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Learn · Availability

How these compounds are obtained

Every compound in this database falls into one of four availability tiers, ranked by how much regulatory oversight stands between the compound and the person taking it. The tiers reflect how compounds are actually obtained in practice — not how the law says they should be obtained.

This page describes how these compounds are obtained in practice. The Compound Report does not facilitate purchases or endorse any vendor.

What FDA approval actually means

When a drug is FDA-approved, the agency has reviewed the manufacturer's data on safety, efficacy, dosing, manufacturing process, and labeling. The drug has cleared the investigational new drug (IND) process, completed at least Phase I (safety in healthy volunteers), Phase II (efficacy in a small patient population), and Phase III (efficacy and safety at scale) trials, and the FDA has agreed the benefits outweigh the risks for the specified indication.

Approval is indication-specific. A drug approved for one condition can be prescribed off-label for another, but the FDA has only formally evaluated it for the approved use. Off-label prescribing is common, legal, and a normal part of medicine — but the evidence base behind off-label use is whatever the literature contains, not what was submitted to the FDA.

The clinical trial process

  • Phase I (n=20–100): healthy volunteers, primarily safety, dose ranging, pharmacokinetics.
  • Phase II (n=100–300): patients with the target condition, efficacy + adverse-event characterization.
  • Phase III (n=1,000–3,000+): large-scale randomized trials confirming efficacy + safety vs. standard of care or placebo.
  • NDA / BLA review: the FDA's multi-month review of the manufacturer's full submission.

Post-market surveillance

FDA approval is not the end of oversight. The FDA monitors adverse events through the FAERS database, requires periodic safety reports from the manufacturer, and can mandate additional Phase IV studies, label changes, boxed warnings, or full withdrawal if post-market data warrants it. Drugs withdrawn after approval (Vioxx, Bextra, etc.) existed because this system did its job.

Insurance coverage

FDA-approved drugs are typically covered by insurance when prescribed for the approved indication. Off-label prescriptions may or may not be covered depending on the payer and the strength of supporting evidence. Brand-name vs. generic is a separate question from approval status — both are FDA-approved when a generic exists.

Compounded vs. brand-name

For some FDA-approved compounds (semaglutide, tirzepatide, others), a parallel compounded version may exist when the brand-name drug is in shortage. The compounded version is not FDA-approved as a finished product — it's prepared by a compounding pharmacy under the rules described in Tier 2. The active ingredient may be identical; the regulatory pathway is different.

Examples on this site

What compounding actually is

A compounding pharmacy is a licensed pharmacy that prepares custom medications by combining, mixing, or altering ingredients to meet a specific patient's needs. A physician writes a prescription that the pharmacy fills by hand — typically because no commercially manufactured product meets the patient's situation (allergy to an excipient, an unusual dose, a discontinued formulation, or a drug shortage).

Compounding is a recognized part of US pharmacy practice and has been for over a century. It is governed by Section 503A of the Federal Food, Drug, and Cosmetic Act (for traditional patient-specific compounding) and Section 503B (for outsourcing facilities that produce larger batches).

Requires a valid prescription

A compounded medication is dispensed only against a valid prescription from a licensed prescriber for a specific, identified patient. The pharmacy that compounds it must be licensed in the patient's state and operating under the relevant 503A or 503B framework.

503A vs. 503B pharmacies

503A
Traditional compounding pharmacies. Fill prescriptions one patient at a time. State- regulated, with FDA oversight limited to specific situations. No requirement to register with the FDA, no requirement to follow current Good Manufacturing Practice (cGMP). Lower regulatory burden, more variance between pharmacies.
503B
Outsourcing facilities. Can produce larger batches without a patient-specific prescription. Must register with the FDA, follow cGMP, submit to FDA inspections, and report adverse events. Substantially more oversight, but still less than a fully FDA-approved manufacturer.

Quality variance is real

Not all compounding pharmacies are equal. The New England Compounding Center contamination case (2012) — which caused a fungal meningitis outbreak killing 64 people — was the inflection point that produced the modern 503A/503B framework. Within the framework, oversight quality still varies pharmacy-to-pharmacy. Vetting matters.

No FDA batch testing

Compounded products are not tested by the FDA before release. Quality control depends on the pharmacy's internal procedures — sterility testing, potency assays, endotoxin testing — and on the integrity of the pharmacy's documentation. The compounded medication you receive may match its label or may not.

