Insights/Which Peptides Are Legal? What Your Business Can Offer, Dispense and Advertise in 2026
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FUSE Health · 19 min read · June 22, 2026

Which Peptides Are Legal? What Your Business Can Offer, Dispense and Advertise in 2026

Which Peptides Are Legal_ What Your Business Can Offer, Dispense and Advertise in 2026 - FUSE
TLDR

Which peptides are legal depends on your structure, not the molecule. Six peptides got an FDA advisory nod in July 2026 and none of them became legal to compound. Here is what your business can offer, dispense and advertise today, with the date it was last checked.

Which peptides are legal? Fewer than your supplier's catalogue suggests, and far fewer than the internet decided in July.

On 23 and 24 July 2026, an FDA advisory committee voted to recommend six peptides for the 503A Bulks List. BPC-157 cleared 8 to 6 with one abstention. TB-500 and KPV, the same margin. MOTS-c went 7 to 5, Semax 8 to 5, Epitalon 7 to 4. One substance, emideltide, was voted down 7 against to 6 for. Within about a week, half the market had decided peptides were legal again.

They aren't. As of 6 August 2026, not one of those six can be lawfully compounded, and no peptide has ever been added to the 503A Bulks List by rule. FDA's own scientific reviewers recommended against all seven before the committee overruled them.

That gap, between what operators believe and what's actually true, is where peptide programs die. Not at launch. Three months in, when a pharmacy refuses the order, a processor freezes the account, or an ad platform pulls certification, and the whole funnel stops at once.

So this page does something the other results for this question don't. It answers it from your side of the desk: what can my business legally offer, dispense and advertise, today, with a date on it.

The three questions hiding inside "are peptides legal"

Most operators ask one question and get three answers, which is why the internet looks contradictory.

The first question is whether the FDA has approved the peptide as a drug. For almost every peptide people want to sell, the answer is no. The second is whether you can sell it without a prescription. Almost always no, and the exceptions are narrower than the research-use-only peptide market pretends. The third is the one that actually decides your business: if a prescription is required, is there a pharmacy that can legally fill it?

Which Peptides Are Legal_The three questions hiding inside are peptides legal - FUSE

That third question is where the money is, and it's the one nobody answers. A peptide can be prescribable in theory and unfillable in practice, because no pharmacy has a lawful route to compound it. BPC-157 sits exactly there right now. A prescriber can write it. No 503A pharmacy can lawfully make it. The prescription is a piece of paper.

So which peptides are legal is really four questions stacked: the peptide's federal compounding status, the licence of whoever prescribes, the type of pharmacy that dispenses, and the state your customer is standing in. Change any one of those four and the answer changes. That's not a loophole, and it isn't a technicality. It's the actual structure of the rule.

The Operator Legality Ledger: which peptides are legal today

Below is every peptide operators ask us about most, with where it stands on 6 August 2026. Read it by column, not by row. The peptide name tells you almost nothing on its own. "Who can supply it" is the column that decides whether you have a business.

One column that no other guide includes: what you're allowed to say in advertising. A peptide can be lawful to dispense and still get your ad account and your LegitScript certification pulled if you name it in a campaign. Those are two different regimes and operators conflate them constantly.

Group 1 · FDA-approved products

SubstanceStatus todayWho can supply itWhat ads may saySport (WADA 2026)Verified
Semaglutide (Ozempic, Wegovy, Rybelsus)Approved. Compounding contested.Retail or 503A, patient-specific only, with documented clinical justificationMay name the branded product. Do not advertise a compounded copy.Not listed6 Aug 2026
Tirzepatide (Mounjaro, Zepbound)Approved. Compounding contested.Same as aboveSame as aboveNot listed6 Aug 2026
Liraglutide (Victoza, Saxenda)Approved. Still on the FDA shortage list.Retail or 503A; shortage pathway remains live while the shortage standsSame as aboveNot listed6 Aug 2026
Tesamorelin (Egrifta SV / WR)Approved. Compoundable as a component of an approved drug.503A or retail, subject to the copy rulesMay name the branded productProhibited, S2.2.46 Aug 2026
Bremelanotide / PT-141 (Vyleesi)Approved. Compoundable as a component of an approved drug.503A or retail, subject to the copy rulesMay name the branded productNot prohibited6 Aug 2026

