FDA and state rules, for what you actually buy.
Search a drug, ingredient or device for its live FDA record, or pick your state and a category to see the federal rules and what your state adds — each answer with its citation and source.


FDA records for “testosterone”
Searching FDA approvals, shortages, recalls and device records…
Neuromodulators (botulinum toxins)
FDA pathway: Biologic (BLA)
Seven botulinum toxin BLAs appear in Drugs@FDA, all prescription-only; toxins cannot be compounded, and FDA/CDC warned in 2024 about counterfeit Botox causing hospitalizations.
On MedGrid as: Neuromodulators
The federal rules
FDA-licensed botulinum toxinsDrugs@FDA lists Botox and Botox Cosmetic (onabotulinumtoxinA, BLA 103000), Dysport (abobotulinumtoxinA, BLA 125274, 2009), Xeomin (incobotulinumtoxinA, BLA 125360, 2010), Myobloc (rimabotulinumtoxinB, BLA 103846, 2000), Jeuveau (prabotulinumtoxinA-xvfs, BLA 761085, 2019), Daxxify (daxibotulinumtoxinA-lanm, BLA 761127, 2022) and Letybo (letibotulinumtoxinA-wlbg, BLA 761225, Feb 29, 2024).
All are marked 'Prescription'. Units are product-specific and not interchangeable between brands. Any newer approval (after openFDA's 2026-09-22 refresh) would appear in the Purple Book.
- openFDA Drugs@FDA query: botulinum toxin A products — FDA (openFDA), 2026-09-22
- openFDA Drugs@FDA query: botulinum toxin B (Myobloc) — FDA (openFDA), 2026-09-22
Counterfeit Botox (2024)FDA (Apr 16, 2024; updated May 1, 2024) reported counterfeit Botox found in multiple states and given for cosmetic use, with hospitalizations for blurred vision, trouble swallowing, weakness and breathing problems; FDA worked with CDC and states.
Red flags FDA listed: lot C3709C3, labels reading 'Botulinum Toxin Type A' instead of 'OnabotulinumtoxinA', 150-unit vials, non-English packaging. FDA says products from unlicensed sources may be counterfeit, contaminated or ineffective.
- Counterfeit Version of Botox Found in Multiple States — FDA, 2024-05-02
Biologic: no compounding; imports of unapproved toxins detainedBotulinum toxins are licensed biologics outside the 503A/503B exemptions; Import Alert 66-41 has listed foreign firms offering unapproved botulinum toxin products.
Only FDA-licensed, U.S.-labeled product through the authorized supply chain is legal to administer.
- Notice to compounders: changes that affect compounding as of March 23, 2020 — FDA, 2020-03-05
- Import Alert 66-41 — FDA, 2026-09-11
Changing now
- New toxin approvals (e.g., relabotulinumtoxinA) were not found in openFDA as of 2026-09-22; confirm in the Purple Book. — openFDA Drugs@FDA query: botulinum toxin products
What Connecticut adds
Physicians dispensing from the officeConnecticut prescribers may dispense but must do it personally, label and record it, and notify the Department of Consumer Protection that they dispense.Allowed
May physicians dispense prescription drugs (not just administer them) directly to patients from their practice? "Yes" means allowed under standard rules (labeling, records, and at most a simple notice to the board); "conditional" means a separate dispensing registration, permit or license, or quantity, day-supply or drug-category limits; "no" means prohibited except narrow exceptions.
Conn. Gen. Stat. 20-14c to 20-14f govern practitioner dispensing. Drugs must be personally dispensed by the prescribing practitioner (no delegation, except nurses in hospital emergency departments), recorded in the chart, packaged in child-resistant containers and labeled with patient, prescriber, date, directions and cautions. A practitioner who dispenses anything other than professional samples must notify the Commissioner of Consumer Protection and confirm the intent to continue every two years at renewal of the state controlled substance registration (Sec. 21a-317).
Answer is yes because only a notice (not a permit) is required; the state controlled substance registration is separately required for controlled substances.
Conn. Gen. Stat. 20-14c, 20-14d, 20-14e, 20-14f
- Chapter 370 - Medicine and Surgery (Secs. 20-14c to 20-14f) — Connecticut General Assembly, 2026-09-23
Who may inject neuromodulators and fillersNo Connecticut rule or board statement on who may inject Botox or fillers was found; check with the Connecticut Board of Examiners for Nursing (Department of Public Health).Not confirmed
Who may administer botulinum toxin and dermal fillers (physicians, PAs, NPs, RNs, LPNs, estheticians, dentists), under what supervision (on-site vs available), and must a physician/NP/PA perform a prior good-faith exam?
The Connecticut Board of Examiners for Nursing (Department of Public Health)'s website was checked on 2026-09-23 for a position statement, advisory opinion or FAQ on cosmetic injectables (neuromodulators, fillers) and none was found (the site blocked automated access). RN practice therefore falls under the state's general nurse practice act, which was not reviewed for this entry.
Board site returned HTTP 403 or did not resolve for automated requests on 2026-09-23; URL taken from the MedGrid agency directory. A Connecticut medical spa statute was searched for in the General Statutes chapters on DPH and medicine (cga.ct.gov) but not found.
- Connecticut Board of Examiners for Nursing (Department of Public Health) — Connecticut Board of Examiners for Nursing (Department of Public Health), 2026-09-23
Corporate practice of medicine / med spa ownershipCompilations describe Connecticut as having a moderate corporate practice of medicine doctrine.CPOM with exceptions
Does the state enforce the corporate practice of medicine doctrine (non-physicians may not own medical practices or employ physicians), and how does that affect med spa ownership?
Permit Health's 2025 guide rates Connecticut 'Moderate', citing Conn. Gen. Stat. §33-182bb and Public Act 09-212; MedPath Compliance (reviewed 2026-06-20) lists it as 'Yes' and reports SB 196 (signed 2026-05-27) limiting private-equity/REIT hospital deals and banning sale-leasebacks.
Conn. Gen. Stat. §33-182bb; P.A. 09-212 (as reported by Permit Health)
- The Corporate Practice of Medicine 50-State Guide — Permit Health, 2025-12-23
- Corporate Practice of Medicine (CPOM) Across the 50 States and D.C. — MedPath Compliance Group, 2026-06-20
State rules for cosmetics and sunscreenConnecticut requires notification and labeling of cosmetics with intentionally added PFAS from July 1, 2026, and bans their sale from Jan 1, 2028.State cosmetic/sunscreen rules
Does the state have cosmetic or sunscreen requirements beyond federal MoCRA, such as ingredient bans (PFAS, formaldehyde, phthalates), ingredient reporting, sunscreen-ingredient bans, or bans on selling animal-tested cosmetics?
