FDA drug compliance information letter U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Public Health Service FOOD AND DRUG ADMINISTRATION May 7, 1973 TO: Manufacturers, Repackers, and Relabelers of Drug Products RE: Drug Surveillance Reports The Food and Drug Administration, as part of its regulation of the American drug The analytical methods used are either those specified by the United States Test results may or may not be indicative of the quality of other lots of the same The second survey report is on Ethinyl Estradiol. J.E. Byr T. E. Byers, Director REPORT ON ETHINYL ESTRADIOL Scope of the Survey This study covered Ethinyl Estradiol Tablets U.S. P. XVIII, marketed as a single active ingredient product in tablet form, in the following dosages: 0.02 mg., 0.05 mg., and 0.5 mg. Of the seven domestic formulators known to produce Ethinyl Estradiol Tablets, samples of batches from four firms were collected in this survey. Batches varied in size from slightly under 200,000 tablets to slightly more than 2,000,000 tablets. Eight batches from four different firms were tested. The output of three firms (Ferndale Laboratories, Inc.; Organon Inc.; and Marshall Pharmacal) was unavailable for sampling. Sampling Information Samples were collected under FDA's FORDS (Formulator-Oriented Rx Drug Studies) Program from the formulators (manufacturing plant or primary distribution warehouse) or from their branch warehouses or major accounts. No collections were made at locations more than once removed from the manufacturer. Samples were collected from batches released for distribution by the firms' quality control. Laboratory Tests Samples were analyzed by semi-automated procedure as described under Method No. 24 of the FDA Drug Autoanalysis Manual. Testing was performed on each of six sub-samples from each batch. Where outside of compendial limits, results were verified by the U.S.P. Method. Summary of Results Of the eight samples analyzed (see Table 1) one sample of 0.05 mg. tablets was found defective due to lack of content uniformity, with a sample defect rate for the survey of 12.5 percent. No samples of other dosage strengths were defective. (a) Defective due to lack of content uniformity (25 tablets defective ranging from 26.5 percent to 183.6 percent of declared). The average for all 30 tablets check analyzed was 75.4 percent of declared. The lot was voluntarily removed by manufacturer from distribution channels. FDA drug compliance information letter U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE. Public Health Service FOOD AND DRUG ADMINISTRATION Bureau of Drugs. Office of Compliance The Food and Drug Administration, as part of its regulation of the American drug supply, routinely conducts drug quality surveys. FDA now intends to publish the results of its drug quality surveys, and to send copies to all manufacturers, repackers and relabelers of drug products. In this way, the industry will be advised concerning FDA's laboratory findings on batches of different classes of marketed drugs. This is in line with FDA's attempts to provide to the public and the regulated industries as much valuable information as it can within the scope of the Freedom of Information Law. It is hoped that information of this nature will lead to better compliance by regulated industries. Each report will include pertinent information such as scope of survey, sampling information, laboratory tests and summary of results. The analytical methods used are either those specified by the United States Pharmacopeia (U.S.P.) and National Formulary (N.F.) or automated procedures developed by FDA or adapted from published methods and validated. Many of the methods may be found in the FDA's "Drug Autoanalysis Manual," available from the Division of Industry Liaison. Samples analyzed and found defective by nonofficial methods are chec. -analyzed by U.S.P., N.F., or other official methods such as those of the Association of Official Analytical Chemists (AOAC). Defective samples are followed up by FDA Field Offices so as to remove offending batch(es) from the market either by legal action, voluntary recall, or destruction, or cooperative action by State or local authorities. Test results may or may not be indicative of the quality of other lots of the same product or other products produced by the listed manufacturer. The third survey report is on Psychostimulants. J. E, Byers T. E. Byers, Director REPORT ON PSYCHOSTIMULANTS Scope of the Survey This survey covered five psychostimulant drugs marketed as single active Of the seven domestic formulators known to produce these drugs, samples of batches from five firms were collected in this survey. The output of two firms, Standard Pharmacal Company and Taylor Pharmacal, was unavailable for sampling. Sampling Information Samples were collected under FDA's FORDS (Formulator-Oriented Rx Drug Studies) Program from the formulators (manufacturing plant or primary distribution warehouse) or from their branch warehouses or major accounts. No collections were made at locations more than once removed from the manufacturer. Samples were collected from batches released for distribution by the firms' quality control. Laboratory Tests Samples were analyzed for compliance with the specifications in the compendial monograph or NDA by the appropriate semi-automated procedure or other method of analysis deemed appropriate by the National Center for Drug Analysis. Testing was performed on each of six sub-samples from each batch. Summary of Results Of the 42 samples analyzed (see Table 1), no samples were found defective. |