{"version":"https://jsonfeed.org/version/1.1","title":"ScriptSafe Regulatory Watch","home_page_url":"https://scriptsafe.com/news","feed_url":"https://scriptsafe.com/news/feed.json","description":"Federal rules, state laws, board actions and payment network policies that affect licensed pharmacies.","authors":[{"name":"ScriptSafe","url":"https://scriptsafe.com"}],"_scriptsafe":{"revision":"2783c18ae26ab56a53d5c6c00869d9cb447e5c57","item_limit":50,"total_visible":16},"items":[{"id":"https://scriptsafe.com/news/medicare-glp-1-bridge-and-mfn-pricing","url":"https://scriptsafe.com/news/medicare-glp-1-bridge-and-mfn-pricing","title":"Retracted: Branded GLP-1 prices keep falling as Medicare's $50 Bridge reaches 600,000 seniors","content_text":"Retracted 2026-09-22: Withdrawn by the editor the day it ran: a pricing and coverage development rather than a regulatory change, outside the scope of Regulatory Watch. The sources remain listed for the record.\n\nThe original summary has been withdrawn.","summary":"Retracted 2026-09-22: Withdrawn by the editor the day it ran: a pricing and coverage development rather than a regulatory change, outside the scope of Regulatory Watch. The sources remain listed for the record.","date_published":"2026-09-22T00:00:00Z","date_modified":"2026-09-22T00:00:00Z","tags":["fda_federal","US","glp-1","medicare","pricing","most favored nation","trumprx","compounding","demand"],"_scriptsafe":{"status":"retracted","lane":"FDA and federal","issuer":"Executive Office of the President","instrument":"Press release","procedural_status":"Announced","jurisdictions":["US"],"source_published_on":"2026-09-18","last_reviewed_on":"2026-09-22","retraction":{"on":"2026-09-22","reason":"Withdrawn by the editor the day it ran: a pricing and coverage development rather than a regulatory change, outside the scope of Regulatory Watch. The sources remain listed for the record."}}},{"id":"https://scriptsafe.com/news/texas-board-proposes-limits-on-prescriber-office-delivery","url":"https://scriptsafe.com/news/texas-board-proposes-limits-on-prescriber-office-delivery","title":"Texas moves to limit deliveries to prescriber offices and adds a telehealth consent record due in 72 hours","content_text":"A Texas State Board of Pharmacy proposal published September 18, 2026 would allow a dangerous drug to go to a prescriber's office only if the patient picks it up or is administered it there. Separately, new rule 291.13 requires documented patient consent before any pharmacist telehealth service, kept two years and produced on demand.\n\nWhat changed\n\nThe Board proposes amending 22 TAC 291.9 so that a dangerous drug may be delivered to a prescriber's office only when it is picked up by or administered to the patient there. The Board's own analysis says the change limits when a pharmacy may deliver a dangerous drug to a prescriber's office. Drone delivery of non controlled, non sterile prescriptions is unchanged. Comments are due 30 days after the September 18 publication; the earliest adoption date is October 18, 2026.\n\nNew rule 291.13 appears as a final adoption item on the Board's August 4, 2026 agenda and in the Board's rules compilation dated September 1. A pharmacist providing a telehealth service, by video or audio only, must first obtain the patient's informed consent to treatment, data collection and data sharing, document it in the pharmacy's system or a logbook, keep it at the licensed location for two years, and produce it within 72 hours of a Board request. Failure to produce it is prima facie evidence of a recordkeeping violation.\n\nWho this affects\n\n- Compounders and nonresident pharmacies shipping office administered products, such as weight management injectables, peptides or hormones, to Texas clinics.\n\n- Any Texas licensed pharmacy, resident or nonresident, whose pharmacists counsel or consult Texas patients remotely.\n\nKey dates\n\n- source published: 2026-09-18 (Proposed amendment to 22 TAC 291.9 published in the Texas Register; filed September 1.)\n\n- comment deadline: 2026-10-18 (Thirty days after publication; the Register lists October 18 as the earliest adoption date.)\n\n- effective: unknown (For 291.13, adopted at the August 4 meeting and printed in the Board's September 1 compilation; the Register adoption notice was not located.)\n\nWhy it matters\n\nClinic drop shipping is how much of the weight management and med spa market is supplied, and Texas proposes to require a patient, not a stock room, at the end of every office delivery. If adopted, Texas shipping records will need to show that patient. The consent rule creates a record the Board can demand in three days; a missing record is itself the violation.\n\nWhat to do now\n\n1. If you deliver to Texas prescriber offices, review which shipments are for a named patient's pick up or administration and which are stock, and consider filing a comment before the deadline.\n\n2. If your pharmacists provide any telehealth service to Texas patients, add a consent capture for treatment, data collection and data sharing, and confirm it is retrievable within 72 hours.\n\n3. Watch the Board's November meeting for adoption of the 291.9 amendment.\n\nSources\n\n- Texas Register, September 18, 2026, Proposed Rules, Title 22 Examining Boards: 22 TAC 291.9 (primary): https://www.sos.state.tx.us/texreg/archive/September182026/Proposed%20Rules/22.EXAMINING%20BOARDS.html\n\n- Texas Register, September 18, 2026 issue, proposed rules (PDF) (primary): https://www.sos.state.tx.us/texreg/pdf/backview/0918/0918prop.pdf\n\n- Texas State Board of Pharmacy, August 4, 2026 meeting agenda (primary): https://www.pharmacy.texas.gov/_assets/documents/about/board-meetings/BN/Aug4_2026/Agenda.pdf\n\n- Texas Pharmacy Rules, 22 TAC Part 15, Board compilation dated September 1, 2026 (primary): https://www.pharmacy.texas.gov/files_pdf/TSBP%20Rules_MASTER%20FILE.pdf\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"A Texas State Board of Pharmacy proposal published September 18, 2026 would allow a dangerous drug to go to a prescriber's office only if the patient picks it up or is administered it there. Separately, new rule 291.13 requires documented patient consent before any pharmacist telehealth service, kept two years and produced on demand.","date_published":"2026-09-22T00:00:00Z","date_modified":"2026-09-22T00:00:00Z","tags":["state","TX","texas","prescriber office delivery","drop ship","telehealth consent","recordkeeping","nonresident pharmacy","proposed rule"],"_scriptsafe":{"status":"published","lane":"State laws and boards","issuer":"State board of pharmacy","instrument":"Proposed rule","procedural_status":"Comment period open","jurisdictions":["TX"],"source_published_on":"2026-09-18","last_reviewed_on":"2026-09-22"}},{"id":"https://scriptsafe.com/news/fda-glutathione-injectable-recalls-supplement-grade-api","url":"https://scriptsafe.com/news/fda-glutathione-injectable-recalls-supplement-grade-api","title":"Compounded glutathione injectables recalled nationwide after a supplement grade ingredient sent patients to hospital","content_text":"FDA reports at least 30 patients harmed by IV glutathione compounded from a single Medisca lot labelled dietary supplement grade. A third Texas compounder, Centric Compounding, has now recalled six lots of glutathione, Myer's Cocktail and Tri-Immune Boost vials shipped to patients' homes.\n\nWhat changed\n\nOn August 27, 2026 FDA said it was aware of at least 30 patients with adverse events after intravenous glutathione, alone or in blends, compounded by different pharmacies that all bought glutathione lot 229536 from Medisca Inc. The material was labelled dietary supplement grade, which FDA says is not an appropriate ingredient for an injectable. Reported effects included fever, chills, signs of shock and sepsis like symptoms, with hospitalizations, consistent with endotoxin exposure. Two Texas pharmacies had already recalled.