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Required all drugs marked in the United States to meet minimal standards of strength, purity, and quality
1906 Pure Food and Drug Act
Established the Food and drug Administration under the department of Health and Human Services to enforce the provisions of the act.
Established more specific regulations to prevent adulteration of (tampering with) drugs, food, and cosmetics.
All labels must be accurate and must include a listing of all active and inactive ingrediants
All new products must be approved by the FDA before public release.
"Warning" labels must be present on certain preparations, for example, "may cause nervousness," and "may be habbit-forming"
1938 Federal Food, Drug, and Cosmetic Act and Amendments of 1951 and 1962
Established the Drug Enforcement Administration (DEA) as a bureau of the Department of Justice to enforce the provisions of the act.
Set much tighter controls on a spacific group of drugs: those that were being abused by society; the name of the act indicates that such substance needed to be controlled. They include depressants, stimulants, psychedelics, narcotics, and anabolic steroids.
1970 Controlled Substance Act
Rules set to assure consumers that they get what they pay for. The law says that all preparations called by the same drug name must be of uniform strength, quality, and purity.
Arranged with the potentially most dangerous at Level I and the least dangerous at Level V. The lower the number, the stricter are the restrictions for control by the DEA. Thus Schedule I drugs are illegal and not approved for medicinal purposes in the United States.
The five schedules of controlled substances
High abuse potential, not approved for medical use in the United States.
Examples: heroin, LSD, mescaline, ecstasy
Schedule I drugs
High abuse potential, may lead to severe dependence, written prescription only, no phoning in of prescription by office health care practitioner, no refills without new written perscription, may be faxed, but original prescription must be handed in to pick up prescription, in emergency, physician may phone in, but handwritten prescription must go to pharmacy within 7 days.
Examples: morphine, codine, methadone, Percocet, Tylox, Dilaudid, Ritalin, cocain, Oxycontin, meperidine (Demerol)
Schedule II drugs
May lead to limited dependence; written, faxed, or verbal (phoned in) prescription, by physician only; may be refilled up to five times in six months.
Examples: Codine nad Hydrocodone with asprin or Tylenol, anabolic (muscle building) steroids
Schedule III drugs
Lower abuse potential than schedule I, II, and III drugs, prescription may be written out by health care practitioner, but must be signed by the physician, prescription may be phoned in by health care practitioner or faxed, may be refilled up to five times in six months.
Examples: Valium, Ativan, Xanax, phenobarbital, Librium, Darvocet, Restoril, Ambien
Schedule IV drugs
Lowest abuse potential compared to other schedules of drugs, consists primarily of preparations for cough suppressents containing codine and preparations for diarrhea.
Examples: Promethazine with codine, Cheratussin AC, Lomotil
Schedule V drugs
Concerned with general safety standards in the production of drugs, food, and cosmetics.
Responsible for approval and removal of products on the market. Special not on drug withdrawls: In rare cases, they may need to reassess and change its approval decision on a drug. A conclsion that a drug should no longer be marked is based on the nature and frequency of hte adverse events and how the drug's benefit and risk balance compares with treatment alternatives. When they believe that a drug's benefits no longer outweigh its risks, the agency will ask the manufacturer to withdraw the drug. Interestingly, they don't have the authority to withdraw a marked drug product itself.
Concerned with controlled substances only, and it enforces laws against drug activities, including illegal drug use, dealing, and manufacturing. Moniters need for changing the schedules fo abused drugs.
Drugs of low profitability.
This act mandates that all OTC drugs a patient is taking must be documented as part of the medical record. It also mandates that pharmacists provide drug use review and patient counseling before dispensing prescriptions to a patient.
Omnibus Budget Reconciliation Act (OBRA) of 1990
Analgesics; anticonvulsants; antihistamines; anti-infective drugs; antineoplastic drugs; antiparkinsonian drugs; autonomic nervous system drugs; cardiovascular drugs; decongestants; endocrine system drugs; eye medications; gastrointestinal drugs; muscle relaxants; musculoskeletal anti-inflamatory drugs; osteoperosis therapy; psychotropic medications; reproductive system drugs; resperitory system drugs; restless legs syndrome agents; sedatives and hypnotics; skin medications; urinary system drugs; vitamins, minerals, and herbs.
Medication that alleviates pain.
Medication used to reduce the number and/or severity of seizures in patients with epilepsy.
Medications that provide symptomatic relief of allergic symptoms caused by histamine release.
Medications used in the treatement of infections; includes antibiotics, antifungals, and antivirals.
Agent that prevents the development, growth, or spreading of malignant cells.
Medications used in the treatment of Parkinson's disease to relieve symptoms and maintain mobility, but do not cure the disease.
Drugs that constrict blood vessels in the respiratory tract, resulting in shrinkage of swollen mucous membranes and opened nasal airway passages.
Medications used to prevent or treat osteoporosis by increasing bone mineral density.
Any substance that acts on the mind.
Drug that promotes sleep
Controlled substances used to promote sedation in smaller doses to promote sleep in larger doses.
Medication used to treat some musculoskeletal disorders associated with pain, spasm, abnormal contraction, or impaird mobility.
Skeletal muscle relaxants
Allergic or excessive response of the immune system to a drug or chemical.