Group 2 · Compoundable today

SubstanceStatus todayWho can supply itWhat ads may saySport (WADA 2026)Verified
SermorelinCategory 1 on the 503B list, flagged as a component of an approved drug503BDescribe the program, not the moleculeProhibited, S2.2.46 Aug 2026
GHK-Cu (non-injectable only)Category 1 on the 503A list, except injectable routes503A, topical and other non-injectable routesDescribe the program, not the moleculeNot named6 Aug 2026
NAD+Category 1 on the 503A list503ADescribe the program, not the moleculeNot listed6 Aug 2026
GlutathioneCategory 1 on the 503A list503A or 503BDescribe the program, not the moleculeNot listed6 Aug 2026
Enclomiphene citrateCategory 1 on the 503A list503ADescribe the program, not the moleculeProhibited as a clomifene component, S4.26 Aug 2026
OxytocinUSP monograph exists503A or 503BDescribe the program, not the moleculeNot listed6 Aug 2026
HCGUSP monograph; also approved as Pregnyl and Novarel503A, 503B or retailMay name the branded productProhibited in males, S2.2.16 Aug 2026

Category 1 means FDA has said it does not intend to act against compounders using the substance while it finishes evaluating. It is not the Bulks List and it is not permanent. Treat it as permission that can be withdrawn, and build your catalogue so that losing one substance does not take the program down.

Group 3 · Recommended by the July 2026 committee, still not lawful to compound

SubstanceStatus todayWho can supply itWhat ads may saySport (WADA 2026)Verified
BPC-157Recommended 8-6-1. Not compoundable. No monograph, not a component of an approved drug, not on the Bulks List.NobodyDo not name in any adProhibited, named in S06 Aug 2026
TB-500 / Thymosin beta-4Recommended 8-6-1. Not compoundable.NobodyDo not name in any adProhibited, named in S2.36 Aug 2026
KPVRecommended 8-6-1. Not compoundable.NobodyDo not name in any adNot named6 Aug 2026
MOTS-cRecommended 7-5-2. Not compoundable.NobodyDo not name in any adProhibited, named in S4.4.16 Aug 2026
SemaxRecommended 8-5-1. Not compoundable.NobodyDo not name in any adNot named6 Aug 2026
EpitalonRecommended 7-4-1. Not compoundable.NobodyDo not name in any adNot named6 Aug 2026

This is the group the market believes changed in July. It did not. A committee recommendation is advice to the FDA. Adding a substance to the 503A Bulks List takes notice-and-comment rulemaking, and as of 6 August 2026 no proposed rule has been published.

Group 4 · Withdrawn, rejected, or restricted

SubstanceStatus todayWho can supply itWhat ads may saySport (WADA 2026)Verified
Emideltide / DSIPVoted down 7 against to 6 for, 24 July 2026NobodyDo not nameNot named6 Aug 2026
CJC-1295Nomination withdrawn by the nominator. Off the 503A list entirely, in no category.NobodyDo not nameProhibited, S2.2.46 Aug 2026
AOD-9604Nomination withdrawn. Off the 503A list entirely.NobodyDo not nameProhibited, named in S2.2.36 Aug 2026
Selank acetateNomination withdrawn. Off the 503A list entirely.NobodyDo not nameNot named6 Aug 2026
Thymosin alpha-1Withdrawn from 503A. Category 3 on the 503B list.NobodyDo not nameNot named6 Aug 2026
Ipamorelin acetateWithdrawn from 503A. Category 2 on the 503B list.NobodyDo not nameProhibited, S2.2.46 Aug 2026
Kisspeptin-10Category 2 on the 503A list.NobodyDo not nameProhibited, S2.2.16 Aug 2026
GHRP-2Category 2 for injectable and nasal routes on the 503B listLimited: 503B, non-injectable and non-nasal routes onlyDo not nameProhibited, S2.2.46 Aug 2026
GHRP-6Category 2 on the 503B listNobodyDo not nameProhibited, S2.2.46 Aug 2026
Ibutamoren mesylate (MK-677)Category 2 on both lists. The most restricted substance on the page. Not a peptide, but routinely bundled with them.NobodyDo not nameProhibited, S2.2.46 Aug 2026
Melanotan II, LL-37, dihexa acetate, PEG-MGFRemoved from Category 2 in April 2026, never placed in Category 1. Queued for a committee meeting before the end of February 2027.NobodyDo not nameNot named6 Aug 2026

What the July 2026 peptide vote actually changed

Procedurally, almost nothing. That's not cynicism; it's just how the machinery works, and understanding it is worth more to you than any headline.

