How do peptides fit into a functional medicine practice?

They enter through the same long visit and laboratory workflow the practice already runs, sorted by evidence grade first: compounds with randomized human trials such as oral NAD+ precursors and oral glutathione, small-trial compounds such as LDN and sermorelin-class analogues, and animal-only compounds such as BPC-157 [1, 5, 8, 9]. Each is dispensed against a patient-specific prescription under section 503A [18].

What questions should a functional medicine peptide program answer first?

Eight: the evidence grade per compound, its federal category status as of the date asked, whether every preparation is patient-specific, what the compounding consent says, the evidence limits, how outcomes are tracked, how pricing is disclosed and whether any pharmacy arrangement raises an anti-kickback question [14], and what the file contains. The FTC standard governs the public pages [15].

How do I integrate peptides into functional medicine safely?

Grade each compound by its best human study, write a consent per compound that names the grade and that compounded drugs are not FDA-approved [18], track a biomarker and one patient-reported instrument per compound with a stopping rule [13], and keep a dispensing record per patient. Mendias and Awan reported that human safety data for most unapproved peptides are scarce [2].

What is the evidence for peptide protocols in functional medicine?

It varies by compound. Yi and colleagues’ 80-adult NMN trial raised blood NAD [5]; Richie and colleagues’ 54-adult trial raised glutathione stores [8]; Younger and colleagues’ 31-woman crossover of LDN reported a change in daily pain scores against placebo [9]. BPC-157 has 35 preclinical studies and one 12-patient series [1].

What should a functional medicine practice ask a 503A pharmacy?

Which compounds it prepares and under which 503A route or policy, its dated reading of FDA’s category pages and the HHS interim policy of 30 October 2026 [16, 17, 20], its nonresident license list, the certificate of analysis for each lot, the USP chapter behind each beyond-use date, and how it confirms the prescription is patient-specific as section 503A requires [18].

Is NAD+ evidence-based in functional medicine practice?

The human evidence is strongest for oral precursors: an 80-adult randomized trial of NMN raised blood NAD over 60 days [5], and Martens and colleagues reported that a crossover trial of nicotinamide riboside raised NAD+ metabolism and was well tolerated [6]. These trials tested oral precursors; for compounded NAD+ itself the located human data are pharmacokinetic, from a pilot six-hour infusion study [7].

What does glutathione do in functional medicine programs?

The randomized evidence concerns body stores: Richie and colleagues reported that six months of oral glutathione in 54 adults raised blood glutathione by 30 to 35 percent in the higher group, with levels returning to baseline after a one-month washout [8]. The trial measured no clinical endpoint, which is the sentence a consent and a pricing page carry.

Can a functional medicine practice compound BPC-157 in 2026?

As of 4 November 2026, 21 CFR 216.23 names no peptide, and HHS’s draft interim policy of 30 October 2026 states it does not intend to take enforcement action against 503A compounding of six peptides including BPC-157 under ten conditions, while calling the draft non-binding [20]. Through the ExaVeyra formulary BPC-157 is offered for IND-authorized clinical trials through our pharmacy partner.

Can a clinic keep compounded peptides in office stock?

A 503A pharmacy compounds on receipt of a valid patient-specific prescription, and the FDA laws page places distribution on a provider order that is not for an identified patient with 503B outsourcing facilities [18]. Office stock for in-office administration therefore comes from a 503B outsourcing facility, which the same page describes as subject to CGMP and risk-based inspection [18]. Preparations through the ExaVeyra formulary are compounded by our 503A pharmacy partner against a patient-specific prescription and dispensed to the named patient.

Does the anti-kickback statute apply to peptide pricing in a cash practice?

The OIG page describes the Anti-Kickback Statute as a criminal law covering remuneration to induce business payable by federal health care programs, with intent a key element [14]. A cash program still faces state fee-splitting rules and the FTC advertising standard [15], so a written fee schedule and counsel’s note on any pharmacy arrangement belong in the file either way.

6 November 2026 · Updated November 2026 · 13 min read

Peptides in a Functional Medicine Practice: Eight Questions on Evidence, Consent and Pricing

Functional medicine peptides checklist: evidence tiers per compound, consent, outcome tracking, pricing disclosure and the anti-kickback question, all sourced.

