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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.

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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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Testosterone & androgens (C-III)

FDA pathway: Drug (NDA/ANDA); DEA Schedule III controlled substance | Compounded 503A

Testosterone is a Schedule III anabolic steroid requiring DEA registration to prescribe or dispense; FDA's 2025 class labeling removed the CV boxed-warning language but added blood-pressure warnings; telemedicine prescribing without an in-person visit is allowed through Dec 31, 2026.

On MedGrid as: Testosterone & Androgens · Testosterone

The federal rules

Schedule III anabolic steroidTestosterone and its salts, esters and ethers are Schedule III anabolic steroids under 21 CFR 1308.13(f).

Schedule III rules (DEA registration, records, prescription limits, PDMP reporting under state law) apply to all testosterone products, including compounded ones.

Current as of 2026-09-23

DEA registration for each practice locationA separate DEA registration is required for each principal place of business or professional practice where controlled substances are dispensed.

Many states also require a state controlled-substance registration (see state_csr).

Current as of 2026-09-23

Telemedicine prescribing through Dec 31, 2026Under DEA/HHS's fourth temporary extension, testosterone (C-III) may be prescribed by telemedicine without a prior in-person visit through Dec 31, 2026.

The permanent special-registration rule was in OMB review as of late Aug 2026. State law may be stricter.

2025 class-wide labeling: CV boxed-warning language removed; blood-pressure warning addedOn Feb 28, 2025 FDA required all testosterone products to add TRAVERSE trial results, remove boxed-warning language on increased cardiovascular risk, keep the age-related hypogonadism limitation of use, and carry a warning about increased blood pressure.

FDA said TRAVERSE showed no increase in adverse cardiovascular outcomes in men with hypogonadism, while ambulatory BP studies confirmed a class-wide blood pressure increase.

Current as of 2025-02-28

Compounded testosterone and enclomipheneCompounded testosterone is subject to the 503A 'essentially a copy' limits because approved injectable, topical and oral products exist; enclomiphene citrate is a 503A Category 1 bulk substance.

A compounded testosterone preparation matching an approved product's strength and route needs a documented patient-specific significant difference.

Changing now

What Louisiana adds

Out-of-state pharmacies shipping into the stateLouisiana requires an out-of-state pharmacy to hold a Louisiana nonresident pharmacy permit, with a Louisiana-licensed pharmacist in charge, before it ships prescriptions to Louisiana residents.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?

La. R.S. 37:1232 requires a nonresident pharmacy permit. The pharmacy must disclose its officers and pharmacist in charge (PIC) and submit its most recent home-state inspection report, plus any inspection reports from other states, FDA or DEA. LAC 46:LIII §2301-2317 apply to any pharmacy outside Louisiana that dispenses prescription drugs to Louisiana residents. Under §2307 (amended October 2025), the PIC must hold an active Louisiana pharmacist license as well as a home-state license and must work at the pharmacy at least 20 hours a week. Louisiana pharmacy law applies to the Louisiana portion of the business (§2309), and the Board may inspect (§2311). The pharmacy must print a toll-free counseling number on every container (§2315). The Board requires an inspection dated within 24 months before each annual renewal, and NABP inspections are accepted. Pharmacies sending sterile or non-sterile compounded preparations to Louisiana residents must submit an NABP VPP inspection, a state inspection using the NABP blueprint, or an ACHC inspection. Otherwise they must attest that they will stop sending compounds. The Louisiana Board of Pharmacy enforces these rules.

R.S. 37:1232 was last amended by Acts 2020, No. 202, effective 2020-07-01. The nonresident chapter was amended at LR 49:680 (April 2023), and §§2301 and 2307 again at LR 51:1588 (October 2025), a recent change. Louisiana also issues a separate Compounded Sterile Preparations (CSP) permit, and §2535(B) requires Board approval before a permit holder starts sterile compounding. Whether nonresident permit holders need the CSP permit was not confirmed.

La. R.S. 37:1232; LAC 46:LIII.2301-2317 (esp. §2307)

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

Office-use compounding from 503A pharmaciesLouisiana's current compounding rules allow non-patient-specific (office-use) compounding only for veterinarians; human compounding is tied to patient-specific prescriptions under federal section 503A.Not allowed

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.

