Regulation prescriptiveness

Australia s Therapeutic Goods Administration (TGA) has perhaps one of the most progressive and comprehensive regulatory systems in the world. Under the Therapeutic Goods Act, the TGA regulates prescription medicines, OTC... 

Federal laws thus take precedence over state laws. Given the key role of the FDA in approving and regulating prescription drugs, states must follow the federal laws. Indeed, the Federal Food, Drug, and Cosmetic Act says that no state may establish requirements for labeling or packaging that differ from requirements of the federal law. 

E-mail druginfo fda.hlis.gov Phone (888) 463-6332 White Oak Building 51 10903 New Hampshire Avenue Silver Spring, MD 20993 The unit within the FDA that regulates prescription drugs by testing... 

The abuse of marketed medications has been at the forefront of public awareness in recent years, mostly due to widespread reports concerning OxyContin and hydrocodone.1 While these are highly regulated, prescription-only medications with recognized potential for abuse, even some over-the-counter (OTC) medications have become problematic, either because of their own effects (e.g., ephedrine) or because they are used in the manufacture of other abused substances (e.g., pseudoephedrine, used to make methamphetamine).2 3... 

Ephedra is subject to the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994. The act essentially protects dietary supplements like ephedra. That is, while U.S. federal agencies can regulate prescription drug and food additives, DSHEA exempts herbal products and supplements from federal regulation. The law states that the United States Food and Drug Administration (FDA) cannot regulate dietary supplements unless, or until, they are proven to be unsafe and pose a risk to users. The United States Drug Enforcement Administration (DEA) monitors ephedrine because it can be used to make methamphetamine. 

With a prescriptive approach to quality assessment, duplicate samples, blanks, standards, and spike recoveries are measured following a specific protocol. The result for each analysis is then compared with a single predetermined limit. If this limit is exceeded, an appropriate corrective action is taken. Prescriptive approaches to quality assurance are common for programs and laboratories subject to federal regulation. For example, the Food and Drug Administration (FDA) specifies quality assurance practices that must be followed by laboratories analyzing products regulated by the FDA. 

Labeling. Labeling, controUed by FDA regulations, includes not only the affixed labels, but also the package inserts that provide mote detailed information. Trade, generic, or common name, dose, number of dose units present, and name and address of manufacturer and distributor ate requited. For nonptescription products, adequate directions for use ate requited. Prescription products must beat the phrase, "Caution Federal law prohibits use without a prescription" on theit labels. 

Tliis law, passed in 1914, regulated the sale of narcotic drugp. Before the passage of this act, any narcotic could be purchased without a prescription. This law was amended many times. In 1970, the Harrison Narcotic Act was replaced with the passage of the Comprehensive Drug Abuse Prevention and Control Act. 

New drugs will only be authorised as prescription medicines in the first instance, as it requires considerable experience in the market to convince the regulators that it is safe to reclassify a drug as an OTC product. The term new drug may mean a new pharmaceutical substance, or a new therapeutic application of an existing one. 

The relevant regulations governing the conduct of clinical trials in the U S are shown in Table 5.4. As they also reflect the principles of GCP, they are quite similar in requirements to those of the E U. However, because they apply to a single jurisdiction, they are framed to provide more prescriptive detail than can be found in the equivalent EU directives. Similarly, they are supported by the ICH- and FDA-specific guidelines. As most of the practices are the same as discussed in the previous section, the chapter will now just examine some of the aspects that are unique to the US regulations. 

Several different niacin formulations are available niacin immediate-release (IR), niacin sustained-release (SR), and niacin extended-release (ER).28,29 These formulations differ in terms of dissolution and absorption rates, metabolism, efficacy, and side effects. Limitations of niacin IR and SR are flushing and hepatotoxicity, respectively. These differences appear related to the dissolution and absorption rates of niacin formulations and its subsequent metabolism. Niacin IR is available by prescription (Niacor ) as well as a dietary supplement which is not regulated by the FDA.28 Currently, there are no FDA-approved niacin SR products, thus, all SR products are available only as dietary supplements. 

Several studies have evaluated dietary supplements such as isoflavones, which are found in soy products and red clover. A well-controlled trial in more than 400 postmenopausal women evaluating a specific isoflavone, ipriflavone, found no benefits on bone mineral density or fracture rates after 3 years.47 Nevertheless, because these therapies are available without prescription and are not regulated by the FDA, patients may choose to self-medicate with isoflavones. Lymphocytopenia appeared in several patients treated with ipriflavone in clinical trials. Additionally, ipriflavone should be used with caution in immunocompromised patients or those with renal disease. It may inhibit CYP1A2 and CYP2C9 and may interact with drugs metabolized by those pathways, such as warfarin. 

M. Danish and S. Rosenbaum, Dosing considerations for non-prescription drugs in infants and children, Clin. Res. Regul. Affairs, 9, 89 (1992). 

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