FDA Peptide Advisory Votes Could Reshape Telehealth and Compounding—But They Are Not Yet a Green Light

The debate over wellness peptides is moving out of the online “grey market” and into the formal FDA regulatory process.

On July 23, 2026, the FDA’s Pharmacy Compounding Advisory Committee recommended placing BPC-157, KPV, TB-500, and MOTS-C on the list of bulk drug substances that may be used in compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act. The committee reviewed both the free-base and acetate forms of the substances. It is scheduled to consider emideltide, epitalon, and Semax on July 24. 

The votes could eventually create a significant opportunity for telehealth platforms, medical practices, and compounding pharmacies interested in longevity, recovery, metabolic health, and other emerging wellness services.

They do not, however, make the peptides FDA-approved. They also do not immediately authorize pharmacies or telehealth companies to begin prescribing, compounding, marketing, or shipping them nationwide.

Why the 503A Bulks List Matters

Section 503A provides a pathway through which a state-licensed pharmacy or licensed physician may compound a medication for an identified individual patient.

When a pharmacy compounds from a bulk drug substance, that substance generally must satisfy one of three conditions: it must comply with an applicable United States Pharmacopeia or National Formulary monograph, be a component of an FDA-approved drug, or appear on FDA’s 503A Bulks List. The substance must also come from an appropriately registered establishment and be accompanied by a valid certificate of analysis. 

Placement on the Bulks List could therefore remove an important federal barrier to lawful compounding of certain peptides.

That is different from FDA drug approval. Compounded drugs do not go through the same premarket review as approved drugs, and FDA does not independently verify their safety, effectiveness, or quality before they are dispensed. 

A favorable committee recommendation is also only one step in the process. FDA must consider the committee’s advice, complete its review, and determine how it will address the substances through regulation or enforcement policy. FDA’s own briefing materials emphasize that the agency will not make a final determination until the advisory process and its reviews are complete. 

The Committee and FDA Staff Reached Different Conclusions

The votes are particularly significant because FDA staff recommended against adding the peptides considered on July 23 to the Bulks List.

FDA has identified concerns involving limited human safety information, potential immunogenicity, peptide-related impurities, and the difficulty of characterizing certain active pharmaceutical ingredients. Its existing safety materials state, for example, that it lacks sufficient information to determine whether BPC-157, KPV, MOTS-C, and TB-500 could cause harm when administered to humans through the proposed routes. 

Supporters offered a different policy argument. Consumers are already purchasing peptides through overseas vendors and online sellers that label their products for research use. Allowing licensed prescribers and regulated pharmacies to serve this market, they argue, could move patients toward products with greater professional oversight, sourcing controls, testing, documentation, and traceability.

That argument may have persuaded the committee. It does not eliminate the underlying questions surrounding evidence, dosing, manufacturing quality, informed consent, adverse-event reporting, and promotional claims.

Why Telehealth Companies Are Paying Attention

Telehealth companies have already been investing in the infrastructure needed to enter the peptide and longevity markets.

Hims & Hers acquired a California-based peptide facility in 2025, describing the transaction as part of its strategy to strengthen its domestic supply chain for personalized medications. Noom announced in April 2026 that it had acquired Tailor Made Compounding, a Section 503A pharmacy operating across numerous states, as it expanded into healthy-aging and peptide-related services. 

A favorable FDA decision could make those investments more commercially valuable. It could also encourage other telehealth platforms, physician groups, pharmacies, and investors to enter the market.

Vertical integration does not simplify the legal analysis, however. It can make the analysis more complicated.

A platform that owns or contracts with a medical practice, pharmacy, laboratory, marketing company, and technology provider must determine which entity is making clinical decisions, prescribing the medication, compounding it, dispensing it, communicating with the patient, collecting payment, maintaining records, and responding to safety concerns.

Each part of that arrangement can be governed by a different set of federal and state requirements.

Inclusion Would Not Permit Unrestricted Peptide Sales

Even after a substance is added to the 503A Bulks List, a pharmacy must continue to satisfy the other conditions of Section 503A.

Compounding generally must occur pursuant to a valid prescription for an identified individual patient, although limited anticipatory compounding may be permitted based on an established prescribing history. Section 503A is not intended to allow a pharmacy to operate as a conventional manufacturer or distribute standardized products without patient-specific prescriptions. 

