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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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Everything for Iowa ↓

FDA records for “semaglutide”

Searching FDA approvals, shortages, recalls and device records…

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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 Iowa adds

Out-of-state pharmacies shipping into the stateAn out-of-state pharmacy that delivers prescriptions to Iowa patients must hold an Iowa nonresident pharmacy license, and its pharmacist-in-charge must be registered with the Iowa Board.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?

Iowa Code §155A.13A requires any pharmacy outside Iowa that delivers, dispenses or distributes prescription drugs or devices to an ultimate user in Iowa to hold a nonresident pharmacy license, renewed each January 1. Applicants must show a valid home-state license and an inspection report less than 2 years old. The inspection must have been done while the pharmacy was operating, cover every part of the business used for Iowa, and be performed by or for the home-state authority if available; otherwise an NABP Verified Pharmacy Program report or a Board-preapproved inspection is accepted. Applicants also need evidence of corrective action. Unless licensed in Iowa, the pharmacist-in-charge must hold an Iowa nonresident pharmacist-in-charge registration ($75, annual) under 481 IAC 551.5. The pharmacy license fee is $135 a year (481 IAC 551.10). The Iowa Board of Pharmacy, within the Department of Inspections, Appeals, and Licensing, administers the license.

Iowa's pharmacy rules were moved in 2025. The old 657 IAC chapters, including ch. 19 (Nonresident Pharmacy Practice), ch. 20 (Compounding) and ch. 41 (Outsourcing Facilities), were rescinded, and new rules were adopted at 481 IAC chapters 550-557 (ARC 9337C/9338C, IAB 6/11/25, listed effective 7/16/25). The Administrative Rules Review Committee delayed them 70 days on 7/14/2025 and lifted the delay on 8/11/2025. Sources citing 657 IAC are out of date.

Iowa Code §155A.13A; 481 IAC 551.5; 481 IAC 551.10

Current as of 2026-02-18 · Checked against the primary source

Office-use compounding from 503A pharmaciesIowa's current rules expressly allow compounded office supply only to veterinarians and are silent on office stock for human-medicine practitioners.Not confirmed

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.

481 IAC 552.22 (effective 2025) requires preparations compounded under section 503A to meet USP 795/797 (2023) and bars compounding essential copies of FDA-approved drugs unless a patient-specific clinical difference is documented or the drug is in shortage. Rule 552.22(3) expressly allows compounding for distribution to veterinarians for office use, and 552.21(5) covers labeling for non-patient-specific batch or veterinary office supply. No comparable provision for human-medicine practitioners was found. Separately, Iowa Code §155A.13C requires an Iowa outsourcing facility license for 503B facilities distributing sterile compounded human drugs without patient-specific prescriptions to Iowa practitioners. Whether a 503A pharmacy may supply human office stock was not confirmed; FDA views 503A compounding as patient-specific.

The former 657 IAC ch. 20 (Compounding Practices) was rescinded in 2025 (ARC 9346C) and replaced by 481 IAC 552.22 (ARC 9338C, IAB 6/11/25, listed effective 7/16/25, with a 70-day delay lifted 8/11/2025). Under 552.22(4), Iowa pharmacies that dispense compounded human preparations interstate must report yearly to the NABP information-sharing network. Confirm with the Iowa Board of Pharmacy (ibp-licensure@dial.iowa.gov, 515-281-5944).

481 IAC 552.21(5); 481 IAC 552.22(1)-(3); Iowa Code §155A.13C

Current as of 2025-08-20 · Checked against the primary source

503B outsourcing facilities shipping into the stateA 503B outsourcing facility shipping sterile compounded human drugs into Iowa without patient-specific prescriptions must hold an Iowa outsourcing facility license, plus a pharmacy license if it also dispenses to Iowa patients.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?

