Pharmaceutical product

Definition and stakes

Council on Pharmacy and Chemistry,  The Propaganda for Reform in Proprietary Medicines…

“ In the light of our knowledge the administration of gland mixtures in the host of conditions enumerated in the advertising circular is irrational and on a par with the use of the shotgun mixtures once in vogue.
Be it a pharmaceutical mixture, a “mixed” vaccine, or a “pluriglandular” product, the combination of two medicinal ingredients in a mixture must be considered contrary to rational therapy unless a good reason exists for such combination. Such mixtures are held in conflict with Rule 10 unless the manufacturer presents acceptable evidence for the value of his combination.
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Source: Gutenberg

Portrait of Antonin Scalia Antonin Scalia,  Eli Lilly and Company v. Medtronic Inc…

“ The term 'human drug product' means the active ingredient of a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act) including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient. ”
Source: Wikisource

Council on Pharmacy and Chemistry,  The Propaganda for Reform in Proprietary Medicines…

“ That physicians have been insufficiently trained in regard to the pharmacy and chemistry of drugs has often been emphasized in pharmaceutical journals where prescriptions containing incompatible drugs are reported and where even plans are brought forward whereby the pharmaceutical profession may aid in remedying this difficulty. ”
Source: Gutenberg

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