FDA panel votes to add peptides to permitted compounding list despite opposition from agency scientists
The Food and Drug Administration’s (FDA) committee on compounded drugs on Thursday broke with agency scientists and voted in favor of adding peptides to the list of substances compounding pharmacies can make, despite concerns being raised over the lack of demonstrated benefits.
The FDA’s Pharmacy Compounding Advisory Committee (PCAC) heard public comments and saw presentation by agency staffers concerning the peptides BPC-157, KPV, TB-500 and MOTS-C. These peptides are purported to help with ulcerative colitis, wound healing, obesity and osteoporosis.
PCAC was tasked with recommending whether to add these peptides to the 503A Bulks list, the substances that 503A compounding pharmacies can make and sell to consumers.
By 7 p.m. EST on Thursday, the committee had voted in favor of adding BPC-157, KPV, and TB-500 to the list, though the votes were split nearly evenly with 8 voting yes, 6 voting no and one member abstaining.
At the time of writing, the committee was still hearing comments and presentations about MOTS-c.
While opponents to adding these peptides to the list argued there wasn’t enough data to prove safety and efficacy, supporters essentially argued there was not enough to disprove these claims either.
Prior to the meeting, FDA scientists concluded in briefing material to the committee that all the peptides being considered lacked the necessary evidence to conclude that they were safe effective for treating the conditions they were purported to help treat.
Staffers reiterated this stance on Thursday. One staffer noted potential issues like a lack of standardization for peptides, sharing that the FDA had encountered many substances all being marketed as “BPC-157” for example that had different active molecules.
“Inconsistent naming conventions can contribute to the [bulk drug substance (BDS)] being not well characterized because there is no basis for a long-term understanding of the composition of the BDS,” the staffer stated in their presentation. “There is no basis for an expectation that the common name will always identify the same BDS, the same specific chemical form and structure.”
Supporters of adding these peptides to the list argued that doing so would direct consumers away from the gray market, where many eager shoppers source supposed “research-grade” peptides from online vendors overseas.
In explaining her “yes” vote, PCAC member Melissa Loseke said, ” just last week, I had a patient whose research-grade whatever that they got from some place that they brought to me to fix was laced with MDMA and ecstasy. That’s not protecting the American people.”
Asare Christian, one of several PCAC members who own clinics offering peptides, argued, “We are always taking risks with patients with all the interventions we do as physicians. And this provides an avenue, an alternative, to support the already existing available tools that we have to take care of patients.”
Several other members of the committee, however, concurred with FDA staffers that there simply was not enough evidence to supporting making these peptides available through compounding pharmacies.
In their first vote on BPC-157, PCAC members Elizabeth Rebello, Brian Serumaga and Josh Mailman were among those who said they believed there was not enough evidence demonstrating efficacy.
Brian Lee, associate professor of medicine at USC’s Keck School of Medicine, warned that while the vote on Thursday would not be an FDA approval, consumers would still perceive it as an endorsement of the peptides.
“I think that the data that we do have, the existing randomized data, is showing that BPC-157 may be no better than placebo,” said Lee. “And knowing that most important serious safety events like liver damage, where there is potential concern here, aren’t detected by self report. So, I think this endorsement can be potentially harmful, and it cannot in good conscience vote yes.”
Copyright 2026 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Read the full story at The Hill ↗
On Thursday, the Food and Drug Administration's (FDA) committee on compounded drugs broke with agency scientists and voted in favor of adding peptides to the list of substances…
This lens runs the verified story through Cinnamon's AI — wired in the next step.
The Food and Drug Administration’s (FDA) committee on compounded drugs on Thursday broke with agency scientists and voted in favor of adding peptides to the list of substances compounding pharmacies can make, despite concerns being raised over the lack of demonstrated benefits.
The FDA’s Pharmacy Compounding Advisory Committee (PCAC) heard public comments and saw presentation by agency staffers concerning the peptides BPC-157, KPV, TB-500 and MOTS-C. These peptides are purported to help with ulcerative colitis, wound healing, obesity and osteoporosis.
PCAC was tasked with recommending whether to add these peptides to the 503A Bulks list, the substances that 503A compounding pharmacies can make and sell to consumers.
By 7 p.m. EST on Thursday, the committee had voted in favor of adding BPC-157, KPV, and TB-500 to the list, though the votes were split nearly evenly with 8 voting yes, 6 voting no and one member abstaining.
At the time of writing, the committee was still hearing comments and presentations about MOTS-c.
While opponents to adding these peptides to the list argued there wasn’t enough data to prove safety and efficacy, supporters essentially argued there was not enough to disprove these claims either.
Prior to the meeting, FDA scientists concluded in briefing material to the committee that all the peptides being considered lacked the necessary evidence to conclude that they were safe effective for treating the conditions they were purported to help treat.
Staffers reiterated this stance on Thursday. One staffer noted potential issues like a lack of standardization for peptides, sharing that the FDA had encountered many substances all being marketed as “BPC-157” for example that had different active molecules.
