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FDA- NEW FOOD AND DRUG ADMINISTRATION
LABELING REQUIREMENTS FOR OXYGEN CYLINDERS
Effective December, 1 1997, the Food and Drug Administration is implementing new labeling requirements for medical oxygen cylinders. On that date,
the following wording must appear as a printed part of the label – stickers applied with the same wording is not acceptable. The wording is as follows and must be placed under the "WARNING" section of the label.
- WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency or resuscitation. For all other applications:
CAUTION: Federal Law prohibits dispensing without prescription.
The above was formalized at a recent meeting of the Compressed Gas Association which was attended by Mr. Duane Sylvia who is a compliance safety
officer from FDA Headquarters in Rockville, MD We are advised that it is not necessary to immediately collect and re-label all cylinders owned by your company; however, when the contents have been used and the cylinders are
being refilled, the label MUST be changed in order to be in compliance with the new labeling requirement. If the cylinders are found to have been filled after December 1, 1997, and have not been relabeled with the prescription
legend, they will be considered "misbranded" and are subject to seizure by the inspector. Additionally, fines for distributing a misbranded product could be charged.
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