\n\nOn September 9, 2026 Centric Compounding of Houston announced a consumer level recall of six lots of Glutathione 200 mg per mL, Myer's Cocktail and Tri-Immune Boost 30 mL multidose vials, which FDA posted on September 13. The firm reported nine adverse event reports and said the products had been distributed nationwide to patients by home delivery and to prescribers. FDA's alert tells compounders to know their ingredient suppliers and never use supplement grade material in injectables.\n\nWho this affects\n\n- 503A compounders making IV nutrient, glutathione or other wellness injectables.\n\n- Telehealth, med spa and wellness programs that prescribe or administer them, and the pharmacies shipping vials to patients' homes.\n\nKey dates\n\n- source published: 2026-09-13 (FDA posted the Centric Compounding recall; the company's release is dated September 9.)\n\n- source published: 2026-08-27 (FDA compounding alert on dietary supplement grade glutathione.)\n\nWhy it matters\n\nWellness injectables are the fastest growing compounded category outside GLP-1s, and this episode shows the failure mode: an ingredient grade problem at one supplier reaching patients through several pharmacies at once. For a certified compounder the question is simple and documentary: can you show, for every injectable, that the active ingredient and excipients were made and certified for injection. A recall with home delivery also means refunds and disputes at scale.\n\nWhat to do now\n\n1. Check every injectable's ingredient sourcing against the supplier's certificate of analysis and grade statement; remove anything labelled for dietary supplement or research use.\n\n2. If you bought glutathione from Medisca in 2026, confirm the lot number and follow the supplier's and FDA's instructions to your customers.\n\n3. Review your recall procedure for home delivered products, including how you reach patients directly and how refunds are handled.\n\nSources\n\n- Centric Compounding Issues Nationwide Recall of Glutathione, Myer's Cocktail, and Tri-Immune Boost Due to Elevated Endotoxin Levels (primary): https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/centric-compounding-issues-nationwide-recall-glutathione-myers-cocktail-and-tri-immune-boost-due\n\n- FDA reminds compounders not to use dietary supplement grade glutathione for injectables (primary): https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-not-use-dietary-supplement-grade-glutathione-injectables\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"FDA reports at least 30 patients harmed by IV glutathione compounded from a single Medisca lot labelled dietary supplement grade. A third Texas compounder, Centric Compounding, has now recalled six lots of glutathione, Myer's Cocktail and Tri-Immune Boost vials shipped to patients' homes.","date_published":"2026-09-22T00:00:00Z","date_modified":"2026-09-22T00:00:00Z","tags":["fda_federal","US","glutathione","injectables","endotoxin","recall","medisca","wellness","iv therapy","503a","ingredient sourcing"],"_scriptsafe":{"status":"published","lane":"FDA and federal","issuer":"U.S. Food and Drug Administration","instrument":"Advisory","procedural_status":"Announced","jurisdictions":["US"],"source_published_on":"2026-09-13","last_reviewed_on":"2026-09-22"}},{"id":"https://scriptsafe.com/news/arizona-pharmacy-statutes-effective-september-12","url":"https://scriptsafe.com/news/arizona-pharmacy-statutes-effective-september-12","title":"Arizona names unpermitted drug distribution a prohibited act and sets a clock on pharmacy ownership changes","content_text":"Two Arizona chapters took effect September 12, 2026: Chapter 203 adds wholesaling or distributing prescription drugs without a Board permit to the list of prohibited acts and lets a pharmacy keep operating through an ownership change if the new owner notifies the Board in seven days; Chapter 207 caps nondisciplinary civil penalties.\n\nWhat changed\n\nChapter 203 (House Bill 2733), approved June 19, 2026, adds section 32-1930.01: a permitted business that changes ownership may keep operating under its existing permit while the new owner's application is reviewed, if the new owner notifies the Board within seven calendar days, applies within thirty, stays compliant and accepts responsibility; the Board may refuse for public safety risk or evidence of fraud or diversion. The same chapter amends section 32-1965 to make wholesaling or distributing a prescription drug or device, controlled substance, nonprescription drug, medical gas or durable medical equipment without a valid Board permit a prohibited act.\n\nChapter 207 (House Bill 2953) caps nondisciplinary civil penalties at $25,000 in any six month period and, for permittees not directly performing patient care, caps $1,000 per violation penalties at $25,000 in aggregate per six months. Neither chapter has an emergency clause, so both took effect on the session's general effective date, September 12, 2026.\n\nWho this affects\n\n- Pharmacies, wholesalers and nonresident permit holders that ship into Arizona.\n\n- Buyers and sellers of Arizona pharmacies, who now have a defined notice and application window.\n\nKey dates\n\n- source published: 2026-09-12 (General effective date of the 2026 session; neither chapter carries an emergency clause.)\n\n- enacted: 2026-06-19 (Both chapters approved by the Governor; filed June 22.)\n\n- effective: 2026-09-12\n\nWhy it matters\n\nThe permit requirement was already there; what changed is that shipping into Arizona without one is now a named prohibited act, the kind of citation a board order is built on. For a nonresident pharmacy the question is the one every certification review asks: is the permit current for the state on the label. The ownership rule gives acquirers a clean signal, a seven day notice, that a merchant's control has changed.\n\nWhat to do now\n\n1. Confirm your Arizona nonresident pharmacy or wholesaler permit is active before the next shipment, and that every product category you ship is covered by it.\n\n2. If you are buying or selling an Arizona permitted pharmacy, calendar the seven day notice and thirty day application deadlines from the change date.\n\n3. Tell your processor about any ownership change at the same time you tell the Board.\n\nSources\n\n- Chapter 203, House Bill 2733, Fifty-seventh Legislature, Second Regular Session (primary): https://www.azleg.gov/legtext/57leg/2R/laws/0203.pdf\n\n- Chapter 207, House Bill 2953, Fifty-seventh Legislature, Second Regular Session (primary): https://www.azleg.gov/legtext/57leg/2R/laws/0207.pdf\n\n- General Effective Dates (primary): https://www.azleg.gov/general-effective-dates/\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"Two Arizona chapters took effect September 12, 2026: Chapter 203 adds wholesaling or distributing prescription drugs without a Board permit to the list of prohibited acts and lets a pharmacy keep operating through an ownership change if the new owner notifies the Board in seven days; Chapter 207 caps nondisciplinary civil penalties.","date_published":"2026-09-22T00:00:00Z","date_modified":"2026-09-22T00:00:00Z","tags":["state","AZ","arizona","nonresident permit","wholesaling","ownership change","civil penalties","board of pharmacy"],"_scriptsafe":{"status":"published","lane":"State laws and boards","issuer":"State legislature","instrument":"Statute","procedural_status":"In effect","jurisdictions":["AZ"],"source_published_on":"2026-09-12","last_reviewed_on":"2026-09-22"}},{"id":"https://scriptsafe.com/news/fda-starter-parenteral-nutrition-compounding-policy","url":"https://scriptsafe.com/news/fda-starter-parenteral-nutrition-compounding-policy","title":"FDA lets pharmacies compound neonatal starter nutrition without patient specific prescriptions for 180 days","content_text":"After two outsourcing facilities that made standardized neonatal starter parenteral nutrition announced permanent shutdowns, FDA issued an immediately effective guidance on September 4, 2026 describing what it will not enforce, for which products, under which conditions, until March 8, 2027.