Public Act 24-59 (Substitute SB 292, 2024; C.G.S. §22a-903c): starting July 1, 2026, manufacturers of cosmetics containing intentionally added PFAS must give prior written notice to the Department of Energy and Environmental Protection (DEEP) and label the products. From Jan 1, 2028, manufacturing or selling cosmetics with intentionally added PFAS is prohibited. Unavoidable trace quantities are excepted.
The Connecticut statutes website could not be reached (certificate error), so the dates are from two consistent 2026 law-firm and compliance compilations. Federal MoCRA and FDA cosmetic and OTC sunscreen rules apply in every state.
Conn. Gen. Stat. §22a-903c (Public Act 24-59)
- State PFAS Bans in Cosmetics Expand Ahead of 2026 (updated Jan. 14, 2026) — Morgan, Lewis & Bockius LLP, 2026-01-14
- PFAS in Cosmetics: US State Bans and Compliance Deadlines - 2026 Update — Adherent (formerly Compliance & Risks), 2026-03-13
Compare every state: Physicians dispensing from the office · Who may inject neuromodulators and fillers · Corporate practice of medicine / med spa ownership · State rules for cosmetics and sunscreen
Connecticut at a glance
Every topic we research, for Connecticut. Open any line for the rule, its citation and the source.
Pharmacy & compounding
Out-of-state pharmacies shipping into the stateOut-of-state pharmacies must register with the Connecticut Department of Consumer Protection as nonresident pharmacies to ship prescriptions into Connecticut, with added approval and inspection proof for sterile compounding.License required
Must a pharmacy located in another state hold a license/registration from this state to ship prescriptions (including patient-specific 503A compounded preparations) to patients or practitioners here?
Conn. Gen. Stat. §20-627 defines a nonresident pharmacy as one outside Connecticut that ships, mails or delivers legend drugs or devices into the state under a prescription. It must register with the Department of Consumer Protection upon approval of the Commission of Pharmacy. Before registration it must submit its most recent home-state inspection report, which must include a USP <797> section if it delivers sterile compounded products. It must also keep its home license, report ownership changes within 10 days and discipline within 10 business days, provide a toll-free pharmacist line, and supply recall recipient lists within 24 hours. A nonresident pharmacy that dispenses non-patient-specific sterile products must file its home-state manufacturing license or registration and any FDA registration. Under §20-633b(b)(2), a nonresident pharmacy may not compound sterile products for Connecticut until a sterile-compounding addendum is approved, which requires written proof it passed a home-state inspection.
The statute does not require a Connecticut-licensed pharmacist-in-charge; it requires disclosure of pharmacists dispensing to Connecticut residents. §20-627 was last amended by P.A. 18-141.
Conn. Gen. Stat. §20-627; §20-633b(b)(2)
- Conn. Gen. Stat. Chapter 400j — Pharmacy (§20-627, §20-633b) — Connecticut General Assembly, 2026-09-23
Office-use compounding from 503A pharmaciesConnecticut lets licensed pharmacies supply non-sterile compounded products for in-office administration up to a 30-day supply, but sterile products may go out without a patient-specific prescription only if the pharmacy also holds a DCP manufacturer registration and any required federal registration.Allowed with limits
May a 503A (traditional) pharmacy dispense or distribute compounded preparations to a practitioner for office use (administration in the office, not patient-specific)? The federal position is that 503A requires patient-specific prescriptions; this is what the state pharmacy act and board rules allow.
Regs. Conn. State Agencies §20-576-71(c) lets a non-sterile compounding pharmacy (defined as a pharmacy licensed under §20-594) provide non-patient-specific non-sterile compounded products to physicians, osteopaths, podiatrists, dentists and veterinarians to administer in their practice, limited to a 30-day supply. For sterile products, Conn. Gen. Stat. §20-633b(d)(1) says a sterile compounding pharmacy may only provide patient-specific sterile pharmaceuticals to patients, practitioners or facilities. Under §20-633b(d)(2), one that provides sterile products without a patient-specific prescription must also obtain a Department of Consumer Protection registration under §21a-70 and any required federal license or registration, and may keep no more than a 30-day on-site inventory. An older rule allowing a two-week sterile office supply (§20-576-66(c), 2011) predates these statutory limits. A nonresident pharmacy dispensing non-patient-specific sterile products must file its home-state manufacturing license and FDA registration (§20-627(b)(4)).
The non-sterile office-use rule applies by its terms to pharmacies licensed under §20-594 (in-state). Whether a registered nonresident pharmacy may ship non-sterile office-use stock into Connecticut is not expressly addressed. The regulation compilation is dated 2024-12-27, within the 2-year window. The 30-day non-sterile supply allowance is broader than FDA's patient-specific reading of 503A.
Regs. Conn. State Agencies §20-576-71(c); §20-576-66(c); Conn. Gen. Stat. §20-633b(d); §20-627(b)(4); §21a-70
- Regs. Conn. State Agencies §§20-576-1 to 20-576-79 — The Practice of Pharmacy (revised 2024-12-27) — Connecticut Secretary of the State — eRegulations, 2024-12-27
- Conn. Gen. Stat. Chapter 400j — Pharmacy (§20-627, §20-633b) — Connecticut General Assembly, 2026-09-23
503B outsourcing facilities shipping into the stateConnecticut requires a Department of Consumer Protection manufacturer registration for drug compounders, but an out-of-state manufacturer registered with FDA may instead file a copy of its FDA registration; out-of-state sterile compounding pharmacies shipping non-patient-specific product must register.Depends
Does the state require an FDA-registered 503B outsourcing facility located outside the state to hold a state license/registration (as an outsourcing facility, nonresident manufacturer, wholesaler or pharmacy) before shipping into the state?
