In our recent update on peptide regulation, we noted that the FDA is only one layer of the compliance picture. For any company with exposure to multi-state compounding or telehealth operations — whether as an operator, a brand manufacturer monitoring the competitive landscape, or an investor — a jurisdiction-by-jurisdiction breakdown of state requirements is essential. This post maps how states are currently regulating the compounding of GLP-1 receptor agonists (semaglutide and tirzepatide chief among them), along with the broader class of peptides now drawing federal and state attention, and offers practical cross-jurisdictional risk insights.[1]
States generally do not set their own substantive baseline for what may lawfully be compounded. That eligibility baseline is fixed federally, chiefly by Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), and that baseline is largely uniform across the country. Where states diverge, and diverge sharply, is in how aggressively they enforce and what sourcing and quality conditions they impose on top of the federal baseline. For a multi-state operator, that distinction is the difference between a defensible program and a false sense of security.
Two Federal Tracks Moving in Opposite Directions
Before turning to the states, it is important to distinguish between two federal developments moving in opposite directions — one for peptides generally, and the other for GLP-1s (which are also peptides) specifically.
The first is the peptide track, where the current administration has been loosening restrictions imposed by the prior administration. In 2023, the FDA placed a group of popular peptides into Category 2 of the interim 503A bulk substances scheme, effectively barring their compounding on safety grounds. In April 2026, FDA removed twelve of those peptides from Category 2 and scheduled a Pharmacy Compounding Advisory Committee (“PCAC”) meetings to consider several of them for inclusion on the 503A Bulks List (Category 1). To be clear, removal from Category 2 does not constitute a federal or state authorization to compound, but the removed peptides were not moved into Category 1. These peptides sit in a regulatory gray zone: no longer explicitly flagged as presenting a significant safety risk, but not affirmatively cleared for compounding either.[2]
The second is the GLP-1 track, and restrictions are tightening. The GLP-1 receptor agonists were never on the 503A or 503B Bulks Lists. Their compounding was permitted only through the drug shortage pathway under Section 503A of the FD&C Act, and that pathway has closed as FDA resolved the tirzepatide and semaglutide shortages.[3] FDA has since reinforced its position through compliance policy guidance on what constitutes compounding “essentially a copy” of an FDA-approved drug under Section 503A(b)(2),[4] a proposal to exclude these molecules from the 503B Bulks List, and successive waves of dozens of warning letters to compounders and telehealth marketers of compounded GLP-1 products.[5]
The upshot is that the substantive federal rules for GLP-1 copies are now reasonably settled and restrictive, while the peptide rules remain in flux. As the state survey below shows, nearly every state that has taken a position has done so with respect to GLP-1 compounding specifically, not the broader peptide category.
What the Market Looks Like Right Now
Regulatory pressure has reshaped commercial activity in many ways. Compounders and telehealth platforms are pivoting toward so-called “personalized” or combination formulations, such as semaglutide paired with vitamin B12 or other additives, and toward non-standard strengths and microdoses, in an effort to distinguish their products from FDA-approved, innovator drug counterparts. However, the FDA has signaled that adding B12 alone is generally insufficient to escape “essentially a copy” treatment. Other trends include a shift to oral and sublingual dosage forms, aggressive cash-pay pricing through telehealth channels, and growing interest in investigational GLP-1s and other peptides as the semaglutide and tirzepatide pathways narrow.
Brand manufacturers have responded with enforcement activity of their own. Two large pharmaceutical companies, Lilly and Novo Nordisk, have filed trademark, patent, and false advertising suits across dozens of jurisdictions, and at least one compounder has countersued on antitrust grounds. For brand manufacturers, these private enforcement actions complement, and in some states outpace, regulatory enforcement.[6]
The State Overlay: A Floor That Only Goes Up
The most important structural feature of the state landscape is that no state can fall below the federal compounding standard. A state board of pharmacy can impose stricter requirements, but it cannot relax federal ones. The real question, then, is not whether a state “bans” or “allows” compounding of these products, but how much it adds on top of the federal floor and how actively it enforces.
State approaches can be categorized into five broad groups, ranging from a single strict outlier to a silent majority.
The Outlier: California
The outlier is California — the one state that has codified a substantive standard stricter than federal law. Its comprehensively rewritten compounding regulations, effective October 1, 2025, tighten the “essentially a copy” analysis by requiring pharmacists to verify and document a clinically significant, patient-specific difference. They also impose California-specific conditions, including a requirement that the certificate of analysis name the active ingredient manufacturer, not merely the distributor.[7]
The Enforcers: Ohio and Washington
The enforcers are Ohio and Washington. Both issued GLP-1-specific board guidance that largely restates federal law, but both have demonstrated a willingness to enforce. Ohio’s July 2025 guidance treats semaglutide and tirzepatide as no longer compoundable as copies post-shortage, expressly prohibits the investigational peptides retatrutide and cagrilintide, and requires that active ingredients be purchased from an Ohio-licensed distributor. Ohio’s pharmacy board also reports summarily suspending more than thirty clinics and medical spas since the beginning of 2025.[8][9] Similarly, Washington’s Pharmacy Quality Assurance Commission issued a semaglutide statement and then took concrete action, imposing a stop-service order on a GLP-1 sterile compounder for sterile compounding and licensure failures.[10][11] The takeaway is that in these states, the primary source of risk is the board’s willingness to act, not whether the underlying rule differs from the federal standard.