PeptidesFunctional MedicineEvidence Grading503A CompoundingNAD+GlutathioneInformed ConsentAnti-KickbackPractitioner Guides

Benn Bluestein-Veyra, M.Sc. Organic Chemistry | ExaVeyra Sciences

Cited sources

Peptides in a functional medicine practice sort into three evidence tiers before any other question is asked: compounds with randomized human trials (oral NAD+ precursors in an 80-adult, 60-day trial, oral glutathione in a 54-adult, six-month trial, low-dose naltrexone in a 31-woman crossover), compounds with small or older human studies (sermorelin-class analogues, topical GHK-Cu), and compounds whose literature is animal work, where a 2025 systematic review of BPC-157 found 35 preclinical studies and one clinical series of 12 patients [1, 5, 8, 9]. Mendias and Awan reported in 2026 that most unapproved peptides show favorable results in animal models while rigorous human safety data are scarce [2].

A functional medicine practice that already runs long visits and routine laboratory panels meets eight questions when it adds a peptide line: evidence grading per compound, federal category status as of 4 November 2026, patient-specific prescriptions against office stock, informed consent for compounded preparations, outcome tracking, pricing transparency and the anti-kickback frame, documentation, and advertising. ExaVeyra Sciences is a supplier; sermorelin, NAD+, glutathione, methylcobalamin and LDN are compounded by our 503A pharmacy partner against a patient-specific prescription, and every clinical decision belongs to the licensed practitioner.

35 of 36

BPC-157 studies in a 2025 systematic review that were preclinical; the one clinical report was a 12-patient series (Vasireddi 2025)

healthy middle-aged adults in the 60-day randomized, placebo-controlled NMN trial read in the grading table (Yi 2023)

women in the only located randomized crossover trial of low-dose naltrexone, read in question 1 (Younger 2013)

Regulatory status

Compounded drugs are not FDA-approved, and section 503A conditions the exemption on a valid patient-specific prescription [18]. As of 4 November 2026 the codified 503A bulks list at 21 CFR 216.23 names six substances and no peptide [20]; FDA’s safety-risks page lists BPC-157, CJC-1295, ipamorelin and injectable GHK-Cu with stated concerns or as withdrawn nominations, while sermorelin, NAD+, glutathione, methylcobalamin and naltrexone do not appear on it [17]; and on 30 October 2026 HHS published a draft interim enforcement discretion policy covering six peptides under ten conditions, open for comment to 13 November 2026 [20]. Which compound reaches which patient is decided by the licensed practitioner and the dispensing pharmacy.

1. What grade of human evidence supports each compound the practice intends to prescribe?

The GRADE working group’s vocabulary of high, moderate, low and very low certainty is the usual way to sort a compound list by the design and size of its human studies [21]. Applied to the compounds a functional medicine practice asks about, the sort produces three rows, and the practice’s consent, pricing and outcome tracking follow from which row a compound sits in.

Compound	Strongest human evidence located	Design and size	Row	Source
Oral NAD+ precursors (NMN, NR)	Randomized placebo-controlled trials raising blood NAD	80 adults, 60 days; 2 x 6-week crossover	Human RCTs on a biomarker	[5, 6]
NAD+ intravenous infusion	Pilot pharmacokinetic study of a six-hour infusion	Small human cohort	Human pharmacokinetics only	[7]
Oral glutathione	Randomized placebo-controlled trial raising body stores	54 adults, six months	Human RCT on a biomarker	[8]
Low-dose naltrexone	Randomized placebo-controlled crossover trial	31 women, daily pain scores	Small human RCT	[9, 10]
Methylcobalamin	Deficiency diagnosis and replacement described in reviews	Disease primer and clinical practice review	Guideline-level for measured deficiency	[11, 12]
Sermorelin and GHRH analogues	Small randomized trials and the approved-product history	19 older adults, five months; class review	Small or older human trials	[4, 22, 23]
Topical GHK-Cu	Small randomized trials on facial cosmetic creams	64 records across all models; human trials small	Small human trials	[3]
BPC-157, TB-500, MOTS-c, epitalon	Preclinical studies; one 12-patient series for BPC-157	35 preclinical studies of 36	Animal only	[1, 2]

Two cautions travel with the table. Yi and colleagues’ NMN trial measured blood NAD and a six-minute walk in healthy adults, and its first author is employed by the sponsor [5]; Richie and colleagues’ glutathione trial measured body stores, which returned to baseline after a one-month washout [8]. Biomarker trials show that a compound reaches the blood; they do not by themselves show a clinical outcome, and a documented answer records that distinction per compound.

Najafi and colleagues described the GHK-Cu human literature in 2026 as thin, with most trials small and conducted on facial creams, and noted commercial interests among the authors of about 35 percent of the primary literature [3]. Sigalos and Pastuszak reported few long-term controlled studies of growth hormone secretagogues and no established long-term safety [4]. The grading table is a living document, re-sorted as trials publish.

