drugs and virtually all nonprescription drugs is similar to current agency expiration dating rules applied largely to antibiotics that are known to deThe Food & Drug Administration teriorate with time. last week issued new good manufacIn a prepared statement, FDA turing practice (GMP) rules for Commissioner Donald Kennedy making pharmaceuticals including a noted that "when more stringent key new provision requiring that all standards would result in greater asprescription and most nonprescrip- surances of better drug quality, we tion drugs must be marked with ex- have incorporated them into these piration dates on their labels. regulations. We also have made sure Last revised in 1971, the new rules that the new regulations do not imtake into account technological pose stringent controls in areas where changes in drug manufacture since they are not needed." that time, FDA says. Drug GMP's In a related development conwere first issued in 1963 under the cerning drug manufacturing, Health, 1962 Kefauver-Harris amendments Education & Welfare Secretary Joto the Food, Drug & Cosmetic Act. seph A. Califano succeeded in duckUnder the new rules, each drug ing a Congressional contempt citation firm now must have a quality control by providing a House subcommittee operation with the power to accept or with information from FDA files reject all pharmaceutical raw mate- about generic drug-making practices. rials or finished products. Drug The material was sought by the makers also must employ modern House Interstate & Foreign Comquality control technology to ensure merce Committee's Investigation that their drugs are up to par. Subcommittee. Califano initially reFirms, too, will be required by the fused to provide the data in August agency to evaluate their products on because of trade secret legal restraints a batch-by-batch schedule at least and was cited for contempt. The once per year to determine the need contempt citation has been withfor improvements in manufacturing drawn now that Califano has handed specifications or for changes in man- over the generic drug-making inforufacturing practices or quality con- mation in acceptable form—the trade trols. FDA's requirement for labeling secrets have been cut out of the ma• the expiration date for prescription terial.
Expiration dates to be required on drug labels
Electric car demonstrates state of technology "The electric car of today," General Electric called the vehicle as It rolled the car out last week for public inspection. Powered by 18 6-volt, lead acid batteries, the auto is an experimental car designed from scratch to provide data on how far present technology can go toward providing a practical electric car. Here, GE electronics specialist Douglas G. Gruber demonstrates how the batteries slide beneath the car on a movable trolley for servicing or replacing. Designed to use off-the-shelf components and battery systems now commercially available, the car was built to GE specifications by Triad Services Inc., Dearborn, Mich. The batteries were supplied by Globe-Union Inc., Milwaukee. On the basis of initial tests, the car has a range of 75 miles at a constant 40 mph, a cruising speed of 55 mph, and a passing speed of up to 60 mph. It can accelerate from 0 to 30 mph in nine seconds.
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C&EN Oct. 2, 1978
NRC says fertilizer may deplete ozone layer Increased use of nitrogen fertilizers is likely to deplete the earth's ozone layer in years ahead, according to a comprehensive evaluation released by the National Research Council on the environmental impact of nitrates. The major effect probably will not be felt until the 22nd century, however, and the increase in food production that comes from use of this fertilizer seems more important to society than the possible effect of the nitrates on the ozone layer, at least for the next decade or so, the NRC report concludes. Like chlorofluorocarbons, nitrate ion formed at the earth's surface seems unreactive in the lower atmosphere and probably migrates quantitatively to the stratosphere. Here it catalyzes the photolysis of atmospheric ozone to molecular oxygen. Unlike chlorofluorocarbons, nitrates are naturally occurring substances that presumably have been playing their role in atmospheric chemistry for millions of years. This role is being re-examined, however, because human activities have greatly increased the level of nitrogen fixation and nitrate formation. The NRC report estimates that 29 to 41% of nitrogen fixation in 1976 came about because of human activities, primarily fertilizer production, cultivation of nitrogen-fixing legumes, and combustion of nitrogen-containing fuels. Estimates of the impact of these activities on the ozone layer are only "educated guesses," the report warns. Nevertheless, it estimates that human-induced nitrogen fixation most probably will reduce ozone concentrations 1.5 to 3.5%, and the decrease probably will begin about the beginning of the 22nd century. Among the other environmental effects of nitrates considered in the evaluation is their contribution to formation of iV-nitrosamines, a class of chemicals that are carcinogenic in many laboratory animals and suspected carcinogens in man. How much of a health hazard dietary nitrates and nitrites may be and whether there is any exposure level that is safe are questions that cannot be answered from present limited data, the study says. The panel recommends that reasonable measures be taken to minimize human exposure to iV-nitroso compounds. However, what level of control is reasonable can't be determined without more quantitative estimates of the cancer hazard, according to the NRC panel. •
