In early 2026, Indiana introduced legislation that should get the attention of every medical spa, wellness clinic, and practice offering compounded medications across the country.
The bill, SB 282, does not just tighten rules for pharmacies. It fundamentally expands oversight of medical spas and creates some of the most detailed statutory requirements we have seen around compounded medications, including injectables, GLP-1s, and potentially peptides.
Even if you do not operate in Indiana, this bill matters. A lot.
Because this is exactly how enforcement trends start.
What SB 282 Actually Does
At its core, this bill does two major things:
- It significantly increases regulation around compounded medications made from bulk drug substances.
- It places medical spas directly under pharmacy board-style oversight for the first time.
That combination is not accidental.
Across the country, regulators are increasingly concerned about where compounded medications are coming from, how they are stored, and who is actually responsible when something goes wrong.
Indiana is simply putting those concerns into statute.
Other states are likely to follow.
New Rules for Compounded Medications
Under SB 282, compounded drugs must meet far more stringent requirements than many practices are used to seeing.
1. Bulk substances must meet strict standards
Compounded medications may only be made from bulk drug substances that:
- meet USP standards if a monograph exists
- or appear on an FDA-recognized list of allowable substances
- and are pharmaceutical grade
This is a major shift. Many products currently circulating in the wellness and aesthetics space do not meet this standard.
If a substance is not clearly recognized or supported by FDA or USP pathways, compounding it becomes legally risky.
This is one of the reasons peptides are increasingly coming under scrutiny nationwide.
2. Certificates of analysis are no longer optional
The bill requires detailed documentation for each bulk drug substance, including:
- identity testing
- impurity analysis
- source documentation
- lot tracking
Practices and pharmacies must be able to prove exactly where a product came from and what it contains.
“I bought it from a reputable vendor” will no longer be enough. It is already not enough in many states.
3. FDA inspection history matters
Bulk drug manufacturers must be:
- registered with the FDA
- and have undergone recent FDA inspection showing compliance
This is a big deal.
Many suppliers used by clinics are not FDA-inspected manufacturing facilities. This bill draws a bright line between pharmaceutical manufacturing and loosely regulated suppliers.
4. Extensive recordkeeping requirements
Records must be kept for years after expiration and must be produced to regulators quickly upon request.
This includes:
- purchasing records
- testing documentation
- compounding data
- distribution tracking
This is the kind of traceability system pharmacy boards have wanted for a long time.
Medical Spas Are Now Directly in the Crosshairs
One of the most important parts of SB 282 is that it does not stop at pharmacies.
The bill formally regulates medical spas themselves.
If enacted, Indiana medical spas would be required to:
- register with the Board of Pharmacy
- designate a responsible individual for compliance
- report serious adverse events within a short timeframe
- submit to inspections
- face suspension or discipline for violations
This is a significant shift in how states view medical spas.
Historically, many spas believed they were regulated primarily through medical boards or supervising providers. This bill makes it clear that when prescription drugs and compounded products are involved, pharmacy boards want jurisdiction too.
Why This Matters Even Outside Indiana
If you operate in another state and are thinking “this does not apply to me,” that is exactly the mindset regulators count on.
Here is the reality we are seeing nationwide:
- Pharmacy boards are increasingly investigating clinics, not just pharmacies
- Enforcement often begins with storage and possession issues
- Research products on site are a frequent trigger
- Lack of documentation is one of the fastest ways to get fined
Indiana is simply codifying what many boards are already doing informally.
Other states often follow.
The Bigger Trend: From Gray Area to Regulated Industry
For years, the wellness and aesthetics space has operated in gray areas, particularly around compounded medications.
That gray area is shrinking.
Bills like SB 282 signal a broader shift toward:
- formal registration
- traceability
- defined accountability
- board-level enforcement
This does not mean compounded therapies are disappearing.
It does mean the “casual” models are disappearing.
What Practices Should Be Doing Now
Regardless of what state you operate in, this is the moment to evaluate:
- Where your compounded products come from
- Whether your suppliers meet FDA and USP standards
- What documentation you actually have on file
- Who is legally responsible for oversight
- Whether your current model would survive a board audit
- What your patient consents say
- What your website says
- What your protocols say
Many practices are surprised to learn that liability does not sit only with the pharmacy or the vendor you are buying from.
Possession, storage, administration, and marketing can all create exposure.
Final Thoughts
SB 282 is not about aesthetics alone. It is about regulators asserting control over an industry that has grown quickly without consistent oversight.
This bill is not an outlier.
It is a preview.
Practices that adapt early will continue to grow safely. Practices that ignore these signals may find themselves reacting after regulators show up.
At Lengea Law, we are already helping clients evaluate compounding relationships, restructure high-risk models, and prepare for the next phase of enforcement.
Because compliance is no longer theoretical.
It is happening in real time.
Contact us for a compliance assessment of your practice today.