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 “botulinum”
Searching FDA approvals, shortages, recalls and device records…
Syringes & needles
FDA pathway: Device class II (510(k))
Piston syringes and hypodermic needles are Class II devices with performance standards; OSHA requires employers to use and annually evaluate safety-engineered sharps.
On MedGrid as: Syringes & Needles · Injection Supplies
The federal rules
Device classificationPiston syringes (21 CFR 880.5860) and hypodermic single-lumen needles (880.5570) are Class II; antistick (safety) syringes are product code MEG, Class II, 510(k).
Verify a product's 510(k) and UDI before purchase.
- 21 CFR 880.5860 — Piston syringe — eCFR, 2026-09-01
- 21 CFR 880.5570 — Hypodermic single lumen needle — eCFR, 2026-09-01
- openFDA device classification: FMF, FMI, MEG — FDA (openFDA), 2026-09-23
OSHA safety-engineered sharpsOSHA's Bloodborne Pathogens standard requires the exposure control plan to document, at least annually, consideration and implementation of commercially available safer medical devices, with input from front-line staff.
It defines 'sharps with engineered sharps injury protections' and 'needleless systems'. These requirements were added by the Needlestick Safety and Prevention Act of 2000 (statute not separately retrieved).
- 29 CFR 1910.1030 — Bloodborne pathogens — eCFR, 2026-09-01
Changing now
- FDA device recalls and safety communications for syringes (check MAUDE and recalls). — MAUDE
What Oklahoma adds
No state-specific topics apply to this category beyond the federal rules.
Look it up yourself
Oklahoma at a glance
Every topic we research, for Oklahoma. Open any line for the rule, its citation and the source.
Pharmacy & compounding
Out-of-state pharmacies shipping into the stateAn out-of-state pharmacy that dispenses or delivers prescriptions to Oklahoma residents must hold an Oklahoma Non-Resident Pharmacy license and name an Oklahoma-licensed pharmacist-in-charge; sterile compounders also need a sterile compounding permit.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?
59 O.S. §353.18(A) makes it unlawful to sell or offer dangerous drugs at retail, or to accept prescriptions, without a Board of Pharmacy license, including when the sale happens out of state and the drug is delivered into Oklahoma. Under OAC 535:15-3-9, a non-resident pharmacy needs: an annual non-resident license; a resident-state license in good standing; an inspection report from the past 24 months by its home state or a Board-approved organization, at first licensure and at every renewal; a commercial (non-residential) location; and toll-free pharmacist counseling. It must name a pharmacist-in-charge licensed both in its home state and by Oklahoma, who must be on site at least 20 hours a week. Oklahoma law applies to the Oklahoma part of its operation, and the Board may inspect it on site at the pharmacy's expense. A non-resident pharmacy that compounds sterile preparations must also hold a sterile compounding permit, renewed with its non-resident license (OAC 535:15-9-3, 15-9-4).
The source is the Board's own unofficial compilation of statute and rules (July 2026); the official text is at rules.ok.gov (not fetched). Oklahoma requires an Oklahoma-licensed PIC; a 90-day extension is possible in urgent situations. The fee is $150 per year for a non-resident pharmacy license and $75 for a sterile compounding permit.
59 O.S. §353.18(A); OAC 535:15-3-9; OAC 535:15-9-3, 535:15-9-4; OAC 535:1-11-1
- Oklahoma Pharmacy Law Book — 59 O.S. §353.1 et seq. and OAC Title 535 (unofficial compilation effective July 11, 2026) — Oklahoma State Board of Pharmacy, 2026-07-11
- Oklahoma State Board of Pharmacy — Laws & Rules — Oklahoma State Board of Pharmacy, 2026-09-23
Office-use compounding from 503A pharmaciesOklahoma allows an Oklahoma retail pharmacy with a Drug Supplier Permit to supply drugs to prescribers for office administration (capped at 5% of its sales), but the rules do not spell out limits specific to compounded human drugs, and out-of-state pharmacies are not eligible.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.
OAC 535:15-7 defines a 'drug supplier' as a licensed retail pharmacy that supplies legend drugs to licensed prescribers for office administration. It requires a Drug Supplier Permit and a valid retail pharmacy license. These sales may not exceed 5% of the pharmacy's total annual sales, and separate invoice records are required. The compounding rules (535:15-10) tie compounding to a prescriber's prescription or order and to anticipatory batches based on regular prescribing patterns. They state an office-use allowance without patient-specific prescriptions only for animal drugs (535:15-10-13). Board inspection forms check 'Office-use meds sold per invoice w/DS permit' (retail form, July 2025) and 'Preparing "For Office Use"' / 'Office Use properly labeled' (compounding form, 2014), which shows the Board inspects office-use supply. Because the permit is open only to Oklahoma retail pharmacies, a non-resident pharmacy has no stated route to ship office stock into Oklahoma. In-state office stock without a patient-specific prescription goes beyond FDA's 503A position.
