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CDER Year 2000 Information

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Good News for Consumers:  Nearly All U. S. Pharmaceutical Companies Ready for Y2K

Both a survey and follow-up audit of U.S. pharmaceutical manufacturers indicate that prescription and Over-the-Counter (OTC) medicines will be available and in good supply through the Year 2000.  By the end of October 1999, 98 percent of prescription drug firms had responded to a U.S. Food and Drug Administration (FDA) Y2K readiness survey indicating that they have, or soon will have, plans in place to ensure that Y2K computer problems will have no impact on drug supplies and availability.

The FDA Y2K readiness survey and audit placed particular emphasis on three priority areas:  1) drug manufacturers that produce the top 200 prescribed drug products; 2) companies that manufacture products used to treat rare diseases; and 3) companies that are the sole producers of a particular drug. Of the 98 percent priority companies that completed the survey, 95 percent indicate they would be ready for Year 2000 by the end of October 1999.

All told, 4,228 pharmaceutical manufacturers (including OTC, bulk drugs, drug distributors and repackers, and gas manufacturers) were surveyed throughout the summer. Most either responded to the survey indicating they have plans in place for Y2K, provided a form letter stating their readiness, indicated they were subsidiaries of another company, or were no longer in the business. The survey of prescription drug manufacturers had a particularly high completion rate of 98 percent. Of the 1,054 prescription drug firms that responded to the survey, more than 73 percent had taken all necessary steps to prepare for Y2K; nearly 94 percent of the companies indicated they would be ready within weeks.

In addition to the survey, the Agency launched an audit program in August 1999. The audit program consisted of site visits to 161 priority companies and 22 non-priority companies. As of October 1999, 88 percent of audits were completed and confirm FDA’s Y2K readiness survey results:  92 percent of pharmaceutical manufacturers are on track with appropriate Y2K actions planned with only minor Y2K issues.

After January 2000, FDA will compile and evaluate any drug shortage reports received to determine if Y2K has had any impact on the drug supply. To help consumers prepare for any medical situation at any time, FDA supports the following:

  • make a list of your prescription and important nonprescription medication(s);

  • get a normal refill of your medication when you have a 5 to 7 day supply remaining (the drug supply system is resilient and can correct any issue that might arise within 5 to 7 days);

  • create a personal health record for the entire family;

  • keep records of insurance claims; and

  • carry current insurance cards at all times.

To obtain additional information about the Federal government's response to Y2K, call 1-888-USA-4Y2K; for drug-specific questions, use FDA's toll-free telephone number, 1-888-INFO-FDA, or visit its website at www.fda.gov/cder/y2k.

Center for Drug Evaluation and Research's Interim Report Assessment of the Pharmaceutical Industry's Readiness for Year 2000 [HTML] or [Acrobat]  (10/19/1999)

Consumer and Provider Information (8/2/1999)

Preparing for the Year 2000 as it Relates to My Pharmaceutical Needs pdf.gif (146 bytes) (Consumer Brochure)  (12/13/1999)

Frequently Asked Questions (8/2/1999)

Information on Industry Readiness (8/2/1999)

Other FDA Information (8/2/1999)

Additional Y2K Resources (8/2/1999)


FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OTCOM/DML
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