Conn. Gen. Stat. §21a-70 requires wholesalers and manufacturers to hold a DCP certificate of registration, renewed annually. It defines 'manufacturer' to include anyone inside or outside Connecticut who compounds drugs for sale, and any sterile compounding pharmacy that dispenses sterile products without a prescription or patient-specific order. §21a-70(b) exempts from the certificate an out-of-state manufacturer that is registered with FDA and files a copy of that registration with the Commissioner, but not a sterile compounding pharmacy as defined in §20-633b. A 503B that is not a pharmacy therefore appears to need either a DCP certificate or an FDA-registration filing with DCP. A 503B that also operates as a pharmacy and ships non-patient-specific sterile products needs a §21a-70 registration plus nonresident pharmacy registration (§20-627(b)(4); §20-633b(d)(2)). The statutes do not use the term 'outsourcing facility'.
How DCP treats FDA 503B outsourcing-facility registration under the §21a-70(b) out-of-state FDA-registered manufacturer exemption was not confirmed; no DCP outsourcing-facility guidance was reviewed. Check with the Connecticut Department of Consumer Protection, Drug Control Division.
Conn. Gen. Stat. §21a-70(a)-(b); §20-633b(d)(2); §20-627(b)(4)
- Conn. Gen. Stat. Chapter 417 — §21a-70 Registration of manufacturers and wholesalers of drugs — Connecticut General Assembly, 2026-09-23
- Conn. Gen. Stat. Chapter 400j — Pharmacy (§20-627, §20-633b) — Connecticut General Assembly, 2026-09-23
FDA compounding MOUConnecticut has not signed FDA's standard compounding MOU, so under the statute its 503A pharmacies are limited to 5% out-of-state distribution, although FDA is not enforcing that limit while it rewrites the MOU.Not signed
Has the state signed FDA's standard Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products (October 2020)? If not, FD&C Act §503A limits its 503A pharmacies' out-of-state distribution to 5% of total prescription orders (currently not enforced by FDA pending rulemaking).
Signing the standard MOU means the state board agrees to investigate complaints about compounded drugs its 503A pharmacies ship out of state and to identify and report to FDA pharmacies that distribute "inordinate amounts" interstate (more than 50% of their compounded prescriptions); in exchange, the statutory 5% out-of-state cap in FD&C Act §503A(b)(3)(B) does not apply to that state's pharmacies. FDA lists only Colorado, Kentucky and New Hampshire as signatories; Connecticut is not among them. For a non-signing state, FD&C Act §503A(b)(3)(B)(ii) caps a 503A pharmacy's out-of-state distribution of compounded drugs at 5% of its total prescription orders. FDA now considers the October 2020 standard MOU suspended (it does not expect signatory states to carry out MOU activities and will not sign new ones) and is not enforcing the 5% limit until a final rule and an updated MOU are published; FDA's rulemaking (RIN 0910-AI71) listed a proposed rule for 11/2026 in the Fall 2025 Unified Agenda.
The FDA list of signed MOUs (current as of 2023-01-23) is older than 2 years, but FDA stopped entering new agreements under the 2020 MOU in October 2022, so no state can have signed since. The FDA "Compounding Information for States" page (current as of 2026-08-28) still describes the MOU as awaiting rulemaking. Pending: FDA proposed rule on 503A distribution (RIN 0910-AI71, NPRM projected 11/2026); H.R. 5316 (introduced 2025-09-11, referred to House Energy & Commerce) would remove the MOU provision from §503A.
FD&C Act §503A(b)(3)(B) (21 U.S.C. 353a(b)(3)(B))
- Compounding MOUs (list of signed standard MOUs) — U.S. Food and Drug Administration, 2023-01-23
- Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs — U.S. Food and Drug Administration, 2022-10-20
- Compounding Information for States — U.S. Food and Drug Administration, 2026-08-28
- Federal Register 87 FR 63770 (Oct. 21, 2022), Doc. 2022-22876 — MOU suspension and extension of 5% enforcement period — Federal Register / GovInfo, 2022-10-21
Prescribing, dispensing & telehealth
State controlled-substance registrationConnecticut requires every practitioner who prescribes, administers or dispenses controlled substances to hold a Controlled Substance Practitioner registration from the Department of Consumer Protection (DCP).State CS registration required
Besides DEA registration, does the state require practitioners to hold a separate state controlled substance registration, license or permit to prescribe, administer or dispense controlled substances (e.g. testosterone, Schedule III)? "Conditional" means a state registration is needed only in some settings, such as keeping controlled-substance stock in the office.
Conn. Gen. Stat. Sec. 21a-317 requires every practitioner who distributes, administers or dispenses, or proposes to distribute, prescribe, administer or dispense, any controlled substance in Connecticut to obtain a certificate of registration from the Commissioner of Consumer Protection and, if prescribing, to register with the state PDMP (CPMRS). 'Practitioner' expressly includes physicians, physician assistants, APRNs and nurse-midwives (Sec. 21a-316). The application fee is $20 and the registration is biennial (Sec. 21a-318); renewal is $40 biennially, and a separate fee is required for each place of business or professional practice where the practitioner stores, distributes or dispenses controlled substances (Sec. 21a-321). Since 2022, a practitioner who transports controlled substances to treat a patient at a location other than the registered address must notify DCP first and return unused drug to the registered address.
DCP's own practitioner-registration pages (portal.ct.gov/dcp) could not be reached in this session (DNS failure), so fees are from the statute, not the agency page. DEA registration requires state authority to handle controlled substances, so in practice the DCP registration comes first. Per-location: a separate fee is charged for each site where controlled substances are stored or dispensed.
Conn. Gen. Stat. Secs. 21a-316, 21a-317, 21a-318, 21a-321
- Connecticut General Statutes Chapter 420c - Controlled Substances Registration (Secs. 21a-316 to 21a-328) — Connecticut General Assembly, 2026-09-23
- Registration Q&A (state authority prerequisite; separate registration per location) — DEA Diversion Control Division, 2024-12-01
PDMP check before prescribingConnecticut requires a CPMRS review before prescribing more than a 72-hour supply of any controlled substance (including testosterone), and at least every 90 days during ongoing treatment.Check required (covers C-III)
Must a prescriber query the state Prescription Drug Monitoring Program before prescribing, and does the mandate cover Schedule III drugs such as testosterone? "Yes" means a mandate that reaches Schedule III; "conditional" means a mandate limited to certain drugs (e.g. opioids or benzodiazepines) or situations; "no" means no prescriber query mandate.
