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Licenses and compliance: the states a vendor is licensed in and the documents it publishes, each marked verified or not
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GLP-1 & metabolic injectables

FDA pathway: Drug (NDA) | Compounded 503A/503B

Approved semaglutide, tirzepatide and orforglipron products are Rx drugs; the shortages are resolved, FDA's compounding wind-downs ended in 2025, the Fifth Circuit upheld FDA in Aug 2026, and FDA has proposed barring 503B bulk compounding of these molecules.

On MedGrid as: GLP-1 & Metabolic Injectables · GLP-1 Therapeutics

The federal rules

Shortages resolved; compounding wind-down dates passedTirzepatide's shortage was resolved Oct 2, 2024 (reaffirmed Dec 19, 2024) and semaglutide's on Feb 21, 2025; FDA's enforcement-discretion periods ended in 2025.

FDA's GLP-1 page (content current 04/01/2026) says: tirzepatide 503A discretion has ended and 503B ended March 19, 2025; semaglutide 503A ended April 22, 2025 and 503B ended May 22, 2025. After that, compounding 'essentially copies' of these approved drugs is not protected by shortage status; a 503A prescriber must document a patient-specific significant difference for a non-copy.

Courts upheld FDA's delisting (OFA v. FDA)District courts denied injunctions (Mar 5, 2025 tirzepatide; Apr 24, 2025 semaglutide) and the Fifth Circuit affirmed in both cases on Aug 27, 2026.

In No. 25-10600 (tirzepatide) the Fifth Circuit assumed, without deciding, that FDA erred by not using notice-and-comment procedures, held that the compounders had not shown prejudice from it, and held the shortage determination was not arbitrary or capricious. In No. 25-10758 (semaglutide; opinion revised Sept 1, 2026) it affirmed for the same reasons: any notice-and-comment error was harmless. Both are unpublished per curiam opinions.

503B bulk exclusion proposed (April 2026)FDA proposed on Apr 30, 2026 to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk.

FDA's Federal Register notice (91 FR 23431, May 1, 2026) proposes not to include the three substances on the 503B Bulks List; the comment period was extended to July 30, 2026 (91 FR 38719). FDA's release quoted the Commissioner: 'When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need.' No final decision had been published as of 2026-09-23.

Safety: salt forms, dosing errors, adverse eventsFDA has 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide (as of May 31, 2026), and says semaglutide sodium/acetate salts are different active ingredients from the approved drugs.

FDA also reports hospitalizations linked to dosing errors with compounded injectable semaglutide, counterfeit Ozempic in the supply chain, and products falsely labeled 'for research purposes'.

Current as of 2026-09-01

Marketing: no 'same as Wegovy/Zepbound' or 'FDA-approved' claimsFDA warning letters to telehealth firms cite claims that compounded GLP-1s are the same as, generic versions of, or as proven as approved drugs, or that they come from 'FDA-approved' pharmacies.

FDA's telehealth guidance page (content current 06/15/2026) lists prohibited practices, including branding that suggests the telehealth firm is the compounder. Example: June 8, 2026 warning letter to Medica Weight Loss stated 'Compounded drug products are not FDA-approved' and that calling a pharmacy 'FDA-approved' is false and misleading.

GLP-1 API imports: Import Alert 66-80 'Green List'Since September 2025, GLP-1 APIs from manufacturers not on FDA's Green List are detained at the border.

Covers semaglutide, tirzepatide, liraglutide, exenatide, orforglipron, retatrutide and dulaglutide APIs. FDA found 21% of inspected GLP-1 API makers noncompliant with CGMP and cited firms that register, refuse records requests, then deregister.

Current as of 2026-09-21

Changing now

What Arizona adds

Out-of-state pharmacies shipping into the stateArizona requires an out-of-state pharmacy to hold an Arizona Board of Pharmacy nonresident pharmacy permit, plus its home-state license, before it ships prescription drugs into Arizona.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?

