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Guidance Document Change: Adoption of guidance document concerning regulatory considerations for IV hydration clinics and med spas in Virginia

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10/6/26  2:21 pm
Commenter: Eli Lilly and Company

Lilly Comment: Regulatory Considerations for IV Hydration Clinics and Med Spas in Virginia
 

 

 

 

October 6, 2026

 

Via Comment Portal

 

Erin Barrett

Director of Legislative and Regulatory Affairs

Perimeter Center

9960 Mayland Drive, Suite 300

Henrico, VA 23233

erin.barrett@dhp.virginia.gov

           

Re:      Regulatory Considerations for IV Hydration Clinics and Med Spas in Virginia

Dear Director Barrett:

I write on behalf of Eli Lilly and Company (“Lilly”) to comment on the Virginia Board of Pharmacy (“VA BOP”), Virginia Board of Medicine (“VA BOM”), and Virginia Board of Nursing (“VA BON”) (collectively, the “Boards”) Joint Guidance Document titled “Regulatory Considerations for IV Hydration Clinics and Med Spas in Virginia” (“Guidance”).  Lilly appreciates the opportunity to provide input on this important regulatory initiative.

As a medicine company founded and headquartered in Indiana, Lilly has been at the forefront of drug innovation and drug quality for more than 150 years.  At Lilly, patient safety is at the heart of everything we do.  We believe our commitment to patient safety aligns with the Boards’ longstanding dedication to public health and the effective regulation of the practice of pharmacy, medicine, and nursing in Virginia.

Lilly commends the Boards for issuing the Guidance, which sets forth how existing Virginia law applies to IV hydration clinics and med spas.  As the Guidance rightly acknowledges, “IV hydration clinics and med spas offering … weight loss drugs such [as] GLP-1, GIP, or other peptides … are expanding across Virginia.”[1]  Specifically, the Guidance explains that: (1) practitioners at med spas are regulated by the VA BOM and/or the VA BON; (2) certain activities, such as prescribing medications, evaluating patients, and administering medications without a license, constitute the unlawful practice of medicine or nursing; (3) compounding activities must comply with United States Pharmacopeia (“USP”) chapters on compounding; (4) dispensing of prescription drugs, in any setting, is regulated by the VA BOP; and (5) a licensed prescriber must evaluate each patient and issue patient-specific orders rather than relying on protocols or standing orders.

Lilly supports the Guidance’s clear articulation of compounding requirements in the section titled “Compounding, Mixing, Diluting, and Reconstituting.”  The Guidance correctly states that “[a]ll IV fluids, including plain IV saline, are prescription drugs” and that “[d]rugs may only be mixed or compounded pursuant to a valid patient-specific prescription or order.”[2]  Further, the Guidance appropriately warns that “compounded drugs are not FDA-approved, and improper sterile technique can pose significant risks, including infection, contamination, and dosing errors.”[3]  This warning is well-founded.  As referenced in the Guidance, the United States Food and Drug Administration (“FDA”) has warned that compounded drugs “can be risky for patients” because they are not evaluated for safety, efficacy, or quality.  The risk is not hypothetical: a study from researchers at Binghamton University found that patients who took compounded GLP-1/GIP drugs reported adverse events that required hospitalization at a 2.5 times higher rate and were over 8.5 times more likely to have an adverse event that involved product quality issues as compared to those taking FDA-approved medicines.[4]

Lilly also supports the Guidance’s recognition that when a drug is mixed with additives, such as vitamins or minerals, the result is a compounded drug subject to regulation by the VA BOP.  Critically, the Guidance makes clear that compounding is the practice of pharmacy under Virginia Code § 54.1-3401, and that pursuant to Virginia Code § 54.1-3410.2, all non-sterile and sterile compounding must be performed in compliance with USP compounding standards.  Lilly welcomes the Guidance’s recognition that under Virginia law “a pharmacist may not perform regular compounding of inordinate amounts of drugs that are essentially copies of manufactured drugs.”[5]  This provision serves as an important safeguard against unlawful mass compounding that circumvents the FDA approval process.[6]  Further, the Guidance appropriately notes that when mixing, diluting, or reconstituting of drugs is delegated, individuals must be “trained to follow aseptic techniques and supervised in their work.”[7]  These provisions serve to protect Virginia patients from the serious risks posed by improper compounding practices.

