food and drug act of 1906
prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. Government pre-approval of drugs is required
Harrison Tax Act 1914
in response to growing addiction to opiates and cocaine-containing medicines, the Harrison Tax Act established that manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax
Food, Drug and Insecticide Administration 1927
the law enforcement agency is formed that would be renamed in 1930 as the food and drug administration
Food, Drug and Cosmetic (FDC) Act 1938
In response to the fatal poisoning of 107 people, primarily children, by an untested sulfanilamide concoction, this comprehensive law requires new drugs to be shown to be safe before marketing
Alberty Food Products v. U.S. 1950
The US court of Appeals rules that the purpose for which a drug is to be used must be included on the label
Durham-Humphrey Amendment 1951
THis law defines what drugs require a prescription by a licensed preactitioner and requires them to include this Legend on the label: "Caution: Federal Law prohibits dispensing without a prescription: or the more recent "RX only
Kefauver-Harris Amendment 1962
requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug
Fair Packaging and Labeling Act 1966
this requires all consumer products in interstate commerce to be honestly and informatively labeled
Poison Prevention Packaging Act 1970
Requires child-proof packaging on all controlled and most prescription drugs dispensed by pharmacies. Non-child proof containers may only be used if the prescriber or patient requests one
Controlled Substances Act (CSA) 1970
The CSA classifies five levels of drugs (controlled substances) that have potential for abuse and therefore restricts their distribution. The Drug Enforcement Administration (DEA) as a division of the Justice Department was established by the CSA and enforces its regulations.
Medical Device Amendment 1976
Requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices.
Orphan Drug Act 1983
Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) 1984
This act allowed for both the extension of drug patent terms and quicker introduction of lower cost generic drugs.
Prescription Drug Marketing Act 1987
Restricts distribution of prescription drugs to legitimate commercial channels and requires drug wholesalers to be licensed by the states.
Omnibus Budget Reconciliation Act (OBRA) 1990
Among other things, this act requires pharmacists to offer counseling to medicaid patients regarding medications
Anabolic Steroid Control Act 1990
this act was passed to "address the abuse of steroids by athletes, and, especially, youngsters and teenagers.
Health Insurance Portability and Accountability Act 1996
Among other things this act defined the scope of health information that may and may not be shared among health care providers without patient consent and provided for broad and stringent regulations to protect patients' right to privacy. All "covered entities," meaning any health care provider using electronic claims transmissions, billing or other electronic transfer of patient information are required to be compliant with HIPPA privacy and security regulations. These regulations governed the transfer of patient health information whether it is communicated electronically, on paper, or orally.
food and drug administration
the leading enforcement agency at the federal level for regulations concerning drug products.
drug enforcement administration
the agency which controls the distribution of drugs that may be easily abused
Health Insurance Portability and Accountability Act (HIPPA) 1996
Provided broad and stringent regulations to protect patients' privacy
new drugs
all new drugs, whether made domestically or imported, require FDA approval before they can be marketed in the US
Clinical test
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.
Patent Protection
a patent for a new drug gives its manufacturer an exclusive right to market the new 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 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
NDC (National Drug Code) number
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
DEA number/formula
the number all prescribers of controlled substances are assigned and which must be used on all controlled drug prescriptions. It has two letters followed by 7 single digit numbers. AB1234563. the formula for checking a DEA number is: if the sum of the first, third and fifth digits is added to twice the sum of the second, fourth and sixth digits, the total should be a number whose last digit is the same as the last digit of the DEA number
recalls
recalls are, with a few exceptions, voluntary on the part of the manufacturer. there are three classes of recalls. I where there is a strong likelihood that the product will cause serious adverse effects, or death; II where a product may cause temporary but reversible adverse effects or in which there is little likelihood of serouse adverse effects; III where a product is not likely to cause adverse effects
MedWatch
FDA reporting program for health care professionals to report adverse effects that occur from the use of an approved drug or other medical product. the Medwatch online voluntary reporting form 3500 is used for FDA regulated drugs, biologics, medical devices, and special nutritional products and cosmetics.
liability
legal liability means you can be prosecuted for misconduct
negligence
failing to do something that should or must be done.
schedule I:
each drug has a high potential for abuse and no accepted medical use in the US. It may not be prescribed. Heroin, various opium derivatives, and hallucinogenic substances are included on this schedule
schedule II:
each drug has a high potential for abuse and may lead to physical or psychological dependence, but also has a currently accepted medical use in the US. Amphetamines, opium, cocaine, methadone, and various opiates are included on this schedule
schedule III:
each drugs ;postential for abuse is less than those in schedules I and II and there is currently accepted medical use in the US. but abuse may lead to moderate or low physical dependence or high psychological dependence. anabolic steroids and various compounds containing limited quantities of narcotic substances such as codeine are included on this schedule
Schedule IV:
each drug has a low potential for abuse relative to schedule III drugs and there is a current accepted medical use in the us but abuse may lead to limited physical dependence or psychological dependence. Phenobarbital, the sedative chloral hydrate, and the anethetic methohexital are included in this group
schedule V:
each drug has a low potential for abuse relative to schedule IV drugs and there is a current accepted medical use in the us but abuse may lead to limited physical dependence or psychological dependence. compounds containing limited amounts of a narcotic such as codeine are included in this group