The FDA’s Pharmacy Compounding Advisory Committee recently voted to add six peptide substances to its list of legally compoundable drugs. The vote–which is not yet law–signals a change in attitude at the agency. (Image: GoodIdeas/Shuterstock)
On July 23 and 24, the Food and Drug
Administration’s Pharmacy Compounding Advisory Committee (PCAC) met to consider whether a set of peptides should be
added to the 503A Bulks List,
which would permit licensed compounding pharmacies to legally make these drugs
by physician prescription.
In a
reversal of the committee’s past stance, PCAC voted to add six peptides–BPC-157,
MOTS-c, KPV, TB-500, Epitalon, and Semax to the 503A list. Use of these and
many other peptide agents has risen rapidly over the last few years, despite
existing in a legal and regulatory gray zone.
Advocates
for peptide therapies contend that in the absence of clear FDA rules permitting
compounding pharmacies to make them, patients are turning to highly
questionable and potentially dangerous online sources of peptides.
Many clinicians are missing opportunities to prevent neuropathy by failing to check vitamin B12 levels in their diabetic patients on metformin. That’s the conclusion of a massive scoping review of evidence from databases across the globe, undertaken by Ian Parsonage and colleagues at the School of Health Sciences at the University of Bath, UK. The […]
Pistachio nuts are a rich source of naturally-occurring melatonin, and Australian researchers have shown that supplementation with pistachio-derived melatonin is equally effective in improving sleep parameters, as more the widely available synthetic forms of melatonin. Some cultivars of pistachio (Pistacia vera, Anacardiaceae) naturally produce as much as 223 µg/g of phytomelatonin. That fact prompted Network […]
Pain
and chronic inflammation underlie many conditions that holistic practitioners
encounter every day — from joint degeneration and neuropathy to migraine,
menstrual disorders, and post-exercise recovery.
Yet
the dominant pharmaceutical toolkit remains constrained by adverse effects,
dependency risk, and an inability to address the underlying biology of
neuroinflammation.
This
webinar invites you to explore palmitoylethanolamide (PEA) –a well-researched,
endogenously produced lipid mediator that the human body already uses to
regulate pain and repair damaged tissue.
Specifically, we will focus on Levagen®+, Saanroo’s clinically-validated PEA formulation powered by patented LipiSperse® dispersion technology, which greatly improves absorption and bioavailability of PEA.
Chemist
Ramasamy V. Venkatesh will lay out the scientific basis for clinical use
of PEA, reviewing its multi-receptor mechanism — primarily through PPAR-α
activation, alongside indirect modulation of CB1 and CB2 receptors and
interactions with GPR55 and TRPV1. You’ll learn how this “parallel
endocannabinoid” signaling pathway makes PEA uniquely suited to address
both peripheral and central pain while avoiding psychoactive effects.
Dr. Venkatesh will also present a comprehensive review of the clinical research on Levagen®+ across multiple pain and inflammation applications. Highlights include randomized, double-blind, placebo-controlled trials showing Levagen®+’s efficacy for joint pain and stiffness, acute menstrual pain, migraine, and exercise-induced muscle damage.
You will gain a deep understanding of how to apply Levagen®+ in the care of diverse patient subgroups—not as a one-size-fits-all supplement, but as a precision tool that targets endocannabinoid-adjacent pathways involved in pain.
Ramasamy V. Venkatesh is a chemist with over 40 years of experience in the healthcare industry, specializing in pharmaceuticals and nutraceuticals. He is the founder and managing director of the Gencor Group worldwide. He has extensive international business experience in the pharmaceutical and nutraceutical sectors, having conducted business in more than 70 countries. His expertise covers R&D management, scientific reviews, product development, clinical trials, branding, and strategic partnerships, with a proven track record of successfully launching branded products globally in the nutraceutical market. Venkatesh serves on several advisory boards across the nutraceutical and pharmaceutical industries. In 2024, he received the Nutri Champion Award from NutraIngredients in 2024, for the significant impact his work has had on the dietary supplement industry. He is known for raising standards by using high-quality, clinically supported ingredients.
Venkatesh is highly respected by colleagues, clients, and the industry at large for his exceptional work ethic and selfless dedication. His commitment extends beyond his professional achievements, as he also actively promotes equal opportunities and empowers women in business and sports.
