Labelling regulatory controls

Immunochemical methods employing either radioactive (113) or chemiluminescent (114) labels have long been available for urine analysis but they were limited to the determination of 17 -19-nortestosterone. Injection, however, of 19-nortestosterone or its esters into veal calves results in formation of 17 -19-nortestosterone as the predominant metabolite in urine (115). Therefore, efficient regulatory control is not possible unless the latter metabolite can be also determined (116). 

Operations dealing with hazardous materials involve storage, and transport. Space does not permit a detailed account of the topic, except to outline some aspects.10 Some aspects of transportation of hazardous materials consist of regulatory control, classification, packaging and labelling, transport containers, hazards and hazard assessment as well as emergency planning. 

The term soap thus has two meanings. The first is the FDA s definition, which is used for legal purposes. The second is the generic sense, whereby soaps may refer to cleansing products that may not meet the specifics of FDA s definition. Such products must, therefore, be labeled as cosmetics. The Federal Trade Commission (FTC) and the Consumer Products Safety Commission (CPSC) handle the regulatory control for soaps. 

Pharmacists should be aware of the differences in safety standards and regulatory control between drugs and dietary supplements (Table 1). When counseling people about dietary products, pharmacists must be aware that the DSHEA allows the promotion of substances that may have variable potency, unidentified components, unproven efficacy, and unknown adverse effects. The DSHEA does not require warnings about drug interactions or medical conditions under which a dietary supplement should not be used. In view of the liberal labeling provisions of the DSHEA, pharmacists cannot trust dietary supplement company literature and should consult reliable information sources (Table 2)." ... 

Water Pollution Control Act ("Clean Water Act", CWA) of 1948 [PL 80-845] and Amendments in 1956, 1961, 1965, 1966, 1970, 1972, 1977, 1981, 1987, 1988, 1990-92, 1994, 1995, 1996 Officially labeled the CWA in 1977 [PL 95—217] codified under Title 33, 33 U.S.C. 1251-1387 CWA works in concert with SDWA on regulatory controls on surface ambient water supplies for Pb and other contaminants Act administratively empowers agencies to issue discharge permits and control priority pollutants... 

Worker safety studies are not likely to normally include a control substance (i.e., a material used in the study to serve as basis of comparison with the test substance). However, if a control substance is included as a treatment group, then it must (1) be fully characterized as to its identity, purity (or strength), and stability (and solubility, if appropriate) (2) be appropriately tested in mixtures with any carrier used and (3) meet all the other GLP recordkeeping, labeling, and storage requirements, as specified for the test substance. There is some regulatory relief here, however, in that water, by definition, is excluded from being considered a control substance, and vehicles (those substances added to enhance solubilization or dispersion of the test substance) are addressed separately in the FIFRA GLP Standards. 

Single-site IVD "Home brew" or "in-house" IVD made with "in-house" reagents FDA requests labeling disclosing the "in-house" nature of the test, but no regulatory requirements are in place CLIA requires analytical validation and quality control systems... 

Regulatory authorities recognize that, in spite of all the control systems put in place, deviations and changes are sometimes inevitable. A robust GMP system includes procedures to handle, review, and approve changes in raw materials, specifications, analytical methods, facilities, equipment, processes, computer software, and labeling and packaging. All the changes have to be documented with references for traceability. 

Regulatory authorities inspect GMP facilities to ensure compliance to GMP. The FDA carries out surveillance and compliance inspections. A system-based approach is adopted quality, facilities and equipment, materials, production, packaging and labeling, and laboratory control. Deficiencies are reported on Form FDA-483, which may lead to a warning letter and consent decree if unresolved. 

But DSHEA is very different then the standard approval process for drugs and medical devices, and emphasizes the regulatory enforcement of label claims and advertising and marketing issues rather than the efficacy and quality of the supplements themselves. Unlike new drug and medical device applications, controlled clinical trials aren t part of the supplement review process, nor is any FDA inspection of a company s manufacturing facilities or quality control systems. 

As industrial chemicals, FWAs are regulated by national laws such as the Toxic Substance Control Act in the United States and the relevant classification, packaging, and labeling directives in the European Community. For specific applications such as food packaging, the national regulatory requirements must be complied with. 

Producers using purchased complete feed do not have to pay as much attention to quality control. Feed manufacturers are required by feeds legislation in most countries to supply feed of a high standard, which requires them to test ingredients and finished products routinely. In addition, regulatory officials check commercial feeds at random for label compliance. However, it is still advisable for the organic producer to carry out routine checks on any purchased feeds and to communicate regularly with suppliers to ensure that the purchased products meet the standards expected. 

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