LAC 46:LIII §2533 defines compounding as preparation 'for his patient as the result of a practitioner's prescription drug order' or in anticipation of such orders. Under §2535(A)(2)(a)-(b), sterile and non-sterile compounding under a patient-specific prescription must comply with section 503A of the federal Food, Drug, and Cosmetic Act and USP <797>/<795>. The only non-patient-specific authorization is §2535(E), which covers orders from a licensed veterinarian for animal patients. Those products may not be redistributed or resold, and are capped at 5% of the pharmacy's total drug products by dosage units each month; for out-of-state Louisiana-licensed pharmacies, the cap is measured against their Louisiana business. The current text of §2535 contains no equivalent human office-use authorization. The Board states that all compounding must comply with USP chapters, 21 CFR and the federal Act. The Louisiana Board of Pharmacy enforces these rules.

§2535 was last amended at LR 49:66 (January 2023); earlier versions were not reviewed. §2533 still defines 'practitioner administered compounds' (compounds made on a prescriber's medical order for administration by the prescriber), and an older labeling rule for them remains in the nuclear pharmacy chapter. The current §2535 does not authorize them for human use; check with the Louisiana Board of Pharmacy before relying on 503A office stock.

LAC 46:LIII.2533; LAC 46:LIII.2535(A)(2), (E)

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

503B outsourcing facilities shipping into the stateNot confirmed: the Louisiana Board of Pharmacy has no outsourcing-facility license, and whether an out-of-state 503B needs a Louisiana Board of Drug and Device Distributors license could not be verified.Not confirmed

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?

The Louisiana Drug and Device Distributors Act (La. R.S. 37:3461) says any person engaged in distributing legend drugs 'shall be licensed.' R.S. 37:3462 defines 'manufacturer' to include anyone who prepares legend drugs in dosage form by 'compounding,' and defines 'distribution' as sale or delivery to anyone other than the consumer or patient. The sections reviewed do not mention outsourcing facilities or say how they apply to firms located outside Louisiana. The Louisiana Board of Pharmacy rules (LAC 46:LIII) contain no outsourcing-facility permit. The Board does issue a controlled dangerous substance license class called 'Registered Outsourcing Facility' (CDS-ROF), which covers controlled substances. A 503B that dispenses patient-specific prescriptions to Louisiana residents would fall under the nonresident pharmacy permit (R.S. 37:1232).

The Louisiana Board of Drug and Device Distributors website could not be reached, and the search budget was used up, so its licensing of out-of-state 503B facilities was not confirmed. Check with that board and the Louisiana Board of Pharmacy (https://www.pharmacy.la.gov/, 225-925-6496). The statute suggests a distributor or manufacturer license is likely required, but this is unconfirmed.

La. R.S. 37:3461; La. R.S. 37:3462

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

State controlled-substance registrationLouisiana requires every practitioner who prescribes, possesses or dispenses controlled substances to hold an annual Controlled Dangerous Substance (CDS) license from the Louisiana Board of Pharmacy, which the DEA relies on to issue a Louisiana DEA registration.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.

Board rule LAC 46:LIII.2705 requires every person who procures, possesses, prescribes or dispenses any controlled dangerous substance in Louisiana to obtain a CDS license from the Board of Pharmacy before doing so; practitioners must hold a valid Louisiana professional license or credential. A CDS license is valid for one year and expires annually on the date of initial licensure (LAC 46:LIII.2707); fees are set by R.S. 40:972 and R.S. 40:1013. The Board's FAQ explains that the CDS license is supplied to DEA to show eligibility for a DEA registration and that both are required. For prescribing, one CDS license covers any Louisiana location, but procuring and possessing controlled substances requires a separate CDS license at each location where they are kept.

Sec. 2705 was last amended LR 51:1589 (October 2025). Fee amount not confirmed (set in R.S. 40:972, not opened). Per-location: only where controlled substances are procured/possessed; prescribe-only needs one license statewide.

LAC 46:LIII.2705; LAC 46:LIII.2707; R.S. 40:972

Current as of 2025-10-20 · Checked against the primary source

PDMP check before prescribingLouisiana requires a PMP check only before initially prescribing an opioid (then every 90 days for ongoing treatment), 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.