In addition, Lilly commends the Boards for reiterating the prohibition on medications labeled “for research purposes only” (“RUO”) or similar designations.  The Guidance states that any such medication “is unlawful to possess by IV hydration clinics and med spas and is both a violation of state and federal law regardless of patient ‘consent.’”[8]  This is a critical patient safety provision, as RUO products cannot legally be administered or compounded for human use, have not been evaluated for safety or efficacy, and pose serious risks when administered to patients.  Lilly shares the Boards’ concerns regarding the prescribing, administering, and dispensing of RUO products and investigational drugs by med spas, as well as the purchase and use of these products by consumers.

To this point, Lilly wishes to reiterate that the RUO designation is widely used as a pretext to evade restrictions on importing and selling unapproved drug products.  RUO products are not human drug quality substances and, notwithstanding the product label, these products are routinely marketed, packaged, and sold explicitly for human use.  Entities that sell “research use only” weight loss products, peptides, SARMs, and other drugs to American consumers are engaged in dangerous and illegal conduct.  Indeed, prosecutors have taken enforcement action in multiple states against sellers that market purported RUO products for human consumption.[9]

Virginia is not alone in wanting to address these concerns.  Several other State Boards of Pharmacy are actively taking enforcement action against facilities compounding and dispensing RUO and investigational products.[10]  FDA has also issued numerous warning letters to telehealth companies, distributors, compounding pharmacies, and outsourcing facilities for marketing and selling investigational drugs.[11]  Lilly strongly encourages the Boards to prioritize enforcement against any entity compounding and/or selling these products in Virginia.

The threat to Virginia patients from RUO products and investigational drugs is real.  The United States poison control network reported a 265% increase in calls related to the use of retatrutide during just the first few months of 2026.[12]  According to reports from Australian authorities, at least seven individuals were hospitalized after taking black-market retatrutide.[13]  FDA has already stated that retatrutide “cannot be used in compounding under federal law” and has pursued enforcement against compounders that have done so.[14]

While the Guidance is a positive step, Lilly encourages the Boards to support future legislative changes that would enable more comprehensive regulation of IV hydration clinics and med spas in Virginia, including changes to the VA BOP’s ability to regulate these entities at the facility level.  The NABP Model Act, for example, would require standalone med spa facility licensure, formal “Responsible Person” Board registration, mandatory inspection schedules, facility-level enforcement sanctions, and adverse event reporting.[15]  The current Guidance, by contrast, relies on individual practitioner licensing and traditional pharmacy dispensing permits where applicable, lacks fixed inspection cadences, contains no facility-level sanctions framework, and does not require mandatory adverse event reporting to state licensing boards.  Closing these gaps through legislative action would significantly enhance the Boards’ ability to protect Virginians and advance public health.

Lilly appreciates the Boards’ commitment to patient safety and the opportunity to comment on these important matters.  If you have any questions or would like to discuss any of the above further, we would be happy to provide additional information.

 

Sincerely,

 

 

Brad Jordan, PhD

Associate Vice President

Regulatory Policy & Strategy

Eli Lilly and Company



[1] Va. Bd. of Pharmacy, Va. Bd. of Med. & Va. Bd. of Nursing, Regulatory Considerations for IV Hydration Clinics and Med Spas in Virginia 1 (draft 2026) [hereinafter Guidance].

[2] Id. at 5-6.

[3] Id. at 5.

[4] Kenneth L. McCall et al., Safety Analysis of Compounded GLP-1 Receptor Agonists: A Pharmacovigilance Study Using the FDA Adverse Event Reporting System (2025), https://www.tandfonline.com/doi/full/10.1080/14740338.2025.2499670.

[5] Guidance, supra note 1, at 6.

[6]  See, e.g., Warning Letter from U.S. Food & Drug Admin. to Empower Clinic Servs., LLC d/b/a Empower Pharmacy, No. 738238 (Sept. 18, 2026), https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026 (finding evidence that a 503A compounding pharmacy was compounding drugs in inordinate amounts and explaining that “[e]vidence collected includes (1) orders/prescriptions that lack any prescriber determination of significant difference from the commercially available product; (2) orders/prescriptions with purported prescriber determinations of ‘significant difference’ that appear to be repeated verbatim across many records, suggesting that they may be pre-generated for selection by the prescriber, rather than written by the prescriber for an identified individual patient; and (3) the volume of particular products compounded and orders filled.  Generating prescriptions through means that undermine the individualized nature of a prescriber's clinical judgment (for example through third-party technology platforms that provide prescribers with pre-selected menu options for choosing a statement of significant difference) call the individualized nature of those determinations into question, potentially undermining claims that such prescriber determinations of significant difference are sufficient to meet the conditions of section 503A.”).