Ariz. Admin. Code R4-23-607(A) says a person that is not an Arizona resident may not sell or distribute any controlled substance or prescription-only drug or device into Arizona without both a current Board-issued nonresident permit (pharmacy, manufacturer or wholesale) and the equivalent license from its home state. A.R.S. §32-1929(D) requires a Board application for a pharmacy outside the state that will dispense, sell or distribute drugs into Arizona, and the application must name the individual responsible to the Board. Under R4-23-607(E)(1), a nonresident pharmacy may sell prescription drugs in Arizona only to Board-permitted pharmacies, manufacturers or wholesalers, to Arizona-licensed medical practitioners, or to Arizona residents with a valid prescription. The rule text reviewed has no Arizona-licensed pharmacist-in-charge requirement, no separate nonresident sterile-compounding permit and no inspection-report requirement. The Arizona State Board of Pharmacy enforces these rules.

R4-23-607 was last amended effective 2020-03-14 (26 A.A.R. 223), and the Cornell copy shows it as current on 2026-09-23. The Board's own site (pharmacy.az.gov) blocked automated access with bot protection, so its current application checklist was not checked. It is not confirmed whether the Board asks nonresident applicants for an inspection report; check with the Board. Harbor Compliance (secondary) lists the application documents as a home-state permit copy, a list of officers and any disciplinary orders, with a $480 biennial fee. Pending or changing items: Arizona HB4036 (2026), titled "bulk drug substances; prohibitions", would have restricted compounding of certain weight-management drugs and added bulk-ingredient quality rules with $1,000-per-dose penalties (House summary dated 2026-02-13: https://www.azleg.gov/legtext/57leg/2R/summary/H.HB4036_021326_IT.DOCX.htm). Secondary sources (Frier Levitt; medspastandards.com, 2026-05-23) report it was withdrawn from committee on 2026-02-18.

A.R.S. §32-1929(D); Ariz. Admin. Code R4-23-607(A), (E)(1)

Current as of 2026-09-23 · Checked against the primary source

Office-use compounding from 503A pharmaciesArizona lets a pharmacy compound drugs for a practitioner to administer to the practitioner's own patients, with special labeling, but not for resale or dispensing.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.

A.R.S. §32-1901 defines compounding to include preparing drugs 'for administration by a medical practitioner to the medical practitioner's patient and not for sale or dispensing.' The same definition excludes preparing drugs for sale to pharmacies, practitioners or other entities for dispensing or distribution, and copying commercially available products from bulk. Ariz. Admin. Code R4-23-410(B)(3) bars providing compounded products to anyone for dispensing or distribution. The exception is a product given to a medical practitioner to administer to their own patient, with each container accompanied by the written list required by R4-23-410(I)(5). The label must show the pharmacy's name, address and phone number, the product name, lot number and beyond-use date, and the statements 'Not For Dispensing' and 'For Office or Hospital Administration Only.' The rule sets no numeric quantity cap, but anticipatory batches require a history of valid prescriptions. R4-23-607(E)(1) lets a permitted nonresident pharmacy sell prescription drugs to Arizona-licensed medical practitioners, so the rules do not on their face bar nonresident office-use shipments. FDA's position is that 503A compounding needs patient-specific prescriptions, so this state allowance goes further than the federal view.

R4-23-410 was last amended effective 2006-12-04 (12 A.A.R. 3981). Cornell shows it as current on 2026-09-23, but it is older than two years and possibly stale if the Board has adopted newer USP-based compounding rules; check with the Board. It is not confirmed whether the Board applies R4-23-410 labeling to nonresident pharmacies. The Board website blocked automated access. AZ HB4036 (2026), "bulk drug substances; prohibitions", was reported withdrawn from committee on 2026-02-18 (secondary sources); see nonresident_pharmacy AZ notes.

A.R.S. §32-1901 (definition of "compounding"); Ariz. Admin. Code R4-23-410(B)(3); R4-23-607(E)(1)

Current as of 2026-09-23 · Checked against the primary source

503B outsourcing facilities shipping into the stateArizona requires an out-of-state 503B outsourcing facility to hold a Board-issued nonresident permit (handled as a nonresident manufacturer permit) before it ships into Arizona.State license required

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?