Conn. Gen. Stat. 21a-254(j)(9) requires the prescribing practitioner or authorized agent to review the patient's PDMP record before prescribing greater than a 72-hour supply of any controlled substance. For continuous or prolonged treatment, the review must be repeated at least every 90 days (annually for Schedule V nonnarcotic drugs). If the system is down, a practitioner may prescribe and must review within 24 hours of regaining access. The section does not apply to samples dispensed by a physician or controlled substances dispensed to hospital inpatients. Administered by the Department of Consumer Protection, with discipline under 21a-322.
Frequency: before any Rx over a 72-hour supply, then at least every 90 days for ongoing treatment. Testosterone (C-III) is caught when prescribed for more than 72 hours. The duty is framed around prescribing; in-office administration is not expressly addressed. The CGA 'current' chapter page is revised to January 1, 2025 and refers readers to the 2026 Supplement (revised to Jan 1, 2026) for 2025-session changes, which was not checked. The DCP PMP page could not be reached (DNS failure).
Conn. Gen. Stat. § 21a-254(j)(9), (j)(12)
- Connecticut General Statutes Chapter 420b - Dependency-Producing Drugs (Sec. 21a-254) — Connecticut General Assembly, 2025-01-01
Physicians dispensing from the officeConnecticut prescribers may dispense but must do it personally, label and record it, and notify the Department of Consumer Protection that they dispense.Allowed
May physicians dispense prescription drugs (not just administer them) directly to patients from their practice? "Yes" means allowed under standard rules (labeling, records, and at most a simple notice to the board); "conditional" means a separate dispensing registration, permit or license, or quantity, day-supply or drug-category limits; "no" means prohibited except narrow exceptions.
Conn. Gen. Stat. 20-14c to 20-14f govern practitioner dispensing. Drugs must be personally dispensed by the prescribing practitioner (no delegation, except nurses in hospital emergency departments), recorded in the chart, packaged in child-resistant containers and labeled with patient, prescriber, date, directions and cautions. A practitioner who dispenses anything other than professional samples must notify the Commissioner of Consumer Protection and confirm the intent to continue every two years at renewal of the state controlled substance registration (Sec. 21a-317).
Answer is yes because only a notice (not a permit) is required; the state controlled substance registration is separately required for controlled substances.
Conn. Gen. Stat. 20-14c, 20-14d, 20-14e, 20-14f
- Chapter 370 - Medicine and Surgery (Secs. 20-14c to 20-14f) — Connecticut General Assembly, 2026-09-23
Prescribing by telehealthConnecticut bars telehealth prescribing of Schedule I, II and III controlled substances, including testosterone, except non-opioid Schedule II-III drugs for psychiatric disability or substance use disorder.Allowed with extra conditions
For a patient located in the state: must the prescriber hold this state's license (or a telehealth registration or special license), is an in-person exam required before prescribing (generally or for controlled substances), are there state limits on prescribing Schedule III drugs such as testosterone by telehealth, and is the state an Interstate Medical Licensure Compact member? "Yes" means a state license and the in-person standard of care apply (opioid-only or Schedule II-only limits are described but do not change the answer); "conditional" means extra state conditions such as a telehealth registration route, an in-person exam requirement, controlled-substance limits reaching Schedule III, or registration of telehealth businesses. Federal DEA rules apply on top.
Telehealth providers must hold the appropriate Connecticut license; a temporary out-of-state registration for behavioral health ended June 30, 2025. Conn. Gen. Stat. 19a-906(c) says no telehealth provider may prescribe any Schedule I, II or III controlled substance through telehealth, except a non-opioid Schedule II or III drug prescribed consistent with the federal Ryan Haight Act to treat a psychiatric disability or substance use disorder. Testosterone therefore requires an in-person visit to prescribe. Non-controlled drugs such as GLP-1s, sildenafil and finasteride follow the ordinary standard of care. IMLC: member (IMLC map dated 3/15/2026).
CCHP quotes an older wording of 19a-906 (MAT or psychiatric exception); the official text revised to January 1, 2026 limits the exception to non-opioid Schedule II/III drugs for psychiatric disability or SUD. Check for 2026 session changes.
Conn. Gen. Stat. 19a-906(c)
- Chapter 368ll - Telehealth (Sec. 19a-906), revised to January 1, 2026 — Connecticut General Assembly, 2026-01-01
- Connecticut - Professional Requirements — Center for Connected Health Policy (CCHP), 2026-09-17
- IMLC Commission - Compact State Map (participating states) — Interstate Medical Licensure Compact Commission, 2026-09-23
Aesthetics, IV therapy & practice ownership
Who may inject neuromodulators and fillersNo Connecticut rule or board statement on who may inject Botox or fillers was found; check with the Connecticut Board of Examiners for Nursing (Department of Public Health).Not confirmed
Who may administer botulinum toxin and dermal fillers (physicians, PAs, NPs, RNs, LPNs, estheticians, dentists), under what supervision (on-site vs available), and must a physician/NP/PA perform a prior good-faith exam?
The Connecticut Board of Examiners for Nursing (Department of Public Health)'s website was checked on 2026-09-23 for a position statement, advisory opinion or FAQ on cosmetic injectables (neuromodulators, fillers) and none was found (the site blocked automated access). RN practice therefore falls under the state's general nurse practice act, which was not reviewed for this entry.
Board site returned HTTP 403 or did not resolve for automated requests on 2026-09-23; URL taken from the MedGrid agency directory. A Connecticut medical spa statute was searched for in the General Statutes chapters on DPH and medicine (cga.ct.gov) but not found.
- Connecticut Board of Examiners for Nursing (Department of Public Health) — Connecticut Board of Examiners for Nursing (Department of Public Health), 2026-09-23
IV hydration and vitamin therapyNo Connecticut rule or board statement specific to elective IV hydration was found; check with the Connecticut Board of Examiners for Nursing (Department of Public Health).Not confirmed
What does the state require for elective IV hydration/vitamin (incl. NAD+) therapy: who may start IVs, is a patient-specific order or good-faith exam required before a patient's first IV, are standing orders allowed, and are there rules for mobile IV services?
The Connecticut Board of Examiners for Nursing (Department of Public Health)'s website was checked on 2026-09-23 for guidance on IV hydration clinics (prior exams, standing orders, mobile services) and none was found (the site blocked automated access).
Board site returned HTTP 403 or did not resolve for automated requests on 2026-09-23; URL taken from the MedGrid agency directory.