[7] Guidance, supra note 1, at 6.

[8] Id. at 7.

[9] See, e.g., U.S. Dep't of Justice, Illinois Man and Indiana Woman Sentenced Respectively to 70 Months and 16 Months in Prison For Selling Unapproved Drugs in Interstate Commerce (July 30, 2026), https://www.justice.gov/usao-ndin/pr/illinois-man-and-indiana-woman-sentenced-respectively-70-months-and-16-months-prison; Alabama Attorney General, Attorney General Marshall Settles Lawsuit with Cullman Clinic for Administering Dangerous, Unapproved Weight Loss Drugs (Jan. 12, 2026), https://www.alabamaag.gov/wp-content/uploads/2026/01/2026.1.12-Attorney-General-Marshall-Settles-Lawsuit-with-Cullman-Clinic-for-Administering-Dangerous-Unapproved-Weight-Loss-Drugs.pdf; Connecticut Attorney General, Attorney General Tong Announces Online Platform to Cease Bootleg GLP-1 Weight Loss Drug Sales Nationwide Following Connecticut Investigation (May 6, 2026), https://portal.ct.gov/ag/press-releases/2026-press-releases/attorney-general-tong-announces-online-platform-to-cease-bootleg-weight-loss-drug-sales.

[10]  State Boards of Pharmacy are actively enforcing against pharmacies for compounding and dispensing retatrutide.  Three examples include: (i) Brooksville Pharmaceuticals: On April 21, 2026, the Oregon Board of Pharmacy finalized a Consent Order imposing a $79,000 civil penalty after finding that between April 2022 and April 2025, Brooksville dispensed 79 compounded prescriptions containing retatrutide to Oregon patients (Oregon Board of Pharmacy, “Case Number 2025-0732, Consent Order in the Matter of the Retail Drug Outlet Registration of Brooksville Pharmaceuticals, Inc. dba Brooksvilla Pharmaceuticals,” Apr. 21, 2026, https://orbop.mylicense.com/verification/Download.aspx?saveas=2025-0732.pdf&document_id=fa620b96-4d13-4937-9f94-90017031dc75%3b1.0); (ii) CRE8 Pharmacy Group, LLC: On July 10, 2025, the Ohio Board of Pharmacy summarily suspended CRE8’s pharmacy license for dispensing 41 prescriptions for compounded drugs lacking USP monographs, citing 12 prescriptions for retatrutide (Ohio Board of Pharmacy, “Case Number A-2025-0117, Settlement Agreement with the Ohio Board of Pharmacy, In the Matter of CRE8 Pharmacy Group, LLC,” July 10, 2025, https://pharmacy.ohio.gov/dddquery/pdfs/0242000190.pdf); and (iii) Slimbolic DBA Slimbolic Weight Loss & Med Spa: On December 16, 2025, the Ohio Board of Pharmacy summarily suspended the medical spa’s license after inspections identified the non-sterile compounding and procurement of unapproved drugs, including retatrutide (Ohio Board of Pharmacy, “Case Number A-2024-0469 & A-2025-0105, Order of the Ohio Board of Pharmacy In the Matter of Slimbolic DBA Slimbolic Weight Loss & Med Spa,” Dec. 16, 2025, https://pharmacy.ohio.gov/dddquery/pdfs/0260002573.pdf).

[11] FDA, FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, https://tinyurl.com/yft4z8ca. 

[12] Daniel Gilbert, Adam Yamaguchi & Laura Geller, This Weight-Loss Drug Hasn't Been Approved by the FDA. Doctors Are Prescribing It Anyway, CBS News (June 8, 2026), https://www.cbsnews.com/projects/2026/experimental-weight-loss-drug/ (“Exposures to the drug tracked by America's Poison Centers have surged since last year, averaging about 95 per month in the first four months of 2026, a 265% increase from the last four months of 2025.”).

