Don't fall victim to temptation

Thursday, August 26, 2010

A. FDA electronic registration reminds me of a quote by the cartoonist Doug Larson: “Home computers are being called upon to perform many new functions, including the consumption of homework formerly eaten by the dog.”

Previously, all drug manufacturers (like oxygen transfillers and distributors whose name is on the label) registered with the FDA by  mail. Last summer, the FDA began requiring electronic registration. It is something that can, with hard work, be done in-house. However, many firms elect to have their registration done by a reputable electronic registration service to keep costs—and headaches—to a minimum.

Oxygen transfillers must register annually with the FDA on or before Dec. 31 of the year. I recommend registering by your anniversary date because many other agencies require proof of registration and this method makes sense to other organizations.

To register electronically, you need to have a special account with the FDA and a computer that can handle the required registration software. Requesting the account and securing your computer can take two weeks, and the software settings are so temperamental that, in my organization, we keep two dedicated computers for FDA registrations. Additionally, the FDA requires a Dun & Bradstreet Number for each location to uniquely identify your firm and keep the FDA up to date on your corporate contact information.

I know it’s easy to opt for claiming that the dog ate your FDA registration. But I also know that if you fall victim to temptation, you’ll be in the doghouse. The FDA can write you a warning letter, report non-compliance to interfere with reimbursement, stop your business or, in extreme cases, send you to jail.