Month: December 2013
What is required on an oxygen drug product label? Oxygen drug product labels are governed by 3 different agencies. The FDA because its a drug product, and the DOT and OSHA because it is considered a Hazardous Material. Each agency is a different government entity that has its own requirements. For example, the oxygen diamond and the proper shipping name (Oxygen, Compressed) appearing on the label is for the benefit of the DOT: They want to make sure that the hazardous material is properly identified during transport in the event of an accident so that first responders can react accordingly. The FDA wants the label to indicate what the drug product is (Oxygen) so patients and caregivers know what they are administering to people. So while the DOT would mandate Oxygen, Compressed, the FDA does not care that it is the proper shipping name- just that it properly conveys the identity of the drug product. To learn more about the requirements, check out the video below. Why do I need
Are you confused about FDA registration? Dont be! Applied takes the worry out of annual registration for you! The FDA says that any firm that transfers oxygen from one container to another, via gas to gas, liquid to gas, or liquid to liquid; is considered a drug manufacturer by the FDA and is required to register with the FDA every year between October 1st and December 31st of the year. (See 21 CFR 207.21(a)). When you are getting ready to register or renew with the FDA, remember these tips. Your transfilling site address must match the address on file with Dun and Bradstreet, so be sure to check your DUNS number. If you are filling different cylinder sizes since the last time you registered, your drug listing should be updated. If you are no longer filling at a specific location, it is recommended that you remove the location from the FDA database as well. Starting June 1, 2009 the FDA stopped receiving paper submissions for registration. Registration must now be done electronically.
Who? What? Where? When? The FDA requires that training be completed on a frequent and continuing basis. This has been interpreted to mean twice a year. This training must be completed by anyone who can affect the purity of the oxygen. Personnels training in Current Good Manufacturing Processes is required by law (21 CFR 211.25). Some examples of those that must complete FDA training include fillers, drivers, quality control unit, and warehouse personnel. The DOT requires that training be done at least every three years, and within 90 days of the start of employment for new employees. Drivers, loaders, and people in charge of storage of oxygen cylinders for ANY amount of oxygen delivered (1 cylinder to over 1,001lbs), must successfully complete DOT training. This training touches on three areas which include Job Specific Training, HazMat Security Awareness Training and HazMat Safety Training. Training needs to be completed in each area in order for an employee to be considered DOT compliant. Applied