The revisions on the 2012 draft guidance on the certification process for medical gases includes new discussions on the labeling for final use containers and what documentation is necessary for marketers of a medical gas that are not the original manufacturer or marketer.
The revisions are in response to comments made on the initial guidance on certifying medical gases, though FDA says it doesn’t believe the changes will have too much of an impact on industry.
The revised draft guidance states that in the absence of a regulation, FDA recommends that the labeling for final use containers containing nitrogen, medical air, carbon monoxide, or any medically appropriate combination of designated medical gases bear the warning statement set forth in § 201.161(a):
‘‘Warning—Administration of (name of gas) may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of (name of gas) and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken.”
FDA also recommends that the labeling for oxygen final use containers “should convey that uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful, and that oxygen should not be used on patients who have stopped breathing unless used in conjunction with resuscitative equipment.”
But the agency doesn’t expect this change to have much of an impact on industry as the labeling currently used is already consistent with the recommendations in the revised draft guidance. As a result, FDA estimates that it will take each person or entity approximately 0.1 hours to review the information to ensure that their labeling is consistent with the revised draft guidance.
In addition, a person or entity that markets a medical gas but isn’t the original manufacturer nor the original marketer should verify and document that the gas they receive is from a certified source, FDA says.
FDA calls on these marketers to include the name of the original manufacturer(s) or marketer(s) as well the applicable new drug application number or numbers associated with the gas, and the information should be verified by reference to the FDA database "Drugs@FDA.gov."
Each customer should also obtain documentation from their immediate supplier, and proper certification by a supplier should be verified initially for existing suppliers and for new suppliers as part of a vendor qualification process, though once qualified, companies can just provide an annual letter from the immediate supplier attesting or certifying that the gas was originally manufactured at one or more firms with granted certifications.
Based on FDA’s knowledge of the medical gas marketplace, the agency estimates that about 4,000 persons or entities that market a medical gas (but are neither the original manufacturer nor the original marketer) will document and record that the gas they receive is from a certified source. FDA also estimates that each recordkeeper will maintain approximately three records per year.
The December 2012 draft guidance also contained a detailed implementation timeline, which has been removed in this revised version because the dates listed in the implementation timeline have all passed.
In addition to the revisions, the draft guidance provides information for entities looking to certify their products. FDA notes that in the revised guidance, which it’s re-opening for comments, it has not made any changes to the draft certification request form (Form FDA 3864) and form instructions.
The form requests that sponsors include a description of the gas, identifying information about the sponsor and manufacturing facility, and any other "information deemed appropriate," FDA explained.
Within 60 days of filing an application, a medical gas will be granted certification barring the presence any one of three conditions: if the gas for which approval is sought is not a designated medical gas, if the sponsor's request lacks the information necessary to make a decision, and/or if the product would pose a risk to public health. Any sponsor of a denied application will be given one month of leeway in which to refile a certification request before FDA takes enforcement action against the company if it continues to market a medical gas.
Revised FDA Draft Guidance