The Pharmacy Compounding Advisory Committee advises. It doesn't legislate, and it doesn't issue rules. For a peptide to become compoundable under 503A, FDA has to put it on the Bulks List, and that takes notice-and-comment rulemaking: a proposed rule in the Federal Register, a comment window, a review of what came back, then a final rule. FDA isn't bound by the committee either. This time, its own reviewers argued the other way on all seven peptides.

Which Peptides Are Legal_What the July 2026 peptide vote actually changed - FUSE

We checked on 6 August 2026. No proposed rule has been published, nothing sits on the Federal Register public inspection list, and neither nomination list has moved since 14 May. The most recent proposed rule touching the 503A Bulks List still dates from September 2019.

What did change is commercial pressure. Your customers read the same headlines. Suppliers have started quoting BPC-157 as though July settled something. If you sell peptides, you are about to spend the next two quarters explaining to people why you won't sell them the thing a Forbes headline said was becoming legal. Build the explanation now, and it becomes a trust asset. Improvise it later, and it reads like an excuse.

One honest caveat, because it cuts against us. FDA has a second option: it could extend enforcement discretion through guidance rather than waiting on a rule, which would move much faster than rulemaking. It hasn't. If it does, the group-three rows above change quickly, and the changelog at the foot of this page is where you'll see it.

Who can prescribe, who can dispense, and where you actually sit

Four roles, and most operators only own one of them.

The prescriber is a licensed clinician acting inside their state scope with a real patient relationship. The pharmacy is either a state-licensed 503A or a registered 503B outsourcing facility, and which one you need depends entirely on the substance. The platform carries the intake, the clinical review, the routing and the records. The marketer is you: brand, storefront, customer relationship, growth.

Here is the part that trips people up. If you're a coach, an influencer, a supplement brand, or a med spa without a prescriber on staff, you cannot dispense anything. Not with a disclaimer, not through a partner who ships on your behalf, not by calling it research material. What you can do is own the storefront and the customer while a licensed prescriber and a licensed pharmacy sit behind it in a defined workflow. That distinction is the entire business model, and it's legal specifically because the roles stay separate.

503A and 503B, in one screen

A 503A pharmacy compounds for a named patient against a prescription. It can only use a bulk substance if that peptide has a USP or NF monograph, is a component of an FDA-approved drug, or appears on the 503A Bulks List. Three routes, and every peptide has to clear one of them.

A 503B outsourcing facility can make batches without patient-specific prescriptions, but only from substances on its own clinical-need list or from drugs currently in shortage. FDA has finalised five substances on that clinical-need list. Not one is a peptide.

That's why the "who can supply it" column reads "nobody" so often. It isn't that the peptide is banned. It's that neither statutory door opens for it.

The research-use-only trap in peptide sales

Search for how to sell peptides online and the top answers will walk you through research-use-only peptide labelling, high-risk payment processors and how to keep a Google Merchant account alive. It's practical advice for a model that doesn't survive contact with a regulator.

Research-use-only is a statement about intended use. It holds when the peptide genuinely goes to research and the marketing matches. It stops holding the moment anything on your site, in your email flow, in a creator's caption, or in a customer service reply suggests a person should put it in their body. Dosing charts break it. Reconstitution guides break it. Before-and-after photos break it. A testimonial breaks it. The label on the vial doesn't decide intended use. Your marketing does.

FDA sent more than 55 warning letters to online sellers in this space on 16 September 2025, and misleading direct-to-consumer marketing was the through-line. The enforcement risk is real, but it usually isn't what ends the business first. What ends it first is infrastructure. Processors classify you as high risk and hold your funds. Ad platforms deny certification. Then a supplier disappears, and you find out your COAs came from a lab you never verified.

