Constitutional and statutory policy basis
- Section 15, Article II of the 1987 Philippine Constitution requires the State to protect and promote the right to health of the people and instill health consciousness.
- Section 11, Article XIII of the 1987 Philippine Constitution mandates an integrated and comprehensive approach to health development to make essential goods, health and other social services available to all people at affordable cost.
- Republic Act No. 9711 (the Food and Drug Administration (FDA) Act of 2009) empowers FDA to develop and issue policies, standards, regulations, and guidelines covering establishments, facilities, and health products, including drug products.
- Republic Act No. 9502 (the Universally Accessible Cheaper and Quality Medicines Act of 2008) treats “drugs and medicines” as any article recognized in the current official United States Pharmacopeia–National Formulary (USP-NF) and other specified national compendia, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals.
- The circular recognizes that oxygen, nitrous oxide, carbon dioxide, and other medical gases recognized in different pharmacopeias have diverse indications for use and are therefore classified as drugs under FDA regulatory jurisdiction.
Covered establishments and medical gases
- These rules apply to all government and private hospitals and other health facilities engaged in the manufacture of medical gases.
- “Medical gases” refers to any gas or mixture of gases intended for administration to patients for anesthetic, therapeutic, diagnostic or prophylactic purposes.
- Medical gases may be manufactured in a liquefied, non-liquefied, or cryogenic state and may be administered as a gas.
- Medical gases may be stored in cylinders, pressurized storage tanks, or low pressure collecting tanks.
- For licensing purposes, hospitals and other health facilities manufacturing medical gases must treat the activity as drug manufacturing under the circular’s framework.
Licensing requirement and who is “manufacturer”
- All government and private hospitals and other health facilities engaged in the manufacture of medical gases must secure a License to Operate (LTO) as a drug manufacturer.
- “Manufacturer” covers any establishment engaged in any or all operations involved in the production of drug products, including:
- preparatory processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing, and labeling with the end in view of storage, sale or distribution.
- The manufacturer term does not apply to compounding and filling of prescriptions in drugstores and hospital pharmacies.
- The LTO requirement applies regardless of:
- method of medical gas manufacturing (e.g., concentrator, chemical synthesis, purifier),
- scale of manufacturing (e.g., small, medium, large),
- mode of gas delivery (e.g., from cylinders, from a medical gas pipeline system),
- end users (e.g., inpatients, other consumers),
- type of ownership (e.g., DOH-retained, LGU-owned, privately-owned).
Application documents and filing requirements
- A complete application must use a completely filled-out and notarized application form signed by the pharmacist and owner/authorized representative.
- An applicant must submit proof of business name registration:
- Single proprietorship: DTI Certificate of Business Registration.
- Corporation, partnership, and other juridical person: SEC Certificate of Registration and Articles of Incorporation.
- Cooperative: Cooperative Development Authority Certificate of Registration plus approved by-laws.
- Government-owned or controlled corporation: the law highlighting the provision creating the establishment.
- Proof of business name registration must specify the exact and complete address (including, where applicable, unit number, floor, building, lot, block, phase, street, barangay, city/municipality, province).
- The application must include credentials of the Pharmacist-in-Charge, consisting of:
- valid PRC ID,
- Certificate of Attendance to an appropriate FDA Licensing Seminar,
- resignation letter of the pharmacist from a previous employer (if previously employed).
- The application must also list other qualified personnel, including:
- the hospital engineer or equally qualified person overseeing operations of the manufacturing facility, and
- personnel responsible for maintenance.
- Credentials of other qualified personnel must be verified during inspection, not submitted during application.
- The applicant must submit a Risk Management Plan (RMP) describing how to identify, characterize, prevent or minimize risks related to medical gases, including pharmacovigilance activities and interventions to manage risks.
- The applicant must submit a Location Plan consisting of a sketch showing clear directions with identified landmarks for inspection purposes, plus GPS coordinates in decimal degrees (DD) [Latitude and Longitude].
- The applicant must submit a Site Master File (SMF) in accordance with the latest edition of PIC/S-GMP under the Pharmaceutical Inspection Cooperation Scheme (PIGS).
