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
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.
Jim Byington has been involved with cryogenic medical oxygen and compressed medical gases for more than 35 years. He is the former owner of Mountain Aire Medical Equipment Corp. and has held positions with CAIRE and Lincare. He now operates Compass Point Consultants and can be reached at email@example.com or (850) 501-4876.