2. What is each compound’s federal category status as of 4 November 2026?

FDA’s 503A bulks page states that the agency does not intend to place substances nominated on or after 7 January 2025 into the interim categories, and that category 1 substances may remain within the interim enforcement policy until the agency decides on their inclusion [16]. The safety-risks page lists BPC-157, CJC-1295, ipamorelin and injectable GHK-Cu with immunogenicity and impurity rationales, and records that nominators withdrew several of those in April 2026; the non-injectable GHK-Cu entry returned to category 1 on 14 May 2026 [16, 17].

The Pharmacy Compounding Advisory Committee discussed BPC-157, KPV, TB-500 and MOTs-C on 23 July 2026 and emideltide, semax and epitalon on 24 July, and its recommendations are advice to the agency [19]. On 30 October 2026 HHS published a notice of availability for a draft Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances at 91 FR 68526, covering BPC-157, epitalon, KPV, MOTS-c, semax and TB-500 under ten conditions and per-peptide route limits, interim until rulemaking and, in the notice’s words, not binding on HHS or the public [20].

The conditions described in the policy read like a functional medicine chart: a single active ingredient from the list, a bulk substance from an FDA-registered original manufacturer with a certificate of analysis, adverse event reporting to MedWatch and the states, a label stating the product is a compounded drug not for resale, oral bioavailability documentation for oral forms, and a valid patient-specific prescription [20]. The codified list at 21 CFR 216.23 still names six substances and no peptide, so the six peptides remain offered for IND-authorized clinical trials through our pharmacy partner, with the sponsor’s IND number, sponsor details and protocol confirmed before any supply [20].

3. Is every preparation dispensed against a patient-specific prescription, and where would office-use stock come from?

The FDA laws page states that one condition of section 503A is that drugs are compounded on receipt of valid patient-specific prescriptions, while outsourcing facilities under section 503B are subject to CGMP, are inspected on a risk-based schedule, and may distribute in response to a provider order that is not for an identified patient [18]. A functional medicine practice that wants a vial on the shelf for an in-office infusion is asking a 503B question; a practice that writes a prescription after a visit and labs is asking a 503A question.

NAD+, glutathione, methylcobalamin, sermorelin and LDN through the ExaVeyra formulary are compounded by our 503A pharmacy partner against a patient-specific prescription and dispensed to the named patient, into states where the pharmacy holds a nonresident license (33 jurisdictions including Puerto Rico). A documented answer is the dispensing record per patient and, where any office stock exists, its separate 503B source and invoice.

The FDA pages supply the first two sentences of any compounding consent: compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they are marketed [18]. The grading table supplies the third: the row the compound sits in, stated in plain words, with the size and design of the best human study.

For compounds in the small-trial rows the consent carries the specific caution the literature gives. Toljan and Vrooman concluded in 2018 that the low-dose features of naltrexone have been only recently and still scarcely evaluated [10]; Grant and colleagues’ infusion study found no change in plasma NAD+ until after two hours and is pharmacokinetic, with no clinical endpoint [7]. A documented answer is a consent per compound, versioned and dated, that a patient can read in the time a long visit allows.

5. Several questions remain open in the published evidence

A functional medicine practice is used to working at the edge of the evidence, and stating the edge in writing is what makes the program defensible. The points below set out what the evidence does not yet show.

Clinical outcomes for NAD+ precursors: the randomized trials measured blood NAD and a six-minute walk in healthy adults, with the NMN trial’s first author employed by the sponsor [5, 6].
Intravenous NAD+: the only human data located are pharmacokinetic, from a pilot infusion study [7].
Glutathione: the six-month trial raised body stores, which returned to baseline after washout, and measured no clinical endpoint [8].
Low-dose naltrexone: the crossover trial enrolled 31 women, and its authors called for parallel-group trials; the review literature describes the field as scarcely evaluated [9, 10].
Secretagogues: few long-term controlled studies and no established long-term safety including cancer incidence [4]; the GHRH analogue trial enrolled 19 older adults [22].
GHK-Cu: small human trials on facial creams, with commercial interests in about 35 percent of the primary literature [3].
BPC-157 and the other animal-only peptides: no clinical safety data were found by the systematic review, and the HHS interim policy of October 2026 is an enforcement position rather than an evidence finding [1, 20].

6. How will the practice track outcomes for each compound?

A functional medicine practice already repeats laboratory panels, which makes biomarker tracking natural for the compounds whose trials measured biomarkers: blood NAD for the precursors [5, 6], glutathione in blood for oral glutathione [8], and B12 status with methylmalonic acid or homocysteine for methylcobalamin, as the deficiency literature describes [11, 12]. The chart records the baseline, the interval and the result against the trial’s own measure.

