NOTE: "OTC" over-the-counter = nonprescription

FDA - FOOD AND DRUG ADMINISTRATION
COMPLIANCE POLICY GUIDES                                                                             GUIDE 7124.10

CHAPTER 24 - Devices

SUBJECT: Oxygen Equipment  Emergency and OTC Use

POLICY:

Oxygen equipment intended for emergency use can be marketed for OTC distribution. Such equipment must deliver a minimum flow rate of 6 liters of oxygen per minute for a minimum of 15 minutes. Labeling for emergency oxygen for OTC use may not contain references to heart attacks, strokes, shock or any other medical condition amenable to diagnosis or treatment only by a licensed practitioner .

Oxygen units delivering a minimum flow rate of less than 6 liters of oxygen per minute for a period less than 15 minutes and labeled for emergency use are considered adulterated and misbranded.

If the units are not intended for emergency use and provide less than 6 liters/minute or are labeled for human use for other than emergency use, such units are regarded as prescript ion devices and must bear the prescription legend.

Date:                          10/01/80                                                                                                                           PAGE 1
ISSUING OFFICE:      EDRO, Division of Field Regulatory Guidance
AUTHORITY:             Associate Commissioner for Regulatory Affairs

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