The prescription pathway is slower to set up and considerably harder to knock over. That's the whole trade.

How to sell peptides online legally: the five layers

This is the part operators want and rarely get in one place. Five layers, in this order, because each one depends on the one before it.

Which Peptides Are Legal_How to sell peptides online legally the five layers - FUSE
  • Layer one: entity and licensure

Decide what your company is before you decide what it sells. A brand that owns a storefront and routes to independent clinicians is a different regulated animal from a company that employs prescribers. Several states now register med spas directly. Indiana starts requiring registration with its Medical Licensing Board on 1 January 2027, under an act signed on 5 March 2026. Get this wrong, and every layer above it inherits the problem.

  • Layer two: the prescriber network

You need clinicians licensed in every state you sell into, not a single physician with a broad-sounding title. Coverage gaps show up as silent order failures: the customer pays, the order sits, nobody can tell them why. Async review works in most states for most of these categories. Some require synchronous contact or an in-person exam for particular drug classes, and those rules move.

  • Layer three: pharmacy routing

One pharmacy relationship is a single point of failure, and it will fail, usually at the worst time. Capacity fills. A pharmacy decides to stop compounding a peptide. A licence lapses in a state that happens to be 20 percent of your volume. Route across more than one, and know which type each is, because a 503B cannot fill a 503A-only peptide and no amount of goodwill changes that.

  • Layer four: state verification before approval

Every order needs a check of peptide against state before anyone approves it. At ten customers you can do this in a spreadsheet. At a hundred you can't, and at a thousand the spreadsheet is a liability with a filename. This has to be automated, and it has to run before approval rather than as a reconciliation afterwards. Interstate shipping adds its own layer: nearly every state requires a non-resident pharmacy licence before a pharmacy can ship in, so a 50-state footprint means roughly 50 licences and renewals sitting behind your checkout.

  • Layer five: advertising compliance

Build this last, and it will invalidate the four layers beneath it. Google and Microsoft both require LegitScript certification for pharmacy and telemedicine advertisers. LegitScript reviews the whole site, not the ad. Name a Category 2 substance anywhere on your storefront, and the certification fails regardless of how careful the ad copy is.

If you want the storefront side of this in more detail, our guide to HIPAA-compliant storefront setup covers the technical layer, and the pharmacy comparison guide covers how to evaluate a partner.

What you can and cannot say

Advertising is governed separately from dispensing, and the line is not where most operators assume.

Which Peptides Are Legal_Which Peptides Are Legal_What you can and cannot say - FUSE

You are allowed to say that you offer a clinical program, that a licensed clinician evaluates eligibility, and that medications, if prescribed, are dispensed by a licensed pharmacy. Compounding pharmacies have been permitted to advertise since the Supreme Court struck down the original restriction in Thompson v. Western States Medical Center in 2002, and Congress removed it from the statute in 2013.

What you cannot do is make disease or treatment claims for a peptide FDA has not approved. The FTC standard is competent and reliable scientific evidence, which for a health benefit claim means randomised controlled human trials. Animal data doesn't clear it. Mechanism doesn't clear it. Testimonials need the same underlying substantiation as the claim they imply, which is why creator content is the most common place a compliant peptide program springs a leak.

The practical rule we give operators: advertise the program, not the molecule. It is a smaller promise, and it is the one you can keep.

The state layer: where the federal peptide answer stops being enough

Federal status is the floor. Which peptides are legal in practice also depends on the state your customer is in, and four states have moved recently enough to matter.

California rewrote its "essentially a copy" rules, operative 1 October 2025. A compounded preparation now needs a documented clinically significant difference for the individual patient, and the pharmacist has an affirmative duty to verify it. If any part of your program touches compounded GLP-1s, this is the rule that governs your economics.

Indiana enacted Senate Enrolled Act 282 on 5 March 2026. From 1 July 2026, any bulk substance used in compounding must come from an FDA-registered facility with a valid certificate of analysis. From 1 January 2027, med spas register with the Medical Licensing Board.

Louisiana went the other way. Senate Bill 30 lifted the state's prohibition on treating obesity via telehealth, which had blocked a category of program outright.