Patient-reported measures carry the rest. Anderson and colleagues’ 2024 umbrella review of 34 reviews found that low perceived value, complex instruments and delayed feedback were the main barriers to patient-reported outcome measures in routine practice, and that phased implementation, training, clear goals and integration into patient pathways enabled them [13]. A documented answer is one instrument per compound, scored at baseline and at each follow-up, with the result fed back at the visit.

A biomarker per compound where the trials measured one, with the interval written into the protocol
One validated patient-reported instrument per program, scored at baseline and each follow-up
A stopping rule: a compound without a measured change after the stated interval is reviewed with the patient
An adverse event route to MedWatch and the state, named in the protocol

7. How is pricing disclosed, and does any arrangement with the pharmacy raise an anti-kickback question?

The Office of Inspector General’s physician roadmap states that the Anti-Kickback Statute is a criminal law prohibiting the knowing and willful payment of remuneration to induce or reward referrals or the generation of business payable by federal health care programs, and that each party’s intent is a key element [14]. Heron and colleagues reviewed in-office dispensing in 2023 and concluded that it can be practiced ethically with careful consideration, while noting that physician opinion on the practice varies widely [14].

A documented answer has two parts. The first is a written fee schedule the patient sees before the first prescription, separating the visit, the labs and the preparation, with the pharmacy’s charge stated as the pharmacy’s. The second is counsel’s note on any arrangement between the practice and the pharmacy, read against the OIG page and any state fee-splitting rule, filed before the program opens [14].

The Federal Trade Commission’s Health Products Compliance Guidance applies to the program’s public pages: health benefit claims require competent and reliable scientific evidence, generally randomized, controlled human clinical testing, and testimonials may not convey claims the practice could not make directly [15]. A pricing page that lists the compound, the row it sits in and the fee says what the practice can substantiate.

8. What does the file for each patient and each compound contain?

The documentation question gathers the first seven into a checklist. A practice that can print the file for any patient has answered a board, a payer or a patient before the question is asked, and the long visit that defines functional medicine is where the file is built.

Question	Why it matters	What a documented answer looks like
1. Evidence grade per compound	Human RCTs exist for some compounds and none for others [1, 5, 8, 9]	A grading table with design, size and row, re-sorted as trials publish
2. Federal category status	FDA pages, the July 2026 committee and the HHS interim policy of 30 October 2026 [16, 17, 19, 20]	The pharmacy’s dated statement per compound with the federal pages as read
3. Patient-specific prescription	503A is conditioned on it; office stock is a 503B matter [18]	A dispensing record per patient and a separate 503B source for any stock
4. Compounding consent	Compounded drugs are not FDA-approved [18]	A versioned consent per compound naming its evidence row
5. Evidence limits	Biomarker trials show exposure, not outcome [5, 7, 8]	A limits statement in consent and marketing
6. Outcome tracking	PROM integration fails on value and feedback [13]	One biomarker and one instrument per compound with a stopping rule
7. Pricing and anti-kickback	AKS is criminal and turns on intent [14]; FTC governs claims [15]	A fee schedule the patient sees and counsel’s note on pharmacy arrangements
8. Documentation	The file is the program	Visit, labs, grade, consent, prescription, dispensing record, follow-up, outcome

A documented program opens the verified account

A functional medicine practice that answers the eight questions in writing holds a grading table, a dated category statement, a dispensing record, a consent per compound, an outcome plan, a fee schedule and counsel’s note. ExaVeyra Sciences connects that practice with our 503A pharmacy partner, which compounds sermorelin, NAD+, glutathione, methylcobalamin and LDN against a patient-specific prescription and holds nonresident licenses in 33 jurisdictions including Puerto Rico; each lot carries its certificate of analysis on request.

Anyone may ask the scientific team a question or apply without an NPI, and NPI verification, which takes one to three business days, gives access to the practitioner portal, product documentation and pricing. Practices that grade their compound list before they price it tend to find the conversation with patients easier, because the long visit already has the evidence on the table.

Educational Disclaimer: This article is for educational purposes only and does not constitute medical or legal advice. It does not identify any material, compound, device setting or protocol as safe, effective or appropriate for any patient, and it is not intended to diagnose, treat, cure, or prevent any disease. Questions about a treatment belong with the reader’s own licensed provider. Exosome material is supplied for topical aesthetic use by licensed practitioners. No exosome product is FDA-approved for any use, and ExaVeyra Sciences makes no statement about administration, route, or outcome. Compounded medications are not FDA-approved. They are prepared by a 503A compounding pharmacy licensed by the Texas State Board of Pharmacy for an individual patient against that patient’s prescription, and are available to NPI-verified licensed practitioners only, in the states where the pharmacy is licensed. Product, device and brand names mentioned are trademarks of their respective owners and are used only to identify the products discussed. Their mention is not an endorsement, and those owners have not reviewed or endorsed this article. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, or plan of care. Findings described are attributed to the peer-reviewed literature, trial registries and agencies cited. The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.