\n\nWhat changed\n\nFDA's guidance, Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates, was issued September 4, 2026 and noticed in the Federal Register on September 9. For 180 days, until March 8, 2027, FDA does not intend to act against a state licensed pharmacy or federal facility that compounds the starter parenteral nutrition products listed in the guidance's Appendix A for hospitals without patient specific prescriptions, if every listed condition is met.\n\nFor 503B outsourcing facilities, FDA likewise does not intend to act on the use of a bulk substance not otherwise permitted under section 503B(a)(2)(A), or on certain stability and dating shortfalls, provided the facility uses a default beyond use date of no more than 30 hours at room temperature and 9 days refrigerated, with further conditions that depend on whether an aggregate batch exceeds 5,000 units. FDA says it may extend, modify or withdraw the policy.\n\nWho this affects\n\n- Hospital and health system 503A pharmacies asked to supply neonatal units.\n\n- 503B outsourcing facilities that take on the discontinued products.\n\nKey dates\n\n- source published: 2026-09-04 (FDA press announcement; guidance immediately in effect.)\n\n- effective: 2026-09-09 (Federal Register notice of availability.)\n\n- expires: 2027-03-08 (The temporary policy runs 180 days from publication.)\n\nWhy it matters\n\nThis is what an FDA shortage accommodation actually looks like: a named product list, explicit conditions, a start date and an end date, in a published guidance. A compounder that cites a supply gap to justify compounding anything else without a patient specific prescription is outside this policy, and the contrast with the GLP-1 shortage list fight is instructive.\n\nWhat to do now\n\n1. If you supply a neonatal unit, read Appendix A and the conditions before compounding under this policy, and tell your state board.\n\n2. If you do not, note the shape of the policy and do not read it as permission for anything beyond its list.\n\n3. Diary March 8, 2027; the policy ends unless FDA extends it.\n\nSources\n\n- FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products (primary): https://www.fda.gov/news-events/press-announcements/fda-takes-steps-maintain-newborn-access-life-saving-starter-nutrition-products\n\n- Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry (primary): https://www.fda.gov/media/194633/download\n\n- Federal Register notice of availability, FR Doc. 2026-18368 (primary): https://www.govinfo.gov/content/pkg/FR-2026-09-09/html/2026-18368.htm\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"After two outsourcing facilities that made standardized neonatal starter parenteral nutrition announced permanent shutdowns, FDA issued an immediately effective guidance on September 4, 2026 describing what it will not enforce, for which products, under which conditions, until March 8, 2027.","date_published":"2026-09-22T00:00:00Z","date_modified":"2026-09-22T00:00:00Z","tags":["fda_federal","US","fda","compounding","parenteral nutrition","neonatal","503a","503b","guidance","shortage"],"_scriptsafe":{"status":"published","lane":"FDA and federal","issuer":"U.S. Food and Drug Administration","instrument":"Final guidance","procedural_status":"In effect","jurisdictions":["US"],"source_published_on":"2026-09-04","last_reviewed_on":"2026-09-22"}},{"id":"https://scriptsafe.com/news/ftc-processor-orders-nuvei-humboldt","url":"https://scriptsafe.com/news/ftc-processor-orders-nuvei-humboldt","title":"FTC orders two processors to screen merchants, with negative option and healthcare products under extra scrutiny","content_text":"Settlements with Nuvei and Humboldt Merchant Services, announced September 4 and 8, 2026, write the FTC's merchant screening expectations into court orders: subscription and healthcare merchants get enhanced underwriting, a chargeback trip wire of one percent and 75 chargebacks a month triggers investigation, and mailbox only new merchants cannot be boarded.\n\nWhat changed\n\nThe FTC alleged that Nuvei processed more than $30 million for a tech support scam and other deceptive merchants it knew or should have known about, and that Humboldt processed for more than 1,000 shell merchants fronting for unauthorized billing schemes at chargeback rates almost ten times what the card brands treat as excessive. Nuvei pays $4.85 million and Humboldt $12 million. Both settled by stipulated order; the allegations are the FTC's.\n\nBoth orders define a Covered Client that must be screened before boarding and watched after. Nuvei's includes any merchant with a negative option feature or a Healthcare-Related Product, defined to include access to healthcare providers or networks, virtually or in person; screening means reading the full website, six months of processing statements and marketing materials, and any covered client above a one percent chargeback rate with more than 75 chargebacks in two of six months must be investigated. Humboldt may not board e-commerce merchants with a negative option, no processing history or an entity under a year old whose only address is a mailbox store, registered agent or virtual office, nor any MATCH listed merchant.\n\nWho this affects\n\n- Telehealth and online pharmacy merchants billing subscriptions or offering access to providers, especially new entities or those using a virtual office address.\n\n- Acquirers, payment facilitators and ISOs, whose underwriting files now have a federal template to match.\n\nKey dates\n\n- source published: 2026-09-04 (Nuvei complaint and stipulated order filed; FTC announcement.)\n\n- source published: 2026-09-08 (Humboldt Merchant Services complaint and stipulated order announced.)\n\nWhy it matters\n\nProcessors read FTC orders as a checklist for everyone. A telehealth pharmacy with recurring billing, a virtual office address and a dispute rate near one percent now matches the profile two processors were just ordered to screen or refuse. The cure is the file a certification review builds anyway: a real address, licensure that checks out, a website that says what the business does, and dispute history you can show.\n\nWhat to do now\n\n1. Check your last six months of statements against a one percent chargeback rate and 75 chargebacks a month.\n\n2. List a physical operating address on your merchant account, not a mailbox store or registered agent.\n\n3. If you bill subscriptions, give your acquirer your current checkout, cancellation flow and refund terms.