La. R.S. 40:978(F) requires a prescriber or delegate to access and review the patient's PMP record before initially prescribing any opioid and at least every 90 days if treatment continues beyond 90 days; the Board of Medical Examiners rule LAC 46:XLV.6935 repeats this. Exceptions: hospice or terminally ill patients, cancer-related chronic or intractable pain, patients treated in a hospital, PMP outages (check once restored and chart the delay), and no more than a single 7-day supply. Enforced by the prescriber's licensing board - a first failure draws a notice, a second is treated as a complaint.

Testosterone (C-III) is not caught. Statute last amended by Acts 2024, No. 205 per the history note. A repealed medical-marijuana rule (LAC 46:XLV.7717) had its own PMP review requirement.

La. R.S. 40:978(F); La. Admin. Code tit. 46, § XLV.6935

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

Physicians dispensing from the officeLouisiana physicians need a dispensing permit from the Board of Medical Examiners, and controlled substances may be dispensed only up to a 48-hour supply.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.

The Louisiana State Board of Medical Examiners issues dispensing permits to MDs and DOs holding a Louisiana license, a Louisiana CDS license and DEA registration; the fee is $75 per dispensing location (rules at LAC 46:XLV, Subpart 3, Chapter 65). Physicians with three or more years in practice may dispense at most a 48-hour supply of controlled substances (with a 7-day Lyrica sample exception); those with less than three years may dispense only legend drugs. This effectively rules out dispensing ongoing testosterone.

Board page has no date; access date used.

LAC 46:XLV, Chapter 65

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

Prescribing by telehealthLouisiana requires a Louisiana license and allows telemedicine exams, but a physician may not prescribe a controlled substance by telemedicine without at least one in-person visit in the past year (facility patients excepted).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.

Telemedicine prescribing is held to the same standards as face-to-face practice, and the exam need not be in person if the technology gives the physician the clinical information needed (LAC 46:XLV.7503-7505). A physician may not prescribe any controlled substance by telemedicine unless the physician has had at least one in-person visit with the patient within the past year and the prescription meets the in-person standard of care; the in-person requirement does not apply to patients treated at a Louisiana-licensed, DEA-registered healthcare facility (LAC 46:XLV.7513). Testosterone prescribing by telemedicine therefore needs an annual in-person visit. IMLC: member.

Rule 7513 promulgated 2009 and last amended February 1, 2017 (LII copy); CCHP (updated 2/16/2026) shows the same text. The board may grant written case-by-case exceptions.

LAC 46:XLV.7503-7505, 7513

Current as of 2026-02-16 · Checked against the primary source

Who may inject neuromodulators and fillersLouisiana RNs may inject Botox (FDA-approved products) but not dermal fillers; a physician or collaborating NP must first take a history and examine the patient and must be physically on the premises during RN treatment.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?

The Louisiana State Board of Nursing's declaratory statement on cosmetic and aesthetic dermatological procedures (adopted 2011-03-02) says a trained RN may perform Botox (or similar FDA-approved) cosmetic injections and superficial sclerotherapy on the order of a qualified physician or an NP in a Board-approved collaborative practice, but RN scope excludes all dermal fillers. Treatment must be preceded by a history, physical exam and diagnosis by the physician or NP, informed consent and a medical record; the RN may then follow standing orders and protocols. Procedures must be done in a medical facility or office with the physician or NP physically present on the premises and immediately available, and the setting needs written policies and competency validation. Qualified NPs may perform cosmetic procedures as a subspecialty within their collaborative agreement.

Adopted 2011 — possibly stale, but still posted as current on the Board's scope-of-practice page on 2026-09-23. Biostimulators and skin boosters are not addressed; as injectable fillers they are likely within the filler exclusion — confirm with LSBN.

LSBN Declaratory Statement 'Cosmetic and Aesthetic Dermatological Procedures and Treatments Performed by RNs and APRNs' (adopted 2011-03-02); La. R.S. 37:911 et seq.

Current as of 2011-03-02 · Checked against the primary source

Louisiana at a glance

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

Pharmacy & compounding

Out-of-state pharmacies shipping into the stateLouisiana requires an out-of-state pharmacy to hold a Louisiana nonresident pharmacy permit, with a Louisiana-licensed pharmacist in charge, before it ships prescriptions to Louisiana residents.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?

