Regulatory feed
Published med-spa & injectable compliance alerts · monitoring, not legal advice
Free weekly Brief
Get the changes that matter in plain English, every week — and be alerted when the rules move. No charge.
Members get the full “what to do” on every alert — in real time, for your states. Become a member →
Border enforcement · last 90 days
FDA Import Refusals · counts of published records
FDA refused 108 shipments of unapproved or violative injectables at the U.S. border from 73 firms across 23 countries — the gray-market corridor to source away from.
| Product class | Shipments | Firms | Countries |
|---|---|---|---|
| Dermal fillersincl. Across Co., Ltd, LABORTORIES FILLMED, Dongkook Pharmaceutical Co., Ltd. | 54 | 37 | 12 |
| Botulinum toxinincl. Allergan Pharmaceuticals Ireland, Medytox Inc., Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) | 29 | 16 | 8 |
| GLP-1 drugsincl. NGUYEN VIET ANH - CCCD#035094002294, Eli Lilly Japan K.K.Seishin Laboratories, CHONGUHAN MEDICAL TECHNOLOGIES | 14 | 13 | 9 |
| Injectable anestheticsincl. SELECTPHAMA, Vivozon Pharmaceutical, LABORATORIO PIERSAN S.A. | 11 | 11 | 6 |
Source: FDA Data Dashboard import refusals. A refusal is a border action, not a finding against any U.S. practice. Named firms are the foreign shippers/manufacturers on FDA’s record.
Showing material changes. 217 routine background items are collapsed.
Show everything →- MONITORFEDGLP-1 CompoundingJul 30, 2026
FDA / Federal Register Notice: Outsourcing Facility Fee Rates for Fiscal Year 2027
New FDA fees for outsourcing facilities will impact med spas using compounds.
What to do — members only.Become a member →Federal Registerprimary source ↗ - CRITICALFEDGLP-1 CompoundingFDA: OAIJul 8, 2026
FDA Warning Letter: Spa De Soleil, Inc. (Drugs)
FDA warns Spa De Soleil over drug compounding practices.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - MONITORFEDGLP-1 CompoundingJun 26, 2026
FDA / Federal Register Notice: List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period
FDA extends comment period on GLP-1 compounding decisions.
What to do — members only.Become a member →Federal Registerprimary source ↗ - CAUTIONFEDGLP-1 CompoundingJun 23, 2026
FDA Warning Letter: ketaminelab.org (Drugs)
FDA Warning Letter issued to ketaminelab.org for drugs.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONFEDMarketing & AdvertisingJun 12, 2026
FTC Files Contempt Motion Against Amare Global and Three Individuals Over Unsubstantiated Health Claims
FTC targets deceptive health claims affecting aesthetic practices.
What to do — members only.Become a member →FTC Enforcementprimary source ↗ - CAUTIONFEDGLP-1 CompoundingJun 11, 2026
FDA shortage: Liraglutide Injection (Injection) — Currently in Shortage
Liraglutide remains in shortage; compounding is still permitted.
What to do — members only.Become a member →FDA Drug Shortagesprimary source ↗ - CRITICALFEDGLP-1 CompoundingMay 27, 2026
FDA recall (Class II): Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, Fl 34108, …
FDA recalls contaminated Liraglutide Injection; check your inventory!
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFEDGLP-1 CompoundingMay 1, 2026
FDA / Federal Register Notice: List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
FDA evaluates bulk drug substances; GLP-1 agents may be impacted.
What to do — members only.Become a member →Federal Registerprimary source ↗ - MONITORCOMulti-topicApr 23, 2026
CO SB130: Medical Spas Deceptive Trade Practices
Colorado SB130 — pending bill on med-spa trade practices. Tracking.
What to do — members only.Become a member →LegiScanprimary source ↗ - MONITORFEDGLP-1 CompoundingApr 22, 2026
FDA recall (Class II): Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Bea…
FDA recalls semaglutide compound over sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONFLScope of PracticeMar 13, 2026
FL H1429: Licensure of Medical Spas
New regulations for med spas on licensure and compliance.
What to do — members only.Become a member →LegiScanprimary source ↗ - CRITICALFEDGLP-1 CompoundingMar 11, 2026
FDA recall (Class II): Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, Ks 66061,…
FDA recalls Semaglutide for sterility issues—act now!
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONFEDGLP-1 CompoundingMar 11, 2026
FDA recall (Class II): Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, Ks 66061, …
FDA recalls Tirzepatide Inj over sterility concerns; check your stock!
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONFEDGLP-1 CompoundingMar 11, 2026
FDA recall (Class II): Semaglutide, For Rx compounding use only, packaged in a) 1g, Ndc 84385-106-01; b) 5g, Ndc 84385-106-02; c) 10g, Ndc 843…
FDA recalls specific compounded GLP-1 products due to quality issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONINNATIONALMulti-topicMar 5, 2026
IN SB0282: Compounding drugs; registration of medical spas.
New regulations for medical spas in Indiana take effect in 2027.
