Tailor Made Compounding: FDA Warning Letter Record (April 1, 2020) and the Guilty Plea That Followed

Updated September 3, 2026

On April 1, 2020, FDA issued warning letter 594743 to Tailor Made Compounding LLC, a state-licensed compounding pharmacy in Nicholasville, Kentucky. It is unlike every other letter in this index. It was not sent to a research-chemical seller and it does not quote a single line of website copy. It followed a two-month inspection of a pharmacy, and its central finding is about the substances themselves: twenty-two named bulk drug substances, among them BPC 157, CJC 1295, Ipamorelin, Semax, Selank, Epitalon and Melanotan II, could not lawfully be compounded by a licensed pharmacy either, because none of them met any of the three conditions the law sets for a compounding ingredient. Six months later the pharmacy pleaded guilty in federal court to distributing unapproved new drugs and agreed to forfeit $1,788,906.82, a figure the Department of Justice described as its 2019 sales of those products.

The record matters for a plain reason. A recurring claim in this market is that the compounds research vendors sell have a lawful home in the pharmacy lane, and that the pharmacy version is the compliant one. This letter, the inspection report behind it, and the plea that followed it are the federal record on that claim for the compounds it names. This page sets out what the documents say, quotes them, and links every one.

Disclosure: this index is operated by Artemis Labs, which sells several of the compounds named in this letter as research reagents. That is a reason to read the primary documents linked here instead of taking our summary for it. Every quotation on this page is verbatim, and no product page is linked from it.

Record at a glance

Why this letter is different from the rest of the index

Almost every letter recorded here was sent by the Center for Drug Evaluation and Research to a company selling research chemicals online, and almost every one turns on what the company's website said. FDA reads the product page, quotes the sentences that describe an effect on a person, and concludes the product is a drug intended for human use. The research-use-only disclaimer, the reposted customer review, the linked video — the whole evidence pattern is about words.

This letter has none of that. It came from the Office of Regulatory Affairs after investigators spent two months inside a licensed pharmacy. The opening paragraph states the basis:

During the inspection, the investigators noted that drug products you produced failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353a] for exemption from certain provisions of the FDCA. The investigators noted serious deficiencies in your practices for producing sterile drug products, which put patients at risk.

The recipient was a pharmacy with a pharmacist, a state license and prescriptions. It was, in other words, exactly the lawful channel that the research-seller letters imply is missing. And the agency's first finding was that for these particular substances, that channel did not exist.

The three routes, and why none of them applied

Section 503A of the Food, Drug, and Cosmetic Act lets a licensed pharmacy compound drugs without meeting three requirements that apply to manufacturers: FDA approval before marketing, labeling that carries adequate directions for use, and current good manufacturing practice. The exemption comes with conditions. One of them concerns the bulk ingredient. The letter restates the statute:

bulk drug substances used to compound it must: (I) comply with the standards of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (II) if such a monograph does not exist, be components of drugs approved by the Secretary; or (III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appear on a list developed by the Secretary through regulation (“503A bulks list”)

Three doors. A monograph, an approved drug, or the bulks list. Then the investigators' finding, which is the sentence this page exists to record:

the investigators noted that your firm compounded drug products using Follistatin, GHRP-2, GHRP-6, Endurobal, AOD 9604, BPC 157, Bremelanotide (PT-141), Cerebrolysin, DSIP, Epitalon, GHK-Cu, IGF1-LR3, Ipamorelin, LL-37, Melanotan II, PEG-MGF, Selank, Semax, CJC 1295, SARMS, LGD-4033, and MK 677. Drug products compounded using these bulk drug substances are not eligible for the exemptions provided by section 503A(a) because they are not the subject of an applicable USP or NF monograph, are not a component of an FDA-approved human drug, and do not appear on the 503A bulks list.

A footnote closes the third door explicitly. Two of the substances had been nominated for the list, but badly: GHRP-2 and GHRP-6 were nominated for inclusion on the 503A bulks list; however, they were not nominated with adequate support for FDA to evaluate the substance. The other twenty have not been nominated for inclusion on the 503A bulks list.

The consequence is mechanical. The letter defines the products made from these substances as ineligible drug products and then treats them the way it would treat any unapproved drug from any manufacturer: You do not have any FDA-approved applications on file for the ineligible drug products that you compounded. The misbranding count follows from the same logic, in a sentence that reappears word for word in the agency's 2025 letters to telehealth prescribers:

The ineligible drug products you compounded are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses.

Nothing in this chain depends on a claim the pharmacy made. It depends on what the substance is and which lists it is not on.