Iowa Code §155A.13C requires any FDA-registered outsourcing facility (21 U.S.C. §353b) that distributes sterile compounded human drug products without a patient-specific prescription to a practitioner or agent in Iowa to hold an Iowa outsourcing facility license first. The license is renewed each January 1 and costs $400 a year (481 IAC 551.14). Applicants must show current FDA outsourcing-facility registration and FDA inspection correspondence from the prior 5 years (Form 483s, warning letters, responses, corrective actions). They must also show a supervising pharmacist licensed in good standing in the facility's state, who is subject to a criminal-history check, and a satisfactory cGMP inspection within the prior 2 years by the home-state regulator or a Board-approved entity. A facility that also dispenses patient-specific prescriptions to Iowa patients must hold an Iowa pharmacy or nonresident pharmacy license. DIAL says a facility must stop distributing into Iowa immediately if its FDA registration lapses.

The DIAL page says outsourcing facilities that ship sterile compounded human drugs into, out of or within Iowa without patient-specific prescriptions need the license; the supervising-pharmacist background check fee is $45. The former 657 IAC ch. 41 (Outsourcing Facilities) was rescinded in 2025 and replaced by 481 IAC ch. 551/554.

Iowa Code §155A.13C; 481 IAC 551.14; 481 IAC ch. 554

Current as of 2026-02-18 · Checked against the primary source

State controlled-substance registrationIowa requires anyone who prescribes, stores, dispenses or uses controlled substances - including out-of-state practitioners prescribing to Iowa patients via telehealth - to hold an Iowa Controlled Substances Act (CSA) registration from the Board of Pharmacy.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.

Iowa Code Sec. 124.302 requires every person who dispenses controlled substances in Iowa to obtain and maintain a registration issued by the Board of Pharmacy, and 'dispense' includes prescribing and administering (Sec. 124.101). The Board's page (now under the Department of Inspections, Appeals, and Licensing) lists individual practitioners who prescribe to patients located in Iowa, including via telehealth when the practitioner is outside Iowa, and sets a $90 initial and biennial renewal fee (may be prorated to align with the professional license). The CSA registration number can be used to obtain the DEA registration, and the CSA becomes active after PMP registration. An individual needs only one CSA registration unless procuring or stocking their own controlled substances, in which case each location where stock is kept must be separately registered and an inspection is required first.

Rules were renumbered to 481 IAC chapters 551 and 553 under the DIAL reorganization. The Board page also notes that testosterone gel/injectable waste is RCRA hazardous pharmaceutical waste that must be incinerated. Per-location: separate CSA only where stock is kept.

Iowa Code Sec. 124.302; Iowa Code Sec. 124.101; 481 IAC ch. 551 and 553

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

PDMP check before prescribingIowa requires prescribers to use the PMP before issuing an opioid prescription, 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.

Iowa Code 124.551A requires prescribers to register with the PMP when registering or renewing their controlled substance registration and to use the PMP database before issuing an opioid prescription, as set by their licensing board's rules; use is not required for inpatient hospice or long-term residential facility patients. The Board of Medicine rule (now 481-655.2(8), formerly 653-13.2) repeats that physicians must use the program before prescribing opioids and notes that hospital orders are not prescriptions for this purpose. The PMP is administered by the Iowa Board of Pharmacy.

Testosterone (C-III) is not caught. Iowa's 2025 rule reorganization moved Board of Medicine rules from agency 653 to 481 (e.g., 653-13.2 -> 481-655.2), so the TTAC citations to 653-13.2/653-19.4 are now transferred and 657-37.1 was rescinded 7/16/2025.

Iowa Code § 124.551A; Iowa Admin. Code r. 481-655.2(8)

Current as of 2025-05-21 · Checked against the primary source

Physicians dispensing from the officeIowa physicians may dispense as an incident to practice, report to their board every two years that they dispense, and must offer a prescription the patient can fill elsewhere.Allowed

May physicians dispense prescription drugs (not just administer them) directly to patients from their practice? "Yes" means allowed under standard rules (labeling, records, and at most a simple notice to the board); "conditional" means a separate dispensing registration, permit or license, or quantity, day-supply or drug-category limits; "no" means prohibited except narrow exceptions.