La. R.S. 37:1232 requires a nonresident pharmacy permit. The pharmacy must disclose its officers and pharmacist in charge (PIC) and submit its most recent home-state inspection report, plus any inspection reports from other states, FDA or DEA. LAC 46:LIII §2301-2317 apply to any pharmacy outside Louisiana that dispenses prescription drugs to Louisiana residents. Under §2307 (amended October 2025), the PIC must hold an active Louisiana pharmacist license as well as a home-state license and must work at the pharmacy at least 20 hours a week. Louisiana pharmacy law applies to the Louisiana portion of the business (§2309), and the Board may inspect (§2311). The pharmacy must print a toll-free counseling number on every container (§2315). The Board requires an inspection dated within 24 months before each annual renewal, and NABP inspections are accepted. Pharmacies sending sterile or non-sterile compounded preparations to Louisiana residents must submit an NABP VPP inspection, a state inspection using the NABP blueprint, or an ACHC inspection. Otherwise they must attest that they will stop sending compounds. The Louisiana Board of Pharmacy enforces these rules.

R.S. 37:1232 was last amended by Acts 2020, No. 202, effective 2020-07-01. The nonresident chapter was amended at LR 49:680 (April 2023), and §§2301 and 2307 again at LR 51:1588 (October 2025), a recent change. Louisiana also issues a separate Compounded Sterile Preparations (CSP) permit, and §2535(B) requires Board approval before a permit holder starts sterile compounding. Whether nonresident permit holders need the CSP permit was not confirmed.

La. R.S. 37:1232; LAC 46:LIII.2301-2317 (esp. §2307)

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

Office-use compounding from 503A pharmaciesLouisiana's current compounding rules allow non-patient-specific (office-use) compounding only for veterinarians; human compounding is tied to patient-specific prescriptions under federal section 503A.Not allowed

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.

LAC 46:LIII §2533 defines compounding as preparation 'for his patient as the result of a practitioner's prescription drug order' or in anticipation of such orders. Under §2535(A)(2)(a)-(b), sterile and non-sterile compounding under a patient-specific prescription must comply with section 503A of the federal Food, Drug, and Cosmetic Act and USP <797>/<795>. The only non-patient-specific authorization is §2535(E), which covers orders from a licensed veterinarian for animal patients. Those products may not be redistributed or resold, and are capped at 5% of the pharmacy's total drug products by dosage units each month; for out-of-state Louisiana-licensed pharmacies, the cap is measured against their Louisiana business. The current text of §2535 contains no equivalent human office-use authorization. The Board states that all compounding must comply with USP chapters, 21 CFR and the federal Act. The Louisiana Board of Pharmacy enforces these rules.

§2535 was last amended at LR 49:66 (January 2023); earlier versions were not reviewed. §2533 still defines 'practitioner administered compounds' (compounds made on a prescriber's medical order for administration by the prescriber), and an older labeling rule for them remains in the nuclear pharmacy chapter. The current §2535 does not authorize them for human use; check with the Louisiana Board of Pharmacy before relying on 503A office stock.

LAC 46:LIII.2533; LAC 46:LIII.2535(A)(2), (E)

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

503B outsourcing facilities shipping into the stateNot confirmed: the Louisiana Board of Pharmacy has no outsourcing-facility license, and whether an out-of-state 503B needs a Louisiana Board of Drug and Device Distributors license could not be verified.Not confirmed

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?

The Louisiana Drug and Device Distributors Act (La. R.S. 37:3461) says any person engaged in distributing legend drugs 'shall be licensed.' R.S. 37:3462 defines 'manufacturer' to include anyone who prepares legend drugs in dosage form by 'compounding,' and defines 'distribution' as sale or delivery to anyone other than the consumer or patient. The sections reviewed do not mention outsourcing facilities or say how they apply to firms located outside Louisiana. The Louisiana Board of Pharmacy rules (LAC 46:LIII) contain no outsourcing-facility permit. The Board does issue a controlled dangerous substance license class called 'Registered Outsourcing Facility' (CDS-ROF), which covers controlled substances. A 503B that dispenses patient-specific prescriptions to Louisiana residents would fall under the nonresident pharmacy permit (R.S. 37:1232).

