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An act to regulate import, manufacture, distribution and sale of Drugs and Cosmetics. The Drugs and Cosmetics Rules, 1945 are the rules which the government of India established through the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules and present guidelines for the storage, sale, display and prescription of ...
The Drugs and Cosmetics Act, 1940 is an act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. [1] The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards. [2] The related Drugs and Cosmetics Rules ...
Schedule H. Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945 introduced in 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. The manufacture and sales of all drugs are covered under the Drugs and Cosmetics Act and ...
1308.11 — List of Schedule I drugs; 1308.12 — List of Schedule II drugs; 1308.13 — List of Schedule III drugs; 1308.14 — List of Schedule IV drugs; 1308.15 — List of Schedule V drugs; See also. Title 21 of the United States Code - Food and Drugs; EudraLex (medicinal products in the European Union) References
Except when dispensed directly to an ultimate user by a practitioner other than a pharmacist, no controlled substance in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), may be dispensed without the written or electronically transmitted (21 CFR 1306.08) prescription of ...
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of ...
The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as ...