The July 2026 PCAC Peptide Meeting
On July 23 and 24, 2026, the FDA’s Pharmacy Compounding Advisory Committee, known as PCAC, met at the agency’s White Oak campus in Silver Spring, Maryland to consider whether seven peptides should be added to the Section 503A Bulk Drug Substances List. For anyone operating in the peptide, telehealth, or compounding space, this was one […]
Why High-Income Regulated Businesses Get Audited and How to Prepare
Fast growth is exciting, especially in emerging industries where revenue can scale quickly. But for RUO peptide companies, telehealth companies, cannabis operators, psychedelic ventures, kratom brands, and crypto businesses, high revenue can also bring a different kind of attention. Seven- and eight-figure years are no longer unusual in these spaces. That kind of income can […]
How to Start a Peptide Company: A Practical Guide for RUO Founders
The RUO peptide space has grown quickly over the past few years, and with that growth has come a new wave of founders trying to figure out how to build the business the right way from the beginning. For many operators, the focus starts with the product: what to sell, where to source it, how […]
FDA Warning Letters for GLP-1 Telehealth and Peptide Companies: What Your Website Needs to Fix
The FDA has sent an escalating number of warning letters to telehealth companies offering compounded GLP-1 medications and peptides since September 2025. The letters share a common theme: the FDA is looking closely at website language and using those claims as evidence of misbranding and unapproved new drug violations under the Federal Food, Drug, and […]
6 Website Compliance Mistakes That Put RUO Peptide Companies at Risk
For an RUO peptide company, the website is not just a marketing tool. It is often the first place a regulator, payment processor, or plaintiff’s attorney will look to understand how the business is presenting its products. That matters because an “RUO” label alone does not protect a company. Under FDA’s intended-use framework, regulators and […]
Do RUO Peptide Companies Need Safety Data Sheets?
If you sell research-use-only peptides, you have probably been asked for a Safety Data Sheet by a distributor, payment processor, freight carrier, or customer compliance department. Some RUO peptide sellers treat the SDS as a box to check, a PDF added to the website to look legitimate, but that is a mistake. A properly drafted […]
Who Owns the AI Tools Your Team is Building?
Who Owns the AI Tools Your Employees Are Building? Businesses that never thought of themselves as technology companies are suddenly building technology. A marketing agency may create an AI workflow that drafts and routes client campaigns, a medical practice may build an intake-and-triage automation on top of an LLM and an accounting firm may create […]
White Label Telehealth: Contract Terms That Can Lock You In Before You Build Your Own MSO/PC
For founders building in GLP-1 weight loss, TRT, hormone therapy, peptides, hair loss, or sexual health, the pitch is appealing: plug into an existing network, use a ready platform, access providers and pharmacy fulfillment, and get to market in weeks instead of building the entire clinical infrastructure from scratch. White label telehealth can be a […]
Telehealth M&A: Structuring GLP-1, TRT, Hormone Therapy, and Peptide Deals Without Stepping on a Landmine
Structuring GLP-1, TRT, Hormone Therapy, and Peptide Deals Without Stepping on a Landmine Telehealth M&A is accelerating across GLP-1 weight loss, TRT, hormone therapy, and peptides. LumaLex Law has seen a marked increase in inquiries from clients and prospective clients in these verticals, including operators, private equity sponsors, independent sponsors, and public-market acquirers. For years, […]
Did Your Business Just Download Claude for Small Business? Read This First.
We’ll say it plainly: we’re excited about Claude for Small Business. Anthropic launched Claude for Small Business on May 13, 2026, and for small businesses, it represents the kind of technology shift that can close the gap between lean companies and larger enterprises with more staff, more systems, and more resources. At LumaLex Law, we […]