“Inconsistent naming conventions can contribute to the [bulk drug substance (BDS)] being not well characterized because there is no basis for a long-term understanding of the composition of the BDS,” the staffer stated in their presentation. “There is no basis for an expectation that the common name will always identify the same BDS, the same specific chemical form and structure.”
Supporters of adding these peptides to the list argued that doing so would direct consumers away from the gray market, where many eager shoppers source supposed “research-grade” peptides from online vendors overseas.
In explaining her “yes” vote, PCAC member Melissa Loseke said, ” just last week, I had a patient whose research-grade whatever that they got from some place that they brought to me to fix was laced with MDMA and ecstasy. That’s not protecting the American people.”
Asare Christian, one of several PCAC members who own clinics offering peptides, argued, “We are always taking risks with patients with all the interventions we do as physicians. And this provides an avenue, an alternative, to support the already existing available tools that we have to take care of patients.”
Several other members of the committee, however, concurred with FDA staffers that there simply was not enough evidence to supporting making these peptides available through compounding pharmacies.
In their first vote on BPC-157, PCAC members Elizabeth Rebello, Brian Serumaga and Josh Mailman were among those who said they believed there was not enough evidence demonstrating efficacy.
Brian Lee, associate professor of medicine at USC’s Keck School of Medicine, warned that while the vote on Thursday would not be an FDA approval, consumers would still perceive it as an endorsement of the peptides.
“I think that the data that we do have, the existing randomized data, is showing that BPC-157 may be no better than placebo,” said Lee. “And knowing that most important serious safety events like liver damage, where there is potential concern here, aren’t detected by self report. So, I think this endorsement can be potentially harmful, and it cannot in good conscience vote yes.”
Copyright 2026 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Read the full story at The Hill ↗
The Food and Drug Administration’s (FDA) committee on compounded drugs on Thursday broke with agency scientists and voted in favor of adding peptides to the list of substances compounding pharmacies can make, despite concerns being raised over the lack of demonstrated benefits.
The FDA’s Pharmacy Compounding Advisory Committee (PCAC) heard public comments and saw presentation by agency staffers concerning the peptides BPC-157, KPV, TB-500 and MOTS-C. These peptides are purported to help with ulcerative colitis, wound healing, obesity and osteoporosis.
PCAC was tasked with recommending whether to add these peptides to the 503A Bulks list, the substances that 503A compounding pharmacies can make and sell to consumers.
By 7 p.m. EST on Thursday, the committee had voted in favor of adding BPC-157, KPV, and TB-500 to the list, though the votes were split nearly evenly with 8 voting yes, 6 voting no and one member abstaining.
At the time of writing, the committee was still hearing comments and presentations about MOTS-c.
While opponents to adding these peptides to the list argued there wasn’t enough data to prove safety and efficacy, supporters essentially argued there was not enough to disprove these claims either.
Prior to the meeting, FDA scientists concluded in briefing material to the committee that all the peptides being considered lacked the necessary evidence to conclude that they were safe effective for treating the conditions they were purported to help treat.
Staffers reiterated this stance on Thursday. One staffer noted potential issues like a lack of standardization for peptides, sharing that the FDA had encountered many substances all being marketed as “BPC-157” for example that had different active molecules.
“Inconsistent naming conventions can contribute to the [bulk drug substance (BDS)] being not well characterized because there is no basis for a long-term understanding of the composition of the BDS,” the staffer stated in their presentation. “There is no basis for an expectation that the common name will always identify the same BDS, the same specific chemical form and structure.”
Supporters of adding these peptides to the list argued that doing so would direct consumers away from the gray market, where many eager shoppers source supposed “research-grade” peptides from online vendors overseas.
In explaining her “yes” vote, PCAC member Melissa Loseke said, ” just last week, I had a patient whose research-grade whatever that they got from some place that they brought to me to fix was laced with MDMA and ecstasy. That’s not protecting the American people.”
Asare Christian, one of several PCAC members who own clinics offering peptides, argued, “We are always taking risks with patients with all the interventions we do as physicians. And this provides an avenue, an alternative, to support the already existing available tools that we have to take care of patients.”
Several other members of the committee, however, concurred with FDA staffers that there simply was not enough evidence to supporting making these peptides available through compounding pharmacies.
In their first vote on BPC-157, PCAC members Elizabeth Rebello, Brian Serumaga and Josh Mailman were among those who said they believed there was not enough evidence demonstrating efficacy.
Brian Lee, associate professor of medicine at USC’s Keck School of Medicine, warned that while the vote on Thursday would not be an FDA approval, consumers would still perceive it as an endorsement of the peptides.
“I think that the data that we do have, the existing randomized data, is showing that BPC-157 may be no better than placebo,” said Lee. “And knowing that most important serious safety events like liver damage, where there is potential concern here, aren’t detected by self report. So, I think this endorsement can be potentially harmful, and it cannot in good conscience vote yes.”
Copyright 2026 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Read the full story at The Hill ↗
This lens runs the verified story through Cinnamon's AI — wired in the next step.
- On Thursday, the Food and Drug Administration's (FDA) committee on compounded drugs broke with agency scientists and voted in favor of adding peptides to the list of substances…