Companies must also consider:

• State pharmacy and prescriber licensing requirements

• Telehealth prescribing and patient-evaluation standards

• Corporate-practice-of-medicine restrictions

• Pharmacy ownership and management rules

• Interstate dispensing and distribution limitations

• Supplier qualification and certificate-of-analysis requirements

• Sterility, potency, quality-control, and recordkeeping obligations

• Patient disclosures and informed-consent procedures

• Advertising and social-media claims

• Adverse-event collection and regulatory reporting

• Contracts among the platform, medical group, pharmacy, laboratory, and suppliers

The promotional issue may be especially important. A business should not describe a compounded peptide as “FDA-approved” simply because its underlying bulk substance appears on the 503A Bulks List. Claims concerning healing, recovery, weight loss, anti-aging, cognitive performance, or disease treatment must also be evaluated in light of the available evidence and applicable FDA, Federal Trade Commission, medical-board, and consumer-protection requirements.

How Lanton, Lanton & Sosa Law Can Help

Lanton, Lanton & Sosa Law assists telehealth platforms, compounding pharmacies, physicians, healthcare entrepreneurs, and investors with the legal and regulatory questions involved in developing or expanding peptide-related services.

Our attorneys can evaluate whether a proposed product and dispensing model fits within Section 503A or another regulatory pathway, review state pharmacy and medical-practice requirements, and assess corporate and contractual relationships among the telehealth platform, prescribers, pharmacies, laboratories, suppliers, and management entities.

We can also assist with pharmacy and professional licensing strategy, telehealth policies, patient disclosures, marketing review, quality and supplier agreements, adverse-event procedures, acquisition due diligence, medical- and pharmacy-board inquiries, and responses to FDA or state enforcement activity.

The peptide market may be moving toward a more regulated pathway. A single advisory committee vote does not complete that transition. Companies considering entering the market should understand how the federal compounding rules interact with state licensing, clinical practice, pharmacy operations, contracting, advertising, and patient safety before launching or expanding a program.

This article reflects developments available as of the morning of July 24, 2026. The PCAC meeting and FDA review process remain ongoing.

Lanton Law Speaks at Summit & Reverse Expo

We were pleased to be invited to Orlando, Florida to speak with IDN with our presentation titled “Price, Innovation & Policy: What’s on the Horizon for the Industry.

U.S. House passes legislation to extend telehealth waivers through 2024

The U.S. House of Representatives has passed passed the Advancing Telehealth Beyond COVID-19 Act of 2022 (H.R. 4040). The bill proposes to extend telehealth flexibilities under Medicare that were initially authorized during the public health emergency of COVID-19. The bill heads to the U.S. Senate. 

Specifics of the proposal are as follows:

• Provides that certain flexibilities continue to apply until December 31, 2024, if the emergency period ends before that date. 

• Beneficiaries to continue to receive telehealth services at any site, regardless of type or location (e.g., the beneficiary's home); 

• Occupational therapists, physical therapists, speech-language pathologists, and audiologists to continue to furnish telehealth services;

• Federally qualified health centers and rural health clinics to continue to serve as the distant site (i.e., the location of the health care practitioner);

• Evaluation and management and behavioral health services to continue to be provided via audio-only technology; and

• Hospice physicians and nurse practitioners to continue to complete certain requirements relating to patient recertifications via telehealth.

The bill also delays implementation of certain in-person evaluation requirements for mental health telehealth services until January 1, 2025, or the first day after the end of the emergency period, whichever is later.

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on healthcare/life science and technology. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Expert Discusses Long-Term Implications of Roe V. Wade Decision for Pharmacists, Contraception Access

In an interview with Pharmacy Times, Ron Lanton III, Esq, partner at Lanton Law, discussed the recent Supreme Court ruling on Dobbs v. Jackson Women’s Health and what this could mean for pharmacists. In the interview, Lanton said the decision leaves many things ambiguous, which will most likely result in litigation around the country in the coming weeks and months.

The interview can be viewed here. We have also provided the text from Aislinn Antrim’s interview at Pharmacy Times below:

In an interview with Pharmacy Times, Ron Lanton III, Esq, partner at Lanton Law, discussed the recent Supreme Court ruling on Dobbs v. Jackson Women’s Health and what this could mean for pharmacists. In the interview, Lanton said the decision leaves many things ambiguous, which will most likely result in litigation around the country in the coming weeks and months.

Aislinn Antrim: Hi, I'm Aislinn Antrim with Pharmacy Times,and I'm here with Ron Lanton, partner at Lanton Law, to discuss the recent Supreme Court decision in Dobbs v. Jackson Women's Health and what this means for pharmacists, contraception access, and all of these other questions. So to get started, can you explain the Supreme Court reasoning in this case?