What to do — members only.Become a member →LegiScanprimary source ↗ - MONITORAZScope of PracticeFeb 10, 2026
AZ HB4047: Medical spas; licensure; regulation
New licensure requirements for med spas in Arizona.
What to do — members only.Become a member →LegiScanprimary source ↗ - MONITORMSGLP-1 CompoundingFeb 3, 2026
MS SB2544: Mississippi Active Pharmaceutical Ingredient Quality Assurance Act; enact to impose certain provisions for compounding.
New regulations could impact drug compounding for med spas.
What to do — members only.Become a member →LegiScanprimary source ↗ - MONITORFEDAesthetic DevicesJan 28, 2026
FDA device recall (Class II): Brand Name: Leaseir Product Name: Leaseir Mhr Xcell Model/Catalog Number: Mhr 110-b Software Version: 1.5.0.0 Product D…
Leaseir MHR Xcell laser recalled for safety issues.
What to do — members only.Become a member →FDA Device Recallprimary source ↗ - MONITORMAMulti-topicJan 27, 2026
MA H5087: Regulating the operation of medical spas
New regulations for med spas could redefine injector practices.
What to do — members only.Become a member →LegiScanprimary source ↗ - MONITORIAScope of PracticeJan 20, 2026
IA HSB591: A bill for an act establishing the medical spa oversight Act, and making penalties applicable.
New regulation may change operations for Iowa med spas.
What to do — members only.Become a member →LegiScanprimary source ↗ - CRITICALFEDGLP-1 CompoundingJan 7, 2026
FDA recall (Class II): Wegovy (Semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880…
FDA recalls Wegovy; med spas must check supplies!
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORPAScope of PracticeDec 16, 2025
PA HB1881: Further providing for pharmacy technician and pharmacy technician trainee registration, qualifications and supervision; providing for administration of injectable medications, biologicals and immunizations, for clinical laboratory certificate and for report on pharmacy-administered vaccines; and making a repeal.
PA bill may expand pharmacy technicians' role in injectables.
What to do — members only.Become a member →LegiScanprimary source ↗ - MONITORFEDGLP-1 CompoundingNov 5, 2025
FDA recall (Class II): Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeff…
Urgent FDA recall of Tirzepatide Injection impacts med spas.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONFEDGLP-1 CompoundingNov 5, 2025
FDA recall (Class II): Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef…
Urgent: FDA recalls compounded semaglutide injection.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFEDGLP-1 CompoundingOct 15, 2025
FDA recall (Class II): Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 Nw 2nd Ave Ste 20…
Important FDA recall on GLP-1 compounded product—act now!
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFEDGLP-1 CompoundingOct 15, 2025
FDA recall (Class II): Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 Nw 2nd Ave Ste 204 Boca Raton…
FDA recalls GLP-1 product over sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CRITICALFEDGLP-1 CompoundingSep 10, 2025
FDA recall (Class II): Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
FDA recalls compounded GLP-1 product for being subpotent.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CRITICALFEDGLP-1 CompoundingAug 13, 2025
FDA recall (Class II): Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, …
Important recall for GLP-1 products; take immediate action.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CRITICALFEDGLP-1 CompoundingAug 13, 2025
FDA recall (Class II): Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steri…
FDA recalls compounded GLP-1 product; check your stock now!
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFEDGLP-1 CompoundingJul 30, 2025
FDA / Federal Register Notice: Outsourcing Facility Fee Rates for Fiscal Year 2026
New FDA fees for outsourcing facilities impact compounding.
What to do — members only.Become a member →Federal Registerprimary source ↗ - CRITICALFEDGLP-1 CompoundingJul 2, 2025
FDA recall (Class II): Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewo…
FDA recalls Tirzepatide injections; action needed now.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CRITICALFEDGLP-1 CompoundingJul 2, 2025
FDA recall (Class II): Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, Co 80…
FDA recalls GLP-1 product over sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONRINATIONALScope of PracticeJun 30, 2025
RI H5351: Mandates cosmetic medical procedures be performed by a physician, PA, APRN, or delegated to a qualified non-physician, non-PA or non-APRN under the supervision of a physician, physician assistant, or advanced practice registered nurse.
Major changes in who can perform cosmetic procedures in RI med spas.
What to do — members only.Become a member →LegiScanprimary source ↗ - CRITICALFEDGLP-1 CompoundingMay 7, 2025
FDA recall (Class II): Wegovy (Semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx …
Urgent recall of Wegovy due to temperature abuse risks.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONCOScope of PracticeApr 7, 2025
CO HB1024: Medical-Aesthetic Services Delegation Disclosures
New disclosure requirements for delegating medical-aesthetic services.
What to do — members only.Become a member →LegiScanprimary source ↗ - CAUTIONMSGLP-1 CompoundingFeb 13, 2025
MS HB1430: Prescription drugs; prohibit licensing boards from prohibiting practitioners from prescribing for off-label use.
Potential changes in off-label prescribing regulations in Mississippi.
What to do — members only.Become a member →LegiScanprimary source ↗