Ariz. Admin. Code R4-23-607(A) bars any nonresident from selling or distributing prescription-only drugs into Arizona without a current Board-issued nonresident pharmacy, manufacturer or wholesale permit plus its home-state license. A.R.S. §32-1901 defines 'manufacturer' to include anyone who compounds or processes any drug 'in a place, other than a pharmacy.' The permit types in A.R.S. §32-1930(A) do not include a separate 'outsourcing facility' permit. A 2025 industry guide (secondary) says the Arizona Board licenses 503B facilities as drug manufacturers. Nonresident applicants submit a home-state permit, a drug or device list and their FDA registration. The Arizona State Board of Pharmacy enforces these rules.

The requirement that a nonresident permit is needed comes from primary sources (R4-23-607(A)). That 503Bs specifically get the nonresident manufacturer permit comes from a secondary source (ProRx eGuide, Dec 2025), which cites the Board's manufacturer-permit page. That page (pharmacy.az.gov/manufacturer-permit-information) blocked automated access and could not be checked. Harbor Compliance lists the Arizona manufacturer permit fee as $1,000, renewed every two years. An in-state representative or recent FDA inspection requirement for nonresident 503Bs was not confirmed.

Ariz. Admin. Code R4-23-607(A); A.R.S. §32-1901 (definition of "manufacturer"); A.R.S. §32-1929(D); A.R.S. §32-1930(A)

Current as of 2026-09-23 · Checked against the primary source

FDA compounding MOUArizona 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; Arizona 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))

Current as of 2026-08-28 · Checked against the primary source

Physicians dispensing from the officeArizona MDs may dispense only after registering with the Arizona Medical Board as a dispensing doctor, and may not dispense Schedule II opioids.Allowed with permit or limits

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.

A.R.S. 32-1491 lets a doctor of medicine dispense drugs and devices if the doctor registers with the board and pays the fee, labels each package (doctor, date, patient, drug, strength, directions), records the drug and reason in the chart, and keeps drugs locked with an ongoing inventory. Before dispensing, the doctor must give the patient a prescription and say it may be filled by the doctor or any pharmacy. Dispensing is limited to the doctor's own patients for conditions the doctor is treating, with direct supervision of staff. Schedule II opioids may not be dispensed (except implantable devices and MAT). Dispensing without registration carries civil penalties of $300 to $1,000 per transaction.

Section applies to MDs (Arizona Medical Board). DOs dispense under a parallel osteopathic provision not reviewed here.

A.R.S. 32-1491

Current as of 2026-09-23 · Checked against the primary source

Prescribing by telehealthArizona lets out-of-state clinicians register (instead of licensing) to provide telehealth, allows prescribing after a telehealth exam, and requires an in-person or audio-video exam only for Schedule II drugs.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.

A clinician not licensed in Arizona may treat Arizona patients by telehealth after registering with the matching Arizona board (proof of an unrestricted license elsewhere, malpractice coverage, a statutory agent, a fee, annual updates) and must register with the Arizona PMP before prescribing controlled substances; registrants may not open an Arizona office or see patients in person (A.R.S. 36-3606). Boards may not require an in-person exam before prescribing except for Schedule II drugs, which need an in-person or audio-visual exam (A.R.S. 36-3602). Testosterone (C-III) has no Arizona-specific telehealth limit beyond general law. IMLC: member.

A.R.S. 36-3602; A.R.S. 36-3606; A.R.S. 32-1401

Current as of 2026-09-23 · Checked against the primary source

Arizona at a glance

Every topic we research, for Arizona. Open any line for the rule, its citation and the source.

Pharmacy & compounding

Out-of-state pharmacies shipping into the stateArizona requires an out-of-state pharmacy to hold an Arizona Board of Pharmacy nonresident pharmacy permit, plus its home-state license, before it ships prescription drugs into Arizona.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?

Ariz. Admin. Code R4-23-607(A) says a person that is not an Arizona resident may not sell or distribute any controlled substance or prescription-only drug or device into Arizona without both a current Board-issued nonresident permit (pharmacy, manufacturer or wholesale) and the equivalent license from its home state. A.R.S. §32-1929(D) requires a Board application for a pharmacy outside the state that will dispense, sell or distribute drugs into Arizona, and the application must name the individual responsible to the Board. Under R4-23-607(E)(1), a nonresident pharmacy may sell prescription drugs in Arizona only to Board-permitted pharmacies, manufacturers or wholesalers, to Arizona-licensed medical practitioners, or to Arizona residents with a valid prescription. The rule text reviewed has no Arizona-licensed pharmacist-in-charge requirement, no separate nonresident sterile-compounding permit and no inspection-report requirement. The Arizona State Board of Pharmacy enforces these rules.