- Connecticut Board of Examiners for Nursing (Department of Public Health) — Connecticut Board of Examiners for Nursing (Department of Public Health), 2026-09-23
Corporate practice of medicine / med spa ownershipCompilations describe Connecticut as having a moderate corporate practice of medicine doctrine.CPOM with exceptions
Does the state enforce the corporate practice of medicine doctrine (non-physicians may not own medical practices or employ physicians), and how does that affect med spa ownership?
Permit Health's 2025 guide rates Connecticut 'Moderate', citing Conn. Gen. Stat. §33-182bb and Public Act 09-212; MedPath Compliance (reviewed 2026-06-20) lists it as 'Yes' and reports SB 196 (signed 2026-05-27) limiting private-equity/REIT hospital deals and banning sale-leasebacks.
Conn. Gen. Stat. §33-182bb; P.A. 09-212 (as reported by Permit Health)
- The Corporate Practice of Medicine 50-State Guide — Permit Health, 2025-12-23
- Corporate Practice of Medicine (CPOM) Across the 50 States and D.C. — MedPath Compliance Group, 2026-06-20
Who may operate aesthetic lasersNo Connecticut rule on who may operate cosmetic lasers was confirmed; check with the Connecticut Medical Examining Board (Department of Public Health).Not confirmed
Who may perform laser/IPL/RF aesthetic procedures (laser hair removal, resurfacing): physicians only, delegated to RNs/PAs, or licensed electrologists/estheticians/laser technicians with state certification?
No Connecticut statute, rule or board policy on delegation of cosmetic laser/IPL procedures or a laser-operator credential was located on 2026-09-23 (the board site blocked automated access).
Board site returned HTTP 403 or did not resolve for automated requests on 2026-09-23; URL taken from the MedGrid agency directory.
- Connecticut Medical Examining Board (Department of Public Health) — Connecticut Medical Examining Board (Department of Public Health), 2026-09-23
Labs, regenerative medicine & cosmetics
State clinical laboratory licensing (beyond CLIA)Not confirmed. No Connecticut lab license beyond CLIA was found in the sources reviewed, but its absence was not verified.Not confirmed
Does the state license clinical laboratories itself, beyond federal CLIA certification, including out-of-state labs that test specimens from the state?
Most states rely on federal CLIA certification alone. The states confirmed in this research as issuing their own lab licenses are California, New York, Pennsylvania, Maryland and Rhode Island (which also reach out-of-state labs testing specimens from their residents), plus Nevada, Washington, Massachusetts, New Jersey and New Hampshire (labs located in the state). Connecticut was not among them, but this research did not confirm its statutes. Connecticut's CLIA state agency is Connecticut Dept. of Public Health, Facility Licensing & Investigations (DPH.FLISLab@ct.gov, 860-509-7400); it can confirm whether any state license or permit applies, including to out-of-state labs.
Connecticut may run its own in-state lab licensing program; this could not be confirmed from a primary source in this pass, so check with the agency before relying on CLIA alone.
Not confirmed
- CLIA State Agency Contacts (updated May 2026) — Centers for Medicare & Medicaid Services, 2026-05-01
Direct-to-consumer lab testingNot confirmed whether Connecticut consumers may order lab tests without a practitioner order. Practitioner-ordered panels are not affected.Not confirmed
May consumers order their own lab tests without a practitioner order (direct access testing)? A practitioner-ordered panel is always fine; this matters for take-home and consumer test kits.
ADLM (formerly AACC) reported in 2019 that 37 states and DC let consumers order some or all tests directly, but it did not publish the state list, and this research did not confirm Connecticut's rule. Connecticut's lab regulator (CLIA state agency) is Connecticut Dept. of Public Health, Facility Licensing & Investigations (DPH.FLISLab@ct.gov, 860-509-7400). The question matters for take-home and consumer test kits, not for panels a clinician orders.
The ADLM figure dates from 2019 (older than 2 years).
Not confirmed
- Direct-to-consumer laboratory testing (position statement, 2019): '37 states and the District of Columbia permit consumers to order some or all of their laboratory tests directly' — Association for Diagnostics & Laboratory Medicine (formerly AACC), 2026-09-23
- CLIA State Agency Contacts (updated May 2026) — Centers for Medicare & Medicaid Services, 2026-05-01
State laws on stem cell / regenerative therapiesNo Connecticut law specific to stem cell, exosome or regenerative therapies was found, so FDA rules and general medical-practice rules apply.No state-specific law (FDA rules apply)
Has the state enacted a law or rule specifically about stem cell, exosome or regenerative-medicine therapies (notice/disclosure duties, permission for certain non-FDA-approved uses, or Right to Try extensions covering them)?
Compilations of state stem-cell laws from 2024 to 2026 list about a dozen states with specific laws (California, Florida, Georgia, Mississippi, Nevada, North Carolina, Tennessee, Texas, Utah, Vermont, Washington and Wyoming), plus Montana's general experimental-treatment law and Kansas's state stem cell center. Connecticut is not among them. Without a state-specific law, regenerative products are governed by federal FDA rules plus the state's general medical practice, advertising and consumer-protection laws, enforced by its medical board. Federal FDA rules still apply regardless of state law: stem cell, birth-tissue and exosome products are regulated by FDA, and a state law cannot make an unapproved biologic FDA-approved.
The finding of no law rests on multi-state compilations (a commercial one from Aug 2026 and a peer-reviewed one from Feb 2024, which is older than 2 years) and targeted searches, not a statute-by-statute review, and neither compilation is exhaustive. General Right to Try laws for terminal patients, where they exist, were not reviewed here.
None found
- State Stem Cell Laws: Accurate 2026 Map Update (lists 12 states with statutes; commercial source) — SaveMyFat, 2026-08-06
- U.S. State Laws on Medical Freedom and Investigational Stem Cell Procedures: A call to focus on state-based legislation (Cytotherapy) — Cytotherapy / PubMed Central, 2024-02-03
State rules for cosmetics and sunscreenConnecticut requires notification and labeling of cosmetics with intentionally added PFAS from July 1, 2026, and bans their sale from Jan 1, 2028.State cosmetic/sunscreen rules
Does the state have cosmetic or sunscreen requirements beyond federal MoCRA, such as ingredient bans (PFAS, formaldehyde, phthalates), ingredient reporting, sunscreen-ingredient bans, or bans on selling animal-tested cosmetics?