The Guidance States
The guidance states, such as Alabama and New Jersey, have issued position statements or declaratory rulings addressing semaglutide compounding, typically prohibiting salt forms and requiring pharmaceutical-grade active ingredients from an FDA-registered source with a valid certificate of analysis, but without adding an enforceable state rule beyond the federal standard or a comparable enforcement record.[12][13] Alabama is a notable variation, as it reached physician-office compounding through a companion declaratory ruling from its medical board rather than the pharmacy board alone. A few additional states fall into this bucket, generally through similar board statements or agency newsletters.[14]
The Consumer Protection Route
The consumer protection route is exemplified by Connecticut, where the pharmacy regulator has taken no GLP-1 position, but the Attorney General has run an active enforcement campaign under the state’s unfair trade practices statute against distributors, med spas, and clinics.[15] Illinois and South Carolina show a similar pattern. In these states, enforcement comes downstream at the consumer protection level, not at the compounding license level. For companies, this is an easily overlooked source of exposure, as it targets marketing and sales conduct regardless of what the pharmacy board has said.
The Silent Majority
The silent majority is the largest group. Texas and Florida are representative in that neither has an official GLP-1 or peptide-specific board position, and both regulate compounding through general frameworks that already incorporate the “essentially a copy” limitation under the FD&C Act and applicable United States Pharmacopeia (“USP”) chapters.[16] Florida’s sterile compounding rule goes a step further, expressly tying the state’s sterile compounding standards to the federal FD&C Act, including Section 503A (21 U.S.C. 353a).[17] Most states sit here, resting on the federal floor.
A related distinction matters when weighing each state’s position. Only California has enacted a GLP-1-relevant rule with the force of law. Nearly everything else in the “stricter” column, such as board guidance, newsletters, position statements, and Attorney General consumer alerts, informs enforcement but does not carry the same legal force as a promulgated regulation. Anyone building a compliance matrix should pay as much attention to the legal form of a state's position as to its substantive content.
Where This Is Headed
Because most states default to the federal standard, the federal trajectory largely drives the state trajectory. If FDA moves peptides onto the 503A Bulks List or otherwise loosens restrictions, the many federal default states will effectively loosen with it, without any state action required. The friction points that will persist are threefold. California will likely remain a distinct compliance jurisdiction because it has codified its own standard. The enforcement-heavy states like Ohio and Washington will likely remain higher risk regardless of where the substantive rule lands, because the risk in those states stems from the boards’ willingness to pursue disciplinary action. And the consumer protection channel, exemplified by Connecticut, will likely continue to police marketing and sales conduct independent of compounding law.
Practical Considerations for Market Participants
For companies operating in or monitoring this space, the elements below reflect the approaches taken in the most restrictive states and represent risk mitigation techniques that may reduce both regulatory and manufacturer litigation exposure:
- Active ingredients should be pharmaceutical grade and never labeled “research use only”, sourced from an FDA-registered establishment, and accompanied by a valid certificate of analysis. Certain states, including California, further require that the certificate identify the actual manufacturer, not merely the distributor.
- Where a compounded product contains a molecule that is a component of an approved drug, the base form of that molecule should be used rather than a salt form. Multiple state boards treat a salt form as a different active ingredient, which may render it ineligible for compounding.
- Investigational GLP-1 receptor agonists, such as retatrutide and cagrilintide, should be avoided entirely. These molecules lack an approved reference product and are expressly prohibited in certain jurisdictions.
- When a compounded product differs from an approved drug, the compounder should document a clinically significant, patient-specific reason for the variation. Relying on trivial additions, such as the inclusion of vitamin B12 alone, is unlikely to withstand scrutiny under the "essentially a copy” standard.
- Marketing claims require the same rigor as the compounding itself. The most active consumer protection and FDA enforcement actions have targeted promotional materials that create the impression a compounded product is FDA-approved or therapeutically equivalent to the branded version. Promotional language and advertising should be reviewed with this enforcement focus in mind.