\n\nSources\n\n- Payment Processor Nuvei Must Implement Robust Merchant Screening Practices and Pay $4.85 Million to Settle FTC Charges (primary): https://www.ftc.gov/news-events/news/press-releases/2026/09/payment-processor-nuvei-must-implement-robust-merchant-screening-practices-pay-485-million-settle\n\n- Stipulated Order for Permanent Injunction, FTC v. Nuvei Corporation et al., D. Ariz. No. 2:26-cv-06306 (primary): https://www.ftc.gov/system/files/ftc_gov/pdf/Nuvei-Order.pdf\n\n- FTC Takes Action Against Payment Processor Humboldt Merchant Services for Knowingly Facilitating Payment Processing for Sham Merchants (primary): https://www.ftc.gov/news-events/news/press-releases/2026/09/ftc-takes-action-against-payment-processor-humboldt-merchant-services-knowingly-facilitating-payment\n\n- Stipulated Order, FTC v. Humboldt Merchant Services (primary): https://www.ftc.gov/system/files/ftc_gov/pdf/Humboldt-StipulatedOrder_0.pdf\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"Settlements with Nuvei and Humboldt Merchant Services, announced September 4 and 8, 2026, write the FTC's merchant screening expectations into court orders: subscription and healthcare merchants get enhanced underwriting, a chargeback trip wire of one percent and 75 chargebacks a month triggers investigation, and mailbox only new merchants cannot be boarded.","date_published":"2026-09-22T00:00:00Z","date_modified":"2026-09-22T00:00:00Z","tags":["payments_advertising","US","ftc","payment processors","merchant screening","chargebacks","negative option","underwriting","match","nuvei","humboldt"],"_scriptsafe":{"status":"published","lane":"Payments and advertising","issuer":"Federal Trade Commission","instrument":"Consent order or settlement","procedural_status":"Announced","jurisdictions":["US"],"source_published_on":"2026-09-04","last_reviewed_on":"2026-09-22"}},{"id":"https://scriptsafe.com/news/third-circuit-upholds-nj-telemedicine-licensure","url":"https://scriptsafe.com/news/third-circuit-upholds-nj-telemedicine-licensure","title":"Third Circuit upholds New Jersey's rule that telehealth doctors must hold a New Jersey license","content_text":"In a precedential opinion filed August 31, 2026, the court rejected First Amendment, Commerce Clause and Privileges and Immunities challenges by two out of state physicians and New Jersey patients. State licensure of telemedicine is content based, the court said, but a long regulatory tradition means strict scrutiny does not apply.\n\nWhat changed\n\nNew Jersey requires any physician who treats a patient located in the state by telemedicine to hold a New Jersey license. In MacDonald v. President of the New Jersey State Board of Medical Examiners, No. 25-2090, two physicians licensed elsewhere and three New Jersey residents argued that the requirement burdened their speech and interstate commerce. The district court dismissed; on August 31, 2026 a Third Circuit panel led by Judge Hardiman affirmed, with one modification, in an opinion designated precedential.\n\nThe court held that the licensing law is content based, since its application turns on what the speaker says, but concluded that strict scrutiny is inappropriate because professional licensing sits within a long and robust regulatory tradition, and that the law passes muster. The remaining constitutional claims were found insubstantial.\n\nWho this affects\n\n- Telehealth platforms whose prescribers treat patients across state lines under licenses from other states.\n\n- Pharmacies that fill those prescriptions, whose validity depends on the prescriber being licensed where the patient is.\n\nKey dates\n\n- source published: 2026-08-31 (Opinion filed.)\n\n- decided: 2026-08-31\n\nWhy it matters\n\nThe pandemic era argument that telemedicine escapes state by state physician licensure has now lost in a precedential appellate opinion. For a pharmacy the consequence is one step removed but concrete: a prescription written by a physician not licensed in the patient's state is not a valid prescription there, and a dispensing pharmacy is expected to know it. Prescriber licensure in the patient's state is a fact a pharmacy, a board or a certifier can check.\n\nWhat to do now\n\n1. For each telehealth platform you fill for, ask how it verifies that the prescriber holds a license in the patient's state at the time of the visit.\n\n2. Spot check a sample of recent telehealth prescriptions against the prescriber's licensure in the patient's state.\n\n3. Read the opinion if you operate in New Jersey, Pennsylvania or Delaware; it is binding law there.\n\nSources\n\n- MacDonald v. President of the New Jersey State Board of Medical Examiners, No. 25-2090, precedential opinion (primary): https://www2.ca3.uscourts.gov/opinarch/252090p.pdf\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"In a precedential opinion filed August 31, 2026, the court rejected First Amendment, Commerce Clause and Privileges and Immunities challenges by two out of state physicians and New Jersey patients. State licensure of telemedicine is content based, the court said, but a long regulatory tradition means strict scrutiny does not apply.","date_published":"2026-09-22T00:00:00Z","date_modified":"2026-09-22T00:00:00Z","tags":["courts","NJ","PA","DE","VI","telemedicine","telehealth","licensure","new jersey","third circuit","first amendment","prescriber"],"_scriptsafe":{"status":"published","lane":"Courts and litigation","issuer":"Federal court","instrument":"Court decision","procedural_status":"Decided","jurisdictions":["NJ","PA","DE","VI"],"source_published_on":"2026-08-31","last_reviewed_on":"2026-09-22"}},{"id":"https://scriptsafe.com/news/fifth-circuit-affirms-glp-1-delisting","url":"https://scriptsafe.com/news/fifth-circuit-affirms-glp-1-delisting","title":"Fifth Circuit upholds FDA's removal of tirzepatide and semaglutide from the shortage list","content_text":"Two Fifth Circuit opinions uphold FDA's removal of tirzepatide and semaglutide from the shortage list. The compounders' appeal is over, and copies of the approved drugs are back under the statutory ban.\n\nWhat changed\n\nOn August 27, 2026 a Fifth Circuit panel affirmed two Northern District of Texas judgments for FDA: No. 25-10600 on Mounjaro and Zepbound (tirzepatide) and No. 25-10758 on Ozempic and Wegovy (semaglutide), the latter revised September 1. The Outsourcing Facilities Association and FarmaKeio brought both appeals.\n\nThe court held that any failure to use notice and comment was harmless because the compounders had actual notice and repeated chances to submit data, and that FDA's reliance on manufacturer supply data was not arbitrary or capricious. With both drugs off the shortage list, compounding essentially a copy of them is prohibited outside the narrow patient specific exceptions.\n\nWho this affects\n\n- 503A and 503B facilities still compounding semaglutide or tirzepatide copies.\n\n- Telehealth platforms built on compounded GLP-1 supply, and the pharmacies filling for them.\n\nKey dates\n\n- source published: 2026-08-27 (Both opinions filed. The semaglutide opinion was revised on September 1, 2026.)\n\n- decided: 2026-08-27\n\nWhy it matters\n\nThe pending litigation was the last cover for volume compounding of these drugs, and it is gone. A general offer of compounded semaglutide or tirzepatide on a pharmacy website is now the fact a reviewer, a processor or FDA will act on. The patient specific exception has to be documented, not assumed.\n\nWhat to do now\n\n1. List every semaglutide and tirzepatide product you offer and the statutory basis for each.\n\n2. Take down any public offer of compounded GLP-1 copies that does not rest on a documented patient specific need.\n\n3. Ask each telehealth partner in writing how it is changing prescribing and marketing after this decision.