The Louisiana Board of Drug and Device Distributors website could not be reached, and the search budget was used up, so its licensing of out-of-state 503B facilities was not confirmed. Check with that board and the Louisiana Board of Pharmacy (https://www.pharmacy.la.gov/, 225-925-6496). The statute suggests a distributor or manufacturer license is likely required, but this is unconfirmed.

La. R.S. 37:3461; La. R.S. 37:3462

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

FDA compounding MOULouisiana 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; Louisiana 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 registrationLouisiana requires every practitioner who prescribes, possesses or dispenses controlled substances to hold an annual Controlled Dangerous Substance (CDS) license from the Louisiana Board of Pharmacy, which the DEA relies on to issue a Louisiana DEA registration.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.

Board rule LAC 46:LIII.2705 requires every person who procures, possesses, prescribes or dispenses any controlled dangerous substance in Louisiana to obtain a CDS license from the Board of Pharmacy before doing so; practitioners must hold a valid Louisiana professional license or credential. A CDS license is valid for one year and expires annually on the date of initial licensure (LAC 46:LIII.2707); fees are set by R.S. 40:972 and R.S. 40:1013. The Board's FAQ explains that the CDS license is supplied to DEA to show eligibility for a DEA registration and that both are required. For prescribing, one CDS license covers any Louisiana location, but procuring and possessing controlled substances requires a separate CDS license at each location where they are kept.

Sec. 2705 was last amended LR 51:1589 (October 2025). Fee amount not confirmed (set in R.S. 40:972, not opened). Per-location: only where controlled substances are procured/possessed; prescribe-only needs one license statewide.

LAC 46:LIII.2705; LAC 46:LIII.2707; R.S. 40:972

Current as of 2025-10-20 · Checked against the primary source

PDMP check before prescribingLouisiana requires a PMP check only before initially prescribing an opioid (then every 90 days for ongoing treatment), 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.

La. R.S. 40:978(F) requires a prescriber or delegate to access and review the patient's PMP record before initially prescribing any opioid and at least every 90 days if treatment continues beyond 90 days; the Board of Medical Examiners rule LAC 46:XLV.6935 repeats this. Exceptions: hospice or terminally ill patients, cancer-related chronic or intractable pain, patients treated in a hospital, PMP outages (check once restored and chart the delay), and no more than a single 7-day supply. Enforced by the prescriber's licensing board - a first failure draws a notice, a second is treated as a complaint.

Testosterone (C-III) is not caught. Statute last amended by Acts 2024, No. 205 per the history note. A repealed medical-marijuana rule (LAC 46:XLV.7717) had its own PMP review requirement.

La. R.S. 40:978(F); La. Admin. Code tit. 46, § XLV.6935

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

Physicians dispensing from the officeLouisiana physicians need a dispensing permit from the Board of Medical Examiners, and controlled substances may be dispensed only up to a 48-hour supply.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.

The Louisiana State Board of Medical Examiners issues dispensing permits to MDs and DOs holding a Louisiana license, a Louisiana CDS license and DEA registration; the fee is $75 per dispensing location (rules at LAC 46:XLV, Subpart 3, Chapter 65). Physicians with three or more years in practice may dispense at most a 48-hour supply of controlled substances (with a 7-day Lyrica sample exception); those with less than three years may dispense only legend drugs. This effectively rules out dispensing ongoing testosterone.

Board page has no date; access date used.

LAC 46:XLV, Chapter 65

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

Prescribing by telehealthLouisiana requires a Louisiana license and allows telemedicine exams, but a physician may not prescribe a controlled substance by telemedicine without at least one in-person visit in the past year (facility patients excepted).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.

Telemedicine prescribing is held to the same standards as face-to-face practice, and the exam need not be in person if the technology gives the physician the clinical information needed (LAC 46:XLV.7503-7505). A physician may not prescribe any controlled substance by telemedicine unless the physician has had at least one in-person visit with the patient within the past year and the prescription meets the in-person standard of care; the in-person requirement does not apply to patients treated at a Louisiana-licensed, DEA-registered healthcare facility (LAC 46:XLV.7513). Testosterone prescribing by telemedicine therefore needs an annual in-person visit. IMLC: member.