R4-23-607 was last amended effective 2020-03-14 (26 A.A.R. 223), and the Cornell copy shows it as current on 2026-09-23. The Board's own site (pharmacy.az.gov) blocked automated access with bot protection, so its current application checklist was not checked. It is not confirmed whether the Board asks nonresident applicants for an inspection report; check with the Board. Harbor Compliance (secondary) lists the application documents as a home-state permit copy, a list of officers and any disciplinary orders, with a $480 biennial fee. Pending or changing items: Arizona HB4036 (2026), titled "bulk drug substances; prohibitions", would have restricted compounding of certain weight-management drugs and added bulk-ingredient quality rules with $1,000-per-dose penalties (House summary dated 2026-02-13: https://www.azleg.gov/legtext/57leg/2R/summary/H.HB4036_021326_IT.DOCX.htm). Secondary sources (Frier Levitt; medspastandards.com, 2026-05-23) report it was withdrawn from committee on 2026-02-18.

A.R.S. §32-1929(D); Ariz. Admin. Code R4-23-607(A), (E)(1)

Current as of 2026-09-23 · Checked against the primary source

Office-use compounding from 503A pharmaciesArizona lets a pharmacy compound drugs for a practitioner to administer to the practitioner's own patients, with special labeling, but not for resale or dispensing.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.

A.R.S. §32-1901 defines compounding to include preparing drugs 'for administration by a medical practitioner to the medical practitioner's patient and not for sale or dispensing.' The same definition excludes preparing drugs for sale to pharmacies, practitioners or other entities for dispensing or distribution, and copying commercially available products from bulk. Ariz. Admin. Code R4-23-410(B)(3) bars providing compounded products to anyone for dispensing or distribution. The exception is a product given to a medical practitioner to administer to their own patient, with each container accompanied by the written list required by R4-23-410(I)(5). The label must show the pharmacy's name, address and phone number, the product name, lot number and beyond-use date, and the statements 'Not For Dispensing' and 'For Office or Hospital Administration Only.' The rule sets no numeric quantity cap, but anticipatory batches require a history of valid prescriptions. R4-23-607(E)(1) lets a permitted nonresident pharmacy sell prescription drugs to Arizona-licensed medical practitioners, so the rules do not on their face bar nonresident office-use shipments. FDA's position is that 503A compounding needs patient-specific prescriptions, so this state allowance goes further than the federal view.

R4-23-410 was last amended effective 2006-12-04 (12 A.A.R. 3981). Cornell shows it as current on 2026-09-23, but it is older than two years and possibly stale if the Board has adopted newer USP-based compounding rules; check with the Board. It is not confirmed whether the Board applies R4-23-410 labeling to nonresident pharmacies. The Board website blocked automated access. AZ HB4036 (2026), "bulk drug substances; prohibitions", was reported withdrawn from committee on 2026-02-18 (secondary sources); see nonresident_pharmacy AZ notes.

A.R.S. §32-1901 (definition of "compounding"); Ariz. Admin. Code R4-23-410(B)(3); R4-23-607(E)(1)

Current as of 2026-09-23 · Checked against the primary source

503B outsourcing facilities shipping into the stateArizona requires an out-of-state 503B outsourcing facility to hold a Board-issued nonresident permit (handled as a nonresident manufacturer permit) before it ships into Arizona.State license required

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?

Ariz. Admin. Code R4-23-607(A) bars any nonresident from selling or distributing prescription-only drugs into Arizona without a current Board-issued nonresident pharmacy, manufacturer or wholesale permit plus its home-state license. A.R.S. §32-1901 defines 'manufacturer' to include anyone who compounds or processes any drug 'in a place, other than a pharmacy.' The permit types in A.R.S. §32-1930(A) do not include a separate 'outsourcing facility' permit. A 2025 industry guide (secondary) says the Arizona Board licenses 503B facilities as drug manufacturers. Nonresident applicants submit a home-state permit, a drug or device list and their FDA registration. The Arizona State Board of Pharmacy enforces these rules.