- The applicant must submit proof of payment (e.g., official receipt or authorized bank payment slip) as proof of filing.
- The applicant must submit a Self-Assessment Toolkit (SATK), which guides submission and serves as the worksheet during FDA evaluation.
- The list of documentary requirements for initial and renewal applications of LTO, reissuance of lost or destroyed LTO, and voluntary cancellation of LTO is attached as Annex A.
- The circular provides that the list of documentary requirements for variations is attached as Annex B.
FDA evaluation, inspections, and basis of decisions
- FDA Regional Field Offices must initially review applications through desktop evaluation to determine compliance with administrative and technical requirements.
- During evaluation, FDA may require additional or supplemental documents as proof of compliance.
- After evaluation, the establishment undergoes a pre-opening inspection to determine compliance with PlC/S-GMP guidelines.
- Pre-opening inspection verification must include, in addition to submitted documents, the establishment’s:
- Quality Management System incorporating the medical gas manufacturing facility,
- Quality Manual and Standard Operating Procedures of the medical gas manufacturing facility,
- Contract Agreement between the supplier/installer of the medical gas manufacturing machine and the establishment,
- Qualification and Validation Documents,
- Master and/or Batch Production Records,
- Specifications,
- Credentials of other qualified personnel,
- relevant reference materials (e.g., Republic Acts, PIC/S-GMP Guide, standard practice guidelines),
- other procedures, protocols, records, and reports required by PlC/S-GMP.
- FDA must issue an inspection report to the drug establishment, and the report serves as the basis for FDA’s further decision/action (including approval/disapproval of LTO).
- After LTO approval, establishments must be subjected to routine inspections for compliance with GMP and other applicable practices.
- Major variation applications may require a post-licensing inspection prior to approval of the variation.
- Establishments may also be inspected when subject to regulatory action based on triggers such as:
- violations of provisions of FDA laws, rules and regulations, and other related laws,
- occurrence of adverse drug reactions,
- other quality, safety, and/or efficacy issues.
Variations to an approved LTO and business continuity
- The circular identifies the following variations to an approved LTO:
- Major Variation:
- Change of Ownership
- Transfer of Location
- Minor Variation – Prior Approval:
- Expansion of Establishment
- Change of Business Name
- Zonal Change in Address
- Minor Variation – Notification:
- Change of Pharmacist-in-Charge or Other Qualified Personnel
- Major Variation:
- FDA must be duly informed of any changes to the approved LTO, whether or not they are classified as variations listed above.
- Documentary requirements for variations are in Annex B.
- All variations are subject to the existing variation/amendment fee.
- Transfer of location is subject to an initial payment for two (2) years validity of LTO.
- Hospitals and other health facilities applying for minor variations may continue business operations provided that an application for such variation has already been filed.
Accessibility, responsibilities of other offices, and LGU role
- FDA electronic fillable forms must be made accessible at the FDA Website.
- FDA and its Regional Field Offices may call on assistance of any department office and/or government agency for effective implementation, consistent with FDA’s regulatory powers under (3), c, Section 2, Article III, Book I of the implementing rules and regulations of Republic Act No. 9711.
- Local Government Units (LGUs) must monitor licensed hospitals and other health facilities within their localities for compliance with existing laws and their respective rules and regulations.
- When LGUs find violations inconsistent with FDA rules and regulations, LGUs must report the violation to FDA for regulatory action.
Transitional rules and inspection phasing
- Hospitals and other health facilities must file their LTO application until 30 June 2015 following the existing documentary requirements.
- Hospitals and other health facilities that continue to engage in the covered activities without filing an application by 30 June 2015 are a ground for filing administrative charges pursuant to existing FDA rules and regulations and the Health Facilities and Services Regulatory Bureau.
- Hospitals and other health facilities with existing medical gas manufacturing facilities that filed the LTO application before 30 June 2015 may continue operations until issuance of LTO.
- FDA must employ an intensive inspection transition phasing using a risk-based approach.
- The inspection transition phasing table classifies hospitals and other health facilities as follows:
- General Hospital: Level 3, Level 2, Level