Clinic launch guides
Building a new service line, properly
Whether you are opening a practice or adding a line to an established one, the questions are the same. What is permitted today, what does a supplier need to show you, and what has to be written down. These guides answer those questions with the regulation quoted and linked, so the reasoning can be checked rather than taken on trust.
Written for licensed practitioners, medical directors and practice owners. Every page carries its primary sources and, where the science is the point, the peer-reviewed literature with DOIs.
Guides
8 of 10 published. The remainder are in review and will appear as they are completed.
Adding Exosomes to a Medical Spa
Permitted application routes, supplier documentation, and state-law disambiguation.
Topical Application and Microneedling
The cosmetic line, the device line, and what a 510(k) clearance actually covers.
Adding 503A Compounded Peptides
The three qualifying routes, the bulks list today, and what the PCAC vote changes.
Adding 503A Compounded Hormones
What compounding is for, the approved alternatives, and the obligations that attach.
New Indications, INDs and Clinical Studies
The pre-IND meeting, the IND contents, IRB review, and trial registration.
Reading the Evidence Behind a Product Claim
What each study design can establish, and the checks that take under a minute.
GLP-1 Supply After the Shortage
Where GLP-1 compounding stands, and which supply routes remain open.
In review
Medical Directors and Delegation
Building a working medical-director arrangement, and who may do what.
In review
Qualifying a Supplier Before the First Order
Documentation to request, what a COA covers, and the receiving checks worth writing down.
Advertising a New Service Line
Substantiation, endorsements, and before-and-after consent.
Frequently Asked Questions
- Who are these guides written for?
- Licensed practitioners, medical directors and practice owners. They assume a reader who is deciding what to offer and how to document it, rather than one being introduced to the category, and they carry their primary sources so the reasoning can be checked rather than taken on trust.
- Do these guides tell me whether my practice is compliant?
- No. They describe what the regulation says and link it, so a practice can see the rule for itself. They are not legal advice and they do not establish that any particular product or practice is compliant. Requirements turn on facts specific to each practice, which is why every guide sends the reader to their own counsel and their state boards.
- How current are they, and how would I know?
- Each guide carries its own review date and the sources it was written against, with the date each source was read. Where a guide relies on peer-reviewed literature, it cites the work with a DOI rather than describing it second hand.
These guides summarize publicly available federal regulation for licensed practitioner education. They are for informational purposes only, they are not legal advice, medical advice, or regulatory guidance, and they do not establish that any particular product or practice is compliant. Consult a healthcare attorney licensed in your jurisdiction and your own state boards before acting on anything here.
There are no FDA-approved exosome products. Biomolecular signaling vesicle products distributed by ExaVeyra Sciences are supplied for topical aesthetic treatments in clinics and for medical, molecular biology, and biochemistry research applications, and are not tissue products as defined by FDA guidelines. Compounded medications are not FDA-approved finished drug products; they are prepared under section 503A against a prescription for an individual patient and are prescription products rather than research-use-only material. ExaVeyra does not supply controlled substances.