The requirement that a nonresident permit is needed comes from primary sources (R4-23-607(A)). That 503Bs specifically get the nonresident manufacturer permit comes from a secondary source (ProRx eGuide, Dec 2025), which cites the Board's manufacturer-permit page. That page (pharmacy.az.gov/manufacturer-permit-information) blocked automated access and could not be checked. Harbor Compliance lists the Arizona manufacturer permit fee as $1,000, renewed every two years. An in-state representative or recent FDA inspection requirement for nonresident 503Bs was not confirmed.

Ariz. Admin. Code R4-23-607(A); A.R.S. §32-1901 (definition of "manufacturer"); A.R.S. §32-1929(D); A.R.S. §32-1930(A)

Current as of 2026-09-23 · Checked against the primary source

FDA compounding MOUArizona 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; Arizona 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))

Current as of 2026-08-28 · Checked against the primary source

Prescribing, dispensing & telehealth

State controlled-substance registrationArizona has no separate state controlled substance registration: state law requires a current Arizona practitioner license plus a federal DEA registration, although physicians who dispense drugs must register with their board to dispense.DEA + state license only

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.

A.R.S. 36-2522(A) requires every person who prescribes, dispenses or administers controlled substances in Arizona to first hold a current license as a medical practitioner and be a registrant under the federal Controlled Substances Act - there is no separate state CS certificate. Separately, an MD who dispenses drugs kept in the office (take-home, not samples) must register with the Arizona Medical Board to dispense, pay the registration fee, and follow labeling, locked-storage and inventory rules (A.R.S. 32-1491(A)); MDs may not dispense Schedule II opioids except implantable devices or medication-assisted treatment (32-1491(B)). Dispensing without board registration carries a civil penalty of $300-$1,000 per transaction.

The dispensing registration is a general drug-dispensing registration with the licensing board, not a controlled-substance registration; DOs, NPs and PAs have parallel dispensing rules under their own boards (not verified here). Arizona also requires CSPMP registration for DEA holders (not opened in this session).

A.R.S. 36-2522; A.R.S. 32-1491

Current as of 2026-09-23 · Checked against the primary source

PDMP check before prescribingArizona's PDMP query mandate applies only to opioid analgesics and benzodiazepines in Schedules II-IV, so testosterone is not covered.Required for some drugs only

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.

Before prescribing an opioid analgesic or benzodiazepine listed in Schedule II, III or IV, a medical practitioner must obtain a 12-month patient utilization report from the Controlled Substances Prescription Monitoring Program, before the prescription and before any subsequent refill. Exemptions: hospice or palliative care; cancer or dialysis patients; when the practitioner will administer the drug; inpatient or residential treatment in hospitals, nursing, assisted living, correctional or mental health facilities; and up to a 5-day supply for an invasive/painful procedure or for an acute injury diagnosed in an emergency department. Separately, pharmacists must check before dispensing a Schedule II drug. Administered by the Arizona State Board of Pharmacy; each practitioner board enforces for its licensees.

Testosterone (C-III, not an opioid or benzodiazepine) is not caught. 36-2606(H) requires EHR vendors serving Arizona practitioners to integrate with the PDMP on or before December 31, 2026. PDMP TTAC also lists board rules and 32-1961.01 etc. (not reviewed).

A.R.S. § 36-2606(E), (G)

Current as of 2026-09-23 · Checked against the primary source

Physicians dispensing from the officeArizona MDs may dispense only after registering with the Arizona Medical Board as a dispensing doctor, and may not dispense Schedule II opioids.Allowed with permit or limits

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.

A.R.S. 32-1491 lets a doctor of medicine dispense drugs and devices if the doctor registers with the board and pays the fee, labels each package (doctor, date, patient, drug, strength, directions), records the drug and reason in the chart, and keeps drugs locked with an ongoing inventory. Before dispensing, the doctor must give the patient a prescription and say it may be filled by the doctor or any pharmacy. Dispensing is limited to the doctor's own patients for conditions the doctor is treating, with direct supervision of staff. Schedule II opioids may not be dispensed (except implantable devices and MAT). Dispensing without registration carries civil penalties of $300 to $1,000 per transaction.

Section applies to MDs (Arizona Medical Board). DOs dispense under a parallel osteopathic provision not reviewed here.