Ron Lanton III, Esq: Absolutely. And before I get started, let me just put a disclaimer out there that while I'm not going to be discussing my personal views about the Supreme Court decision, I'm just going to talk like a lot of health care providers are probably talking right now, where they're just trying to figure out what happened, and what does this mean for them. So, with that out of the way, I'll quickly explained Dobb.

So basically, what happened in this case is that Roe v. Wade and Casey v. Planned Parenthood were both actually overturned by the Supreme Court on the basis that abortion at any time was not protected by the constitution. So basically, what they've done is that they didn't really put any standards around what they thought abortion was, or you know, how many weeks there should be at, because they felt that the state should actually control the outcome. So, the facts within Dobbs is that the state of Mississippi banned abortions at 15 weeks, which is pre-viability (viability referring to if the fetus can survive outside of the womb). And what Justice Alito said, writing for the majority opinion, is a quote that I wanted to make sure that everybody has heard in case they have not read the opinion. And the quote talks about this, it says, “The inescapable conclusion is that a right to abortion is not deeply rooted in the nation's history and traditions. On the contrary, an unbroken tradition of prohibiting abortion, on pain of criminal punishment, persisted from the earliest days of the common law until 1973.” So, this is definitely a landmark decision. You know, my entire life has been post-Roe. So, this is going to be very, very different for a lot of people and we'll see what happens.

Aislinn Antrim: Definitely. Where do states stand currently in terms of abortion access? And where do you see this headed in the coming weeks and months?

Ron Lanton III, Esq: I see a lot of litigation coming in the next weeks and months. Right now, it's kind of weird how we say this, because right now, there are 5 states where abortion is either illegal or banned. Those states are Texas, South Dakota, Oklahoma, Louisiana, and Kentucky. Soon there will be 16. And the reason I say that is because of what's called trigger laws. So basically, if Roe was ever overturned, which it was in this case, there were some states that have laws in the books that said, should this happen, then, you know, within 30 days abortions will be banned in that state.There is also another thing called zombie lawsthat are out there, in addition to the trigger laws, and what zombie laws are, is that these are pre-Roe abortion laws that may come back, they were never officially taken off of the books. So, they're just kind of there and a lot of states really don't know what to do with these and businesses that are operating there don't know what to do with these, or if they'll ever come back. So that number, while it may go up to 16 with the trigger laws, it may be more with these zombie laws. So, we really have to do a close scrutiny of what's on the books. And I think that if health care providers are wondering what that might be, I would just suggest that they look and see if their states do in fact have these laws on the books. There have been some states, though, that have taken the stance that they will be arresting medical providers that actually attempt to do these services. So, my prediction is just like I mentioned earlier, is that we're probably going to see a lot of different lawsuits, just for people that are trying to understand their rights and what they can and can't do, especially the health care providers.

Aislinn Antrim: Absolutely. There are many things that are still really unclear. One of the major things that's come into play is access to mail-order abortion pills, and from my understanding, the FDA has permanently allowed these pills to be accessible by mail. But some governors are still looking to ban them. Can you explain this, what this means, and where it stands?

Ron Lanton III, Esq: Yeah, of course. Well, the FDA has been using the pill since 2000, and in December of 2021 what they did was they had some labeling and some evidence-based medicine requirements that they put in and finalized in December of 2021. I can't really speak to specifics about what those are. I know they did them, but if people are interested, I would just go to the FDA and just look. They have that stuff there on their site. The FDA does allow the pill to be prescribed by mail or by telehealth and it's authorized for use during the first 10 weeks of pregnancy. And what was interesting was that when I was looking at this is that more than half of the abortions in the United States are actually medication abortions, which I did not know.

You have mentioned some of the anti-abortion policies that tend to happen with this. So, there have been some anti-abortion states that have laws on the books that stipulate that this pill either has to be given in-person or it has to be prescribed, instead of done through telehealth or by mail. And also, they're saying it's only allowed through the seventh week, whereby the FDA says that it's the tenth week. So that's different. So, what we're seeing here, and what we're also hearing, is that some states may even try to ban the pill. And there's questions legally on whether they can do this. It's really a Tenth Amendment versus Supremacy Clause question. You know, I don't think the FDA, this is just me personally, I think you should check this out. But you know, just for me, I'm not sure you could do that as a state, just legally, with something that the FDA has already approved. It's also going to come down to what the Board of Medicine in your particular state is allowing a physician to do. So, these are just other things that a health care provider would have to check out.