References

1.Vasireddi N, Hahamyan H, Salata MJ, Karns M, Calcei JG, Voos JE, et al. Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. HSS J. 2025;21(4):485-495. PMID 40756949. PMC12313605. doi:10.1177/15563316251355551Systematic review of PubMed, Cochrane and Embase to June 2024; 36 included studies, 35 preclinical and 1 clinical (a retrospective series of 12 patients). Carries in this article: the authors found no clinical safety data and rated the body of evidence level IV and V, which places BPC-157 in the animal-only row of the grading table. Disclosure: academic authors; none stated in the PubMed record.
2.Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026;56(8):1921-1935. PMID 41966639. doi:10.1007/s40279-026-02437-0Narrative review of approved and unapproved peptides marketed direct to patients, including BPC-157, CJC-1295, GHK-Cu, ipamorelin, MOTS-c, sermorelin, tesamorelin and TB-500. Carries in this article: the authors reported that favorable results come largely from animal models, that rigorous human safety data are scarce, and that social media amplifies a placebo effect. Disclosure: one author receives consulting fees from a device company for unrelated work.
3.Najafi N, Maatouk H, Vardanyan KG, Vartanian KB, Agrawal DK. A Systematic Review of the Mechanisms and Therapeutic Applications of GHK-Cu (Glycyl-L-Histidyl-L-Lysine-Copper Complex) in Topical Microneedle Delivery: A Case for Expanded Clinical Trials. Arch Intern Med Res. 2026;9(3):269-293. PMID 42787770. PMC13604022. doi:10.26502/aimr.0255PRISMA-mapped systematic review of GHK-Cu literature 2005 to 2026; 1,247 records screened, 64 retained and stratified by study model. Carries in this article: the authors described the human literature as thin, with most randomized trials small and conducted on facial cosmetic creams, which places topical GHK-Cu in the small-human-trials row. Disclosure: the authors note commercial interests among the authors of about 35 percent of the primary literature.
4.Sigalos JT, Pastuszak AW. The Safety and Efficacy of Growth Hormone Secretagogues. Sex Med Rev. 2018;6(1):45-53. PMID 28400207. PMC5632578. doi:10.1016/j.sxmr.2017.02.004Review of clinical studies of growth hormone secretagogues in human subjects. Carries in this article: few long-term, rigorously controlled studies exist, available studies indicate the compounds are well tolerated with some concern for blood glucose, and long-term safety including cancer incidence has not been established. Disclosure: NIH extramural support; no conflicts reported.
5.Yi L, Maier AB, Tao R, Lin Z, Vaidya A, Pendse S, et al. The efficacy and safety of β-nicotinamide mononucleotide (NMN) supplementation in healthy middle-aged adults: a randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial. Geroscience. 2023;45(1):29-43. PMID 36482258. doi:10.1007/s11357-022-00705-1Randomized, multicenter, double-blind, placebo-controlled 60-day trial in 80 healthy middle-aged adults. Carries in this article: blood NAD concentrations rose in all NMN groups at days 30 and 60 against placebo and baseline, six-minute walking distance rose against placebo, and no safety issues were found. Disclosure: the first author is employed by the sponsor company, stated in the record.
6.Martens CR, Denman BA, Mazzo MR, Armstrong ML, Reisdorph N, McQueen MB, et al. Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD(+) in healthy middle-aged and older adults. Nat Commun. 2018;9(1):1286. PMID 29599478. PMC5876407. doi:10.1038/s41467-018-03421-7Randomized, double-blind, placebo-controlled 2 x 6-week crossover trial in healthy middle-aged and older adults. Carries in this article: the authors reported that nicotinamide riboside was well tolerated and raised NAD+ metabolism, and framed blood pressure and arterial findings as hypotheses for future trials. Disclosure: the authors declared no competing interests.
7.Grant R, Berg J, Mestayer R, Braidy N, Bennett J, Broom S, et al. A Pilot Study Investigating Changes in the Human Plasma and Urine NAD+ Metabolome During a 6 Hour Intravenous Infusion of NAD. Front Aging Neurosci. 2019;11:257. PMID 31572171. PMC6751327. doi:10.3389/fnagi.2019.00257Pilot pharmacokinetic study of a six-hour intravenous NAD+ infusion in a human cohort, with plasma and urine metabolite measurement. Carries in this article: no change in plasma NAD+ or its metabolites was observed until after two hours, and urinary excretion of NAD+ and methylnicotinamide rose at six hours, the only human infusion data the table can cite. Disclosure: one author is affiliated with an infusion clinic, stated in the record.
8.Richie JP Jr, Nichenametla S, Neidig W, Calcagnotto A, Haley JS, Schell TD, et al. Randomized controlled trial of oral glutathione supplementation on body stores of glutathione. Eur J Nutr. 2015;54(2):251-263. PMID 24791752. doi:10.1007/s00394-014-0706-zSix-month randomized, double-blind, placebo-controlled trial of oral glutathione in 54 non-smoking adults. Carries in this article: blood glutathione rose at one, three and six months, by 30 to 35 percent in erythrocytes, plasma and lymphocytes in the higher group at six months, with a return to baseline after a one-month washout; the trial measured body stores and no clinical outcome. Disclosure: none stated in the PubMed record.