A.R.S. 32-1491

Current as of 2026-09-23 · Checked against the primary source

Prescribing by telehealthArizona lets out-of-state clinicians register (instead of licensing) to provide telehealth, allows prescribing after a telehealth exam, and requires an in-person or audio-video exam only for Schedule II drugs.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.

A clinician not licensed in Arizona may treat Arizona patients by telehealth after registering with the matching Arizona board (proof of an unrestricted license elsewhere, malpractice coverage, a statutory agent, a fee, annual updates) and must register with the Arizona PMP before prescribing controlled substances; registrants may not open an Arizona office or see patients in person (A.R.S. 36-3606). Boards may not require an in-person exam before prescribing except for Schedule II drugs, which need an in-person or audio-visual exam (A.R.S. 36-3602). Testosterone (C-III) has no Arizona-specific telehealth limit beyond general law. IMLC: member.

A.R.S. 36-3602; A.R.S. 36-3606; A.R.S. 32-1401

Current as of 2026-09-23 · Checked against the primary source

Aesthetics, IV therapy & practice ownership

Who may inject neuromodulators and fillersArizona's Board of Nursing has an advisory opinion on medical aesthetic procedures by nurses and other licensees, but its website blocked automated access, so the conditions could not be confirmed.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?

Nevada's 2025 aesthetic practice decision cites an Arizona State Board of Nursing advisory opinion titled 'Medical Aesthetic Procedures Performed by Licensed Nurses, Licensed Cosmetologist, Licensed Aesthetician and Certified Laser Technologists' (3-2021), and Nebraska's 2021 opinion says it adapted Arizona's procedure classification. The Arizona Board of Nursing and Arizona Medical Board websites returned HTTP 403 to automated requests on 2026-09-23, so the opinion's terms were not read. Separately, A.R.S. §32-1456 lets medical assistants administer injections only under the direct supervision of an MD, PA or NP.

Check the Arizona State Board of Nursing advisory opinions page (azbn.gov) directly; it could not be fetched automatically.

A.R.S. §32-1456 (medical assistants only)

Current as of 2026-09-23 · Not independently confirmed

IV hydration and vitamin therapyArizona's Board of Nursing issued an advisory opinion on IV hydration and other therapies (revised May 2024), but its website blocked automated access, so its requirements could not be confirmed.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?

Wisconsin's 2025 IV guidance and Oregon's 2024 IV statement both cite the Arizona State Board of Nursing 'Advisory Opinion: Intravenous Hydration and Other Therapies' (revised May 2024). The document could not be read because the Arizona Board of Nursing site returned HTTP 403 to automated requests on 2026-09-23.

The AZBN opinion was published at azbn.gov/sites/default/files/AO-IV-Hydration-Other-Therapies.pdf according to the Wisconsin document; check it directly.

Current as of 2026-09-23 · Not independently confirmed

Corporate practice of medicine / med spa ownershipCompilations rate Arizona a corporate practice of medicine state based on older case law, though some 2026 guides describe ownership as more flexible in practice.Strong CPOM

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 classifies Arizona as 'Strict (Common Law)', citing Funk Jewelry Co. v. State (1935) and State ex rel. Board of Optometry v. Sears Roebuck & Co. (1967); MedPath Compliance (reviewed 2026-06-20) also lists Arizona as 'Yes' based on case law. Other med spa guides describe Arizona ownership as more permissive, particularly for NPs with full practice authority, so the doctrine's current reach is debated.

The cited cases concern optometry/jewelry businesses; Arizona's modern enforcement against med spa lay ownership was not confirmed.

Funk Jewelry Co. v. State (Ariz. 1935); State ex rel. Bd. of Optometry v. Sears Roebuck & Co. (Ariz. 1967) (as reported by Permit Health)

Current as of 2026-06-20 · From a dated compilation

Who may operate aesthetic lasersArizona certifies laser technicians through the Department of Health Services: certified technicians may do laser/IPL hair removal under indirect supervision and other cosmetic laser procedures only with a physician or NP physically present.Delegable with licensing/training rules

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?