The rules say nothing express about human office-use compounding; whether compounded preparations fall under the Drug Supplier Permit is inferred from the definitions and the Board inspection forms, so confirm with the Oklahoma Board of Pharmacy (405-521-3815). The compounding inspection form is from 2014, so it is possibly stale. Retail pharmacies may not supply compounded preparations to wholesalers, outsourcing facilities or other distributors (535:15-7-3).
OAC 535:15-7-1, 535:15-7-2, 535:15-7-3; OAC 535:15-10-2, 535:15-10-8, 535:15-10-13; 59 O.S. §353.1
- Oklahoma Pharmacy Law Book — OAC 535:15-7 (Drug Supplier Permits) and 535:15-10 (Compounding), compilation effective July 11, 2026 — Oklahoma State Board of Pharmacy, 2026-07-11
- Sample Retail Inspection Form (07/16/2025) — Oklahoma State Board of Pharmacy, 2025-07-16
- Sample Compounding Inspection Form (09/30/2014) — Oklahoma State Board of Pharmacy, 2014-09-30
503B outsourcing facilities shipping into the stateA 503B outsourcing facility, including one out of state, must hold an Oklahoma Outsourcing Facility license and name an Oklahoma-licensed pharmacist-in-charge before shipping into Oklahoma.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?
59 O.S. §353.18(B) makes it unlawful to manufacture, distribute or 'outsource' dangerous drugs without a Board license. This applies when the activity occurs out of state for delivery to patients or customers in Oklahoma. An outsourcing facility must name, in writing, a pharmacist-in-charge licensed by the Oklahoma Board. OAC 535:20-6-3 bars shipping an outsourcing facility's drugs into Oklahoma unless each of its facilities is licensed in Oklahoma, renewed each year, and FDA-registered. Applicants must supply ownership details, background checks and fingerprinting of designated representatives, and proof of FDA and home-state licensure. The Board inspects before licensure (non-residents pay the costs) and may use NABP for inspections. An outsourcing facility that also fills patient-specific prescriptions for Oklahoma must additionally hold an Oklahoma pharmacy or non-resident pharmacy license. Shipments may go only to the address on the recipient's license.
The fee is $200 per year. Each PIC may serve only one facility or pharmacy and must be on site at least 20 hours a week; a non-resident facility may ask for more time for a new PIC to get Oklahoma licensure in urgent situations (535:20-6-6). Taken from the Board's unofficial July 2026 compilation; the official text is at rules.ok.gov.
59 O.S. §353.1(31); 59 O.S. §353.18(A)(5), (B); OAC 535:20-6-3 to 535:20-6-7; OAC 535:1-11-1(12)
- Oklahoma Pharmacy Law Book — 59 O.S. §353.18 and OAC 535:20 Subchapter 6 (Outsourcing Facilities), compilation effective July 11, 2026 — Oklahoma State Board of Pharmacy, 2026-07-11
FDA compounding MOUOklahoma 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; Oklahoma 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 registrationOklahoma requires everyone who prescribes, administers or dispenses controlled dangerous substances within or into the state to hold a registration from the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control (OBNDD).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.
63 O.S. 2-302(A) requires every person who manufactures, distributes, dispenses, prescribes, administers or uses for scientific purposes any controlled dangerous substance 'within or into this state' to obtain a registration issued by the OBNDD Director. A separate registration is required at each principal place of business or professional practice where the applicant prescribes, administers or dispenses (2-302(J)), and a professional license is a prerequisite (2-302(L)). Practitioner registrations run for a period set by the Director of one to three years (2-302(F)); licensing boards, including boards of mid-level practitioners, report their licensees to OBNDD each year. Registered and practical nurses acting under a practitioner are exempt (2-302(H)).
The phrase 'within or into this state' means out-of-state telehealth prescribers sending CDS prescriptions into Oklahoma fall under the requirement. OBNDD's website blocked automated access, so the current fee, term and application order relative to DEA were not confirmed; 2-302(M) (registrations issued November 1, annual) and 2-302(F) (term set by the Director, one to three years) read differently - check with OBNDD. Covers NPs and PAs (mid-level practitioners) as well as physicians.
63 O.S. 2-302
- 63 O.S. Sec. 2-302 - Registration Requirements (OSCN 2026) — Oklahoma State Courts Network, 2026-09-23
PDMP check before prescribingOklahoma requires a PMP check before prescribing or authorizing refills of opioids, benzodiazepines or carisoprodol if 180 days have passed since the last check, 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.
