Kulkarni Law Firm

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Kulkarni Law Firm Legal and regulatory compliance for life science companies and their service providers including CROs, sites , consulting companies , and agencies.

The Kulkarni Law Firm has extensive experience in pharmaceuticals, biopharmaceuticals, and medical devices The Kulkarni Law Firm is focused on the needs of FDA compliant companies. We use our experience not only in pharmaceutical law, but also in clinical trials, regulatory affairs, quality systems, and pharmaceutical manufacturing to meet clients' needs. We work with a variety of clients across four continents. We also stay abreast of the latest news from organizations including HHS, OIG, PhRMA, FTC, and GPHA to provide a broader perspective on their decisions.

FDA’s enforcement push on GLP-1 copies in 503A products signals a new future of pharmacy compounding? I spoke with CBS N...
10/05/2026

FDA’s enforcement push on GLP-1 copies in 503A products signals a new future of pharmacy compounding? I spoke with CBS News to break down the legal implications for healthcare providers and manufacturers.
https://buff.ly/X716RCE

The FDA has warned a major compounding pharmacy that it violated federal law by making copies of blockbuster weight-loss drugs in "inordinate amounts."

Shared my legal perspective with CBS News regarding the FDA's crackdown on GLP-1 drug  . While pharmacies may attempt to...
10/03/2026

Shared my legal perspective with CBS News regarding the FDA's crackdown on GLP-1 drug .
While pharmacies may attempt to reframe their approaches, the regulatory window is rapidly closing.

https://cbsn.ws/4d6GAFg

The FDA has warned a major compounding pharmacy that it violated federal law by making copies of blockbuster weight-loss drugs in "inordinate amounts."

Excited to be quoted by CBS News on the FDA’s latest warning letter to compounding pharmacies producing GLP-1 weight-los...
09/29/2026

Excited to be quoted by CBS News on the FDA’s latest warning letter to compounding pharmacies producing GLP-1 weight-loss drugs. As regulatory boundaries tighten, the avenue for mass compounding is definitely getting narrower.
https://buff.ly/X716RCE

The FDA has warned a major compounding pharmacy that it violated federal law by making copies of blockbuster weight-loss drugs in "inordinate amounts."

09/29/2026

Is the FDA drawing a definitive line in the sand on compounded GLP-1 medications? Read my analysis in CBS News.

As a patient you want to avoid fake bodega peptides! WIRED featured our insight on product safety, and I was quoted!!htt...
09/24/2026

As a patient you want to avoid fake bodega peptides!
WIRED featured our insight on product safety, and I was quoted!!
https://bit.ly/4yVnLNM

WIRED tested samples of four types of peptides. The results show how lightly regulated the industry is, even as popularity surges.

Dont go to your corner store to buy peptides!!? You really need to be told that??We spoke to  about regulatory enforceme...
09/22/2026

Dont go to your corner store to buy peptides!!? You really need to be told that??
We spoke to about regulatory enforcement.
https://bit.ly/4yVnLNM

WIRED tested samples of four types of peptides. The results show how lightly regulated the industry is, even as popularity surges.

09/22/2026

Gotta love it when WIRED quotes me on viral peptide testing!

Independent testing exposes unverified safety risks. What does this mean for you?

https://bit.ly/4yVnLNM

Marketing compounded weight-loss treatments as "FDA-approved" or "generic Ozempic" is drawing heavy scrutiny from state ...
09/18/2026

Marketing compounded weight-loss treatments as "FDA-approved" or "generic Ozempic" is drawing heavy scrutiny from state AGs and advertising regulators. Medspas must re-evaluate their marketing tactics and GLP-1 sourcing to avoid severe deceptive trade practice penalties.
https://buff.ly/NqLmEk9

Owners of medspas—medical clinic/day spa hybrids that offer minimally invasive cosmetic procedures in a spa-like setting—are often fooled by their own relaxed, retail-friendly atmosphere and often believe that they exist in a regulatory gray area.

Dont mix custom vitamin IV bags in a back room. You must meet sterile compounding requiring strict USP  standards. Prepa...
09/16/2026

Dont mix custom vitamin IV bags in a back room. You must meet sterile compounding requiring strict USP standards.

Preparing formulations outside proper cleanroom environments puts both patient safety and professional licenses on the line.

https://buff.ly/NqLmEk9

safety

Owners of medspas—medical clinic/day spa hybrids that offer minimally invasive cosmetic procedures in a spa-like setting—are often fooled by their own relaxed, retail-friendly atmosphere and often believe that they exist in a regulatory gray area.

Labeling "For Research Use Only" won't shield a clinic when selling directly to patients. Avoid board suspensions, sever...
09/15/2026

Labeling "For Research Use Only" won't shield a clinic when selling directly to patients. Avoid board suspensions, severe monetary fines, and criminal charges.

https://bit.ly/4yGrI8R
sciences

Owners of medspas—medical clinic/day spa hybrids that offer minimally invasive cosmetic procedures in a spa-like setting—are often fooled by their own relaxed, retail-friendly atmosphere and often believe that they exist in a regulatory gray area.

Address

100 South Juniper Street, 3rd Floor, Pa 19107
Philadelphia, PA
19104

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