Rule 7513 promulgated 2009 and last amended February 1, 2017 (LII copy); CCHP (updated 2/16/2026) shows the same text. The board may grant written case-by-case exceptions.

LAC 46:XLV.7503-7505, 7513

Current as of 2026-02-16 · Checked against the primary source

Aesthetics, IV therapy & practice ownership

Who may inject neuromodulators and fillersLouisiana RNs may inject Botox (FDA-approved products) but not dermal fillers; a physician or collaborating NP must first take a history and examine the patient and must be physically on the premises during RN treatment.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?

The Louisiana State Board of Nursing's declaratory statement on cosmetic and aesthetic dermatological procedures (adopted 2011-03-02) says a trained RN may perform Botox (or similar FDA-approved) cosmetic injections and superficial sclerotherapy on the order of a qualified physician or an NP in a Board-approved collaborative practice, but RN scope excludes all dermal fillers. Treatment must be preceded by a history, physical exam and diagnosis by the physician or NP, informed consent and a medical record; the RN may then follow standing orders and protocols. Procedures must be done in a medical facility or office with the physician or NP physically present on the premises and immediately available, and the setting needs written policies and competency validation. Qualified NPs may perform cosmetic procedures as a subspecialty within their collaborative agreement.

Adopted 2011 — possibly stale, but still posted as current on the Board's scope-of-practice page on 2026-09-23. Biostimulators and skin boosters are not addressed; as injectable fillers they are likely within the filler exclusion — confirm with LSBN.

LSBN Declaratory Statement 'Cosmetic and Aesthetic Dermatological Procedures and Treatments Performed by RNs and APRNs' (adopted 2011-03-02); La. R.S. 37:911 et seq.

Current as of 2011-03-02 · Checked against the primary source

IV hydration and vitamin therapyNo Louisiana board statement specific to elective IV hydration was found.Not confirmed

What does the state require for elective IV hydration/vitamin (incl. NAD+) therapy: who may start IVs, is a patient-specific order or good-faith exam required before a patient's first IV, are standing orders allowed, and are there rules for mobile IV services?

The Louisiana State Board of Nursing's scope-of-practice documents and practice-petition list (checked 2026-09-23) include IV-related opinions for clinical settings but no statement on IV hydration clinics, prior exams or mobile IV services.

Check with LSBN and the Louisiana State Board of Medical Examiners.

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

Corporate practice of medicine / med spa ownershipLouisiana's corporate practice position comes from a 1992 medical board statement of position, and compilations call its status unclear or nuanced.CPOM with exceptions

Does the state enforce the corporate practice of medicine doctrine (non-physicians may not own medical practices or employ physicians), and how does that affect med spa ownership?

Permit Health's 2025 guide lists Louisiana as 'Unclear', citing the Louisiana State Board of Medical Examiners' Statement of Position (1992-09-24, reviewed 2001-03-21); MedPath Compliance (reviewed 2026-06-20) calls it 'Nuanced'.

LSBME Statement of Position (1992, reviewed 2001) (as reported by Permit Health)

Current as of 2025-12-23 · From a dated compilation

Who may operate aesthetic lasersLouisiana RNs may perform non-ablative laser resurfacing and laser hair removal only on a physician/NP order after that practitioner's exam, with the physician or NP physically on the premises; ablative lasers are outside RN scope.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?

The LSBN declaratory statement (2011) lists non-ablative laser skin resurfacing and laser hair removal among procedures a trained RN may perform, subject to the same conditions as injectables: a prior history, exam and diagnosis by a qualified physician or collaborating NP, a medical facility or office setting, and the physician or NP physically present and immediately available. Ablative lasers are not within RN scope. The Board also lists a practice opinion on RNs performing Class IV laser procedures under the direct supervision of a qualified physician. The statement cites a Louisiana State Board of Medical Examiners Statement of Position on medical lasers (rev. 2001), which was not fetched; whether estheticians or unlicensed technicians may use lasers was not confirmed.

