3-Drug Regulation And Control

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Food and Drug Administration
(FDA)

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The leading enforcement agency at the federal level for regulations concerning drug products.

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Drug Enforcement Administration
(DEA)

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The agency which controls the distribution of drugs that may be easily abused

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Food and Drug Act of 1906

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Prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. Government pre-approval of drugs is required.

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1938 Food, Drug and Cosmetic (FDC) Act

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In response to the fatal poisoning of 107 people, primarily children, by an untested sulfanilamide concoction, this comprehensive law requires new drugs be shown to be safe before marketing.

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1951 Durham-Humphrey Amendment

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This law defines what drugs require a prescription by a licensed practitioner and requires them to include this legend on the label: "Caution: Federal Law prohibits dispensing without a prescription.:

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1962 Kefauver-Harris Amendments

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Requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug.

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1970 Poison Prevention Packaging Act

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Requires child-proof packaging on all controlled and most prescription drugs dispensed by pharmacies.

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1970 Controlled Substances Act
(CSA)

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The CSA classifies drugs that may be easily abused and restricts their distribution. It is enforced by the Drug Enforcement Administration (DEA) within the Justice Department.

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1990 Omnibus Budget Reconciliation Act (OBRA)

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Act required pharmacists to offer counseling to Medicaid patients regarding medication, effectively putting the common practice into law.

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1996 Health Insurance Portability and Accountability Act (HIPAA)

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Provided broad and stringent regulations to protect patients privacy.

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Placebos

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Inactive substances, not real medications, that are used to test the effectiveness of drugs.

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New Drugs

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All new drugs, whether made domestically or imported, require FDA approval before they can be marketed in the United States.

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Clinical tests

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Tests on proposed new drugs (investigational drugs) are "controlled" by comparing the effect of a proposed drug on one group of patients with the effect of a different treatment on other patients.

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blind tests

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Patients in a trial are always "blind" to the treatment, i.e. they are not told which control group they are in. In a "double-blind" test, neither the patients nor the physicians know what the medication is.

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patent protection

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a patent for a new drug gives its manufacturer an exclusive right to market the drug for a specific period of time under a brand name. A drug patent is in effect for 17 years from the date of the drug's discovery. The Hatch-Waxman Act of 1984 provided for up to five year extensions of patent protection to the patent holders to make up for time lost while products went through the FDA approval process.

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generics

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Once a patent for a brand drug expires, other manufacturers may copy the drug and release it under its pharmaceutical or "generic" name.

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labels and labeling

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All drugs are requied to have clear and accurate information for all labels, inserts, packaging, and so on, but there are different information requirements for various categories of drugs.

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prescription drug labels

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The minimum requirements on prescription labels for most drugs are as follows: name and address of dispenser, prescription serial number, date of prescription or filling, name or prescriber, name of patient, directions for use, and cautionary statements.

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NDC (National Drug Code) number

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The number assigned by the manufacturer. Each NDC number has three parts or sets of numbers: The first set indicates the manufacturer; the next set indicates the medication, its strength, and dosage form; the last set indicates the package size.

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controlled substances

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A drug which has the potential to be abused and for which distribution is controlled by one of five "schedules."

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control classification

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Manufacturers must clearly label controlled drugs with their control classification.

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DEA number/formula

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The number all prescribers of controlled substances are assigned. 2 letters followed by 7 digits. AB1234563. Sum of 1st, 3rd, 5th + 2(2nd, 4th, 6th). The total's last digit is the same as DEA number's last digit.

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risks of approved drugs

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There is always the risk that an approved drug may produce adverse side effects when used on a larger population.

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liability

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Legal liability means you can be prosecuted for misconduct.