I do think it is interesting to bring up what the Department of Justice has said about this very issue. So, here's a quote I’d like to share with you. So, in what the Department of Justice has said, has stated, “…and we stand ready to work with other arms of the federal government that seek to use their lawful authorities to protect and preserve access to reproductive care. In particular, the FDA has approved the use of medication (Mifeprex). States may not ban this based on disagreement with the FDA’s expert judgment about safety and efficacy.” So, if a state has a policy where it's just challenging the safety of it, that's not going to stand. So, what really remains to be seen is if states are going to continue to do this regardless, we'll have to see.

Aislinn Antrim: Very interesting. And there are also states where legislators are attempting to interpret IUDs as abortion to restrict their access. What is the legal basis for this? And what are the implications if they are successful?

Ron Lanton III, Esq: Yeah, so let's go back to the Supreme Court majority opinion. In this case, they said that other rights, like the rights to contraception and marriage, do not discuss the ending of human life as abortion does. So, they tried to make a distinction in this ruling. Now, with what you just brought up, I started thinking about Plan B and copper IUDs because those stop an already fertilized egg or an embryo from implanting and thus creating the pregnancy. Right? So, the argument Dobbs was they sided with Mississippi in that Mississippi could deny an abortion at pre-viability, which they already ruled that they can. So, therefore, a state could potentially rule with regards to Plan B or the copper IUD, that these are not contraception and that they are a form of abortion. I mean, theoretically it could happen, as they stop an embryo from implanting, thus stopping human life. So especially if the state believes that human life starts at fertilization, and not implantation. So, many health care providers are definitely likely to be concerned about this because it could also affect IVF treatments. Basically, this ruling has allowed states to ban abortion but kind of has left the door open because they were ambiguous on, you know, they didn't say anything about weeks or what abortion was, there was no definition about it. So, this could potentially bleed over into contraception. So honestly, a legal basis for this could be a new law that describes when human life starts, such as fertilization instead of implantation. So, Dobbs opened the door to that and, you know, that's another one of those things we just don't know.

Aislinn Antrim: Definitely. Many people are urging the Biden administration and Congress to codify a right to abortion. Do you have a sense of whether this could happen or where this stands?

Ron Lanton III, Esq: Well, let's just talk about the Senate makeup right now. So, to get anything passed in Congress has been very difficult to do lately because of just the hyper-partisanship stuff that's been going on. And the Senate, it's almost like forget about it. You know, if you don't have those 60 votes to satisfy the threshold, then you're just not getting anything done. So right now, with an issue this divisive—and really, I mean, anything can be hyper-partisan but, you know, this is definitely one of those issues. I don't know if they can get anything passed in the Senate that could codify Roe.

Now, I like to go back to whether it's accurate when we say codify Roe, because Roe v. Wade hasn't been in place since 1992. And the reason I say that is because the Supreme Court had the Casey v. Planned Parenthood case that I referenced earlier, which was also overturned with Roe in the Dobbs decision. Now, in Casey, the court upheld Roe’s decision holding that a woman has the right to choose to terminate a pregnancy up until the point of fetal viability, and that states could restrict abortion after that point, subject to exceptions such as, you know, protecting the life and health of the pregnant woman. But in Casey the court said that Roe too severely limited state regulation prior to fetal viability and held that states can impose restrictions on abortion throughout pregnancy to protect potential life, as well as the maternal health, which, you know, which has been status quo up until just recently. What was also interesting about Casey is that had had the undue burden test, which basically said that states can't make a law that makes it too hard for someone that wants to seek an abortion. So again, that's been status quo until now. And now we're really not sure what's going to happen.

Aislinn Antrim: Definitely. Going back to what you were saying a few minutes ago, there are also discussions of whether a future Supreme Court case could impact contraception access. What could this look like from a policy or legal standpoint?

Ron Lanton III, Esq: I think [policy and legality] these are 2 related issues, but when we're looking at legalities, I mean, you know, we can split hairs all day but those legally are 2 different issues. So, for contraception that prevents fertilization, you know, such as the pill, that would require a state to draft an entirely new law that outlawed contraception. And that would have to be pushed through several states, and then in order to get to the Supreme Court, someone would have to challenge that and make it all the way up through the ladder. So, these cases are coming faster than they used to before, but that's the process that would have to happen. The rights of contraception is a bit different than what we were talking about in Dobbs because the contraception was actually a different case based on Griswold v. Connecticut. And that basically held that married couples have a protected right to privacy, and that this is being violated by states banning contraception. So, Griswold was not overturned or even mentioned in the majority opinion. Now, I think what has people talking is the Justice Thomas concurring opinion, which basically said that we ought to look at cases like Griswold. Well, that's different from the majority opinion. So, the majority opinion is what we base everything off of now. Concurring opinions happen, judges put their opinions in there all the time. Whether someone later may look at that concurring opinion and shape a different policy, legally or whatnot, that remains to be seen. But the majority opinion did not talk about Griswold. I just want to make sure that was very clear.