Iowa Code 147.107 allows physicians to dispense prescription drugs and controlled substances as an incident to practice. Non-judgmental tasks may be delegated only with the practitioner verifying accuracy in person (or via an automated system with a quality plan). A prescriber who dispenses (other than samples) must report that fact to the licensing board at least biennially and must provide a prescription on request or offer to send it to the patient's chosen pharmacy.

Answer is yes because only a biennial report (not a permit) is required.

Iowa Code 147.107

Current as of 2025-12-10 · Checked against the primary source

Prescribing by telehealthIowa requires an Iowa license and allows the interview and exam to be done by telemedicine if the technology supports an informed diagnosis; static questionnaires do not qualify.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.

Out-of-state physicians may consult with Iowa physicians without an Iowa license but otherwise need one (Iowa Code 148.2). The medical board's telemedicine rule generally expects an in-person interview and exam, but allows them by telemedicine when the technology is sufficient to establish an informed diagnosis as if done in person; a static internet questionnaire is not an acceptable exam for prescribing. No Iowa telehealth-specific Schedule III limit was found. IMLC: member.

Iowa renumbered professional-licensing rules in 2024-2025; the rule number is as CCHP cites it. For controlled substances such as testosterone, Iowa also requires a Board of Pharmacy controlled substance (CSA) registration, which applies to out-of-state practitioners prescribing to patients located in Iowa (Iowa Code 124.302; see the state_csr topic).

Iowa Code 148.2; Iowa Admin. Code 481-655.9 (as cited by CCHP)

Current as of 2026-04-22 · From a dated compilation

Who may inject neuromodulators and fillersNo Iowa rule or Board of Nursing guidance specific to who may inject Botox or fillers was found.Not confirmed

Who may administer botulinum toxin and dermal fillers (physicians, PAs, NPs, RNs, LPNs, estheticians, dentists), under what supervision (on-site vs available), and must a physician/NP/PA perform a prior good-faith exam?

The Iowa Board of Nursing's practice pages (checked 2026-09-23) cover RN/LPN role and scope and LPN IV courses but contain no statement on cosmetic injectables. Iowa's administrative rules were reorganized in 2025 and a Board of Medicine rule on cosmetic procedures could not be located.

Check with the Iowa Board of Nursing and Iowa Board of Medicine.

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

Iowa at a glance

Every topic we research, for Iowa. 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 delivers prescriptions to Iowa patients must hold an Iowa nonresident pharmacy license, and its pharmacist-in-charge must be registered with the Iowa Board.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?

Iowa Code §155A.13A requires any pharmacy outside Iowa that delivers, dispenses or distributes prescription drugs or devices to an ultimate user in Iowa to hold a nonresident pharmacy license, renewed each January 1. Applicants must show a valid home-state license and an inspection report less than 2 years old. The inspection must have been done while the pharmacy was operating, cover every part of the business used for Iowa, and be performed by or for the home-state authority if available; otherwise an NABP Verified Pharmacy Program report or a Board-preapproved inspection is accepted. Applicants also need evidence of corrective action. Unless licensed in Iowa, the pharmacist-in-charge must hold an Iowa nonresident pharmacist-in-charge registration ($75, annual) under 481 IAC 551.5. The pharmacy license fee is $135 a year (481 IAC 551.10). The Iowa Board of Pharmacy, within the Department of Inspections, Appeals, and Licensing, administers the license.

Iowa's pharmacy rules were moved in 2025. The old 657 IAC chapters, including ch. 19 (Nonresident Pharmacy Practice), ch. 20 (Compounding) and ch. 41 (Outsourcing Facilities), were rescinded, and new rules were adopted at 481 IAC chapters 550-557 (ARC 9337C/9338C, IAB 6/11/25, listed effective 7/16/25). The Administrative Rules Review Committee delayed them 70 days on 7/14/2025 and lifted the delay on 8/11/2025. Sources citing 657 IAC are out of date.

