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A.L. LABORATORIES ANNOUNCES AGREEMENT BETWEEN BARRE-NATIONAL AND THE FOOD AND DRUG ADMINISTRATION

 A.L. LABORATORIES ANNOUNCES AGREEMENT BETWEEN BARRE-NATIONAL
 AND THE FOOD AND DRUG ADMINISTRATION
 FORT LEE, N.J., July 31 /PRNewswire/ -- A. L. Laboratories, Inc. (NYSE: BMD) today announced that after extensive negotiations with the Food and Drug Administration (FDA), and in response to regulatory concerns by FDA, Barre-National, Inc., the company's liquid pharmaceutical; subsidiary and FDA have agreed to enter into a judicially binding agreement, in the form of a consent decree, that is commercially acceptable to Barre. The agreement addresses the appropriate regulatory concerns and expectations of FDA by defining the standards Barre must observe in meeting the statutory CGMP (Current Good Manufacturing Practices) obligations for the operations of Barre's Baltimore facility. Under the agreement Barre is continuing to manufacture and ship its product line in conformity with CGMP and will reconfirm the expiration dates of each of its products using statistical methods and procedures approved by FDA.
 In addition, Barre will have an independent regulatory consultant conduct periodic audits to verify that Barre is operating in conformity with CGMP. The initial audit has already been satisfactorily completed.
 Jeffrey E. Smith, executive vice president and member of the office of the chief executive of A. L. Laboratories, Inc. said, "We are confident that Barre, one of the units of our U.S. Pharmaceutical business, can operate successfully under this agreement. Reaching this understanding with FDA is a most important action and exemplifies our desire and willingness to work with FDA in implementing the evolving standards that are the foundation for our industry in the future.
 "Sine our acquisition of Barre in late 1987, we have had many discussions with FDA concerning Barre's regulatory history, clarification of FDA's views on CGMP and the status of Barre's programs related to CGMP. Over the period, we have constantly reassesses our quality and compliance procedures in light of the changing regulatory environment, and have committed extensive resources, especially in 1991, to achieve compliance with the stringent regulatory requirements now applicable to the pharmaceutical industry.
 "The current legislative and regulatory environment and FDA's pursuit of uniform standards of excellence for the industry dictate that considerably more formal and enforceable agreements replace the self- regulation of the past. This approach has already created a more responsive and dynamic industry. We appreciate FDA's working with us in reaching this agreement, and are pleased that it incorporates many programs already adopted.
 "Costs for regulatory compliance have increased in recent years and, we expect, will continue to increase in the future; implementation of this agreement with FDA should not materially add to those costs.
 Relative to others in the generic drug industry, we derive added financial strength from our International Pharmaceutical and Animal Health businesses, and from the diversity within our U.S. Pharmaceutical business, which allows us to make the investments in compliance required to assure our leadership position."
 A.L. Laboratories is a multinational manufacturer and marketer of specialized value-added branded pharmaceuticals and animal health micronutrients, with plant sites located in Chicago Heights, Ill.; Niagara Falls, and Glendale, N.Y.; Baltimore; Bellevue, Wash.; Copenhagen, Denmark; and Jakarta, Indonesia.
 -0- 7/31/92
 /CONTACT: Iris D. Daniels, investor relations manager of A. L. Laboratories, 201-947-7774, or David Walke of Morgen-Walke Associates, 212-986-5900, for A.L. Laboratories/
 (BMD) CO: A.L. Laboratories, Inc. ST: New Jersey IN: MTC SU:


SH-TS -- NY007 -- 5439 07/31/92 08:27 EDT
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Publication:PR Newswire
Date:Jul 31, 1992
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