9.Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum. 2013;65(2):529-538. PMID 23359310. doi:10.1002/art.37734Randomized, double-blind, placebo-controlled crossover trial in 31 women with fibromyalgia. Carries in this article: the trial reported a 28.8 percent reduction in baseline pain with low-dose naltrexone against 18.0 percent with placebo, equal tolerability, and the authors’ call for parallel-group trials. Disclosure: NIH-supported academic study (Stanford).
10.Toljan K, Vrooman B. Low-Dose Naltrexone (LDN)-Review of Therapeutic Utilization. Med Sci (Basel). 2018;6(4):82. PMID 30248938. PMC6313374. doi:10.3390/medsci6040082Narrative review of low-dose, very-low-dose and ultra-low-dose naltrexone. Carries in this article: the authors concluded that the low-dose features of naltrexone have been only recently and still scarcely evaluated scientifically, the reason LDN sits in the small-trials row with a mechanism literature attached. Disclosure: the authors declared no conflict of interest.
11.Green R, Allen LH, Bjørke-Monsen AL, Brito A, Guéant JL, Miller JW, et al. Vitamin B12 deficiency. Nat Rev Dis Primers. 2017;3:17040. PMID 28660890. doi:10.1038/nrdp.2017.40Disease primer. Carries in this article: subclinical deficiency affects 2.5 to 26 percent of the general population depending on the definition, diagnostic biomarkers include total B12, holotranscobalamin, homocysteine and methylmalonic acid, and the Primer describes management by high-dose oral or parenteral supplementation, the laboratory frame for a methylcobalamin prescription. Disclosure: international academic authors.
12.Stabler SP. Clinical practice. Vitamin B12 deficiency. N Engl J Med. 2013;368(2):149-160. PMID 23301732. doi:10.1056/NEJMcp1113996Clinical practice review. Carries in this article: the review sets out the laboratory diagnosis of deficiency and the oral and parenteral replacement routes, the second reference for documenting a methylcobalamin prescription against a measured deficiency. Disclosure: journal clinical practice series.
13.Anderson M, van Kessel R, Wood E, Stokes A, Fistein J, Porter I, et al. Understanding factors impacting patient-reported outcome measures integration in routine clinical practice: an umbrella review. Qual Life Res. 2024;33(10):2611-2629. PMID 39023733. PMC11452453. doi:10.1007/s11136-024-03728-7Umbrella review of 34 reviews, January 2000 to June 2023, on patient-reported outcome measures in routine practice. Carries in this article: barriers included low perceived value, complex instruments and delayed feedback, and enablers included phased implementation, training, clear goals and integration into patient pathways, the frame for the outcome-tracking question. Disclosure: academic authors (Cambridge, Exeter).
14.Heron CE, Purvis CG, Balogh EA, Purvis RS, Feldman SR. Oversight of in-office dispensing and samples in dermatology. Clin Dermatol. 2023;41(2):271-278. PMID 37453714. doi:10.1016/j.clindermatol.2023.06.012 ; with U.S. Department of Health and Human Services, Office of Inspector General, Fraud & Abuse Laws (A Roadmap for New Physicians); verified 4 November 2026. https://oig.hhs.gov/compliance/physician-education/fraud-abuse-laws/Review of the oversight of in-office dispensing and samples, with the ethical concerns and the mitigations the authors describe. Carries in this article: the authors concluded that dispensing can be practiced ethically with careful consideration, and that opinions among physicians vary widely. The OIG page carries the statement that the Anti-Kickback Statute is a criminal law prohibiting knowing and willful payment of remuneration to induce or reward referrals or the generation of business payable by federal health care programs, and that intent is a key element. Disclosure: the senior author reports research, speaking and consulting support from multiple pharmaceutical companies, stated in the record.
15.Federal Trade Commission. Health Products Compliance Guidance. December 2022 (updates and replaces the 1998 Dietary Supplements advertising guide). Verified 4 November 2026. https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidanceAgency guidance under Sections 5 and 12 of the FTC Act. Carries in this article: health benefit and safety claims require competent and reliable scientific evidence, generally randomized, controlled human clinical testing, and testimonials may not convey claims that would be deceptive if made directly, the standard against which pricing pages and program descriptions are read.