[13] Vict. Dep’t of Health, Toxicity Linked to Unapproved Peptide Retatrutide (June 19, 2026), https://www.health.vic.gov.au/health-alerts/toxicity-linked-to-unapproved-peptide-retatrutide; Therapeutic Goods Administration, TGA Tests Counterfeit Retatrutide Product Following Serious Adverse Event Report, https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/tga-tests-counterfeit-retatrutide-product-following-serious-adverse-event-report.

[14] FDA, supra note 11.

[15] See Model Med. Spa Oversight Act (Nat'l Ass'n of Bds. of Pharmacy 2026), https://nabp.pharmacy/members/board-resources/model-pharmacy-act-rules/ (last visited Oct. 4, 2026).

CommentID: 242185
 

10/7/26  2:41 pm
Commenter: Anonymous

Collaborative for Evidence-Based Medicines Comment
 

October 7, 2026

 

Via Comment Portal

 

Erin Barrett

Director of Legislative and Regulatory Affairs

Perimeter Center

9960 Mayland Drive, Suite 300

Henrico, VA 23233

erin.barrett@dhp.virginia.gov

             

Re:        Regulatory Considerations for IV Hydration Clinics and Med Spas in Virginia

 

Dear Director Barrett:

 

The Collaborative for Evidence-Based Medicines (“CEBM”) is a national provider-led organization advancing evidence-backed medicines, safe compounding, and stronger oversight and accountability to protect patients.  CEBM brings together providers, patient advocates, academics, consumer groups, manufacturers, and other stakeholders to advance our patient safety mission.  The signatories to this letter are pharmacists, physicians, and regulatory professionals who sit on the CEBM Board. 

 

CEBM writes in strong support of the draft guidance document, Regulatory Considerations for IV Hydration Clinics and Med Spas in Virginia (the “Guidance”).  As the Virginia Boards of Medicine, Nursing, and Pharmacy (hereafter referred to as the “Boards”) acknowledge, IV hydration clinics and med spas offering IV fluids, vitamin and amino acid infusions, GLP-1 and other peptide products, and compounded drugs are expanding rapidly across the Commonwealth, often in consumer-focused settings where patients select treatments from a menu, complete a brief questionnaire, and receive therapy without ever meaningfully interacting with a prescriber (if at all).[1]  These practice models present real and avoidable risks of infection, contamination, and dosing errors.  The Guidance appropriately reminds these businesses that selecting, preparing, compounding, and administering prescription drugs is the practice of medicine, nursing, or pharmacy, and is subject to the same standards that apply in any other clinical setting.

 

The Guidance comes at a critical time.  We urge the Boards to consider the growing body of evidence documenting patient harm from compounded drugs[2] which motivates CEBM’s comments.  For example, a recent study from researchers at Binghamton University found that patients who took compounded GLP-1/GIP drugs reported adverse events that required hospitalization at a 2.5 times higher rate and were over 8.5 times more likely to have an adverse event that involved product quality issues as compared to those taking FDA-approved medicines.[3]  From our perspective as providers and patient advocates, these numbers represent real patients who sought treatment and instead received products that put their health at risk.

 

CEBM particularly supports the Guidance’s clarification of the following points:

  • Patient-specific care.  Each patient must be evaluated by a licensed prescriber who issues a patient-specific order within a bona fide practitioner-patient relationship, and drugs may not be administered under protocols or standing orders.[4]

 

  • Compounding standards.  Adding medications, vitamins, or minerals to IV fluids, or preparing customized formulations such as peptides, is compounding and constitutes the practice of pharmacy, and all such compounding must comply with USP standards as required by Virginia Code § 54.1-3410.2.  The Guidance’s reminder that compounded drugs are not FDA-approved, and that improper sterile technique can cause serious patient harm, is especially important.[5]

 

  • Drug sourcing.  Drugs should be purchased only from licensed wholesale distributors, pharmacies, or outsourcing facilities, and products labeled “for research purposes only” may not be possessed by these businesses regardless of patient consent.  This is a critical safeguard against the unapproved and illegitimate products, including purported GLP-1 drugs, that have proliferated in this market.[6]

 

Further, we appreciate that the Guidance notes, “Any medication indicating ‘for research purposes only’ or other similar statement is unlawful to possess by IV hydration clinics and med spas and is both a violation of state and federal law regardless of patient ‘consent’”.[7]  The compounding of the investigational drug retatrutide has expanded dramatically over the past months, a trend that will likely repeat for future drugs after positive clinical data are announced.  The widespread compounding of unapproved drugs while they are still under clinical investigation puts patients at risk and threatens the foundation of drug development that depends on the creation of rigorous evidence to assess safety and effectiveness before new drugs reach patients.  Patients deserve treatments supported by rigorous evidence, not unauthorized products marketed before the development process is complete.