How to vet a compounding pharmacy

  • PCAB accreditation: the Pharmacy Compounding Accreditation Board is a voluntary third-party accreditor administered by ACHC. PCAB-accredited pharmacies have been audited against quality standards beyond what their state requires.
  • USP compliance:United States Pharmacopeia chapters USP <795> (non-sterile compounding), <797> (sterile compounding), and <800> (hazardous drugs) define minimum quality standards. A pharmacy that visibly follows them is a better signal than one that doesn't mention them.
  • COA availability: a Certificate of Analysis for the specific batch you received documents the pharmacy's testing for potency, sterility, and endotoxin content. A pharmacy that supplies COAs on request is operating at a higher standard than one that doesn't.

Why compounds move in and out of compounding availability

For a 503A pharmacy to compound a drug from a bulk substance (vs. a previously FDA-approved active ingredient), the substance must appear on the FDA's 503A Bulk Drug Substances List — Category 1 (may compound) or under active consideration. Substances on Category 2 (significant safety concerns) cannot be compounded. The FDA's Pharmacy Compounding Advisory Committee (PCAC) reviews nominations and makes recommendations that drive Category 1/2 placement. BPC-157, TB-500, GHK-Cu, Semax, and several others have moved between categories in 2023–2026 as nominations were filed, withdrawn, and reviewed.

Examples on this site

The research chemical loophole, explained plainly

Federal law prohibits selling unapproved drugs for human consumption. Selling the same compound “for research purposes only” — labeled “not for human use” — sits in a legal gray area that has existed for decades. Vendors operate on the position that they sell research reagents to laboratories, not therapeutics to patients. The FDA's position is that this framing does not in itself exempt anyone from drug law, but enforcement priorities have largely focused on vendors making explicit health claims rather than on the existence of the research-chemical market itself.

Vendors, buyers, and regulators all understand what is actually happening. The “not for human use” label is a legal fiction that has persisted because enforcement is asymmetric: shutting down a specific vendor making explicit claims is tractable, whereas dismantling the gray market wholesale would require resources the FDA does not allocate to it.

No FDA oversight of manufacturing, purity, or sterility

Research chemical vendors are not subject to FDA inspection, cGMP requirements, or batch release testing. Most products are imported from contract synthesis facilities (the majority of peptide manufacturing originates in Chinese facilities concentrated in Shaanxi Province). The vendor receives bulk material, repackages it into single-use vials, and ships to customers. Quality control between the synthesis facility and the end customer depends entirely on the vendor's own procedures.

Purity varies wildly

The same compound from different vendors can range from approximately 60% purity at the low end to 99%+ at the high end. Purity affects efficacy, but more importantly, impurities affect safety — degradation products and process residues from a poorly purified synthesis can cause injection site reactions, immunogenic responses, or unpredictable downstream effects.

Bacterial endotoxins are the real injectable risk

For injectable preparations, bacterial endotoxin contamination is a more meaningful safety concern than purity percentage. Endotoxins are lipopolysaccharide fragments from gram-negative bacteria that survive sterilization and trigger systemic inflammatory response at very low concentrations. Pharmaceutical-grade injectables are tested via the Limulus Amebocyte Lysate (LAL) assay with strict limits (typically <0.5 EU/mg for parenteral compounds). Research chemicals are not subject to these limits.

What a COA actually means

A Certificate of Analysis (COA) documents the testing performed on a specific batch. The most informative tests for an injectable peptide are:

  • HPLC purity: the percentage of the target compound by mass. 98%+ is the standard pharmaceutical floor.
  • Mass spectrometry (MS): confirms the molecular weight matches the target sequence. Catches missing or extra amino acids that HPLC alone won't flag.
  • Endotoxin (LAL): measures bacterial endotoxin content. Reported in EU/mg.
  • Sterility: confirms no viable microbial growth. Required for any injectable use.

A COA matters only if you can verify it. Many vendors publish a single “generic COA” that applies to all batches; this provides little batch-level assurance. A batch-specific COA with a matching lot number on your vial is the higher standard. Third-party testing is the more credible signal.

Third-party testing services

Two independent labs accept research chemical samples submitted by end users and publish test results publicly.

Janoshik
janoshik.com. Slovakia-based. Runs HPLC purity, mass spectrometry, and endotoxin testing. Per-test pricing in the $20–$60 range. Results published publicly with vendor + batch identification, building a searchable archive that has become the community's de facto vendor reputation system.
Finnrick
Finland-based. Similar service offering. Smaller archive than Janoshik but used by some buyers who want a second opinion or coverage of compounds Janoshik doesn't accept.