Conclusion
The state layer is real, but it is widely misread. For the substantive question of what may be compounded, almost everywhere the answer is to look to federal rules, with California being the lone state to have written a stricter rule. The true state-to-state variation lies in enforcement intensity, sourcing conditions, and in a few states, a consumer protection posture that operates outside compounding law altogether. As the federal peptide process advances, states that merely mirror federal law will likely follow it, while a small set of jurisdictions will become or continue to pose distinct compliance challenges. Meanwhile, brand manufacturer litigation adds a private enforcement layer that operates independently of any state regulatory posture. Companies that anchor their compliance programs to disciplined sourcing, documented clinically significant differences, avoidance of investigational substances, adherence to USP standards, and restrained marketing practices will be best positioned to operate across jurisdictions as the regulatory landscape continues to evolve.
*Ethan Nikfar was a summer associate in the firm's Century City office.
FOOTNOTES
[1] Sheppard, What to Watch: Status Update on Peptide Regulation (June 15, 2026).
[2] See Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act | FDA; and Pharmacy Compounding Advisory Committee; Notice of Meeting, 91 Fed. Reg. 20465 (Apr. 16, 2026). The 503A Bulks List is codified at 21 C.F.R. § 216.23.
[3] See Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products | FDA (Dec. 19, 2024).
[4] See FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize | FDA (Apr. 1, 2026)
[5] See FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs | FDA; and FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss | FDA.
[6] On the treatment of semaglutide-plus-vitamin-B12 combinations, see supra note 4. On self-pay pricing, see Novo Nordisk Launches Introductory Self-Pay Offer for Wegovy and Ozempic for $199 per Month | Novo Nordisk (Nov. 17, 2025). On brand-manufacturer litigation, see Novo Nordisk Expands Legal Action to Protect US Patients from Unsafe, Non-FDA-Approved Compounded “Semaglutide” | Novo Nordisk (Aug. 5, 2025) (132 complaints across 40 states; 44 permanent injunctions); see also Eli Lilly & Co. v. Strive Pharmacy LLC, No. 1:25-cv-00401 (D. Del. filed Apr. 1, 2025), and Eli Lilly & Co. v. Empower Clinic Servs., LLC, No. 2:25-cv-02183 (D.N.J. filed Apr. 1, 2025) (compounded tirzepatide). On the antitrust countersuit, see Complaint, Strive Specialties, Inc. v. Eli Lilly & Co., No. 5:26-cv-00155 (W.D. Tex. filed Jan. 14, 2026).
[7] See Order of Adoption, Compounded Drug Preparations | California State Board of Pharmacy (eff. Oct. 1, 2025); Cal. Code Regs. tit. 16, §§ 1735 et seq.; Cal. Bus. & Prof. Code §§ 4126.8, 4127. The certificate-of-analysis manufacturer requirement is at 16 C.C.R. § 1736.9(d).
[8] See Compounding of Glucagon-like Peptide-1 Drug Products (GLP-1) in Ohio | Ohio Board of Pharmacy (July 17, 2025); Ohio Rev. Code § 4729.57; Ohio Admin. Code 4729:7-2, 4729:7-3.
[9] See Ohio Board of Pharmacy News, OH Vol. 47 No. 1 (Feb. 2026); Ohio Admin. Code 4729:5-3-04, 4729:6-3-04.
[10] See PQAC Statement on Compounding Semaglutide | Washington Pharmacy Quality Assurance Commission (Aug. 22, 2024); Rev. Code Wash. 18.64.270(2); Wash. Admin. Code 246-945-100.
[11] See Pharmacy Quality Assurance Commission Issues Limited Stop Service on License of Pharmacy | Washington State Department of Health (Mar. 13, 2025).
[12] See Statement Concerning Semaglutide Compounding | New Jersey State Board of Pharmacy (Nov. 6, 2023); N.J.A.C. 13:39.
[13] See Declaratory Ruling on Physician Compounding | Alabama State Board of Medical Examiners (Aug. 8, 2024); Ala. Admin. Code r. 680-X-2-.43; Code of Ala. tit. 34, ch. 23.
[14] See, e.g., West Virginia (Apr. 2023); Oregon (Feb. 2025); Kansas (Apr. 2024); and Kentucky (2025) Board of Pharmacy semaglutide statements.
[15] See AG Tong Sues GLP-1 Weight Loss Drug Distributor | Connecticut Office of the Attorney General (May 2025); Conn. Gen. Stat. § 42-110a et seq. See also Illinois (Jan. 2025) and South Carolina (Jan. 2025) consumer alerts.
[16] See 22 Tex. Admin. Code §§ 291.131, 291.133; Tex. Occ. Code ch. 562; Fla. Stat. ch. 465; Fla. Admin. Code rr. 64B16-27.700, 64B16-27.797.
[17] Fla. Admin. Code r. 64B16-27.797(2) (eff. Feb. 2, 2025) (Section 503A cross-reference adopted by amendment eff. Nov. 16, 2023).