Florida is the useful counter-example. Two bills, SB 860 and HB 877, would have restricted compounded weight-loss drugs. Both died in committee on 13 March 2026. Florida law is unchanged, and if a vendor tells you otherwise, they are working from a headline rather than the bill tracker.

We don't publish a 50-state grid, and the reason is boring: we couldn't keep one accurate. A state gets a row here when someone has verified it against the board or the statute. Silence in the table means unverified, not permitted.

Where peptide programs actually break

Five failure patterns, in rough order of how often we see them.

Reading a committee recommendation as a rule change is the newest and currently the most common. An operator sees the July headlines, decides BPC-157 is one of the legal peptides now, adds it to the catalogue, takes orders, and discovers at the pharmacy that there was never a route to fill them.

Building on one pharmacy is the oldest. Concentration risk in a supply chain where a single partner can decide unilaterally to stop compounding a whole category of peptides.

Launching in a home state and assuming it generalises. The peptide catalogue is built and marketed before anyone checks the states where the audience actually lives, and a meaningful slice of demand turns out to be unservable.

Treating advertising as a marketing problem rather than an infrastructure one. The program is compliant, the storefront names a restricted substance, LegitScript declines, and paid acquisition is dead before it starts.

And manual compliance that works until it doesn't. Checking substance against state by hand is survivable at ten orders and impossible at a thousand. The failure is not gradual. One order goes to the wrong state, the pharmacy flags it, and everything downstream stops at once.

What to do with this in the next 30 days

Take your current or planned peptide catalogue and run every item against the "who can supply it" column above. Anything that reads "nobody" comes out today, including from the pages nobody visits, because LegitScript reads the whole site.

Which Peptides Are Legal_What to do with this in the next 30 days - FUSE

Then check your prescriber coverage against the states your traffic actually comes from rather than the states you meant to launch in. Those two lists are rarely the same, and the difference is usually the reason orders are stalling.

The operators who come through the next twelve months intact won't be the ones who guessed right about which peptides are legal next. They'll be the ones whose structure absorbs the change without anyone touching the storefront. FUSE Health is built for exactly that: peptide status and state rules mapped in advance, verification that runs before approval instead of after, multiple pharmacy routes, and payments and certification configured before the first order rather than after the first problem.

You own the brand and the customer. The rules underneath stay current whether or not you're watching them.

Disclaimer

This page is general information for businesses about regulatory status. It isn't legal or medical advice, it isn't guidance on the use of any substance, and it doesn't recommend any treatment. Regulatory status changes. Check the "last verified" date on the row you're relying on and confirm with your own counsel and your pharmacy partner before acting.

Changelog

DateChange
6 Aug 2026Page rebuilt. Ledger created with 30 substances. Added the outcome of the 23-24 July 2026 committee meeting with vote counts. Corrected the status of CJC-1295, AOD-9604, selank acetate, thymosin alpha-1, and ipamorelin acetate to reflect that their nominations were withdrawn. Corrected liraglutide: still on the FDA shortage list. Confirmed no FDA rulemaking published as of this date.

References

  1. U.S. Food and Drug Administration, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks, content current 22 April 2026.
  2. U.S. Food and Drug Administration, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A, updated 14 May 2026.
  3. U.S. Food and Drug Administration, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B, updated 21 March 2025.
  4. U.S. Food and Drug Administration, 503B Bulk Drug Substances List.
  5. U.S. Food and Drug Administration, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee.
  6. Federal Register, doc. 2026-07361, Pharmacy Compounding Advisory Committee; Notice of Meeting, 16 April 2026, docket FDA-2025-N-6895.
  7. U.S. Food and Drug Administration, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, revised January 2025.
  8. Holland & Knight, FDA Advisory Committee Endorses Compounding of Certain Peptides, 4 August 2026.
  9. Buchanan Ingersoll & Rooney, FDA PCAC Recommends Six Peptides for the 503A Bulks List, 4 August 2026.
  10. McDermott Will & Schulte, Bulk List Bound: PCAC Backs Majority of Peptides in Two-Day Public Meeting, 27 July 2026.
  11. Bass, Berry & Sims, FDA Advisory Committee Recommends Six Peptides for Compounding, 31 July 2026.
  12. Mintz, FDA's Advisory Committee Votes on Peptides: What It Does and Doesn't Do, 29 July 2026.
  13. openFDA Drug Shortages database, liraglutide, records current to 13 July 2026.
  14. California State Board of Pharmacy, Compounded Drug Preparations, regulatory action 2025-0507-02, filed with the Secretary of State 19 June 2025, effective 1 October 2025.
  15. Indiana Senate Enrolled Act 282 (2026), Public Law 136-2026, signed 5 March 2026.
  16. Florida Senate, SB 860 (2026) and HB 877 (2026), both died in committee 13 March 2026.
  17. Federal Trade Commission, Health Products Compliance Guidance, 20 December 2022.
  18. Federal Trade Commission, Health Breach Notification Rule, effective 29 July 2024.
  19. Thompson v. Western States Medical Center, 535 U.S. 357 (2002).
  20. World Anti-Doping Agency, The 2026 Prohibited List, in force 1 January 2026.
Daniel Meursing
Daniel Meursing
CEO

