Medical-grade oxygen is classified as a drug based on existing definitions. This is available in the country in cylindrical tanks, prepared by chemical synthesis from raw materials, or from air separation machines.
FDA has received reports of the existence of oxygen-generating machines being set-up by both public and private hospitals for their own production of medical-grade oxygen, either stored initially in cylindrical tanks, or directly fed into tubes to patients. Upon regulatory inspection, review, and validation of available data on unregistered medical oxygen, the following conclusions were made:
There is no quality assurance/quality control in place, thus safety, efficacy and quality may be compromised
The set-up of the said oxygen-generating machines are on a manufacturing production scale level
Therefore, consistent with the mandates provided to FDA by Republic Act 9711 also known as “Food and Drug Administration (FDA) Act of 2009", and Republic Act 3720 also known as the "Food, Drug and Cosmetic Act" as amended, the FDA hereby reiterates that establishments, including hospitals, involved in the manufacture, sale, offer for sale, and distribution of all drug products, including medical-grade oxygen are required to be licensed with FDA. Furthermore, all drug products are required to be registered before they can be manufactured, distributed, or sold.