Public Act 24-59 (Substitute SB 292, 2024; C.G.S. §22a-903c): starting July 1, 2026, manufacturers of cosmetics containing intentionally added PFAS must give prior written notice to the Department of Energy and Environmental Protection (DEEP) and label the products. From Jan 1, 2028, manufacturing or selling cosmetics with intentionally added PFAS is prohibited. Unavoidable trace quantities are excepted.
The Connecticut statutes website could not be reached (certificate error), so the dates are from two consistent 2026 law-firm and compliance compilations. Federal MoCRA and FDA cosmetic and OTC sunscreen rules apply in every state.
Conn. Gen. Stat. §22a-903c (Public Act 24-59)
- State PFAS Bans in Cosmetics Expand Ahead of 2026 (updated Jan. 14, 2026) — Morgan, Lewis & Bockius LLP, 2026-01-14
- PFAS in Cosmetics: US State Bans and Compliance Deadlines - 2026 Update — Adherent (formerly Compliance & Risks), 2026-03-13
Compare every state
Physicians dispensing from the office. May physicians dispense prescription drugs (not just administer them) directly to patients from their practice? "Yes" means allowed under standard rules (labeling, records, and at most a simple notice to the board); "conditional" means a separate dispensing registration, permit or license, or quantity, day-supply or drug-category limits; "no" means prohibited except narrow exceptions.
The federal floor, for every category
Two federal compounding lanes: §503A pharmacies vs §503B outsourcing facilitiesA §503A pharmacy (or physician) compounds for an identified patient on a prescription; a §503B outsourcing facility is FDA-registered, follows CGMP, and is the only federal lane for non-patient-specific office stock.
Under §503A, a state-licensed pharmacist or physician may compound for an identified individual patient on a valid prescription, or in limited anticipatory quantities (no more than a 30-day supply based on the compounder's own prescription history). 503A compounders are not required to follow CGMP and are not required to report adverse events to FDA. Under §503B, an outsourcing facility registers with FDA, compounds under CGMP, is inspected on a risk-based schedule, must report adverse events, and may distribute non-patient-specific product to hospitals, clinics and practitioners for office use. Neither lane makes a compounded drug 'FDA-approved'. Both lanes restrict 'essentially copies' of approved or marketed drugs and restrict which bulk ingredients may be used. FDA keeps a public list of registered outsourcing facilities (content current as of 09/08/2026).
- Prescription Requirement Under Section 503A of the FD&C Act — Guidance for Industry — FDA/CDER, 2016-12-01
- Registered Outsourcing Facilities — FDA, 2026-09-08
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (503A adverse events not required to be reported) — FDA, 2026-09-01
'Essentially a copy' of an approved or commercially available drugFDA treats a compounded drug with the same active ingredient, a similar strength and a usable route as a marketed product as 'essentially a copy' unless the prescriber documents a patient-specific significant difference on the prescription.
503A (final guidance, Jan 2018): a drug is not 'commercially available' if it is discontinued or is in 'currently in shortage' status on FDA's drug shortage list. FDA generally considers a compounded drug a copy if it has the same API in the same, similar or easily substitutable strength by a route the commercial product can be used by. The prescriber's determination must name the change and the significant difference for that patient; a patient name plus formulation is not enough, and lower price does not count. FDA does not consider copies to be made 'regularly or in inordinate amounts' if the compounder fills four or fewer such prescriptions per calendar month. 503B (final guidance, Jan 2018): outsourcing facilities may not compound drugs identical or nearly identical to an approved drug unless it is on the shortage list; otherwise a prescriber's determination of a clinical difference must be noted on the prescription or order.
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A — Guidance for Industry — FDA/CDER, 2018-01-01
- Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B — Guidance for Industry — FDA/CDER, 2018-01-01
Office use / office stock of compounded drugs (federal position)FDA's position is that §503A compounding requires a prescription for an identified patient; clinics wanting non-patient-specific office stock are directed to §503B outsourcing facilities.
FDA's final 503A prescription-requirement guidance (Dec 2016) says hospitals, clinics and practitioners can obtain non-patient-specific compounded drugs from outsourcing facilities registered under §503B, which may distribute sterile and non-sterile office-use product. 503A anticipatory compounding is limited to no more than a 30-day supply based on the compounder's own prescription history. Some states allow limited 503A office use under state law, but the federal 503A exemptions still depend on patient-specific prescriptions (see state topic office_use_503a).
503B products may not be resold by anyone other than the outsourcing facilitySection 503B(a)(8) bars anyone other than the outsourcing facility from selling or transferring its compounded drugs, so a clinic, distributor or marketplace that takes ownership may not resell 503B product.
FDA's June 2023 draft guidance (still draft) says the drug should go from the outsourcing facility to the entity that dispenses or administers it. FDA does not intend to apply the prohibition to transfers to common carriers, third-party logistics providers, regulators, returns processors, waste handlers or contract test labs, or to recall-related transfers. A state-licensed pharmacy may dispense 503B product against a patient-specific prescription. Clinic-to-clinic resale is the core concern.
- Prohibition on Wholesaling Under Section 503B of the FD&C Act — Draft Guidance for Industry — FDA/CDER, 2023-06-27
Which bulk ingredients compounders may use (503A Categories 1/2/3; 503B bulks list)A 503A compounder may use a bulk ingredient only if it has a USP/NF monograph, is a component of an FDA-approved drug, or is on the 503A bulks list; FDA tolerates interim 'Category 1' substances, flags 'Category 2' as significant safety risks, and treats 'Category 3' as lacking support.
FDA's category list was updated May 14, 2026. 503A Category 2 now contains only cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10 and quinacrine (intrauterine use). Category 1 includes glutathione, methylcobalamin, NAD, NADH, enclomiphene citrate, GHK-Cu (non-injectable routes only), vasoactive intestinal peptide and others. GHRP-2, GHRP-6, mechano growth factor and thymulin are in Category 3. BPC-157, TB-500, CJC-1295, ipamorelin, AOD-9604, Selank, Semax, epitalon, MOTs-C, dihexa, KPV and thymosin alpha-1 are in no category, so they do not get Category 1 enforcement discretion. FDA does not intend to categorize substances nominated on or after Jan 7, 2025. The final 503B bulks list is short (e.g., diphenylcyclopropenone, glycolic acid topical up to 70%, quinacrine oral, squaric acid dibutyl ester, trichloroacetic acid); 503B Category 2 includes GHRP-2, GHRP-6, ipamorelin acetate, ibutamoren, tranilast and others.