 

Beyond the guidance itself, we urge the Board to scrutinize potentially false or misleading marketing of compounded drugs by med spas, hydration clinics, and similar facilities. This can include the marketing of compounded drugs in ways that fail to disclose any meaningful risk information to prospective patients, and creates the impression that certain entities are licensed pharmacies when they are not. The mass marketing of compounded drugs induces demand for these products beyond the limited, gap-filling role compounding is intended to play in our health care system.

 

CEBM commends the Board for its leadership in protecting Virginia patients and urges the Boards to finalize the Guidance.  In addition, CEBM encourages the Boards to support legislation that would enhance the ability of the Boards to oversee med spas and IV hydration clinics. One example of such legislation is the National Association of Boards of Pharmacy (NABP) “Model Medical Spa Oversight Act,” which would require site licensure, specific inspection schedules, and adverse event reporting, all of which will enhance patient safety.[8] Additional legislation would further strengthen the Boards’ ability to take effective action to protect Virginians and ensure that patients receive high-quality care and medication regardless of the setting.

 

Thank you for your consideration.

 

Sincerely,

 

                                                                      

John Hertig, PharmD, MS, CPPS, FASHP, FFIP (Chair of CEBM)  Michael Stepanovic, PharmD, MS

 

 

Dr. Adonis Saremi, MD, MS, DABOM                Donney John, PharmD

 

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

CommentID: 242224
 

10/7/26  2:47 pm
Commenter: Collaborative for Evidence-Based Medicines (CEBM)

CEBM Comment Regulatory Considerations for IV Hydration Clinics and Med Spas in Virginia
 

October 7, 2026

Via Comment Portal

Erin Barrett

Director of Legislative and Regulatory Affairs

Perimeter Center

9960 Mayland Drive, Suite 300

Henrico, VA 23233

erin.barrett@dhp.virginia.gov

             

Re:        Regulatory Considerations for IV Hydration Clinics and Med Spas in Virginia

 

Dear Director Barrett:

 

The Collaborative for Evidence-Based Medicines (“CEBM”) is a national provider-led organization advancing evidence-backed medicines, safe compounding, and stronger oversight and accountability to protect patients.  CEBM brings together providers, patient advocates, academics, consumer groups, manufacturers, and other stakeholders to advance our patient safety mission.  The signatories to this letter are pharmacists, physicians, and regulatory professionals who sit on the CEBM Board. 

 

CEBM writes in strong support of the draft guidance document, Regulatory Considerations for IV Hydration Clinics and Med Spas in Virginia (the “Guidance”).  As the Virginia Boards of Medicine, Nursing, and Pharmacy (hereafter referred to as the “Boards”) acknowledge, IV hydration clinics and med spas offering IV fluids, vitamin and amino acid infusions, GLP-1 and other peptide products, and compounded drugs are expanding rapidly across the Commonwealth, often in consumer-focused settings where patients select treatments from a menu, complete a brief questionnaire, and receive therapy without ever meaningfully interacting with a prescriber (if at all).[1]  These practice models present real and avoidable risks of infection, contamination, and dosing errors.  The Guidance appropriately reminds these businesses that selecting, preparing, compounding, and administering prescription drugs is the practice of medicine, nursing, or pharmacy, and is subject to the same standards that apply in any other clinical setting.

 

The Guidance comes at a critical time.  We urge the Boards to consider the growing body of evidence documenting patient harm from compounded drugs[2] which motivates CEBM’s comments.  For example, a recent study from researchers at Binghamton University found that patients who took compounded GLP-1/GIP drugs reported adverse events that required hospitalization at a 2.5 times higher rate and were over 8.5 times more likely to have an adverse event that involved product quality issues as compared to those taking FDA-approved medicines.[3]  From our perspective as providers and patient advocates, these numbers represent real patients who sought treatment and instead received products that put their health at risk.