Iowa Code §155A.13A; 481 IAC 551.5; 481 IAC 551.10

Current as of 2026-02-18 · Checked against the primary source

Office-use compounding from 503A pharmaciesIowa's current rules expressly allow compounded office supply only to veterinarians and are silent on office stock for human-medicine practitioners.Not confirmed

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.

481 IAC 552.22 (effective 2025) requires preparations compounded under section 503A to meet USP 795/797 (2023) and bars compounding essential copies of FDA-approved drugs unless a patient-specific clinical difference is documented or the drug is in shortage. Rule 552.22(3) expressly allows compounding for distribution to veterinarians for office use, and 552.21(5) covers labeling for non-patient-specific batch or veterinary office supply. No comparable provision for human-medicine practitioners was found. Separately, Iowa Code §155A.13C requires an Iowa outsourcing facility license for 503B facilities distributing sterile compounded human drugs without patient-specific prescriptions to Iowa practitioners. Whether a 503A pharmacy may supply human office stock was not confirmed; FDA views 503A compounding as patient-specific.

The former 657 IAC ch. 20 (Compounding Practices) was rescinded in 2025 (ARC 9346C) and replaced by 481 IAC 552.22 (ARC 9338C, IAB 6/11/25, listed effective 7/16/25, with a 70-day delay lifted 8/11/2025). Under 552.22(4), Iowa pharmacies that dispense compounded human preparations interstate must report yearly to the NABP information-sharing network. Confirm with the Iowa Board of Pharmacy (ibp-licensure@dial.iowa.gov, 515-281-5944).

481 IAC 552.21(5); 481 IAC 552.22(1)-(3); Iowa Code §155A.13C

Current as of 2025-08-20 · Checked against the primary source

503B outsourcing facilities shipping into the stateA 503B outsourcing facility shipping sterile compounded human drugs into Iowa without patient-specific prescriptions must hold an Iowa outsourcing facility license, plus a pharmacy license if it also dispenses to Iowa patients.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?

Iowa Code §155A.13C requires any FDA-registered outsourcing facility (21 U.S.C. §353b) that distributes sterile compounded human drug products without a patient-specific prescription to a practitioner or agent in Iowa to hold an Iowa outsourcing facility license first. The license is renewed each January 1 and costs $400 a year (481 IAC 551.14). Applicants must show current FDA outsourcing-facility registration and FDA inspection correspondence from the prior 5 years (Form 483s, warning letters, responses, corrective actions). They must also show a supervising pharmacist licensed in good standing in the facility's state, who is subject to a criminal-history check, and a satisfactory cGMP inspection within the prior 2 years by the home-state regulator or a Board-approved entity. A facility that also dispenses patient-specific prescriptions to Iowa patients must hold an Iowa pharmacy or nonresident pharmacy license. DIAL says a facility must stop distributing into Iowa immediately if its FDA registration lapses.

The DIAL page says outsourcing facilities that ship sterile compounded human drugs into, out of or within Iowa without patient-specific prescriptions need the license; the supervising-pharmacist background check fee is $45. The former 657 IAC ch. 41 (Outsourcing Facilities) was rescinded in 2025 and replaced by 481 IAC ch. 551/554.

Iowa Code §155A.13C; 481 IAC 551.14; 481 IAC ch. 554

Current as of 2026-02-18 · Checked against the primary source

FDA compounding MOUIowa 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; Iowa 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 registrationIowa requires anyone who prescribes, stores, dispenses or uses controlled substances - including out-of-state practitioners prescribing to Iowa patients via telehealth - to hold an Iowa Controlled Substances Act (CSA) registration from the Board of Pharmacy.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.