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1–3) — FDA, 2026-05-14
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act — FDA, 2026-05-14
- Safety Risks Associated with Certain Bulk Drug Substances for Use in Compounding (Category 2) — FDA, 2026-04-22
- 503B Bulk Drug Substances List — FDA, 2024-05-16
- Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act — FDA, 2025-01-07
Biologics (including hCG, tesamorelin, somatropin) cannot be compounded under 503A/503BSince March 23, 2020, protein products approved as drugs became licensed biologics, and FDA says biological products are not eligible for the 503A or 503B compounding exemptions.
The BPCI Act transition on March 23, 2020 deemed approved NDAs for biological products to be BLAs. FDA's transition list includes chorionic gonadotropin (Pregnyl, Novarel, Fresenius chorionic gonadotropin, Ovidrel), menotropins, follitropins, hyaluronidase, somatropin and tesamorelin acetate (Egrifta/Egrifta SV). FDA's notice to compounders states that 'biological products will not be eligible for the exemptions for compounded drugs under sections 503A and 503B'. Separate FDA guidance (Jan 2018) describes limited conditions for mixing, diluting or repackaging licensed biologics outside their labeling.
'Research Use Only' / 'not for human consumption' productsFDA treats RUO-labeled peptides and GLP-1s as unapproved drugs when marketing, dosing information or bundled syringes/bacteriostatic water show human use; the disclaimer does not make them lawful to administer to patients.
FDA's GLP-1 safety page says companies sold products falsely labeled 'for research purposes' or 'not for human consumption' with dosing instructions for human use. FDA has issued repeated warning-letter rounds to peptide/RUO sellers in 2026 (e.g., letters dated March 31, 2026 to Gram Peptides and others; June 17, 2026 to Wholesale Peptide; August 24, 2026 to Royal Peptides and others). Import Alert 66-41 (unapproved new drugs promoted in the U.S.) has listed, for example, a firm offering PT-141 peptide. RUO material is not a USP-grade or approved-drug-component bulk ingredient for compounding and is not a prescription drug a clinician can lawfully buy for patient use.
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss — FDA, 2026-09-01
- Warning Letter: Gram Peptides (MARCS-CMS 721806) — FDA, 2026-03-31
- Warning Letter: Wholesale Peptide (MARCS-CMS 729447) — FDA, 2026-06-17
- Warning Letter: Royal Peptides LLC (MARCS-CMS 734884) — FDA, 2026-08-24
- Import Alert 66-41: Detention Without Physical Examination of Unapproved New Drugs Promoted in the U.S. — FDA, 2026-09-11
FDA drug shortage list and why it matters for compoundingA drug in 'currently in shortage' status is not 'commercially available', so 503A/503B compounders may make copies of it; when FDA marks the shortage resolved, that permission ends (503B facilities may finish existing orders for up to 60 days).
The 503A copies guidance says a drug appears on the shortage list only if it is in 'currently in shortage' status, not 'resolved'. FDA's shortage-compounding page says compounders must still meet all other 503A conditions (including a valid patient-specific prescription), and FDA 'may take action if an outsourcing facility continues to fill new orders after the approved drug is removed from FDA's drug shortage list, or if it continues to fill existing orders more than 60 days after the drug has been removed.' The GLP-1 episode shows the effect: large-scale semaglutide and tirzepatide compounding depended on shortage status and ended after FDA resolved the shortages. A prescriber or compounder relying on a shortage should note on the prescription that the drug was on the list and the date checked.
FDA Standard MOU on interstate distribution of 503A compounded drugsThe October 2020 standard MOU is suspended after a 2021 court remand; FDA is not enforcing the statutory 5% out-of-state limit and plans a new rule, with a proposed rule projected for November 2026.
Section 503A limits a pharmacy in a state without an FDA MOU to distributing no more than 5% of its compounded prescriptions out of state. FDA published a final standard MOU in October 2020, but a federal court remanded it in September 2021. FDA 'considers the standard MOU published in October 2020 to be suspended' and, per its Oct 21, 2022 Federal Register notice, will not enforce the 5% limit until a final rule and updated MOU are published. The Fall 2025 Unified Agenda lists RIN 0910-AI71 ('Distribution of Compounded Drug Products Under Section 503A') at the proposed-rule stage with an NPRM projected for 11/2026. State nonresident-pharmacy licensing still applies (see state topics nonresident_pharmacy and fda_mou).
- Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs — FDA, 2022-10-20
- Extension of the Period Before FDA Intends To Begin Enforcing the Statutory 5 Percent Limit on Out-of-State Distribution of Compounded Human Drug Products (87 FR, Oct 21, 2022) — Federal Register, 2022-10-21
- Unified Agenda, RIN 0910-AI71: Distribution of Compounded Drug Products Under Section 503A (Fall 2025) — OMB/OIRA, 2025-10-01
DEA telemedicine prescribing of controlled substances (Ryan Haight Act flexibilities)Through December 31, 2026, DEA-registered practitioners may prescribe Schedule II–V controlled substances by telemedicine without a prior in-person visit under a fourth temporary extension; the permanent special-registration rule is still pending.
The Ryan Haight Act generally requires an in-person medical evaluation before prescribing controlled substances over the internet. DEA and HHS published the Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities (90 FR 61301, Dec 31, 2025), effective Jan 1 – Dec 31, 2026. Prescriptions must still be for a legitimate medical purpose and comply with federal and state law; state telehealth and controlled-substance rules still apply (see telehealth_rx, state_csr, pdmp_mandate). The separate buprenorphine (opioid use disorder) telemedicine final rule and the VA continuity-of-care final rule, both published Jan 17, 2025, took effect Dec 31, 2025 after two delays (90 FR 13410). A Federal Register search on 2026-09-23 found no DEA special-registration final rule published in 2026. The Special Registrations for Telemedicine final rule was reported to be in OMB review as of late August 2026, with a final rule forecast for November 2026. Without a new rule or another extension, the in-person requirement returns on Jan 1, 2027.
- Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 90 FR 61301 (Federal Register API record: effective Jan 1 – Dec 31, 2026) — DEA/HHS, Federal Register, 2025-12-31
- Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (FR Doc. 2025-24123) — DEA/HHS, Federal Register, 2025-12-31
- Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for VA Patients — effective Dec 31, 2025, 90 FR 13410 (API record) — DEA/HHS, Federal Register, 2025-03-24
- DEA and HHS Extend Telemedicine Prescribing Flexibilities Through 2026 — Holland & Knight, 2026-01-13
- DEA Prescribing of Controlled Substances (tracker) — Alliance for Connected Care, 2026-08-26
- Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for VA Patients — delay of effective date (FR Doc. 2025-05007) — DEA/HHS, Federal Register, 2025-03-24
FTC health-claim substantiation (advertising)The FTC requires competent and reliable scientific evidence, generally randomized controlled human trials, before a marketer makes health-benefit claims for any health product, including devices, tests, supplements and apps.
The FTC's Health Products Compliance Guidance (Dec 2022) replaced the 1998 supplement advertising guide. Marketers must have substantiation for every objective claim, express or implied, before it runs; for health benefits this generally means randomized, controlled human clinical testing. Qualifying disclosures must be clear and conspicuous, and advertisers are liable for misleading testimonials and endorsements. This sits alongside FDA's rules: FDA regulates labeling and intended use, and FDA warning letters in 2025–2026 target 'same as brand' and 'FDA-approved' claims for compounded drugs.
- Health Products Compliance Guidance — Federal Trade Commission, 2022-12-01
- FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs — FDA, 2026-06-15
Adverse event reporting (MedWatch; 503B mandatory reporting)Clinicians and patients can report problems with drugs, biologics, devices and cosmetics to FDA's MedWatch voluntarily; 503B outsourcing facilities must report adverse events, while 503A pharmacies are not federally required to.
MedWatch accepts voluntary reports for prescription and OTC drugs, biologics (including human cell and tissue products), medical devices, combination products and cosmetics. Manufacturers, packers and distributors named on a marketed prescription drug label must file 15-day 'Alert reports' for serious and unexpected adverse experiences under 21 CFR 310.305; FDA's final guidance (Oct 2015) applies adverse event reporting to 503B outsourcing facilities. FDA notes that federal law does not require state-licensed 503A pharmacies to report adverse events, so compounded-drug events are likely under-reported. Under MoCRA, cosmetic 'responsible persons' must report serious adverse events within 15 business days.
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program — FDA, 2026-09-21
- Adverse Event Reporting for Outsourcing Facilities Under Section 503B — Guidance for Industry — FDA/CDER, 2015-10-01
- 21 CFR 310.305 — Records and reports concerning adverse drug experiences on marketed prescription drugs — eCFR, 2026-09-01
- Modernization of Cosmetics Regulation Act of 2022 (MoCRA) — FDA, 2026-08-10
Where FDA enforcement shows up: warning letters, import alerts, recallsFDA posts warning letters in a searchable database, detains risky imports through import alerts (e.g., 66-80 for GLP-1 APIs, 66-41 for unapproved drugs, 80-04 for gloves, 53-21 for adulterated cosmetics), and publishes recalls in its enforcement reports.
Import alerts let FDA detain products without physical examination. Import Alert 66-80 (GLP-1 receptor agonist bulk drug substances) detains semaglutide, tirzepatide, liraglutide, exenatide, orforglipron, retatrutide and dulaglutide APIs unless the manufacturer is on FDA's 'Green List'; FDA cited that 21% of inspected GLP-1 API makers were noncompliant with CGMP. Import Alert 66-41 covers unapproved new drugs promoted in the U.S. and has listed firms offering unapproved botulinum toxin and PT-141 peptide. Recalls, including Class I recalls of compounded glutathione in July–August 2026, appear in FDA enforcement reports and openFDA.
- FDA Warning Letters (searchable database) — FDA, 2026-09-23
- Import Alert 66-80: GLP-1 Receptor Agonist Bulk Drug Substances (Green List) — FDA, 2026-09-21
- Import Alert 66-41: Unapproved New Drugs Promoted in the U.S. — FDA, 2026-09-11
- openFDA drug enforcement (recall) query: sterile water / glutathione recalls 2023–2026 — FDA (openFDA), 2026-09-16
Compounded peptides: where things stand in September 2026FDA pulled 12 peptides out of Category 2 in April 2026 after nominators withdrew them, and its advisory committee voted in July 2026 to recommend six for the 503A bulks list, but none is on the list or in Category 1 yet, so none has federal compounding permission today.
On April 15, 2026 FDA announced that 12 peptides (BPC-157, cathelicidin LL-37, dihexa acetate, emideltide/DSIP, epitalon, GHK-Cu injectable, KPV, PEG-MGF, melanotan II, MOTs-C, Semax, TB-500) would leave Category 2 after seven days because their nominations were withdrawn; FDA's list shows the change effective April 22, 2026. Law-firm analyses stress that leaving Category 2 does not place a substance on the 503A bulks list or in Category 1. At the July 23–24, 2026 PCAC meeting, members voted to recommend BPC-157 (8–6), KPV (8–6), TB-500 (8–6), MOTs-C (7–5), epitalon (7–4) and Semax (8–5), and against emideltide (6–7); FDA staff had recommended against all of them. FDA must still decide and complete notice-and-comment rulemaking. GHK-Cu, dihexa, LL-37, PEG-MGF and melanotan II are slated for a PCAC meeting before the end of February 2027. Earlier, AOD-9604, CJC-1295, ipamorelin, thymosin alpha-1 and Selank left Category 2 in September 2024, and PCAC voted against CJC-1295 and AOD-9604 on Dec 4, 2024.
- Safety Risks Associated with Certain Bulk Drug Substances for Use in Compounding (Category 2; withdrawn list) — FDA, 2026-04-22
- July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee — FDA, 2026-08-06
- Bulk-list bound? PCAC backs majority of peptides in two-day public meeting — McDermott (law firm), 2026-07-27
- FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings — Orrick, 2026-04-16
- FDA to Remove 12 Popular Peptides from the Category 2 'Do Not Compound' List — Frier Levitt, 2026-09-23
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1–3) — FDA, 2026-05-14
- Pharmacy Compounding Advisory Committee; Notice of Meeting (July 23–24, 2026; 503A bulks nominations), 91 FR 20465 — FDA, Federal Register, 2026-04-16
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Educational summaries of public law and agency guidance, not legal advice. Researched 2026-09-23 from the sources linked on each answer; laws, board rules and FDA policy change, so confirm with the linked agency or your counsel before you rely on an answer. Found something out of date? Tell our compliance desk.
