Respiratory Solutions

Jumping FDA Hoops

• By Jim Byington
• Sep 01, 2010

As wholesale oxygen prices continue to rise, suppliers of home oxygen are evaluating whether to transfill their own gases. If you are considering this and have done the math, you have most likely determined that your options are either to cascade cylinders or to acquire a liquid-to-gas transfilling station. Either way, you will need to become familiar with the Federal Food, Drug and Cosmetic Act as it applies to your oxygen business since you will now be a manufacturer of a prescribed drug.

Section 510 of the act requires all drug manufacturers, including fillers of medical gases, to register annually; to list the drug products being filled and the sizes of cylinders being filled; and to submit appropriate labeling for drug identification, use restrictions, and volume and filler information. When a filler registers, one of the requirements is providing original labels (using a specific format known as Structured Product Labeling) that you will be applying to the drugs’ storage containers. In this phase of the process, you must be sure to provide labels for all high-pressure cylinders and cryogenic storage vessels, including truck-mounted, micro bulk, bulk tankage and home vessels.

Once you have completed this task, you will need to adhere to the FDA requirement to have a thorough and current Good Manufacturing Practice guideline on site that documents the acceptable and appropriate processes for standards of production, addressing items such as the strength and quality of the drug as cited by the United States Pharmacopeia/National Formulary (USP/NF).

Before June 1, 2009, registration and renewal was a paper process. If you were an HME supplier interested in registering with the FDA, you obtained information, booklets and forms by contacting the Product Information Management Branch at (301) 594-1086. And for renewals, the FDA actually sent forms to registered companies that simply required verification of their operation status.

But as of June 1, 2009, changes in our government’s policies involving drug establishments have made the process vastly more difficult. All drug establishment registrations, product listings (including labeling) and renewals must be submitted to the FDA in a new electronic format that requires sophisticated computer technology and knowledge. It requires a new computer language, Data Universal Numbering System (DUNS) numbers, globally unique identifier (GUID) numbers, HTML forms, SSL Certificates and secure electronic gateways.

There is a lot of preparation before a business can even begin to communicate with the FDA for the purpose of filing the required registration. If your company is in this situation, someone within your organization will need to dedicate up to 10 hours over a three-week period just to set up the online portal, plus spend time to review the forms used to generate Structured Product Labeling files. In order to read the downloaded SPL forms on your Web browser, your computer will need to be modified with an add-on utility package to read xHTML format. In addition, you may have to dedicate a computer exclusively for FDA registration and renewal purposes. I suggest that the staff member in charge of this process start oxygen therapy to control the hypoxic condition that may result from the frustration that the FDA has created for businesses that want to package medical oxygen.

If you operate a small home oxygen company, the likelihood that you have a staffer with the technical skills to take on such a challenge is slim. As a result, many companies have cropped up to guide small businesses through the process of FDA registration or renewal.

What’s the bottom line if an HME supplier chooses not to comply? Here is just a sample of the problems companies can experience if they are not registered properly.

• The FDA will consider all your products adulterated and force a recall. Your patients or wholesale customers will be forced to obtain oxygen from another source on very short notice.
• Noncompliance can affect your accreditation and possibly impact your ability to bill government payers.
• Federal marshals can padlock all oxygen-related equipment and force you into federal court.
• Noncompliance will create a serious liability if there is an incident that sparks a patient complaint. Any capable lawyer will destroy your professional credibility if someone is injured or dies when your oxygen’s medical standard is subject to investigation.

In closing, complying with the act can be managed internally or with the support of an outside consultant, but what’s important is that it is managed well, given the penalties described above.

This article originally appeared in the Respiratory & Sleep Management September 2010 issue of HME Business.