The Philippines’ Food and Drug Administration (FDA) has introduced significant updates to its licensing requirements through Administrative Order (AO) No. 2024-0015. These changes strengthen regulatory oversight and ensure public safety by mandating a License to Operate (LTO) for a broader range of establishments. Read more to discover the key aspects of AO No. 2024-0015, who it affects, and how medical businesses can comply with the new rules.
What is an FDA LTO?
A License to Operate (LTO) is a mandatory authorization issued by the FDA to establishments involved in manufacturing, importing, exporting, selling, or distributing health-related products, such as drugs, medical devices, cosmetics, and food. The LTO ensures that businesses meet safety, quality, and regulatory standards to protect consumers.
Overview of AO No. 2024-0015
- Expanded Scope: AO No. 2024-0015 broadens the range of establishments required to secure an LTO, covering both traditional and emerging health product sectors.
- Effective Date: Implemented on November 27, 2024, updating previous FDA guidelines to align with modern commerce trends. Several FDA Advisories have since been released in 2025, showing that AO No. 2024-0015 is now being enforced.
- Digital Health Focus: Includes online platforms and telepharmacies to address the rise of e-commerce in health products.
- Streamlined Processes: Introduces simplified application procedures to facilitate compliance, requiring all applications to be on their online ePortal.
- Stricter Penalties: Enforce heavier fines and potential closures for non-compliance to ensure accountability.
Establishments Required to Obtain an FDA LTO
The types of businesses required to have an FDA LTO include:
Traditional Businesses
- Manufacturers: Businesses producing pharmaceuticals, medical devices, cosmetics, or food products.
- Distributors and Importers: Entities handling the supply chain of health-related products.
- Retailers: Pharmacies, drugstores, and other outlets selling health products to consumers.
- Clinical Laboratories: Facilities conducting diagnostic or testing services.
- Exporters: Companies involved in the export of FDA-regulated products.
New/Clarified Under AO No. 2024-0015
- Dental Laboratories: Facilities that create crowns, dentures, and other dental appliances are now considered medical device manufacturers.
- Optical Laboratories: Labs involved in grinding, coating, or tinting prescription lenses now require an LTO.
- 3D Printing Facilities: Businesses using 3D printing to produce medical or health-related products are classified as manufacturers.
- Diagnostic Kit Assemblers/Repackagers: Companies that assemble, repackage, or label diagnostic test kits must now register as manufacturers or repackers.
- Cold Chain and Logistics Providers: Third-party logistics firms handling regulated products like vaccines or devices now need an LTO.
- E-Commerce Fulfillment Centers: Warehouses that store, pack, or ship FDA-regulated products sold online are now considered part of the distribution chain.
- Medical Device Refurbishers: Establishments that restore used or expired medical equipment for resale are now regulated as manufacturers.
- Component Manufacturers: Producers of parts or accessories for medical devices are newly recognized as FDA-regulated manufacturers.
- Cosmetic Compounders / Refill Stations: Shops that mix, refill, or dispense cosmetic or hazardous household products must now comply with LTO rules.
Clarified Definitions of Manufacturing and Distribution
AO No. 2024-0015 also clarifies which business activities qualify as manufacturing or distribution for purposes of requiring an FDA LTO.
- Manufacturing
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- Defined as the process of producing, preparing, compounding, or processing health products, including drugs, medical devices, cosmetics, and food.
- Includes supporting activities such as packaging, labeling, quality testing, and final product release.
- Now explicitly covers small-scale operations like compounding pharmacies, custom medical device producers, and 3D printing labs.
- Ensures all forms of product preparation, whether industrial or artisanal, fall under FDA oversight.
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- Distribution
- Refers to storing, transporting, and supplying health products to retailers, pharmacies, or consumers.
- Includes both physical and digital supply chain actors, such as e-commerce platforms, telepharmacies, and logistics providers.
- Emphasizes compliance with Good Distribution Practices (GDP) to maintain product integrity during handling.
- Expands regulatory reach to modern distribution models and ensures consistent standards across channels.
Steps to Secure an FDA LTO for Medical Businesses
Medical businesses seeking an FDA LTO under AO No. 2024-0015 must follow a structured process. Here’s a step-by-step overview:
- Determine Eligibility: Confirm that your business falls under the categories outlined in AO No. 2024-0015, such as pharmacies or medical device distributors.
- Prepare Documentation: Gather required documents, including business registration, product lists, Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP) compliance, and qualifications of key personnel (e.g., licensed pharmacists). Be sure your requirements are complete, accurate, and compliant to avoid delays and license denial.
- Submit Application: File your LTO application via the FDA’s online portal, ensuring all forms are complete.
- Pay Fees: The applicable LTO fees, which vary by business type and scale, must be settled per the FDA’s fee schedule.
- Undergo Inspection: Prepare for potential FDA on-site inspections to verify compliance with safety and operational standards.
- Receive LTO: Upon approval, receive the LTO, typically valid for 2 years, and plan for timely renewal.
Final Thoughts
AO No. 2024-0015 introduces key updates to the FDA’s regulatory framework, expanding coverage to online platforms and emerging health sectors. By clarifying and expanding the definitions of manufacturing and distribution, it aims to enhance the safety of all processes involving health products. Stay informed, and don’t hesitate to contact us if you have any questions or need assistance with your application.
Are You Applying for or Renewing Your FDA License to Operate?
Securing all the legal requirements your business needs can be a complex and challenging process. With numerous permits and licenses required by different government agencies, like the License to Operate, it’s easy to miss a document or forget to renew it. Unfortunately, this can lead to costly fines or even force your operations to shut down.
Thankfully, the Business Registration Philippines team provides comprehensive support for your business registration, so you don’t have to stress over the paperwork. We’ll handle the applications and renewals so you can focus on what matters most—running your business and achieving financial success.
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