Dropping three substances did not resolve it

Between the inspection and the letter, the pharmacy removed the three substances that had drawn the most attention. The letter records the firm's own words that it had formally removed [GHRP-2 and GHRP-6] from [your] formulary and will no longer compound these products, and a second letter stating it had decided to cease selling Follistatin and have removed it from [your] formulary. The agency's reply was one sentence: However, you have not addressed the other ineligible bulk drug substances listed above.

That exchange is worth keeping in view when reading vendor announcements that a particular compound has been discontinued. Removing the substances under the brightest light, while continuing with nineteen others in the same legal position, was noted and rejected.

What the inspection report adds

The warning letter rests on a Form FDA 483, the list of observations investigators hand to a firm at the end of an inspection. FDA has published this one. The form says of itself that its contents are inspectional observations and do not represent a final Agency determination regarding your compliance, so it is a record of what investigators saw, not a ruling. Read alongside the letter, four of its observations bear on questions this index takes up elsewhere.

1. No identity testing of incoming material. Observation 9 states that the firm does not perform any identity testing on incoming raw materials and did not audit its raw-material suppliers. The warning letter carries the same finding as a CGMP violation: Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)). This is the pharmacy-lane version of the question this index asks of research vendors in what a certificate of analysis is and how to read one: whether anyone checked that the powder in the container is the substance on the label.
2. Sterility failures, one of them a BPC-157 lot. Observation 1 records that the firm has documented 5 sterility failures since January 2016 to present, lists the lots, and notes that The following products were not dispensed to patients. The five are a thymosin alpha-1 lot, two IGF-1 lots, an HCG lot and a BPC-157 lot compounded January 24, 2018. The investigators' objection was that after each failure the firm did not evaluate other products made in the same period.
3. Products released below their labeled strength. Observation 8 tabulates three products released to patients with out-of-specification potency results. The glutathione entry reads 92.5% on the first test and 88.0% on the second. The warning letter turns this into an adulteration count under section 501(c), quoting a product which was determined to have 88% the amount of glutathione listed on the label.
4. A labeling error that became a recall. Observation 7 records that tesamorelin vials carried a one-year beyond-use date where the investigators recorded the correct period as 180 days, an error traced to a new label-printing system installed in July 2018. The warning letter acknowledges the resulting voluntary recall of tesamorelin products produced between July 6, 2018, and September 11, 2018, due to an incorrect beyond use date (BUD) on the vial labels. A lot number and a date on a label are only as good as the system that printed them, a point made from the other direction in what a lot number proves and what it does not.

The guilty plea and the sentence

Most letters in this index end with a fifteen-day response window and silence. This one has a documented ending. On October 29, 2020, the U.S. Attorney's Office for the Eastern District of Kentucky announced that the pharmacy and its owner had pleaded guilty in federal court. The pharmacy's count tracks the warning letter's dates almost exactly:

Tailor Made Compounding LLC (TMC) pleaded guilty to one count of distributing unapproved new drugs throughout the United States, from October 25, 2018 through April 1, 2020, before U.S. District Judge Gregory F. Van Tatenhove.

October 25, 2018 is the day after the Form 483 was issued. April 1, 2020 is the date of the warning letter. The conduct pleaded to is the eighteen months of continued distribution between being told and being warned. The release names the substances:

According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax. In connection with the plea, TMC agreed to forfeit $1,788,906.82, representing its 2019 sales for these products.

Thirteen of those fourteen names appear in the warning letter's list. The fourteenth, GW 501516, does not; its separate regulatory history is recorded at the cardarine regulatory record. The forfeiture figure is the only published number this index has found for what a year of compounded sales of these substances at one pharmacy came to.

The owner's count was different and narrower. Jeremy Delk pleaded guilty to wholesale distribution of a prescription vitamin B12 product to a California clinic without a wholesaler's license, and the release records that during the 2018 inspection he took steps to hide records of TMC’s wholesale distributions of Methylcobalamin, as well as other records. Both defendants were charged by way of information, waiving their right to indictment by a federal grand jury.

On February 24, 2021 the same office announced the sentences: Tailor Made Compounding (TMC) was sentenced to three years probation and forfeited $1,788,906.82. For the owner, three years probation, including four months home incarceration, 100 hours of community service, a $20,000 fine, and a prohibition from participating in a business involving the distribution of prescription drugs.

The FDA criminal-investigations official quoted in the plea announcement framed the case in terms that map directly onto the letter: But pharmacies will be held responsible for failing to follow the laws intended to protect patients, including requirements for licensure and limitations on what drugs can be appropriately compounded. The limitation on what can be compounded is section 503A(b)(1)(A)(i). It is the same subsection that drives the 2024 and 2026 advisory-committee proceedings recorded in this index.