\n\nSources\n\n- Outsourcing Facilities Association v. FDA (Eli Lilly, intervenor), No. 25-10600, per curiam opinion (primary): https://www.ca5.uscourts.gov/opinions/unpub/25/25-10600.0.pdf\n\n- Outsourcing Facilities Association v. FDA (Novo Nordisk, intervenor), No. 25-10758, per curiam opinion, revised September 1, 2026 (primary): https://www.ca5.uscourts.gov/opinions/unpub/25/25-10758.0.pdf\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"Two Fifth Circuit opinions uphold FDA's removal of tirzepatide and semaglutide from the shortage list. The compounders' appeal is over, and copies of the approved drugs are back under the statutory ban.","date_published":"2026-09-21T00:00:00Z","date_modified":"2026-09-21T00:00:00Z","tags":["courts","US","glp-1","semaglutide","tirzepatide","shortage list","503a","503b","compounding","fifth circuit"],"_scriptsafe":{"status":"published","lane":"Courts and litigation","issuer":"Federal court","instrument":"Court decision","procedural_status":"Decided","jurisdictions":["US"],"source_published_on":"2026-08-27","last_reviewed_on":"2026-09-21"}},{"id":"https://scriptsafe.com/news/dea-telemedicine-special-registration-final-review","url":"https://scriptsafe.com/news/dea-telemedicine-special-registration-final-review","title":"DEA's telemedicine special registration rule reaches final review as the current flexibilities run out on December 31","content_text":"DEA's final rule creating a special registration for telemedicine prescribing of controlled substances reached White House review on August 25, 2026. The temporary flexibilities that allow remote prescribing today expire December 31.\n\nWhat changed\n\nThe Office of Information and Regulatory Affairs lists RIN 1117-AB40, Special Registrations for Telemedicine and Limited State Telemedicine Registrations, as received August 25, 2026 at the final rule stage and economically significant. That review is the last step before publication. The text is not public. It finalizes the proposal DEA published on January 17, 2025.\n\nSeparately, the fourth temporary extension of the pandemic era telemedicine flexibilities, issued by DEA and HHS on December 31, 2025, runs from January 1 through December 31, 2026. It is the authority under which a practitioner may today prescribe a controlled medication to a patient never examined in person.\n\nWho this affects\n\n- Practitioners prescribing controlled substances to patients seen only by telemedicine.\n\n- Pharmacies filling those prescriptions, including mail order pharmacies serving telehealth platforms.\n\nKey dates\n\n- source published: 2026-08-25 (Date the final rule was received by the Office of Information and Regulatory Affairs.)\n\n- expires: 2026-12-31 (The fourth temporary extension of the telemedicine flexibilities ends.)\n\n- effective: unknown (The final rule's effective date will be set when it is published.)\n\nWhy it matters\n\nWhatever the final rule says, the current basis for remote controlled substance prescribing ends December 31, 2026, and the replacement may publish with a short window. A pharmacy filling telehealth prescriptions for phentermine, testosterone or stimulants needs to know before January which prescribers will hold a registration and which prescriptions will stop being valid.\n\nWhat to do now\n\n1. List every telehealth prescriber that sends you controlled substance prescriptions and ask each for its plan for January 1, 2027.\n\n2. Read the January 2025 proposed rule; the final rule will follow its structure.\n\n3. Confirm your own DEA registration and schedule authorizations are current.\n\nSources\n\n- OIRA regulatory review record, RIN 1117-AB40, Special Registrations for Telemedicine and Limited State Telemedicine Registrations (primary): https://www.reginfo.gov/public/do/eoDetails?rrid=1510512\n\n- Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (primary): https://www.govinfo.gov/content/pkg/FR-2025-12-31/html/2025-24123.htm\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"DEA's final rule creating a special registration for telemedicine prescribing of controlled substances reached White House review on August 25, 2026. The temporary flexibilities that allow remote prescribing today expire December 31.","date_published":"2026-09-21T00:00:00Z","date_modified":"2026-09-21T00:00:00Z","tags":["dea_controlled","US","dea","telemedicine","telehealth","controlled substances","special registration","ryan haight"],"_scriptsafe":{"status":"published","lane":"DEA and controlled substances","issuer":"Drug Enforcement Administration","instrument":"Final rule","procedural_status":"Pending","jurisdictions":["US"],"source_published_on":"2026-08-25","last_reviewed_on":"2026-09-21"}},{"id":"https://scriptsafe.com/news/fda-warning-letters-research-peptide-sellers","url":"https://scriptsafe.com/news/fda-warning-letters-research-peptide-sellers","title":"FDA warns five online peptide sellers that research use only labels do not make injectable GLP-1s legal","content_text":"Five FDA warning letters dated August 24, 2026 treat semaglutide, tirzepatide, retatrutide and other injectables sold as research chemicals as unapproved new drugs. The disclaimers did not help, and selling bacteriostatic water alongside made it worse.\n\nWhat changed\n\nFDA's Center for Drug Evaluation and Research sent warning letters to Peak Performance Peptides, Peptide Partners, Royal Peptides, NuScience Peptides and Tex Peptides after reviewing their websites in July 2026. Each cites products such as semaglutide, tirzepatide, retatrutide, survodutide, mazdutide, SS-31, PT-141 and tesamorelin as unapproved new drugs under section 505(a).\n\nFDA's footnote does the work: despite research use only and not for human consumption labels, the sites' own descriptions of appetite suppression and glycemic control show the products are intended as drugs for human use, and marketing bacteriostatic water as a solvent provides the means to prepare an injectable. Each firm has fifteen business days to respond. These are allegations, not findings.\n\nWho this affects\n\n- Online storefronts selling injectable peptides or GLP-1 analogs under research labels.\n\n- Pharmacies, telehealth brands and clinics that share a domain, a brand or a supply chain with one.\n\n- Acquirers with merchants coded as laboratory supply whose catalogs are GLP-1 analogs.\n\nKey dates\n\n- source published: 2026-08-24 (Date on all five letters.)\n\n- compliance deadline: unknown (Each firm must respond within 15 business days of receipt.)\n\nWhy it matters\n\nThe label no longer decides what a product is; the offer does. That is the same question a review of any pharmacy website asks. A pharmacy linked to a research peptide storefront inherits its posture, and a merchant category that says laboratory supply over a catalog of semaglutide is the mismatch that ends merchant accounts.\n\nWhat to do now\n\n1. Compare any research labelled product page you or an affiliate runs against the language these letters cite.\n\n2. Remove clinical framing from research product descriptions, or remove the products.\n\n3. Stop bundling bacteriostatic water, syringes or reconstitution guides with research labelled peptides.\n\nSources\n\n- Warning letter to Peak Performance Peptides, MARCS-CMS 735127 (primary): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026\n\n- Warning letter to Peptide Partners LLC, MARCS-CMS 735063 (primary): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026\n\n- Warning letter to Royal Peptides LLC, MARCS-CMS 734884 (primary): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026\n\n- Warning letter to NuScience Peptides LLC, MARCS-CMS 733652 (primary): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026\n\n- Warning letter to TXP Innovations LLC dba Tex Peptides, MARCS-CMS 735067 (primary): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026\n\n- FDA's concerns with unapproved GLP-1 drugs used for weight loss (secondary): https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"Five FDA warning letters dated August 24, 2026 treat semaglutide, tirzepatide, retatrutide and other injectables sold as research chemicals as unapproved new drugs. The disclaimers did not help, and selling bacteriostatic water alongside made it worse.","date_published":"2026-09-21T00:00:00Z","date_modified":"2026-09-21T00:00:00Z","tags":["fda_federal","US","peptides","research use only","glp-1","retatrutide","semaglutide","tirzepatide","warning letters","bacteriostatic water"],"_scriptsafe":{"status":"published","lane":"FDA and federal","issuer":"U.S. Food and Drug Administration","instrument":"Warning letter","procedural_status":"Final","jurisdictions":["US"],"source_published_on":"2026-08-24","last_reviewed_on":"2026-09-21"}},{"id":"https://scriptsafe.com/news/state-boards-bar-research-grade-peptides","url":"https://scriptsafe.com/news/state-boards-bar-research-grade-peptides","title":"Mississippi, South Carolina and Alabama bar licensees from research grade peptides, waivers or not","content_text":"Mississippi, South Carolina and Alabama have issued near identical notices: no licensee may compound, prescribe, administer or dispense a research grade peptide, patient waivers do nothing, and every drug or ingredient must come from a board permitted pharmacy.