Daniel is a two-time founder who has scaled service businesses across major U.S. markets. A Y Combinator competition winner, he focuses on removing operational and regulatory barriers so operators can build and scale modern healthcare businesses.

Background
Startup Operations & Service Systems
Experience
2x Founder, Multi-Market U.S. Scaling
Qualifications
Healthtech Market Expertise & Operational Scaling
Key Achievement
Scaled Premier Staff & Eventstaff across major U.S. markets

Frequently Asked Questions

Which peptides are legal to sell right now?
The legal peptides today are those that are FDA-approved products, those that are components of approved drugs such as tesamorelin and bremelanotide, and those sitting in Category 1 under FDA's interim policy, including sermorelin, NAD+, glutathione, and enclomiphene citrate. Every other peptide in the Ledger above has no lawful route today.
Do I need a licence to sell peptides?
You personally may not, but someone in the chain must. A licensed clinician has to prescribe, and a licensed pharmacy has to dispense. What you own is the storefront, the brand and the customer relationship. If nobody in your setup holds a prescriber licence and a pharmacy licence, you don't have a compliant program.
Is it illegal to sell peptides online?
Selling a prescription-required substance without a prescription is unlawful. Selling under research-use-only labelling while marketing it for human use is also unlawful, because your marketing determines intended use, not your label. Selling through a licensed prescriber and a licensed pharmacy is lawful, provided the substance has a compounding pathway.
Did the July 2026 FDA vote make BPC-157 legal?
No. The Pharmacy Compounding Advisory Committee recommended six peptides for the 503A Bulks List on 23 and 24 July 2026. A recommendation is advice. Adding a substance to the list requires notice-and-comment rulemaking, and no proposed rule had been published as of 6 August 2026. BPC-157 remains unlawful to compound.
Can a med spa legally sell peptides?
Yes, if three things are true: a licensed prescriber evaluates each customer, a pharmacy of the right type dispenses, and the substance has a lawful compounding pathway in that customer's state. A med spa without a prescriber cannot dispense. Several states now also require the med spa itself to register.
What is the difference between a 503A and a 503B pharmacy?
A 503A compounds for a named patient against a prescription, using substances with a USP monograph, substances that are components of approved drugs, or substances on the 503A Bulks List. A 503B produces batches without patient-specific prescriptions, but only from its clinical-need list or from drugs currently in shortage. No peptide is on either bulks list.
Are peptides controlled substances?
No. Not one of the peptides in the Ledger above is federally scheduled by the DEA. That surprises people who assume peptides are treated like anabolic steroids. Not being scheduled is not the same as being available, though, and the compounding rules are what actually constrain which peptides you can sell.
Will peptides affect athlete customers in competition?
Several are on the WADA 2026 Prohibited List by name, including BPC-157, TB-500, MOTS-c, kisspeptin-10, sermorelin, tesamorelin, ipamorelin, CJC-1295 and AOD-9604. The WADA column in the Ledger tracks this. If you serve competitive athletes or work with coaches, it belongs in your intake.
What happens to my program if the rules change?
That depends on how it was built. If a single substance carries your revenue, a Federal Register notice can end the program. If state rules, substance status, and pharmacy routing sit in configuration rather than in someone's head, a status change is an update, not an outage. This page is reviewed monthly and the changelog on the page records every change.

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