 

CEBM particularly supports the Guidance’s clarification of the following points:

  • Patient-specific care.  Each patient must be evaluated by a licensed prescriber who issues a patient-specific order within a bona fide practitioner-patient relationship, and drugs may not be administered under protocols or standing orders.[4]

 

  • Compounding standards.  Adding medications, vitamins, or minerals to IV fluids, or preparing customized formulations such as peptides, is compounding and constitutes the practice of pharmacy, and all such compounding must comply with USP standards as required by Virginia Code § 54.1-3410.2.  The Guidance’s reminder that compounded drugs are not FDA-approved, and that improper sterile technique can cause serious patient harm, is especially important.[5]

 

  • Drug sourcing.  Drugs should be purchased only from licensed wholesale distributors, pharmacies, or outsourcing facilities, and products labeled “for research purposes only” may not be possessed by these businesses regardless of patient consent.  This is a critical safeguard against the unapproved and illegitimate products, including purported GLP-1 drugs, that have proliferated in this market.[6]

 

Further, we appreciate that the Guidance notes, “Any medication indicating ‘for research purposes only’ or other similar statement is unlawful to possess by IV hydration clinics and med spas and is both a violation of state and federal law regardless of patient ‘consent’”.[7]  The compounding of the investigational drug retatrutide has expanded dramatically over the past months, a trend that will likely repeat for future drugs after positive clinical data are announced.  The widespread compounding of unapproved drugs while they are still under clinical investigation puts patients at risk and threatens the foundation of drug development that depends on the creation of rigorous evidence to assess safety and effectiveness before new drugs reach patients.  Patients deserve treatments supported by rigorous evidence, not unauthorized products marketed before the development process is complete.

 

Beyond the guidance itself, we urge the Board to scrutinize potentially false or misleading marketing of compounded drugs by med spas, hydration clinics, and similar facilities. This can include the marketing of compounded drugs in ways that fail to disclose any meaningful risk information to prospective patients, and creates the impression that certain entities are licensed pharmacies when they are not. The mass marketing of compounded drugs induces demand for these products beyond the limited, gap-filling role compounding is intended to play in our health care system.

 

CEBM commends the Board for its leadership in protecting Virginia patients and urges the Boards to finalize the Guidance.  In addition, CEBM encourages the Boards to support legislation that would enhance the ability of the Boards to oversee med spas and IV hydration clinics. One example of such legislation is the National Association of Boards of Pharmacy (NABP) “Model Medical Spa Oversight Act,” which would require site licensure, specific inspection schedules, and adverse event reporting, all of which will enhance patient safety.[8] Additional legislation would further strengthen the Boards’ ability to take effective action to protect Virginians and ensure that patients receive high-quality care and medication regardless of the setting.

 

Thank you for your consideration.

 

Sincerely,

 

                                                                       

John Hertig, PharmD, MS, CPPS, FASHP, FFIP (Chair of CEBM) 

Michael Stepanovic, PharmD, MS

 

Dr. Adonis Saremi, MD, MS, DABOM           

Donney John, PharmD

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" width="195" height="35" />                                                                                                Malcolm Broussard, BS Pharm, LHD (hon), FLSHP     

  

Elizabeth Johnson, PharmD, FAPhA

Lisa Robin, MLA



[1] Va. Bd. of Med., Va. Bd. of Nursing & Va. Bd. of Pharmacy, Regulatory Considerations for IV Hydration Clinics and Med Spas in Virginia 1 (Sept. 2026) [hereinafter Guidance].

[2] Jordan, B., Arbogast, L., Clemens, M., Huang, L., & Snyder, M. (2026). A novel, widespread impurity in mass-compounded tirzepatide/B12 products: potential patient safety implications. Expert opinion on drug safety, 25(5), 837–845. https://doi.org/10.1080/14740338.2026.2663185

[3] Kenneth L. McCall et al., Safety Analysis of Compounded GLP-1 Receptor Agonists: A Pharmacovigilance Study Using the FDA Adverse Event Reporting System, 25 Expert Op. on Drug Safety 58 (2025), https://www.tandfonline.com/doi/full/10.1080/14740338.2025.2499670.

[4] Guidance, supra note 1, at 2, 5.

[5] Id. at 5-6.

[6] Id. at 2, 7.

[7] Id. at 7.

[8]  See Nat'l Ass'n of Bds. of Pharmacy, Model Medical Spa Oversight Act (2026), https://nabp.pharmacy/members/board-resources/model-pharmacy-act-rules/ (last visited Oct. 4, 2026).

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