\n\nWhat changed\n\nOn August 19, 2026 Mississippi's boards of pharmacy, medical licensure and nursing issued a joint statement: under no circumstances may a provider compound, administer, prescribe or dispense a non FDA approved or research grade peptide, delegation is no workaround, and all prescription products and ingredients must come from an entity permitted by the Mississippi Board of Pharmacy. Unlicensed shippers can be reported.\n\nSouth Carolina's Board of Medical Examiners published the same position, naming semaglutide, stating that any facility inside or outside South Carolina selling drugs into the state without a South Carolina pharmacy permit is acting unlawfully, and warning that buying from an unpermitted facility is aiding unlicensed practice. Alabama's board published matching language earlier in the year.\n\nWho this affects\n\n- Licensees in the three states.\n\n- Compounders and online sellers shipping peptides into them, permitted or not.\n\n- Telehealth and wellness programs offering peptides to their residents.\n\nKey dates\n\n- source published: 2026-08-19 (Mississippi joint statement. The South Carolina and Alabama notices carry no date on their face.)\n\nWhy it matters\n\nWhile FDA's bulk substance process moves slowly, states are settling the question for their own licensees: no research grade product, and only permitted sources. For a shipping pharmacy that turns a nonresident permit into a market access requirement, and the shared wording means more states will follow.\n\nWhat to do now\n\n1. Check your nonresident permits in Mississippi, South Carolina and Alabama and stop shipping peptides where you hold none.\n\n2. Remove research grade or research use only products from any catalog reaching those states.\n\n3. Retire any patient waiver that describes a product as research grade.\n\nSources\n\n- Joint Statement Concerning the Prescribing of Non-FDA Approved (Research-Grade) Peptides (primary): https://www.msbn.ms.gov/sites/default/files/2026-08/1_Joint_Statement_SIGNED_Accessible_0.pdf\n\n- Peptide Statement (secondary): https://www.msbml.ms.gov/peptide-statement\n\n- Notice Concerning the Prescribing of Research-Grade Peptides and FDA-Ineligible Peptides (primary): https://llr.sc.gov/med/news/BME%20Notice%20re%20Peptides.pdf\n\n- Board Issues Official Notice Concerning the Prescribing of Non-FDA Approved (Research-Grade) Peptides (primary): https://www.albme.gov/press-release/board-issues-official-notice-concerning-the-prescribing-of-non-fda-approved-research-grade-peptides\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"Mississippi, South Carolina and Alabama have issued near identical notices: no licensee may compound, prescribe, administer or dispense a research grade peptide, patient waivers do nothing, and every drug or ingredient must come from a board permitted pharmacy.","date_published":"2026-09-21T00:00:00Z","date_modified":"2026-09-21T00:00:00Z","tags":["state","MS","SC","AL","peptides","research grade","mississippi","south carolina","alabama","state boards","nonresident permit","semaglutide"],"_scriptsafe":{"status":"published","lane":"State laws and boards","issuer":"State board of pharmacy","instrument":"Bulletin or notice","procedural_status":"In effect","jurisdictions":["MS","SC","AL"],"source_published_on":"2026-08-19","last_reviewed_on":"2026-09-21"}},{"id":"https://scriptsafe.com/news/mastercard-specialty-merchant-registration-online-pharmacies","url":"https://scriptsafe.com/news/mastercard-specialty-merchant-registration-online-pharmacies","title":"Mastercard now bills every online pharmacy transaction and requires written consent to acquire them","content_text":"The August 2026 rules edition carries Mastercard's rewritten Specialty Merchant Registration Program: online pharmacies stay a registered category, acquirers need Mastercard's written consent to acquire them, and since June every registered transaction carries new network fees.\n\nWhat changed\n\nMastercard's Security Rules and Procedures, Merchant Edition dated 4 August 2026, lists non face to face pharmaceutical merchants under MCC 5122 and 5912 as specialty merchants that must be registered, with every website URL, before acquiring. New section 9.1.1 requires Mastercard's express prior written consent to acquire for specialty merchants from 1 May 2026. Section 9.4.3 requires the acquirer to verify each pharmacy's legal compliance at registration, by legal opinion or accreditation by a recognized third party, and to reconfirm it at least every twelve months.\n\nBulletin 12568.1 sets the fees: the annual registration fee rises to USD 1,000 per merchant and a USD 50,000 High Risk Acquirer License Fee applies from 1 May 2026; a Specialty Merchant Transaction Fee of USD 0.02 and a Volume Fee of 10 basis points apply to registered merchants' purchases and credits from 3 June 2026, first billed 14 June.\n\nWho this affects\n\n- Online and mail order pharmacies acquired card not present under MCC 5122 or 5912.\n\n- Acquirers and payment facilitators that board them.\n\nKey dates\n\n- source published: 2026-08-04 (Security Rules and Procedures, Merchant Edition, 4 August 2026.)\n\n- effective: 2026-05-01 (Prior written consent rule; updated registration fee; high risk acquirer licence fee.)\n\n- effective: 2026-06-03 (Specialty merchant transaction fee and volume fee, first billed 14 June 2026.)\n\n- effective: 2026-10-01 (Prior consent rule in most of the Europe region.)\n\nWhy it matters\n\nTwo things moved. Every registered online pharmacy transaction on Mastercard now costs about ten basis points plus two cents more, and acquirers began passing that through in June. And an acquirer's compliance file on each pharmacy is now a network requirement with a twelve month clock, which is why acquirers ask for a certification at boarding and again at renewal.\n\nWhat to do now\n\n1. Check a June or July statement for new Mastercard specialty merchant fee lines.\n\n2. Ask your acquirer when your next twelve month reverification falls and what it will need.\n\n3. Confirm every URL you take payments on is registered with your acquirer.