16.U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Content current as of 05/14/2026; verified 4 November 2026. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-actAgency page describing the 503A bulks list, the three interim categories and the January 2025 guidance revision. Carries in this article: the agency does not intend to place substances nominated on or after 7 January 2025 into the categories, and category 1 substances may remain within the interim enforcement policy until the agency decides on inclusion or removes them on new safety information.
17.U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. Content current as of 04/22/2026; verified 4 November 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risksAgency page listing category 2 substances with the stated rationale and the substances withdrawn by their nominators. Carries in this article: BPC-157, CJC-1295, ipamorelin and GHK-Cu for injectable routes appear with immunogenicity and impurity rationales, and sermorelin, NAD+, glutathione, methylcobalamin and naltrexone do not appear on the page as read on 4 November 2026.
18.U.S. Food and Drug Administration. Human Drug Compounding Laws. Content current as of 12/17/2024; verified 4 November 2026. https://www.fda.gov/drugs/human-drug-compounding/human-drug-compounding-lawsAgency page summarizing sections 503A and 503B. Carries in this article: one condition of 503A is that drugs are compounded on receipt of valid patient-specific prescriptions; outsourcing facilities are subject to CGMP and may distribute on a provider order that is not for an identified patient, which is where office stock comes from; and compounded drugs are not FDA-approved.
19.U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee, Docket FDA-2025-N-6895. Content current as of 08/06/2026; verified 4 November 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026Meeting page with the agenda. Carries in this article: BPC-157, KPV, TB-500 and MOTs-C related substances were discussed on 23 July and emideltide, semax and epitalon related substances on 24 July; committee recommendations are advice, and a substance’s status is whatever the lists say until a rule places it on the 503A bulks list.
20.U.S. Department of Health and Human Services, Office of the Secretary. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances; notice of availability. 91 FR 68526-68527, 30 October 2026, Docket HHS-OASH-2026-0496, RIN 0910-ZD94; comments to 13 November 2026. Verified 4 November 2026. https://www.federalregister.gov/documents/2026/10/30/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances ; policy document: https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf ; with 21 CFR 216.23, the codified 503A bulks list (2025 edition, govinfo). https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol4/xml/CFR-2025-title21-vol4-sec216-23.xmlFederal Register notice read in full on 4 November 2026. Carries in this article: HHS announced a draft interim policy under which it does not intend to take enforcement action against a state-licensed pharmacy, federal facility or licensed physician compounding under section 503A with BPC-157, epitalon, KPV, MOTS-c, semax or TB-500, subject to ten conditions and route limits, while the bulks list is developed through rulemaking; the notice states that compounded drugs are not FDA-approved and that the draft is not binding. The codified list at 21 CFR 216.23 names six substances and no peptide. The policy document on hhs.gov returned HTTP 403 to automated retrieval on 4 and 5 November 2026, so the ten conditions are described at the level on which two independent legal summaries agree; the owner should read the appendix before this article ships.
21.Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924-926. PMID 18436948. PMC2335261. doi:10.1136/bmj.39489.470347.ADThe GRADE working group’s summary of its approach to rating quality of evidence and strength of recommendations. Carries in this article: the grading vocabulary (high, moderate, low, very low) the table borrows when it sorts compounds by the design and size of their human studies. Disclosure: GRADE working group.
22.Khorram O, Yeung M, Vu L, Yen SS. Effects of [norleucine27]growth hormone-releasing hormone (GHRH) (1-29)-NH2 administration on the immune system of aging men and women. J Clin Endocrinol Metab. 1997;82(11):3590-3596. PMID 9360512. doi:10.1210/jcem.82.11.4363Single-blind randomized placebo-controlled trial of five months in 19 healthy older adults (10 women, 9 men) given a GHRH(1-29) analogue. Carries in this article: integrated 12-hour growth hormone secretion rose 107 percent in men and 70 percent in women and IGF-I rose 28 percent by four weeks, with no adverse effects reported, one of the small human trials of a sermorelin-class analogue. Disclosure: academic authors (University of California, San Diego).
23.Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-157. PMID 18031173. doi:10.2165/00063030-199912020-00007Drug review from the period when sermorelin was an approved product. Carries in this article: the review described sermorelin as a growth hormone-releasing hormone analogue studied in children with idiopathic growth hormone deficiency, the product history behind its position in the table. Disclosure: Adis drug evaluation.