Iowa Code Sec. 124.302 requires every person who dispenses controlled substances in Iowa to obtain and maintain a registration issued by the Board of Pharmacy, and 'dispense' includes prescribing and administering (Sec. 124.101). The Board's page (now under the Department of Inspections, Appeals, and Licensing) lists individual practitioners who prescribe to patients located in Iowa, including via telehealth when the practitioner is outside Iowa, and sets a $90 initial and biennial renewal fee (may be prorated to align with the professional license). The CSA registration number can be used to obtain the DEA registration, and the CSA becomes active after PMP registration. An individual needs only one CSA registration unless procuring or stocking their own controlled substances, in which case each location where stock is kept must be separately registered and an inspection is required first.

Rules were renumbered to 481 IAC chapters 551 and 553 under the DIAL reorganization. The Board page also notes that testosterone gel/injectable waste is RCRA hazardous pharmaceutical waste that must be incinerated. Per-location: separate CSA only where stock is kept.

Iowa Code Sec. 124.302; Iowa Code Sec. 124.101; 481 IAC ch. 551 and 553

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

PDMP check before prescribingIowa requires prescribers to use the PMP before issuing an opioid prescription, 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.

Iowa Code 124.551A requires prescribers to register with the PMP when registering or renewing their controlled substance registration and to use the PMP database before issuing an opioid prescription, as set by their licensing board's rules; use is not required for inpatient hospice or long-term residential facility patients. The Board of Medicine rule (now 481-655.2(8), formerly 653-13.2) repeats that physicians must use the program before prescribing opioids and notes that hospital orders are not prescriptions for this purpose. The PMP is administered by the Iowa Board of Pharmacy.

Testosterone (C-III) is not caught. Iowa's 2025 rule reorganization moved Board of Medicine rules from agency 653 to 481 (e.g., 653-13.2 -> 481-655.2), so the TTAC citations to 653-13.2/653-19.4 are now transferred and 657-37.1 was rescinded 7/16/2025.

Iowa Code § 124.551A; Iowa Admin. Code r. 481-655.2(8)

Current as of 2025-05-21 · Checked against the primary source

Physicians dispensing from the officeIowa physicians may dispense as an incident to practice, report to their board every two years that they dispense, and must offer a prescription the patient can fill elsewhere.Allowed

May physicians dispense prescription drugs (not just administer them) directly to patients from their practice? "Yes" means allowed under standard rules (labeling, records, and at most a simple notice to the board); "conditional" means a separate dispensing registration, permit or license, or quantity, day-supply or drug-category limits; "no" means prohibited except narrow exceptions.

Iowa Code 147.107 allows physicians to dispense prescription drugs and controlled substances as an incident to practice. Non-judgmental tasks may be delegated only with the practitioner verifying accuracy in person (or via an automated system with a quality plan). A prescriber who dispenses (other than samples) must report that fact to the licensing board at least biennially and must provide a prescription on request or offer to send it to the patient's chosen pharmacy.

Answer is yes because only a biennial report (not a permit) is required.

Iowa Code 147.107

Current as of 2025-12-10 · Checked against the primary source

Prescribing by telehealthIowa requires an Iowa license and allows the interview and exam to be done by telemedicine if the technology supports an informed diagnosis; static questionnaires do not qualify.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.

Out-of-state physicians may consult with Iowa physicians without an Iowa license but otherwise need one (Iowa Code 148.2). The medical board's telemedicine rule generally expects an in-person interview and exam, but allows them by telemedicine when the technology is sufficient to establish an informed diagnosis as if done in person; a static internet questionnaire is not an acceptable exam for prescribing. No Iowa telehealth-specific Schedule III limit was found. IMLC: member.

Iowa renumbered professional-licensing rules in 2024-2025; the rule number is as CCHP cites it. For controlled substances such as testosterone, Iowa also requires a Board of Pharmacy controlled substance (CSA) registration, which applies to out-of-state practitioners prescribing to patients located in Iowa (Iowa Code 124.302; see the state_csr topic).

