Organizations
As the dental industry evolves, Dental Service Organizations (DSOs) have become increasingly popular. These entities offer a range of management and administrative services to dental practices, allowing dentists to focus on patient care. However, the growing...
Understanding the Legal Landscape of IV Hydration Therapy: Key Regulations for Medical Spas and Functional Medicine Practices
IV hydration therapy has surged in popularity, offering a quick and effective way to address issues like dehydration, fatigue, and nutrient deficiencies. However, as with any medical treatment, it is subject to stringent regulations to ensure it is administered safely...
How Often Should Good Faith Exams Be Conducted? A Guide for Healthcare Providers
The Importance of Good Faith Exams Good Faith Exams (GFEs) are a critical component of medical practice, especially in medical spas and in IV hydration clinics. These preliminary assessments are conducted by qualified healthcare providers before any treatment is...