\n\nSources\n\n- Security Rules and Procedures, Merchant Edition, 4 August 2026, Chapter 9: Specialty Merchant Registration Program (primary): https://www.mastercard.com/content/dam/mccom/shared/business/support/rules-pdfs/SPME-Manual.pdf\n\n- AP/LAC/MEA/US 12568.1, New and Updated Specialty Merchant Registration Program Fees, published 28 October 2025 (secondary): https://paymentcloudinc.com/blog/wp-content/uploads/2026/05/mastercard-high-risk-registration-2026.pdf\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"The August 2026 rules edition carries Mastercard's rewritten Specialty Merchant Registration Program: online pharmacies stay a registered category, acquirers need Mastercard's written consent to acquire them, and since June every registered transaction carries new network fees.","date_published":"2026-09-21T00:00:00Z","date_modified":"2026-09-21T00:00:00Z","tags":["payments_advertising","US","mastercard","specialty merchant","mcc 5912","mcc 5122","acquirer","fees","registration","card not present"],"_scriptsafe":{"status":"published","lane":"Payments and advertising","issuer":"Card network","instrument":"Program rule","procedural_status":"In effect","jurisdictions":["US"],"source_published_on":"2026-08-04","last_reviewed_on":"2026-09-21"}},{"id":"https://scriptsafe.com/news/ftc-states-sue-hims-hers-subscription-billing","url":"https://scriptsafe.com/news/ftc-states-sue-hims-hers-subscription-billing","title":"FTC and two states sue Hims and Hers over charge at intake subscriptions, hidden cancellation and health data sharing","content_text":"A July 29, 2026 complaint by the FTC, Utah and California alleges customers were charged and enrolled in recurring prescription plans right after an intake form, that cancellation was hidden, and that health data went to Meta and Snap. The company denies it, and nothing is decided.\n\nWhat changed\n\nThe complaint, filed in the Northern District of California on a 2 to 0 Commission vote, alleges Hims and Hers promised a provider consultation, took billing details with assurances of no charge until a prescription, then enrolled most consumers in a recurring subscription shortly after the intake form without a consultation or a chance to approve the treatment. It alleges refill timing was not clearly disclosed and the online cancel button was hidden behind several steps.\n\nIt further alleges that sensitive health information was shared with advertising platforms including Meta and Snap through customer lists and website tracking, despite privacy promises. Claims are under the FTC Act, the Restore Online Shoppers' Confidence Act, Utah's Consumer Sales Practices Act and California's false advertising and unfair competition laws. These are allegations in a pending case.\n\nWho this affects\n\n- Telehealth platforms billing recurring prescription subscriptions from an intake form.\n\n- Pharmacies that fulfil those subscriptions and appear on the card statement.\n\n- Any pharmacy site running advertising pixels on pages where patients enter health information.\n\nKey dates\n\n- source published: 2026-07-29 (Complaint filed in the Northern District of California; FTC press release.)\n\nWhy it matters\n\nThe same checkout that draws a consumer protection complaint draws card network disputes, and a dispute program does not distinguish the platform that built the funnel from the pharmacy that filled the order. Charge at intake, an undisclosed refill cycle and a buried cancel path are the pattern on both sides.\n\nWhat to do now\n\n1. Walk through your own or your partner's checkout and confirm the charge, the refill cycle and the cancel path are shown before any card is charged.\n\n2. Provide a one step online cancellation for any recurring program.\n\n3. Audit which third party tags fire on pages where a patient enters a condition or medication.\n\nSources\n\n- FTC and States Act Against Hims and Hers for Deceptive and Unlawful Privacy Practices (primary): https://www.ftc.gov/news-events/news/press-releases/2026/07/ftc-states-act-against-hims-hers-deceptive-unlawful-privacy-practices\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"A July 29, 2026 complaint by the FTC, Utah and California alleges customers were charged and enrolled in recurring prescription plans right after an intake form, that cancellation was hidden, and that health data went to Meta and Snap. The company denies it, and nothing is decided.","date_published":"2026-09-21T00:00:00Z","date_modified":"2026-09-21T00:00:00Z","tags":["payments_advertising","US","UT","CA","ftc","rosca","subscription","negative option","telehealth","privacy","pixels","chargebacks"],"_scriptsafe":{"status":"published","lane":"Payments and advertising","issuer":"Federal Trade Commission","instrument":"Enforcement action","procedural_status":"Pending","jurisdictions":["US","UT","CA"],"source_published_on":"2026-07-29","last_reviewed_on":"2026-09-21"}},{"id":"https://scriptsafe.com/news/senate-help-advances-safe-drugs-act","url":"https://scriptsafe.com/news/senate-help-advances-safe-drugs-act","title":"Senate committee advances the SAFE Drugs Act with interstate reporting and labeling duties for 503A compounders","content_text":"S. 3794 cleared the Senate HELP Committee 17 to 5 on July 22, 2026. The reported bill keeps adverse event reporting, interstate volume reports and a not FDA approved label for 503A compounders, and drops the monthly cap on essentially a copy compounding.\n\nWhat changed\n\nThe committee agreed to the SAFE Drugs Act of 2026, sponsored by Senators Banks and Heinrich, and Senator Cassidy reported it with an amendment on July 27 as Calendar No. 524. As reported it amends section 503A: compounders sending products out of state must forward serious adverse event reports to FDA, the home state and each receiving state, and anyone sending more than five percent of annual output out of state must report units by product type, by month and by state each January.\n\nEvery 503A product would carry a statement that it was compounded for an individual patient and has not been approved by FDA, plus MedWatch contacts. The committee struck the introduced bill's definitions, large scale outsourcing provisions, establishment fee and its limit of twenty essentially a copy compounds per month. The bill is not law and awaits floor action.\n\nWho this affects\n\n- 503A pharmacies shipping across state lines, especially above the five percent threshold.\n\n- Nonresident and mail order compounders serving telehealth platforms nationally.\n\nKey dates\n\n- source published: 2026-07-22 (Committee roll call vote, 17 to 5.)\n\n- effective: unknown (If enacted, interstate volume reporting starts with the first calendar year after enactment.)\n\nWhy it matters\n\nInterstate volume is what separates a community compounder from a national fulfilment operation, and today nothing reports it federally. A by state volume report is a record a receiving state can compare against its permit roll, so a pharmacy should already be able to say which states it ships to and whether it is licensed there.\n\nWhat to do now\n\n1. Work out what share of your compounded output left your state in the last year.\n\n2. Confirm you hold a nonresident permit in every state you ship to.\n\n3. Compare your labels with the proposed not FDA approved statement.\n\nSources\n\n- HELP Committee executive session results, July 22, 2026 (primary): https://www.help.senate.gov/hearings/the-following-agenda-to-be-considered-07-22-2026\n\n- S. 3794, SAFE Drugs Act of 2026, reported in Senate with an amendment, Calendar No. 524 (primary): https://www.govinfo.gov/content/pkg/BILLS-119s3794rs/html/BILLS-119s3794rs.htm\n\n- Senate HELP Committee advances Sen. Banks' SAFE Drugs Act (secondary): https://www.banks.senate.gov/news/press-releases/senate-help-committee-advances-sen-banks-safe-drugs-act/\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"S. 3794 cleared the Senate HELP Committee 17 to 5 on July 22, 2026. The reported bill keeps adverse event reporting, interstate volume reports and a not FDA approved label for 503A compounders, and drops the monthly cap on essentially a copy compounding.","date_published":"2026-09-21T00:00:00Z","date_modified":"2026-09-21T00:00:00Z","tags":["fda_federal","US","safe drugs act","s. 3794","503a","interstate","adverse events","labeling","congress"],"_scriptsafe":{"status":"published","lane":"FDA and federal","issuer":"United States Congress","instrument":"Bill","procedural_status":"Pending","jurisdictions":["US"],"source_published_on":"2026-07-22","last_reviewed_on":"2026-09-21"}},{"id":"https://scriptsafe.com/news/fda-warning-letters-telehealth-glp-1-marketing-june-2026","url":"https://scriptsafe.com/news/fda-warning-letters-telehealth-glp-1-marketing-june-2026","title":"FDA's June warning letters treat website claims about compounded GLP-1s as misbranding","content_text":"Warning letters dated June 8, 2026 cite telehealth websites for calling compounded semaglutide and tirzepatide clinically proven and their compounder FDA licensed. FDA treats the web copy itself as misbranding.