A.A.C. R9-7-1438 (amended effective 2024-01-04) lets health professionals (physicians, NPs, PAs meeting licensing requirements) perform laser and IPL cosmetic procedures. Laser technicians must complete 24 hours of didactic training, pass a department-approved exam (80% minimum), complete at least 24 hours of hands-on training with at least 10 supervised procedures per procedure type, and be certified; they may perform hair removal under indirect supervision (physician/NP need not be on site) and other cosmetic procedures (skin rejuvenation, vascular, tattoo removal, etc.) under direct supervision (physician/NP physically present). Supervising professionals must observe each technician at least every six months and keep records for three years. Lasers are registered with ADHS radiation regulation (A.A.C. Title 9, Ch. 7, Art. 14).

Whether RNs need technician certification was not confirmed from the fetched summary.

Ariz. Admin. Code R9-7-1438, R9-7-1439 (amended by 30 A.A.R. 164, eff. 2024-01-04)

Current as of 2024-01-04 · Checked against the primary source

Labs, regenerative medicine & cosmetics

State clinical laboratory licensing (beyond CLIA)Arizona requires only federal CLIA certification for clinical laboratories.CLIA only

Does the state license clinical laboratories itself, beyond federal CLIA certification, including out-of-state labs that test specimens from the state?

A 2021 law-firm review cites A.R.S. §36-462 for the point that Arizona requires only a CLIA certificate. The Arizona Department of Health Services' Office of Laboratory Licensing and Certification is the state's CLIA agency. Arizona separately guarantees consumer direct-access testing (see that topic).

Source is from 2021 (older than 2 years), so it may be stale; confirm with ADHS (CLIAAZ@AZDHS.GOV).

A.R.S. §36-462 (as cited by Fox Rothschild, 2021)

Current as of 2021-01-29 · From a dated compilation

Direct-to-consumer lab testingArizona lets consumers order any lab test a licensed lab offers on a direct-access basis, with no practitioner order.Consumers may order tests

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.

A.R.S. §36-468 provides that a person 'may obtain any laboratory test from a licensed clinical laboratory on a direct access basis without a health care provider's request or written authorization' if the lab offers that test to the public on that basis. The lab must give the report to the person tested, stating in bold that the person is responsible for consulting their own provider. Labs may not bill insurers for direct-access tests, and providers have no duty to act on results they did not order.

Arizona's law has been in effect for about a decade (KJZZ, 2025).

A.R.S. §36-468

Current as of 2026-09-23 · Checked against the primary source

State laws on stem cell / regenerative therapiesNo Arizona 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. Arizona 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.

Pending/failed: SB 1214 (2026), the 'Arizona Stem Cell and Regenerative Therapy Act', passed both chambers but was vetoed by Gov. Hobbs on June 19, 2026. 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.

State rules for cosmetics and sunscreenNo Arizona-specific cosmetic or sunscreen requirements beyond federal law (MoCRA/FDA) were found.None found beyond federal

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?

Arizona does not appear on 2026 compilations of state PFAS-in-cosmetics laws, on the list of states banning animal-tested cosmetics, or among the jurisdictions with sunscreen-ingredient bans. Federal MoCRA and FDA rules on cosmetics and OTC sunscreens still apply. Other state laws that touch cosmetics generally, such as state food-drug-cosmetic acts or consumer-protection laws, were not surveyed.

The animal-testing list is Wikipedia's 'as of 2023' compilation (older than 2 years); effective dates were not confirmed.

None found

Current as of 2026-03-13 · From a dated compilation

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.