Aislinn Antrim: Definitely. Thank you. Could this Dobbs ruling potentially impact the legality of scientific research and innovation in the area of women's health and contraception?

Ron Lanton III, Esq: Yes. So, any current or future research that is connected to the use of an already fertilized egg or an embryo may be deemed unlawful by a state, depending on what their abortion laws actually are. So, as we talked about earlier, Dobbs opens the door for states to determine when human life actually begins. And they're now able to put in their own standards about how they feel about abortion. So, I think in order to answer your question, it really depends on how the state is going to regulate the practice of medicine. So, it’s going to come down to where you live and how medicine is regulated.

Aislinn Antrim: With a wide range of restrictions varying state-to-state, do you have any resources or suggestions for pharmacists who may not know exactly how to handle things in their state, what's legal what they can and can't do? Where can they look?

Ron Lanton III, Esq: That's a good question. I think if I were a pharmacist in this environment, I would definitely look at the Board of Pharmacy to see if there's any guidance about that. I think the second thing that you have to do is really understand how Plan B is going to be regulated. And I think if that's the case, you might want to call an attorney—I'd hate to even get to that kind of level, but you want to make sure that you're complying with what is going on. But I think an issue that most people miss is privacy and HIPAA. And, you know, if you have someone that's coming to a pharmacy that is in a state like the Northeast, where it's pretty much status quo with how they're going to rule or regulate this issue, you know, you can't be telling another state what's going on based on that. So, you really should understand your privacy laws and just look at that in your state. And just make sure you have a good understanding of HIPAA, which will help you in your practice going forward. So, I think those are the 3 places that I would look at first, to make sure. So, make sure that you understand your privacy, get a lawyer if you have questions about things, and just make sure that you're familiar with Board of Pharmacy and their policies and procedures.

Aislinn Antrim: Absolutely. Well, we've covered a lot. Is there anything that you wanted to add?

Ron Lanton III, Esq: I wish I could, I wish I had a crystal ball to kind of figure out how all this is going to go. Like I said, I think with this decision it's going to be a lot of litigation. So, this is not going to be over by, you know, any short imagination. This is going to go on for quite a while. And the only thing that could change things again, back to the way things were, is either an act by Congress, which would invalidate a court decision, or this comes back up through the Supreme Court again and they rule a different way. So that's a long way of me saying that we just have to wait and see what happens.

Aislinn Antrim: Absolutely. Well, thank you so much for diving into this with me.

Ron Lanton III, Esq: You’re welcome, thank you for the time.

Lanton Law Interviews Famlee Founder & CEO Shelley Bailey

Ron Lanton of Lanton Law interviews Shelley Bailey of Famlee. They discuss fertility, entrepreneurship and the benefits of technology for the advancement of women's health. The interview can be heard here.

President Biden Signs the Consolidated Appropriations Act of 2022 Impacting Telehealth and Health System Stakeholders

On March 15, 2022 President Biden signed the Consolidated Appropriations Act of 2022 into law. The announcement can be viewed here. This $1.5 trillion omnibus appropriations bill is important as there are several provisions applicable to hospitals and health systems contained within; namely touching on issues such as 340B eligibility and telehealth. 

Specifically regarding 340B the bill allows for limited protections for certain 340B hospitals that lost their eligibility due to a drop in their disproportionate share hospitals (DSH) adjustment percentage below the required threshold for 340B eligibility to gain limited access to the program. Access to the 340B drug discounts would be available only from the date of the bill’s enactment through the end of 2022 and not retrospectively.

For telehealth stakeholders, the new law would extend several telehealth flexibilities for 151 days after the end of the COVID-19 public health emergency. Additionally, the Medicare Payment Advisory Commission (MedPAC) shall “conduct a study on the expansions of telehealth services” and report their findings to Congress no later than June 2023.

Stakeholders in these groups have a lot of uncertainty in their specific industries. 

Lanton Law is a national boutique healthcare and technology law and government affairs firm.  We closely monitor legislative, regulatory and legal developments for our clients. Contact us to learn about how either our legal or lobbying services can help you attain your goals.