\n\nWhat changed\n\nFDA's Office of Compounding Quality and Compliance sent letters to telehealth marketers including OrderlyMeds and AltRx after reviewing their websites in March 2026. Claims such as clinically proven weight loss, and sourcing from an FDA licensed pharmacy, are cited as false or misleading, making the products misbranded under sections 502(a) and 502(bb) and their shipment a violation of section 301(a).\n\nThe letters state there is no FDA approved or FDA licensed designation for pharmacies or outsourcing facilities and that registration is not approval. Where a telehealth brand's name appears on the vial without qualification, FDA cites the rule that a name on a label represents the named party as the maker. Recipients have fifteen business days to respond. The letters follow the thirty FDA announced on March 3, 2026, and are allegations, not findings.\n\nWho this affects\n\n- Telehealth companies marketing compounded GLP-1s.\n\n- The 503A and 503B facilities whose products appear under a partner's brand.\n\n- Any pharmacy site describing compounded products as clinically proven or FDA approved.\n\nKey dates\n\n- source published: 2026-06-08 (Date on the letters.)\n\n- compliance deadline: unknown (Fifteen business days from receipt to respond.)\n\nWhy it matters\n\nThese letters are triggered by web copy, not inspections, which makes them the nearest thing to a published rulebook for pharmacy websites: no clinically proven, no FDA approved or FDA licensed, no implying a compounded product was evaluated, and no partner branding that hides who made the drug. The label point reaches the pharmacy, not only the marketer.\n\nWhat to do now\n\n1. Search your site and your partners' sites for clinically proven, FDA approved, FDA licensed and FDA registered near any compounded product, and fix each instance.\n\n2. State plainly that compounded drugs are not FDA approved wherever one is offered.\n\n3. Check that every vial label dispensed under a partner arrangement names your pharmacy as the compounder.\n\nSources\n\n- Warning letter to OrderlyMeds LLC dba OrderlyMeds, MARCS-CMS 728291 (primary): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/orderlymeds-llc-dba-orderlymeds-728291-06082026\n\n- Warning letter to Trinity Healthcare Supply LLC dba AltRx, MARCS-CMS 728236 (primary): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/trinity-healthcare-supply-llc-dba-altrx-728236-06082026\n\n- FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s (secondary): https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"Warning letters dated June 8, 2026 cite telehealth websites for calling compounded semaglutide and tirzepatide clinically proven and their compounder FDA licensed. FDA treats the web copy itself as misbranding.","date_published":"2026-09-21T00:00:00Z","date_modified":"2026-09-21T00:00:00Z","tags":["fda_federal","US","glp-1","semaglutide","tirzepatide","telehealth","misbranding","website claims","warning letters","fda licensed"],"_scriptsafe":{"status":"published","lane":"FDA and federal","issuer":"U.S. Food and Drug Administration","instrument":"Warning letter","procedural_status":"Final","jurisdictions":["US"],"source_published_on":"2026-06-08","last_reviewed_on":"2026-09-21"}},{"id":"https://scriptsafe.com/news/california-nonresident-pharmacy-pic-requirement","url":"https://scriptsafe.com/news/california-nonresident-pharmacy-pic-requirement","title":"California now requires a California licensed pharmacist in charge at every nonresident pharmacy","content_text":"Since July 1, 2026 a pharmacy outside California may not ship prescriptions to California patients unless its pharmacist in charge for California operations holds a California license. The Board can now inspect nonresident pharmacies at their expense.\n\nWhat changed\n\nAB 1503, Chapter 196 of the Statutes of 2025, made a California licensed pharmacist in charge, employed and working at the nonresident pharmacy, a prerequisite to registration and ongoing licensure from July 1, 2026, with 90 day notice of designation and Board training required. The Board's April 30, 2026 policy statement says plainly that a nonresident pharmacy may not ship prescriptions or provide any pharmacy service to California patients unless that pharmacist is licensed in California.\n\nThe Board may inspect nonresident pharmacies from the same date and require a deposit for its costs. It has said it will not proactively interrupt otherwise lawful service during the transition and will weigh good faith efforts, which is an enforcement priority, not a change to the operative date.\n\nWho this affects\n\n- Every nonresident pharmacy licensed in California.\n\n- Mail order, telehealth fulfilment and compounding pharmacies shipping into the state.\n\nKey dates\n\n- source published: 2026-04-30 (Board policy statement on the new requirements approved.)\n\n- enacted: 2025-10-01 (AB 1503, Chapter 196, Statutes of 2025.)\n\n- effective: 2026-07-01 (Nonresident pharmacist in charge and inspection provisions operative.)\n\nWhy it matters\n\nA nonresident license used to be a filing; California made it a staffing requirement with a named, California licensed pharmacist behind it. Both licenses are public records, so whether a pharmacy complies is a fact a board, a processor or a certifier can check, and the Board's own words make shipping without it unlawful.\n\nWhat to do now\n\n1. Confirm a pharmacist at your location holds an active California license and has been designated to the Board for California operations.\n\n2. If not, start the California licensure application now and document the date.\n\n3. Assemble the inspection record set the Board's policy statement lists.\n\nSources\n\n- Board of Pharmacy Policy Statement: Nonresident Pharmacies (primary): https://www.pharmacy.ca.gov/about/nonresident_phy_policy.pdf\n\n- New Requirements for Nonresident Pharmacies (primary): https://www.pharmacy.ca.gov/applicants/new_requirements_nrp.shtml\n\n- AB 1503 (Berman), Chapter 196, Statutes of 2025, chaptered text (primary): https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202520260AB1503\n\nInformational summary, not legal advice. Verify against the primary source.","summary":"Since July 1, 2026 a pharmacy outside California may not ship prescriptions to California patients unless its pharmacist in charge for California operations holds a California license. The Board can now inspect nonresident pharmacies at their expense.","date_published":"2026-09-21T00:00:00Z","date_modified":"2026-09-21T00:00:00Z","tags":["state","CA","california","nonresident pharmacy","pharmacist in charge","ab 1503","inspection","licensure"],"_scriptsafe":{"status":"published","lane":"State laws and boards","issuer":"State board of pharmacy","instrument":"Statute","procedural_status":"In effect","jurisdictions":["CA"],"source_published_on":"2026-04-30","last_reviewed_on":"2026-09-21"}}]}