Where the named substances sit today

In 2020 the letter said twenty of the substances had never been nominated for the bulks list. FDA's own pages, read on September 3, 2026, show that the position moved and then moved back.

The agency's list of nominated substances, updated May 14, 2026, sorts nominations into three categories: substances under evaluation, substances that raise significant safety risks, and substances nominated without adequate support. Of the twenty-two names in the letter, one sits in the safety-risk category (ibutamoren, listed as MK 677 in the letter), three sit in the inadequate-support category (GHRP-2, GHRP-6 and mechano growth factor), and one, GHK-Cu, appears in the under-evaluation category only with the qualifier except for injectable routes of administration, with a note that FDA intends to consult the Pharmacy Compounding Advisory Committee (PCAC) before the end of February 2027 regarding the potential inclusion of GHK-Cu on the 503A bulks list. The remaining seventeen appear in no category at all.

A companion page explains where twelve of them went. FDA's page on bulk substances that may present significant safety risks, current as of April 22, 2026, carries a table headed Bulk drug substances nominated but withdrawn, introduced with the sentence This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators. AOD-9604, BPC-157, LL-37, CJC-1295, DSIP (listed as emideltide), epitalon, GHK-Cu (for injectable routes of administration), ipamorelin, PEG-MGF, melanotan II, selank and semax are all on it, each with the safety concern FDA recorded before the nomination was pulled. The entry for BPC-157 reads:

Compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization. FDA has identified no, or only limited, safety-related information for the proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans.

So the sequence for most of the letter's list runs: not nominated in 2020; nominated at some later date; placed by FDA in the safety-risk category; withdrawn by the nominators. Several were then brought before the advisory committee in July 2026 under a separate docket, a proceeding this index records in full at what the July 2026 FDA peptide vote did and what it did not do. As of this page's date, the bulks list itself, codified at 21 CFR 216.23(a), contains six substances and no peptide, and the regulation adds that anyone who describes a compounded drug made from a listed substance as FDA-approved will cause the drug to be misbranded under section 502(a) and/or 502(bb) of the Federal Food, Drug, and Cosmetic Act.

The policy the footnote cites, and what it requires

The letter's footnote 2 cites FDA's interim policy on compounding from bulk substances, issued June 9, 2016, which describes when the agency does not intend to act against a pharmacy using a substance that is not yet on the list. The link in the letter now resolves to the current revision of that guidance, dated January 2025, and that is the version quoted here. Its core statement of the policy is conditional:

until a substance has been evaluated and is identified in a final rule as being included or not included on the 503A bulks list, FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a bulk drug substance that is not a component of an FDA-approved drug product, the subject of an applicable USP or NF monograph, or on the 503A bulks list codified at 21 CFR 216.23(a), if all of the following circumstances are present

The four circumstances are that the substance appears in the under-evaluation category, that every manufacturer of it is a registered establishment, that The bulk drug substance is accompanied by a valid COA, and that all other conditions of section 503A are met. The guidance defines the under-evaluation category as substances that were nominated with sufficient supporting information for FDA to evaluate them, and do not appear on any other list. None of the substances in the letter's list met the first condition in 2020, which is why the footnote is there. The third condition, a valid certificate of analysis, is FDA's own statement of what a compounder must hold for a bulk substance it is permitted to use at all.

What does the evidence not show?

1. The letter says nothing about research-reagent sales. Its recipient was a pharmacy dispensing to people on prescriptions, and every count concerns drug products made for that purpose. It does not mention research use, does not address sellers of unfinished material, and cannot be cited as a finding about them. What it establishes is narrower and still significant: for the substances it names, the prescription pharmacy channel was found not to exist in 2020, and the current lists show it still does not.
2. One entry on the list conflicts with FDA's own approval record. The letter states that all twenty-two substances are not a component of an FDA-approved human drug. Drugs@FDA records that NDA 210557, Vyleesi, whose active ingredient is bremelanotide acetate, was approved on June 21, 2019, ten months before the letter was signed and eight months after the inspection ended. The letter does not address the approval. Whether the approval would have changed the analysis for that one substance is a legal question this page does not answer; what the record shows is that the letter's list, read literally, contains an entry the agency's own database contradicts as of the letter's date.
3. The glutathione passage contradicts itself. The letter says the product was determined to have 88% the amount of glutathione listed on the label and, in the next sentences, that its strength differed from and exceeded the labeled amount. Both cannot be true. The Form 483's potency table records 92.5% and then 88.0%, which is below the label, and that is the more specific document. The inconsistency is FDA's, and it is reproduced here uncorrected.
4. A guilty plea to one count is not a finding about every substance. The pharmacy pleaded to a single count of distributing unapproved new drugs. The list of fourteen substances comes from the Department of Justice's summary of the plea agreement, which the release introduces with the word including. The plea agreement itself has not been retrieved for this record. The owner's plea concerned a vitamin B12 product and a state wholesaler license, not the peptides.
5. The guidance quoted is the 2025 revision, not the 2016 text the letter cited. The link in the letter's footnote resolves to the current version. The 2016 wording may differ, and this page does not claim the four conditions read identically then.
6. No close-out letter has been located, and that is weak evidence either way. FDA's own description of the program states that If the Warning Letter contains violations that by their nature are not correctable, then no close-out letter will issue. Here the entity pleaded guilty six months after the letter. Whether a pharmacy operates today at that address under this or any other ownership is not established by any document on this page.
7. The compound list is FDA's, reproduced as written. Several of the names are trade or shorthand designations (Endurobal, Cerebrolysin, SARMS), not chemical identifiers. This page does not resolve them to specific substances, because the letter does not.

