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action active addition adequate adverse agencies agents American approved approximately Assistant Association assure cent Center clinical combination Committee Company complete components continuing cost DATE Department determine direct disease dosage dose Drug Administration drug products drug utilization Education effective efficacy efforts established evaluated evidence expenditures experts Federal firms Food and Drug Government Health Service hospital increased indicated industry inspection isoniazid labeling Laboratories LIBRARY OF CONGRESS Lilly limited lots manufacturer NAME oral packaging patients persons Pharmaceutical pharmacist pharmacy physicians possible practices prescribing prescription drugs present problem procurement profession professional programs Public Health purchase question reactions reason received recommended records Research responsible role sample selection Social Security Administration sources specific standards Supply Tablets tests therapeutic therapy tion United Welfare
8234. lappuse - ... that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.
8341. lappuse - Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.
8341. lappuse - ... a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this act as to safety and has the identity and strength and meets the quality and purity characteristics, which it purports or is represented to possess...
8336. lappuse - The effects of drugs vary from patient to patient and from time to time in the same patient.
8341. lappuse - A medicated article(s) or their components shall be maintained in a clean and orderly manner and shall be of suitable design, size, construction, and location to facilitate maintenance and operation for its intended purpose.
8330. lappuse - Usage in Pregnancy: Adverse effects on nidation in rats, embryo viability in mice, and metabolism in vitro of rat testis and human spermatozoa have been attributed to lithium. as have teratogenicity in submammalian species and cleft palates in mice. Studies in rats, rabbits and monkeys have shown no evidence of lithium-induced teratology. There are lithium birth registries...
8341. lappuse - ... direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those com-ponents that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (8) Inactive ingredient means any component other than an active ingredient.
8333. lappuse - Patients: Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles, the patient should therefore be cautioned accordingly.
8342. lappuse - ... could contribute contamination to any drug product. Potable water shall meet the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations set forth in 40 CFR Part 141 . Water not meeting such standards shall not be permitted in the potable water system. (b) Drains shall be of adequate size and, where connected directly to a sewer, shall be provided with an air break or other mechanical device to prevent back-siphonage.