FDA & Medical Gases Archive

  • Preventing Medical Gas Mix-ups

    Save lives with four simple steps Since 2000, there have been no fatal incidents involving medical gas mix-ups resulting from incorrectly connected cryogenic medical gas containers. However, in the previous 17 years, 12 people died and many more were injured as a result of medical gas mix-ups. This result is due, in large part, to the highly [...]

    Read More.

  • The Two Critical Questions For Your Food Compliance

    Is my business a ‘Qualified Facility’? The new Food and Drug Administration (FDA) food regulations are now in place (21 CFR Part 117). Though many of the new requirements are similar to the old regulations, the emphasis is now on having a Food Safety Management System rather than a checklist of activities to assure compliance. “Food [...]

    Read More.

  • Appropriate Medical Gas Regulations

    The latest developments It has been over 26 years since the FDA issued official guidance for medical gases. Since then, a lot has changed about medical gas compliance. The agency has issued three unofficial series of medical gas documents since the 1989 guidance (Fresh Air, Gas What and the 2003 Draft Guidance). Even these newer documents [...]

    Read More.

  • The Top 12 Questions You Can Expect During An FDA Inspection

    FDA issues new guidance to inspectors. On March 15, 2015, the FDA implemented a new medical gas inspection guidance document for inspectors called Compliance Program Guidance Manual, Compressed Medical Gases. In addition, the FDA trained state Boards of Pharmacy on how to use this new manual to inspect a medical gas facility. While the FDA’s interpretation [...]

    Read More.

  • Response to Medical Gas Legislative Action

    We learned of a new Michigan law which went into effect September 30, 2014 that established additional safeguards relative to the practice of drug compounding. The law was in response to several instances where tainted drugs from compounding pharmacies were found and, in one case, led to a nationwide outbreak of meningitis. Although the law [...]

    Read More.

  • When Can I Sell Medical Oxygen?

    On its face, this seems like a simple question. However, there are some interesting exceptions and conditions for selling medical oxygen. Below are the answers to seven questions about the sale of medical oxygen. Can I sell medical oxygen to a patient with a prescription? Yes, if a patient presents you with a valid prescription, and if [...]

    Read More.

  • The Latest Medical Gas USP Monographs

    Since 2009, the Unites States Pharmacopeia (USP) has proposed revisions to the medical gas monographs. GAWDA and the Compressed Gas Association’s Medical Gas Committees have supported the efforts to modernize the antiquated and hazardous wet-chemical test procedures. After a proposed new test procedure is developed and validated, the formal USP monograph revision process involves multiple comments [...]

    Read More.

  • The Business Owner’s FDA Checklist

    Eight quick action items to prepare for an investigation Most FDA inspections are fairly routine, and while we are occasionally surprised by the agency’s actions, most FDA investigators follow a predictable script. Knowing this, you can be prepared for the inspection. Your next FDA inspection will be more successful when you are prepared. Of course, we recommend [...]

    Read More.

  • Handling Extreme FDA Inspections

    The FDA regularly inspects GAWDA members for compliance with food, drug and device regulations. Most of these inspections are routine and reasonable. However, there are a few inspections each year that become very difficult…even adversarial. In the past year, these difficult inspections have occurred at GAWDA members with exemplary compliance programs. For example: In one case, the [...]

    Read More.

  • Food And Drug Gas Production

    GAWDA CONSULTANT CORNER FDA & MEDICAL GASES There have been some recent FDA inspections with violations of cleanliness standards. This article highlights things you can reasonably implement to avoid compliance problems with cleanliness. Cylinder/Container Cleanliness (21 CFR 211.94) Current Good Manufacturing Practices specify that the container (cylinder) must be cleaned before use. The intent of this [...]

    Read More.