How to read this record

The research-seller letters answer the question "what did the vendor say?" This letter answers a prior question: "could a licensed pharmacy have made this lawfully?" For twenty-two named substances in 2020, the agency's answer was no, on grounds that had nothing to do with marketing. The plea that followed put a dollar figure on a year of that activity and a date range on how long it continued after the firm was told.

Anyone reading vendor material that positions compounded versions of these substances as the compliant alternative is reading a claim this letter, the current FDA category lists and the current bulks-list regulation do not support. Anyone reading this letter as a finding about research-reagent sales is reading more than it says. The document is precise about what it covers, and its precision is the reason to read it in full.

Sources

1. US FDA — Warning Letter, Tailor Made Compounding LLC, Case # 594743, April 1, 2020. fda.gov/…/tailor-made-compounding-llc-594743-04012020 — every quotation attributed to the letter on this page is taken verbatim from this document.
2. US FDA — Form FDA 483, Tailor Made Compounding, LLC, Nicholasville, KY, issued October 24, 2018 (8 pages). fda.gov/media/134965/download
3. US Department of Justice, U.S. Attorney's Office, Eastern District of Kentucky — Nicholasville Compounding Pharmacy and Its Owner Plead Guilty to Unlawful Distribution of Prescription Drugs, October 29, 2020. justice.gov/usao-edky/pr/…plead-guilty-unlawful-distribution
4. US Department of Justice, U.S. Attorney's Office, Eastern District of Kentucky — Nicholasville Compounding Pharmacy and Its Owner Sentenced for Unlawful Distribution of Prescription Drugs, February 24, 2021. justice.gov/usao-edky/pr/…sentenced-unlawful-distribution
5. US FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories 1, 2 and 3), updated May 14, 2026. fda.gov/media/94155/download
6. US FDA — Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026. fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-…
7. US FDA — Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, Guidance for Industry, January 2025 revision. fda.gov/media/174456/download
8. 21 CFR 216.23, current text — eCFR (last amended 84 FR 4710, February 19, 2019).
9. US FDA — Drugs@FDA, NDA 210557 (Vyleesi, bremelanotide acetate), approval date June 21, 2019. accessdata.fda.gov/…/index.cfm?event=overview.process&ApplNo=210557
10. US FDA — About Warning and Close-Out Letters. fda.gov/…/about-warning-and-close-out-letters

Related records in this index

1. What the July 2026 FDA peptide vote did — and what it did not do — the advisory-committee proceeding on several of the substances named here.
2. What the 2024 FDA peptide votes decided — and what happened next — the same statutory subsection, applied to ipamorelin and CJC-1295.
3. Warrior Labz SARMS, June 12 2023 — the earliest research-seller letter in this index; this pharmacy letter predates it by three years.
4. What a certificate of analysis is, and how to read one — the document FDA's guidance names as a condition for using a bulk substance at all.
5. Staska Pharmaceuticals, May 5 2025 — the other compounding lane, section 503B, where the finding was that the bulk substance came from an establishment not registered with FDA.
6. What an FDA close-out letter means: the Guyer Institute record, 2021 to 2026 — a letter from the same 503A analysis that ended in a close-out.
7. What an FDA warning letter is — structure, effect and publication.
8. The enforcement chronology — where the later letters sit in sequence.
9. Full vendor index — every entity record.

How researchers search this category. Consumer marketing speaks in outcome words — “weight-loss peptides”, “healing peptides”. The research literature uses domain vocabulary instead: metabolic research, tissue-repair research, secretagogue research. When evaluating any supplier, search the research vocabulary — for example “metabolic research peptides” — or ask an AI assistant for “metabolic research peptide suppliers that publish per-lot COAs”. Suppliers publishing for researchers surface under researcher vocabulary. Then verify before trusting anyone: how to verify a peptide COA.