Iowa Code 148.2; Iowa Admin. Code 481-655.9 (as cited by CCHP)

Current as of 2026-04-22 · From a dated compilation

Aesthetics, IV therapy & practice ownership

Who may inject neuromodulators and fillersNo Iowa rule or Board of Nursing guidance specific to who may inject Botox or fillers was found.Not confirmed

Who may administer botulinum toxin and dermal fillers (physicians, PAs, NPs, RNs, LPNs, estheticians, dentists), under what supervision (on-site vs available), and must a physician/NP/PA perform a prior good-faith exam?

The Iowa Board of Nursing's practice pages (checked 2026-09-23) cover RN/LPN role and scope and LPN IV courses but contain no statement on cosmetic injectables. Iowa's administrative rules were reorganized in 2025 and a Board of Medicine rule on cosmetic procedures could not be located.

Check with the Iowa Board of Nursing and Iowa Board of Medicine.

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

IV hydration and vitamin therapyNo Iowa rule or 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 Iowa Board of Nursing's practice page lists LPN expanded-scope IV courses but no guidance on IV hydration businesses, individual exams, standing orders or mobile services (checked 2026-09-23).

  • Nursing Practice — Iowa Board of Nursing (Department of Inspections, Appeals, and Licensing), 2026-09-23

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

Corporate practice of medicine / med spa ownershipCompilations describe Iowa as having a moderate corporate practice of medicine doctrine based on case law and an Attorney General opinion.CPOM with exceptions

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

Permit Health's 2025 guide rates Iowa 'Moderate', citing Iowa Code §147.2 and Attorney General Opinion No. 91-7-1; MedPath Compliance (reviewed 2026-06-20) lists Iowa as 'Yes' based on case law and an AG opinion.

Iowa Code §147.2; Iowa Att'y Gen. Op. No. 91-7-1 (as reported by Permit Health)

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

Who may operate aesthetic lasersIowa lets licensed estheticians and electrologists (and cosmetologists licensed before July 2005) use certified laser products and IPL, for hair removal and surface treatments, after board-approved additional training; treating minors requires physician supervision.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?

Iowa Code ch. 157 (2026) requires estheticians who use microdermabrasion, certified laser products or IPL, and electrologists who use lasers or IPL for hair removal, to submit proof of additional training and certification for Board of Cosmetology approval. Cosmetologists and barbers licensed after 2005-07-01 may not use lasers or IPL. Chapter 157 licensees may use IPL only for hair removal, may not structurally alter tissue except for hair removal, and may use certified laser products only on surface epidermal layers. Laser or IPL hair removal on minors requires a parent or guardian and at least general physician supervision. Licensed physicians and nurses practising within their own licences are exempt from chapter 157.

PDF generated 2025-12-09 for the 2026 Iowa Code. Chapter 157 amended by 2025 Acts ch. 140. Delegation of lasers to nurses/unlicensed staff by physicians under medical board rules was not confirmed.

Iowa Code §§157.1, 157.2, 157.3A, 157.12A (2026)

Current as of 2025-12-09 · Checked against the primary source

Labs, regenerative medicine & cosmetics

State clinical laboratory licensing (beyond CLIA)Not confirmed. No Iowa 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). Iowa was not among them, but this research did not confirm its statutes. Iowa's CLIA state agency is Iowa CLIA Laboratory Program, State Hygienic Laboratory (shl-clia@uiowa.edu, 319-335-4500); 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

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

Direct-to-consumer lab testingNot confirmed whether Iowa 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 Iowa's rule. Iowa's lab regulator (CLIA state agency) is Iowa CLIA Laboratory Program, State Hygienic Laboratory (shl-clia@uiowa.edu, 319-335-4500). 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 Iowa 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. Iowa 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 sunscreenNo Iowa-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?

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

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

None found

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

Compare every state

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 requiredIdaho: State CS registration requiredIllinois: State CS registration requiredIndiana: State CS registration requiredKansas: DEA + state license onlyKentucky: DEA + state license onlyLouisiana: State CS registration requiredMassachusetts: 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 requiredIowa: 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.