and applicable
state agencies regulate gases (including oxygen for emergency or therapeutic use) and equipment
used in medical and food applications. Gas Regs, Inc. can assist your firm by interpreting and
offering guidance for complying with these sometimes confusing laws and regulations, specifically
as they apply to gases and gas related equipment. These include:
- The Federal Food, Drug and Cosmetic Act and similar state laws,
- Federal and state registration and product listing regulations
- Federal and state regulations applicable to manufacturing, warehousing, and distributing gases classified as:
- Drugs (e.g. Oxygen USP, Nitrous Oxide, USP, etc.)
- Medical devices (e.g., Lung Diffusion, Blood Gas mixes, etc.)
- Food additives and gases used in food processing and packaging
- FDA and DOT regulations applicable to the cylinders and containers used to hold these drugs, devices, and food additives, and the labels used to identify them
- Device regulations applicable to medical gas equipment and some medical gas containers
- FDA's new Electronic Records and Signature rule (21CFR Part 11)
Gas Regs, Inc. can assist your firm with handling, investigating, and reporting customer complaints, when required. Although recalls are voluntary actions taken by a firm they should always be viewed seriously. Gas Regs, Inc. can assist you with any recall initiated as a result of a complaint, initiated by your supplier, or recommended to your firm by the FDA.
The Federal Food, Drug and Cosmetic Act, authorizes the FDA to conduct facility inspections, including inspection of vehicles used to transport gases. State laws provide state Departments of Health or Boards of Pharmacy with similar inspectional authority. Gas Regs, Inc. can assist your firm with:
- Developing a procedure and protocol for properly managing facility inspections (also see training tab)
- Developing written responses to federal and state inspections including 483's and Warning Letters
- Developing a compliance improvement plan and, if necessary, presenting the plan to appropriate government officials
If enforcement action, such as seizure or injunction, has already taken place or is imminent, Gas Regs, Inc. has worked with several Washington DC based law firms specializing in Food and Drug Law, and can assist you in obtaining proper counsel if needed. Gas Regs, Inc. can assist your lawyers with Consent Decree review and provide assessment and certification services if required by a decree.
Gas Regs, Inc., can also offer expert testimony as to current regulatory practice within the medical and food gases industry.