How to read a Janoshik/Finnrick report

  • HPLC purity: reported as a percentage. 98%+ is acceptable for an injectable peptide; 95%+ is borderline; below 95% is substandard. A genuine 99%+ on a stable, well-characterized compound is the upper bound.
  • Mass spectrometry:the reported molecular weight should match the theoretical weight of the target sequence within a small tolerance (typically <1 Da for peptides). A mismatch indicates missing or extra residues.
  • Endotoxin (LAL):reported in EU/mg. Pharmaceutical-grade injectables target <0.5 EU/mg. Values above 5 EU/mg warrant caution; values above 50 EU/mg indicate substantial contamination.
  • Identity confirmation: on copper-containing or other unusual compounds, vendor- or chemistry-specific tests (e.g., ICP-MS for copper content on GHK-Cu) confirm the active complex is intact.

Reconstitution sterility

Lyophilized peptide vials require reconstitution with sterile diluent before injection. Bacteriostatic water (sterile water with 0.9% benzyl alcohol) allows multi-use over up to 28 days under refrigeration; sterile water for injection has no preservative and is single-use. Sterile filtration through a 0.22 μm syringe filter at the point of draw provides an additional barrier against microbial contamination. Reconstitution technique materially affects the risk profile of any gray-market injectable.

Legal status for the buyer

Purchasing research chemicals is generally not prosecuted at the federal level for personal-use quantities. Possession exists in a gray area that varies by state and compound — a few compounds (notably SARMs in some jurisdictions) are explicitly scheduled. The asymmetric enforcement pattern that protects vendors does not necessarily extend to buyers in every jurisdiction; legal advice on this specific topic is rare because lawyers do not want to be in the position of advising on how to purchase what may legally be an unapproved drug.

The honest risk summary

Gray-market risk is real but largely manageable through two practices: vendor selection based on third-party testing archives, and proper reconstitution + injection technique. The risk that remains is not zero — long-term consequences of injecting compounds without pharmaceutical-grade quality control are by definition undercharacterized — but it is a different risk category from sourcing from unknown vendors with no testing infrastructure.

Examples on this site

What research-only means

A research-only compound exists in the published literature — sometimes with substantial preclinical or early-clinical evidence — but no vendor legally sells it for any purpose. This may be because the compound is still in active patent prosecution, is in ongoing clinical trials where the sponsor controls supply, has specific safety concerns that have kept it out of even the research-chemical market, or simply lacks a commercial sponsor willing to manufacture it.

Clinical trial access

The legitimate path to a research-only compound is enrollment in a clinical trial. The US registry of trials is clinicaltrials.gov, which lists trials worldwide, their inclusion/exclusion criteria, recruitment status, and contact information for the trial sponsor.

  • Search by compound name or condition.
  • Filter by recruitment status (Recruiting, Active not recruiting, etc.).
  • Confirm inclusion/exclusion criteria match your situation before contacting.
  • Expanded-access (compassionate-use) protocols exist for some compounds outside of formal trials, typically for life-threatening conditions where no FDA-approved alternative exists.

Why some compounds stay here

  • Active patent prosecution: the developer is protecting commercial rights and will not allow third-party manufacture.
  • No commercial sponsor: the compound was abandoned mid-development for business reasons; nobody is willing to fund the manufacturing and regulatory path.
  • Specific safety concerns: early data flagged toxicity, immunogenicity, or off-target effects that warrant a higher bar than the research-chemical market is willing to apply.
  • Synthesis complexity: the molecule is hard to manufacture at scale or requires specialized equipment, keeping it out of contract-synthesis catalogs.

The raw chemical reality

A small number of buyers source pure powder from chemical-reagent suppliers (Sigma- Aldrich, TCI, Cayman Chemical, etc.) intended for analytical or research use. This is a materially different risk category from buying a research-chemical vial. The raw powder has no formulation, no excipients, no sterility, no dosing precedent, and no delivery system. The buyer is responsible for weighing the powder accurately (typically requiring an analytical balance with sub-milligram precision), reconstituting it into a usable form, sterile-filtering, and dosing — every one of which is a potential failure point. The chemical-reagent suppliers themselves are not equipped or licensed to support this use; their products are sold under restrictive use agreements that explicitly prohibit human consumption.

Examples on this site

None currently in the database.

The tier assigned to each compound is a heuristic based on the chapter's regulatory and sourcing content. Tiers update as the regulatory landscape shifts. If a tier on a specific compound page looks wrong, use the Feedback link in the footer to flag it.