Possibly stale (2011). A vendor compilation lists Louisiana as 'physicians only' for laser hair removal, which conflicts with the LSBN statement for RNs; check with LSBME.

LSBN Declaratory Statement on cosmetic and aesthetic dermatological procedures (2011-03-02)

Current as of 2011-03-02 · Checked against the primary source

Labs, regenerative medicine & cosmetics

State clinical laboratory licensing (beyond CLIA)Not confirmed. No Louisiana 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). Louisiana was not among them, but this research did not confirm its statutes. Louisiana's CLIA state agency is Louisiana Dept. of Health, Health Standards Section CLIA Program (225-342-9324); 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. ASCLS lists Louisiana among the states that license clinical laboratory personnel, which applies to labs located in the state.

Not confirmed

Current as of 2026-05-01 · Not independently confirmed

Direct-to-consumer lab testingNot confirmed whether Louisiana 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 Louisiana's rule. Louisiana's lab regulator (CLIA state agency) is Louisiana Dept. of Health, Health Standards Section CLIA Program (225-342-9324). 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

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

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

State rules for cosmetics and sunscreenLouisiana is listed among the states that ban the sale of cosmetics tested on animals; no PFAS-in-cosmetics or sunscreen law was found.State cosmetic/sunscreen rules

Does the state have cosmetic or sunscreen requirements beyond federal MoCRA, such as ingredient bans (PFAS, formaldehyde, phthalates), ingredient reporting, sunscreen-ingredient bans, or bans on selling animal-tested cosmetics?

A 2023 compilation lists Louisiana among the ten states with cosmetic animal-testing sales bans. Louisiana does not appear on 2026 lists of states with PFAS-in-cosmetics laws.

The animal-testing list is Wikipedia's 'as of 2023' compilation (older than 2 years); effective dates were not confirmed. Federal MoCRA and FDA cosmetic and OTC sunscreen rules apply in every state.

Louisiana cosmetic animal-testing law (citation not confirmed)

Current as of 2026-09-23 · From a dated compilation

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.

State CS registration required · 23Required in some settings · 3DEA + state license only · 23Not confirmed · 2
Alaska: DEA + state license onlyAlabama: State CS registration requiredArkansas: DEA + state license onlyArizona: DEA + state license onlyCalifornia: DEA + state license onlyColorado: DEA + state license onlyConnecticut: State CS registration requiredWashington DC: State CS registration requiredDelaware: State CS registration requiredFlorida: DEA + state license onlyGeorgia: DEA + state license onlyHawaii: State CS registration requiredIowa: State CS registration requiredIdaho: State CS registration requiredIllinois: State CS registration requiredIndiana: State CS registration requiredKansas: DEA + state license onlyKentucky: DEA + state license onlyMassachusetts: State CS registration requiredMaryland: State CS registration requiredMaine: DEA + state license onlyMichigan: State CS registration requiredMinnesota: DEA + state license onlyMissouri: State CS registration requiredMississippi: DEA + state license onlyMontana: DEA + state license onlyNorth Carolina: DEA + state license onlyNorth Dakota: Not confirmedNebraska: DEA + state license onlyNew Hampshire: DEA + state license onlyNew Jersey: State CS registration requiredNew Mexico: State CS registration requiredNevada: State CS registration requiredNew York: DEA + state license onlyOhio: Required in some settingsOklahoma: State CS registration requiredOregon: DEA + state license onlyPennsylvania: DEA + state license onlyRhode Island: State CS registration requiredSouth Carolina: State CS registration requiredSouth Dakota: State CS registration requiredTennessee: Not confirmedTexas: DEA + state license onlyUtah: State CS registration requiredVirginia: Required in some settingsVermont: DEA + state license onlyWashington: DEA + state license onlyWisconsin: DEA + state license onlyWest Virginia: Required in some settingsWyoming: State CS registration requiredLouisiana: State CS registration requiredConnecticut: State CS registration requiredCTWashington DC: State CS registration requiredDCDelaware: State CS registration requiredDEMassachusetts: State CS registration requiredMAMaryland: State CS registration requiredMDNew Hampshire: DEA + state license onlyNHNew Jersey: State CS registration requiredNJRhode Island: State CS registration requiredRIVermont: DEA + state license onlyVT

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.