63 O.S. Sec. 2-309D(G)(2) requires registrants or their staff, before prescribing or authorizing a refill of opiates, synthetic or semisynthetic opiates, benzodiazepines or carisoprodol for a patient of record, to access the central repository if 180 days have elapsed since the previous check, and to note the check in the patient file. It does not apply to hospice or end-of-life care or to prescriptions for residents of nursing facilities. Failure to check can be grounds for discipline by the registrant's licensing board, which has sole enforcement responsibility; the PMP is run by the Oklahoma Bureau of Narcotics and Dangerous Drugs Control.
Source older than 2 years - possibly stale; last amended Laws 2022, SB 1151, emerg. eff. April 25, 2022, and this is the current OSCN text. PDMP TTAC also lists 63 O.S. 2-309I (opioid prescribing limits) and OAC 510:5-3-3.
63 O.S. Sec. 2-309D
- 63 O.S. Sec. 2-309D - Confidential Nature of Information - Disclosure - Investigative Reports — Oklahoma State Courts Network (Oklahoma Statutes), 2022-04-25
Physicians dispensing from the officeOklahoma physicians reportedly may dispense after a free registration with the state medical board, with real-time PMP reporting of dispensed controlled substances.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 vendor summary reports that Oklahoma physicians may dispense in the normal course of practice once registered with the Oklahoma State Board of Medical Licensure and Supervision as a dispensing physician (no charge), and that Schedule II-V drugs dispensed from the office must be reported to the Oklahoma PMP in real time (within five minutes). The statute and rule text were not reviewed.
Confirm with the Oklahoma medical board (and the osteopathic board for DOs).
Oklahoma dispensing physician registration - not verified
- Oklahoma Physician Dispensing Laws & Regulations — PharmaLink (vendor summary), 2026-09-23
- Oklahoma State Board of Medical Licensure and Supervision — Oklahoma State Board of Medical Licensure and Supervision, 2026-09-23
Prescribing by telehealthOklahoma requires an Oklahoma (or IMLC) license for telemedicine and bars using telemedicine to establish a relationship for prescribing opioids, benzodiazepines or carisoprodol; Schedule III drugs such as testosterone are not on that list.Allowed (standard rules)
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.
(1) Physicians treating patients in Oklahoma through telemedicine must be fully licensed in Oklahoma, and a relationship may be established by telemedicine only if the physician holds an Oklahoma license, confirms the patient's identity and location and discloses credentials (59 O.S. 478.1; OAC 435:10-7-13). (2) The Board's face-to-face encounter requirement is satisfied by a telemedicine exam using interactive real-time audio and video that provides information equivalent to an in-person exam (OAC 435:10-7-12, 435:10-7-13). (3) Telemedicine may not be used to establish a relationship for prescribing opiates (including synthetic and semisynthetic), benzodiazepines or carisoprodol, except opioid antagonists or partial agonists and FDA-approved Schedule III-V drugs for MAT or detoxification; no Oklahoma telehealth limit reaches testosterone. (4) IMLC: member.
Borderline under the classification rule: the telemedicine limit reaches opioids plus Schedule IV benzodiazepines and carisoprodol, but not testosterone or non-opioid Schedule III drugs, so it was treated as 'yes'. Board rules date from 2014-2015 and are the current text. The statute covers allopathic and osteopathic physicians.
59 O.S. 478.1 (amended 2023, HB 2686); OAC 435:10-7-12; OAC 435:10-7-13
- 59 O.S. 478.1 - Telemedicine - Establishment of physician-patient relationship - Prescribing — Oklahoma State Courts Network, 2023-05-15
- Okla. Admin. Code 435:10-7-13 - Telemedicine — Legal Information Institute (Oklahoma Board of Medical Licensure and Supervision rule text), 2014-09-12
- Okla. Admin. Code 435:10-7-12 - Physician/patient relationship — Legal Information Institute (Oklahoma Board of Medical Licensure and Supervision rule text), 2015-09-11
- 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 fillersOklahoma RNs may inject neuromodulators and fillers without a prescriber on site, but only with an individualized order and a completed history and physical by the prescriber (in person or telemedicine); standing orders do not substitute.RNs may inject with added conditions
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?
Oklahoma Board of Nursing Guideline P-25 on cosmetic/aesthetic dermatological procedures (approved 2026-03-24, revised 2026-05-19) covers neuromodulator and dermal filler injections, lasers and light treatments. RNs need no on-site physician, APRN or PA if there is a valid individualized order and a completed history and physical by the prescriber; standing orders are not an appropriate substitute, and physicians must establish the relationship through an initial evaluation, face to face or by telemedicine. LPNs may perform these procedures under supervision by an RN, physician or dentist on the same conditions. Nurses need documented competency, and settings must keep on-site procedure and emergency policies.
