Regulation defined

U.S. regulations define this standard as foUows proof spirit shaU be held to be that alcohoHc Hquor which contains one-half its volume of alcohol of a specific gravity of 0.7939 at 15.6°C ie, the figure for proof is always twice the percent alcohol content by volume. For example, 100° proof means 50% alcohol by volume. In the United Kingdom as weU as Canada, proof spirit is such that at 10.6°C alcohol weighs exactiy twelve-thirteenths of the weight of an equal bulk of distiUed water. A proof of 87.7° indicates an alcohol concentration of 50%. A conversion factor of 1.142 can be used to change British proof to U.S. proof. 

U.S. regulations define two types of gin distilled gin and compounded gin. Distilled gin is produced from the original mash or the redistikation of neutral spirits with juniper berries and other botanicals. Distiked gin may retain this labeling as long as juniper berries are present during distikation and other aromatics used in the formula may be added as Hquid concentrates purchased or produced by the distiker. 

OSHA regulations define specific time requirements for investigating any release or potential release of any chemical that is within the scope of 29 CFR 1910. 

Blatteis CM (2006) Endotoxic fever new concepts of its regulation define new approaches to its management. Pharmacol Therap 111 194-223... 

In general, informed consent requires the satisfaction of two conditions. First, trained medical personnel must tell the person to be treated what alternative treatments exist, the benefits and dangers associated with the proposed treatment, and the disadvantages of forgoing treatment. Second, once the person has received all the relevant medical information, he or she must freely and voluntarily decide whether or not to undergo the treatment." Coercion is anathema to informed consent, as emphasized by a US Department of Health and Human Services regulation defining informed consent ... 

The FDA s regulations define drug product as a finished dosage form, for example, a tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. 21 C.F.R. 210.3(4). 

Andrew Feenberg makes a similar point when he says that regulation defines the cultural framework of the economy it is not an act in the economy (Feenberg, 1999, p97, emphasis in original). 

By law, all drugs must meet certain minimum specifications which certify acceptable purity for human consumption. Most manufacturers of licit preparations, or products prepared in accordance with regulations defined by law and enforced by the Food and Drug Administration (FDA), in the United States, will adopt... 

The next change in definition has to do with the term that we we have been using. Please note that I have mentioned field studies, ecotox studies, genetic tox studies. What is a "study" The current GLP regulations define a study" as shown below ... 

Neither the FDC Act nor FDA s implementing regulations define the term switch, which typically refers to moving a drug product from Rx to OTC status. FDA will allow a switch when the prescription requirements are no longer necessary to protect the public health and the drug is safe and effective for use in self-medication as directed in the proposed OTC product labeling [89]. 

The Hazardous Substances regulations define a hazardous substance as one which ... 

The inspection of process vessels and storage tanks represent examples of closed-space inspection. It is necessary for the management to define the closed-space inspection and provide a set of regulations for inspection. The chosen inspector must be aware of all the regulations defined by the management for inspection, along with the permission for inspection. Before entry all the technical safety requirements must be met. It is also necessary that the inspector in the closed-space process vessel must be in constant communication with other personnel outside during the entire duration of inspection. It is also possible to use mechanical robotic systems in some cases to avoid the hazards involved in closed-space entry for inspection. 

Melo-Oliveira, R., Oliveira, I. C., and Comzzi, G. M. (1996). Arabidopsis mutant analysis and gene regulation define a nonredundant role for glutamate dehydrogenase in nitrogen assimilation. Proc. Natl. Acad. Sci. U.S.A. 93, 4718-4723. 

The European Union regulations define decaffeinated as coffee (bean) containing 0.3% or less of caffeine (normal content 1-3%). 

In the United States, GLP regulations (21 CFR 58) apply to safety or animal toxicology studies performed during research and development. These regulations define GLPs for conducting non-clinical laboratory studies that support or are intended to support applications for research or marketing permits for products... 

Outer Packages The Regulations define the conditions of the outer package with respect to text and specific labeling (See Labeling and Consumer Information on page 241). 

Federal regulations define sponsor as a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. ... 

In general, the term sponsor refers to a commercial manufacturer that has developed a product in which it holds the principal financial interest. A sponsor may also be a physician, commonly called a sponsor-investigator , which federal regulations define as an individual who both initiates and conducts an investigation and under whose immediate direction the investigational drug is administered or dispensed. ... 

Legislators in all countries have recognized that many forms of enzymatic and thermal processing are needed to develop the flavors perceived to be natural by consumers, in traditional food. In the United States, the Code of Federal Regulations defines natural... 

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