United States Subjects

Regulatory Status. Undetermined in the United States. Subject of a German therapeutic monograph use not recommended for eye conditions because of hygienic concerns and nondocumented efficacy. 

Crude preparations of mescaline (61) from peyote were first reported by the Spanish as they learned of its use from the natives of Mexico during the Spanish invasion of that country in the sixteenth century. The colorful history (44) of mescaline has drawn attention to its use as a hallucinogen and even today it is in use among natives of North and South America. Although in connection with dmg abuse complaints, mescaline is considered dangerous, it has been reported (45) that it is not a narcotic nor is it habituating. It was also suggested that its sacramental use in the Native American Church of the United States be permitted since it appears to provoke only visual hallucination while the subject retains clear consciousness and awareness. 

Annual Proceedings of the Safety Seminars, Dept, of Defense, Explosive Safety Board, Washington, D.C. International symposia on explosives and closely related subjects are excellent sources of information, ie, international symposia on detonation symposia on combustion symposia on chemical problems connected with the stabiUty of explosives international pyrotechnics seminars symposia on compatibiUty of plastics and other materials with explosives, propellants, and pyrotechnics, and processing of explosives, propellants, and ingredients and symposia on explosives and pyrotechnics Mineral Industy Surveys, U.S. Bureau of Mines, Pittsburgh, Pa. Periodic pubhcations dedicated primarily to explosive studies in Propellants and Explosives Journal of Ha yardous Materials, and apparent consumption of industrial explosives and blasting agents in the United States. 

Vinal fibers, or poly(vinyl alcohol) fibers, are not made in the United States, but the fiber is produced commercially in Japan, Korea, and China where the generic name vinylon is used. These materials are the subject of this article (see also Vinyl polymers, vinyl alcohol polymers). 

Fine chemicals are produced by a wide spectmm of manufacturers, largely because the distinction between different kinds of chemicals is not sharp. There are specialty producers of fine chemicals. Many companies that manufacture dmgs also manufacture the chemical substances that are used in preparing the dosage forms. A number of companies manufacture dmg chemicals and food chemicals. Some fine chemicals are made by manufacturers of heavy chemicals, and either may be simply a segment of their regular production, or some of that production which has been subjected to additional purification steps. Many fine chemicals are imported into the United States from countries such as Japan, Germany, and the Netherlands. 

Sulfites and related compounds have been the subject of much controversy. It has been shown that these chemicals may cause serious allergic reactions in sensitive individuals. In the United States, sulfite-containing foods must be labeled as such, and sulfites ate prohibited in areas such as salad bats where labeling is inappropriate. 

Hair Coloring Regulation Issues. In the United States the classification of color additives is complex. Under the Federal Food, Dmg and Cosmetic Act, all cosmetic colors must be the subject of an approved color additive petition to the Food and Dmg Administration there is an exception for coal-tar colorants used to color hair. Based on the composition of these colorants, FDA can require a certification on each manufactured batch of colorant to assure conformance with the approved specifications. In the early 1990s FDA has required certification only for synthetically derived coal-tar type colors. Many of the approved color additives, both certified and noncertified, are restricted ia their potential use. These restrictions can be found ia the color additive regulations ia the Code of Federal Regulations at 21 CFR 73 and 74. 

Lubricants. Petroleum lubricants continue to be the mainstay for automotive, industrial, and process lubricants. Synthetic oils are used extensively in industry and for jet engines they, of course, are made from hydrocarbons. Since the viscosity index (a measure of the viscosity behavior of a lubricant with change in temperature) of lube oil fractions from different cmdes may vary from +140 to as low as —300, additional refining steps are needed. To improve the viscosity index (VI), lube oil fractions are subjected to solvent extraction, solvent dewaxing, solvent deasphalting, and hydrogenation. Furthermore, automotive lube oils typically contain about 12—14% additives. These additives maybe oxidation inhibitors to prevent formation of gum and varnish, corrosion inhibitors, or detergent dispersants, and viscosity index improvers. The United States consumption of lubricants is shown in Table 7. 

Metformin. Metformin [657-24-9] (1,1-dimethylbiguanide), mol wt 129.17, forms crystals from propanol, mp 218—220°C, and is soluble in water and 95% ethanol, but practically insoluble in ether and chloroform. Metformin, an investigational dmg in the United States, does not increase basal or meal-stimulated insulin secretion. It lowers blood glucose levels in hyperglycemic patients with Type II diabetes but has no effect on blood glucose levels in normal subjects. It does not cause hypoglycemia. Successful metformin therapy usually is associated with no or some weight loss. 

Electrolytic Preparation of Chlorine and Caustic Soda. The preparation of chlorine [7782-50-5] and caustic soda [1310-73-2] is an important use for mercury metal. Since 1989, chlor—alkali production has been responsible for the largest use for mercury in the United States. In this process, mercury is used as a flowing cathode in an electrolytic cell into which a sodium chloride [7647-14-5] solution (brine) is introduced. This brine is then subjected to an electric current, and the aqueous solution of sodium chloride flows between the anode and the mercury, releasing chlorine gas at the anode. The sodium ions form an amalgam with the mercury cathode. Water is added to the amalgam to remove the sodium [7440-23-5] forming hydrogen [1333-74-0] and sodium hydroxide and relatively pure mercury metal, which is recycled into the cell (see Alkali and chlorine products). 

Once the patent appHcation is complete and the inventor has made a formal declaration of inventorship, the appHcation is filed with the U.S. PTO. In the U.S. PTO, the appHcation is the subject of a thorough, formal, and substantive examination by a patent examiner. Once the patent examiner is convinced that the patent appHcation satisfies the statutory requirements provided for under the laws of the United States, the patent appHcation will be allowed to issue as a patent. Issuance takes the form of a pubHcation provided by the U.S. Government. The pubHcation of patents occurs only on Tuesdays that ate not federal hoHdays. At the time of issuance, the patent is assigned a number and made pubHc in a form which allows all interested patties to obtain access to it. 

A fundamental requirement for obtaining a patent is defining an advance, development, or invention which is within those classes of "subject matter" which the law of the United States regards as patentable. Two classes of patentable subject matter, ie, computer software and biotechnology, are the subject of relatively new and evolving law. However, other types of subject matter rest on fairly certain ground as to patentabiUty. Examples of patents directed to various types of subject matter are described in the following. 

Has the Invention Been the Subject of a Prior Foreign Patent Although one cannot be sure when, or even whether, a patent wiU issue from any appHcation, it is good practice to make sure your U.S. patent appHcation is filed within 12 months of the first foreign filed appHcation. The patenting of an invention in another country by the inventor or another party wiU preclude the issuance of a patent on the same invention in the United States. 

The Federal Food, Dmg and Cosmetic (FDAC) Act defines dmgs as "...articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man..." and "articles (other than food) intended to affect the stmcture of any function of the body of man." In the United States and elsewhere, the introduction of a new dmg is subject to a sequence of weU-defined stages of development and approval (4). Each stage involves either scientific testing or submission and preparation of data and analysis review (Fig. 2). 

Phenohc resins are produced by the condensation of phenol or a substituted phenol, such as cresol, with formaldehyde. These low cost resins have been produced commercially for more than 100 years and in the 1990s are produced by more than 40 companies in the United States. They are employed as adhesives in the plywood industry and in numerous under-the-hood appHcations in the automotive industry. Because of the cycHc nature of the automotive and home building industry, the consumption of phenol for the production of phenohc resins is subject to cycHc swings greater than that of the economy as a whole. 

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