Oklahoma Board of Nursing Policy/Guideline P-25 'Cosmetic/Aesthetic Dermatological Procedures' (approved 2026-03-24; revised 2026-05-19)
- Cosmetic/Aesthetic Dermatological Procedures Guidelines (P-25) — Oklahoma Board of Nursing, 2026-05-19
IV hydration and vitamin therapyOklahoma RNs may give IV hydration without a prescriber on site, but only on an individualized order after the prescriber's history and physical (in person or telemedicine); standing orders are not allowed as a substitute, including at walk-in and mobile drip services.Extra requirements apply
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?
Oklahoma Board of Nursing Guideline P-24 on IV hydration (approved 2026-03-24, revised 2026-05-19) applies to walk-in and mobile hydration clinics and drip bars. RNs do not need a physician, APRN or PA on site if there is a valid individualized order and a completed history and physical by the prescriber; standing orders are not an appropriate substitute, and physicians must establish the relationship through an initial evaluation, face to face or by telemedicine. LPNs may administer under RN, physician or dentist supervision if they meet the Board's LPN IV medication guideline.
Oklahoma Board of Nursing Policy/Guideline P-24 'IV Hydration' (approved 2026-03-24; revised 2026-05-19)
- IV Hydration Guidelines (P-24) — Oklahoma Board of Nursing, 2026-05-19
Corporate practice of medicine / med spa ownershipCompilations list Oklahoma as a state without a meaningful corporate practice of medicine bar.No meaningful 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 lists Oklahoma among non-CPOM states, citing Okla. Stat. tit. 18 §844 and Attorney General Opinion No. 77-168; MedPath Compliance (reviewed 2026-06-20) also lists Oklahoma as 'No'. Laser hair removal facilities must nonetheless be overseen by a physician, PA or APRN under the Laser Hair Removal Act.
Okla. Stat. tit. 18 §844; Okla. Att'y Gen. Op. No. 77-168 (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 lasersOklahoma's Laser Hair Removal Act lets non-licensed 'laser practitioners' perform laser hair removal after 40 hours of training under a supervising physician, PA or APRN who oversees the facility, sets protocols, reviews 10% of charts and evaluates each patient first (in person or telemedicine).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?
Under 59 O.S. §538.3, only FDA-approved lasers or pulsed-light devices for noninvasive procedures may be used; a person must hold an appropriate health professional licence or be a laser practitioner supervised by a physician, certified PA or certified APRN, and non-physician laser practitioners must complete a 40-hour training program overseen by a physician. Each laser hair removal facility must be overseen by a physician, PA or APRN who sets written protocols (including complication management by a physician, PA or APRN), decides how many practitioners they supervise and reviews at least 10% of patient records; the physician, PA or APRN must perform an initial evaluation of each patient, face to face or by telemedicine. The Board of Nursing's P-25 guideline also lets RNs perform aesthetic laser procedures on an individualized order after the prescriber's history and physical.
Statute page shows 'OSCN 2026' with no enactment date on the fetched text.
59 O.S. §538.3 (Laser Hair Removal Act); Oklahoma Board of Nursing Guideline P-25
- 59 O.S. §538.3 – Requirements for Laser Hair Removal — Oklahoma State Courts Network (Oklahoma Statutes), 2026-09-23
- Cosmetic/Aesthetic Dermatological Procedures Guidelines (P-25) — Oklahoma Board of Nursing, 2026-05-19
Labs, regenerative medicine & cosmetics
State clinical laboratory licensing (beyond CLIA)Not confirmed. No Oklahoma 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). Oklahoma was not among them, but this research did not confirm its statutes. Oklahoma's CLIA state agency is Oklahoma State Dept. of Health, Protective Health Services (clia@health.ok.gov, 405-426-8470); it can confirm whether any state license or permit applies, including to out-of-state labs.
Absence of a state license was not verified against the state's statutes or rules.
Not confirmed
- CLIA State Agency Contacts (updated May 2026) — Centers for Medicare & Medicaid Services, 2026-05-01
Direct-to-consumer lab testingNot confirmed whether Oklahoma 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 Oklahoma's rule. Oklahoma's lab regulator (CLIA state agency) is Oklahoma State Dept. of Health, Protective Health Services (clia@health.ok.gov, 405-426-8470). 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 Oklahoma 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. Oklahoma 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 sunscreenNo Oklahoma-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?
Oklahoma 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
- PFAS in Cosmetics: US State Bans and Compliance Deadlines - 2026 Update — Adherent (formerly Compliance & Risks), 2026-03-13
- State PFAS Bans in Cosmetics Expand Ahead of 2026 (updated Jan. 14, 2026) — Morgan, Lewis & Bockius LLP, 2026-01-14
- Testing cosmetics on animals (US state bans 'as of 2023') — Wikipedia, 2026-09-23
Compare every state
State controlled-substance registration. 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.
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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