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"all preparations called by the same drug name must be of uniform strength, quality and purity"
1906 Pure Food and Drug Act
- first gov attempt to establish consumer protection in the mfg of food & drugs
- "req'd uniform strength, quality and purity"
- req'd dangerous ingredients be on label
- established the US Pharmacopeia and Nat'l Formulary; specified the official US standards for making each drug
"1938 Fed Food, Drug and Cosmetic Act and Amendments of 1951 & 1962"
- established food & drug admn
- "est more specific regulations to prevent tampering with drugs, food & cosmetics"
- : all labels must be accurate and include list of all active and inactive ingredients
- : all new products must be approved by the FDA before public release
- : warning labels must be present on certain preparations (ie may cause drowsiness)
- ": created ""legend drugs"" - those drugs that cannot be sold w/o a prescription"
- : also designated which drugs did not need prescriptions
- : both prescr and non prescr drugs must be shown to be EFFECTIVE and SAFE
1970 Controlled Substances Act
- est the Drug Enforcement Admin (DEA) to enforce provisions of the act
- set much tighter controls on specific drugs that needed to be controlled: ie drugs being abused by society
- : assigned abused and addicting drugs into five schedules: C1 (most addictive) - C5 (least addictive)
- : specified handling regs for controlled substances; records to be held for 2 years
- : set limitations on the use of prescription drugs; ie how many refills etc
- ": reqd prescribers to register with DEA for license; includes mfg, vets, pharmacists, physicians"
SCHEDULE 1 OF CONTROLLED SUBSTANCES
- high abuse potential
- not approved for use in US
- "ie heroin, LSD, mescaline, ecstasy"
SCHEDULE 2 OF CONTROLLED SUBSTANCES
- high abuse potential; may lead to severe dependence
- written prescription only; cannot be phoned in; new prescription every refill
- "can be faxed, but original must be presented when picking up med"
- "in an emergency, dr can phone in, but handwritten prescr must be presented at pharmacy within 7 days"
- "ie morphine, codeine, methadone, Percocet, Tylox, Dilaudid, Ritalin, cocaine, Oxycontin, meperidine (Demerol)"
SCHEDULE 3 OF CONTROLLED SUBSTANCES
- may lead to limited dependence
- written faxed or verbal prescriptions by physician only
- may be refilled up to five times in 6 months
- "ie codeine and hydrocodone w/ aspirin or tylenol, anabolic steroids"
SCHEDULE 4 OF CONTROLLED SUBSTANCES
- lower abuse potential
- "prescription can be written out by health care practitioner, but must be signed by the physician"
- prescription may be phoned in or faxed by health care practitioner
- may be refilled up to five times in 6 months
- "ie valium, ativan, xanax, phenobarbital, librium, darvocet, ristoril, ambien"
SCHEDULE 5 OF CONTROLLED SUBSTANCES
- low abuse potential
- primarily for preparations for cough suppressants containing codeine and preparations for diarrhea (ie diphenoxylate)
- "ie Promethazine w codeine, Cheratussin AC, Lomotil"
1983 Orphan Drug Act
give pharmaceutical companies financial incentives to develop medications for diseases that affect only a small number of people
Omnibus Budget Reconciliation Act (OBRA) of 1990
- mandates that all Otc drugs a patient is taking must be documented as part of the medical record
- pharmacists provide drug use review and patient counseling before dispensing prescriptions to a patient
- oversees testing of all proposed drugs before public release
- "inspect plants where foods, drugs, medical devices or cosmetics are made"
- review new drug applications and petitions for food additives
- investigate and remove unsafe drugs from the market
- "ensure proper labeling of foods, cosmetics and drugs"
- established in 1970 to enforce the drug laws
- works with controlled substances only
- separate agency from FDA
- monitors need to move a drug from one schedule to another
Withdrawing a drug from public
- FDA recommends withdrawal when risks outweigh the benefits
- FDA has no authority to remove from market
- FDA can recommend to the manufacturer that it be pulled
healthcare practitioners and the law
- keep current drug reference book
- double lock controlled substances
- conceal & secure drug prescription pads
- "keep accurate records of contolled substances dispensed, received or destroyed. Keep records for 2 years."
- keep up to date with current news from FDA and DEA and controlled substances
- establish a working rapport with a pharmacist
- maintain a professional rapport with the pharmaceutical reps