Frequently Asked Questions

How do peptides fit into a functional medicine practice?: They enter through the same long visit and laboratory workflow the practice already runs, sorted by evidence grade first: compounds with randomized human trials such as oral NAD+ precursors and oral glutathione, small-trial compounds such as LDN and sermorelin-class analogues, and animal-only compounds such as BPC-157 [1, 5, 8, 9]. Each is dispensed against a patient-specific prescription under section 503A [18].
What questions should a functional medicine peptide program answer first?: Eight: the evidence grade per compound, its federal category status as of the date asked, whether every preparation is patient-specific, what the compounding consent says, the evidence limits, how outcomes are tracked, how pricing is disclosed and whether any pharmacy arrangement raises an anti-kickback question [14], and what the file contains. The FTC standard governs the public pages [15].
How do I integrate peptides into functional medicine safely?: Grade each compound by its best human study, write a consent per compound that names the grade and that compounded drugs are not FDA-approved [18], track a biomarker and one patient-reported instrument per compound with a stopping rule [13], and keep a dispensing record per patient. Mendias and Awan reported that human safety data for most unapproved peptides are scarce [2].
What is the evidence for peptide protocols in functional medicine?: It varies by compound. Yi and colleagues’ 80-adult NMN trial raised blood NAD [5]; Richie and colleagues’ 54-adult trial raised glutathione stores [8]; Younger and colleagues’ 31-woman crossover of LDN reported a change in daily pain scores against placebo [9]. BPC-157 has 35 preclinical studies and one 12-patient series [1].
What should a functional medicine practice ask a 503A pharmacy?: Which compounds it prepares and under which 503A route or policy, its dated reading of FDA’s category pages and the HHS interim policy of 30 October 2026 [16, 17, 20], its nonresident license list, the certificate of analysis for each lot, the USP chapter behind each beyond-use date, and how it confirms the prescription is patient-specific as section 503A requires [18].
Is NAD+ evidence-based in functional medicine practice?: The human evidence is strongest for oral precursors: an 80-adult randomized trial of NMN raised blood NAD over 60 days [5], and Martens and colleagues reported that a crossover trial of nicotinamide riboside raised NAD+ metabolism and was well tolerated [6]. These trials tested oral precursors; for compounded NAD+ itself the located human data are pharmacokinetic, from a pilot six-hour infusion study [7].
What does glutathione do in functional medicine programs?: The randomized evidence concerns body stores: Richie and colleagues reported that six months of oral glutathione in 54 adults raised blood glutathione by 30 to 35 percent in the higher group, with levels returning to baseline after a one-month washout [8]. The trial measured no clinical endpoint, which is the sentence a consent and a pricing page carry.
Can a functional medicine practice compound BPC-157 in 2026?: As of 4 November 2026, 21 CFR 216.23 names no peptide, and HHS’s draft interim policy of 30 October 2026 states it does not intend to take enforcement action against 503A compounding of six peptides including BPC-157 under ten conditions, while calling the draft non-binding [20]. Through the ExaVeyra formulary BPC-157 is offered for IND-authorized clinical trials through our pharmacy partner.
Can a clinic keep compounded peptides in office stock?: A 503A pharmacy compounds on receipt of a valid patient-specific prescription, and the FDA laws page places distribution on a provider order that is not for an identified patient with 503B outsourcing facilities [18]. Office stock for in-office administration therefore comes from a 503B outsourcing facility, which the same page describes as subject to CGMP and risk-based inspection [18]. Preparations through the ExaVeyra formulary are compounded by our 503A pharmacy partner against a patient-specific prescription and dispensed to the named patient.
Does the anti-kickback statute apply to peptide pricing in a cash practice?: The OIG page describes the Anti-Kickback Statute as a criminal law covering remuneration to induce business payable by federal health care programs, with intent a key element [14]. A cash program still faces state fee-splitting rules and the FTC advertising standard [15], so a written fee schedule and counsel’s note on any pharmacy arrangement belong in the file either way.

The monthly FDA and state law roundup

One email a month for licensed practices: FDA actions, compounding updates and state law changes that affect what you can source, each with its official source linked.

No spam. Unsubscribe any time.

For Clinics

Apply for Clinic Access

NPI-verified clinic access to our full catalog.

Apply for Clinic Access →

Sourcing Guide

Exosome Sourcing

What to look for: COA, particle count, and quality standards.

Read guide →

Compliance Guide

503A and 503B, Explained

How compounding pharmacies work, and what to ask before you order.