Allowed · 24Allowed with permit or limits · 22Prohibited (narrow exceptions) · 4Not confirmed · 1
Alaska: AllowedAlabama: Allowed with permit or limitsArkansas: Allowed with permit or limitsCalifornia: AllowedColorado: AllowedConnecticut: AllowedWashington DC: AllowedDelaware: AllowedFlorida: Allowed with permit or limitsGeorgia: AllowedHawaii: AllowedIowa: AllowedIdaho: Allowed with permit or limitsIllinois: AllowedIndiana: AllowedKansas: AllowedKentucky: AllowedLouisiana: Allowed with permit or limitsMassachusetts: Prohibited (narrow exceptions)Maryland: Allowed with permit or limitsMaine: AllowedMichigan: Allowed with permit or limitsMinnesota: AllowedMissouri: AllowedMississippi: Allowed with permit or limitsMontana: Allowed with permit or limitsNorth Carolina: Allowed with permit or limitsNorth Dakota: AllowedNebraska: Allowed with permit or limitsNew Hampshire: Allowed with permit or limitsNew Jersey: Allowed with permit or limitsNew Mexico: AllowedNevada: Allowed with permit or limitsNew York: Prohibited (narrow exceptions)Ohio: Allowed with permit or limitsOklahoma: Allowed with permit or limitsOregon: Allowed with permit or limitsPennsylvania: AllowedRhode Island: Not confirmedSouth Carolina: Allowed with permit or limitsSouth Dakota: AllowedTennessee: AllowedTexas: Prohibited (narrow exceptions)Utah: Allowed with permit or limitsVirginia: Allowed with permit or limitsVermont: AllowedWashington: AllowedWisconsin: AllowedWest Virginia: Allowed with permit or limitsWyoming: Prohibited (narrow exceptions)Arizona: Allowed with permit or limitsConnecticut: AllowedCTWashington DC: AllowedDCDelaware: AllowedDEMassachusetts: Prohibited (narrow exceptions)MAMaryland: Allowed with permit or limitsMDNew Hampshire: Allowed with permit or limitsNHNew Jersey: Allowed with permit or limitsNJRhode Island: Not confirmedRIVermont: AllowedVT

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).

'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.

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.

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.

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 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).

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.

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.

Current as of 2026-09-23

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.

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.

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.

Search the official databases

FDA

Drugs@FDAApproval status, application number, labels and approval letters for FDA-approved brand and generic drugs.Orange Book: Approved Drug Products with Therapeutic Equivalence EvaluationsTherapeutic-equivalence (AB) ratings, reference listed drugs, patents and exclusivities for approved small-molecule drugs.Purple Book: Database of Licensed Biological ProductsLicensed biologics and their biosimilar and interchangeable products, with exclusivity dates.National Drug Code (NDC) DirectoryThe NDC, labeler, dosage form, marketing category and listing status of a drug product.FDA Drug ShortagesWhether a drug is on FDA's current shortage list, and its status, reason and expected resolution.Registered Outsourcing Facilities (503B)Whether a compounder is a registered 503B outsourcing facility, with its last FDA inspection and any Form 483 or warning letter.Bulk Drug Substances Used in Compounding Under Section 503A (Category 1/2/3 lists)Whether a bulk ingredient (for example a peptide) is in Category 1, 2 or 3 of FDA's interim 503A bulks policy, and links to the final 503A bulks list.503B Bulk Drug Substances ListBulk drug substances that outsourcing facilities may compound from because of clinical need, and substances FDA has placed on or excluded from the list.FDA Warning LettersSearchable warning letters to compounders, telehealth and med-spa sellers, device makers and others, by company, subject and date.FDA Import AlertsProducts and firms that FDA may detain at the border without examination, for example unapproved drugs, peptides and cosmetics.AccessGUDID (Global Unique Device Identification Database)Look up a medical device by UDI or device identifier to see its labeler, model, FDA product code, premarket number and MRI safety status.510(k) Premarket Notification DatabaseWhether a device (for example an aesthetic laser or energy device) was cleared through 510(k), with the K-number, product code and cleared indications.Premarket Approval (PMA) DatabaseClass III devices approved through PMA (for example dermal fillers), with approval orders, supplements and approved indications.MAUDE: Manufacturer and User Facility Device ExperienceReports of adverse events and malfunctions filed for a medical device, by brand, product code or manufacturer.MedWatch Online Voluntary Reporting Form (FDA 3500)Report a serious adverse event, product quality problem or medication error for a drug, biologic, device, compounded product or cosmetic.openFDAPublic APIs and downloads for FDA adverse-event, recall, labeling, NDC, 510(k)/PMA and UDI data.Modernization of Cosmetics Regulation Act of 2022 (MoCRA)Federal cosmetics rules on facility registration, product listing, adverse-event reporting, safety substantiation and labeling, with their compliance dates.Cosmetics Direct (FDA cosmetic registration and listing portal)How cosmetic facilities register and products are listed under MoCRA through FDA's Cosmetics Direct portal.
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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.