Regulations nonprescriptive

In practice, most nonprescriptive regulations also incorporate many prescriptive standards. For example, the SEMS mie that is described in Chapter 5 is basically nonprescriptive, but it does make reference to standards such as API RP 14C that are quite prescriptive in nature and that are often a legal requirement. For example, paragraph 4.2.1.1.4 of the SEMS rule states ... 

Although usually considered to be inactive ingredients in ophthalmic formulations added because they impart viscosity, many of these polymers function as ocular lubricants. They are marketed as the active ingredients in OTC ocular lubricants used to provide relief from dry eye conditions. The regulatory requirements for these OTC products are found in the FDA Code of Federal Regulations (21CFR349.12), and their formulations are presented in the Twelfth Edition of the APhA Handbook of Nonprescription Drugs. 

St. John s wort, an herbal nonprescription medication containing hyperi-cum, may be effective for mild to moderate depression, but it is associated with several drug-drug interactions. Its potency, purity, and manufacture are not regulated by the FDA. As depression is a potentially life-threatening disease, all antidepressant treatments should be overseen by a trained healthcare professional. 

Federal Trade Commission (FTC) - supervises the regulation of advertising of nonprescription drugs. (http //www.ftc.gov)... 

As well as increases in prescription drugs, nonprescription or over-the-counter (OTC) drug sales are also increasing. These also include herbal medicines, food supplements and essential oils. These products are periodically examined with directives to regulate their use, as they are not proved effective... 

A History of Nonprescription Product Regulation by W. Steven Pray... 

Environmental performance is largely driven by regulations because no company is big enough to address such issues alone. Also, whereas PSM programs are nonprescriptive, environmental work is generally driven by detailed, prescriptive rules and standards. 

An important benefit of the nonprescriptive/performance-based approach is that an industry can immediately capture what has been found by experience or test to work well—there is no need for the regulators to catch up with the latest technology. 

At the heart of the safety case approach lies an understanding that is the operator of a facility—not the regulator—who decides how to ensure safe operations. This nonprescriptive approach to the management of safety is similar to the manner in which most PSM programs are prepared and administered. The operator of the facility, known as the duty holder, develops a safety system that is pertinent to that particular facility. The duty holder s performance is then assessed against his or her own standard. 

Although in areas of emerging technology such as genetic manipulation in agriculture (Baram 2002, 2011), the U.S. approach to regulation is notably relaxed and nonprescriptive, thus favouring innovation. 

Safety management systems are largely nonprescriptive that is, the regulations and standards in this field generally provide very little specific detail as to what has to be done. This lack of detail explains why the technical section of the SEMS rule is so short. The regulation merely requires that programs be in place, that they be adhered to, and that they work. 

Regulations can be categorized as being either prescriptive or nonprescriptive/ goal-based. In practice, both approaches are used by all agencies. It is only the level of emphasis that changes. 

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