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LAws and regulations
PTCB laws and stuffs
Law | Definition | Year |
---|---|---|
FDA - Federal, Drug, and Cosmetic Act | -Protects the public health -Label requirements for safe consumer use of OTC products - prohibits the sale of “adulterated” or “misbranded” foods and drugs | |
Adulturation | presence of any decomposed substance, packaging under unsanitary conditions or if the product’s strength or purity is different from what is indicated on the label. | |
misbranding | when the label is false or misleading or when proper warnings and directions are absent. -if the label does not have the name and place of business of the manufacturer. -fails to carry a “Warning – May be habit forming.” if it is habit forming. | |
NDA - New Drug Application | When a drug is in the process of being made or discovered, this application must be filed with the FDA to prove efficacy and safety before being commercially available. | |
Durham - Humphrey Amendment | -Separates drugs into 2 categories: LEGEND AND NON-LEGEND (OTC) -Also called the “Prescription Drug Amendment” -Allows verbal new prescriptions to be called in over the phone and allows refill okays to be done over the phone. | |
Legend | Requires a prescription because the person requires supervision of a physician. The stock bottle is not required to have directions of use but must have on bottle label, “Caution: Federal law prohibits dispensing without a prescription.” | |
Non legend | Requires that all products to have directions of use. Does not require a prescription. | |
Kefauver - Harris Amendment | - Regulates proper drug advertising and package inserts issued by the manufacturer -manufacturers to: register annually be inspected every 2 years report any drug reactions -all medication on the U.S. market to be pure, safe, and effective. | |
PPI’S - Patient Package Inserts | - Regulated by the FDA - Must supply a PPI to patients receiving the following medications Estrogen, Progestin, Intrauterine devices | |
Occupational and Safety Act | ensures a safe and healthful workplace for employees by reducing hazards in the workplace. Audits show compliance. must have Material Safety Data Sheets (MSDS) for any “hazardous materials” in pharmacy | 1970 |
Poison Prevention Packaging Act | requires pharmacies must use child resistant containers (and most OTCs) | |
Poison Log | name and address of purchaser name and quantity of poison dispensed reason full name of dispenser Poison substances: complete name of poison “POISON” boldly imprinted on label place of business of the seller directions of use | |
Controlled Substance Act | regulated by the DEA regulates use and distributes drugs with high abuse potential and/or addiction into one of five schedules (CI – CV) | 1970 |
Codeine | SCh 2 Codeine | Sch 2 |
Cocaine | Cocaine Sch 2 | Sch 2 |
amphetamine/dextroamphetamine | Adderal Sch 2 | Sch 2 |
crack cocaine | Neurocaine, Goprelto, Numbrino | Sch 1 |
crystal methamphetamine | Desoxyn | Sch 1 |
ecstasy | MDMA, Adam and XTC, | Sch 1 |
hashish | Hashdiacetylmorphine and diamorphine | Sch 1 |
heroin | Sch 1 | |
LSD | Sch 1 | |
marijuana | Sch 1 | |
mescaline | Peyote | Sch 1 |
PCP | phencyclidine | Sch 1 |
peyote | Mescaline | Sch 1 |
meperidine | Demerol | Sch 1 |
dextroamphetamine | Dexedrine | Sch 1 |
hydromorphone | Dilaudid | Sch 1 |
methadone | Dolophine | Sch 1 |
fentanyl | Duragesic | Sch 1 |
morphine | MS Contin | Sch 1 |
oxycodone | Oxycontin | Sch 1 |
APAP + oxycodone | Percocet | Sch 1 |
ASA + oxycodone | Percodan | Sch 1 |
methylphenidate | Ritalin | Sch 1 |
secobarbital | Seconal | Sch 1 |
hydrocodone + APAP | Vicodin, Lortab | Sch 3 |
codeine + APAP | Tylenol with Codeine | Sch 3 |
ASA + codeine | Empirin #3 | Sch 3 |
hydrocodone | Hycodan | Sch 3 |
ibuprofen + hyrdocodone | Vicoprofen | Sch 3 |
chlorpheniramine + hydrocodone | Tussionex | Sch 3 |
carisoprodol + codeine | Soma with codeine | Sch 3 |
hydrocodone + guaifensin | Hycotuss | Sch 3 |
lorazepam | Ativan | Sch 4 |
flurazepam | Dalmane | Sch 4 |
propoxyphene + APAP | Darvocet N | Sch 4 |
alprazolam | Xanax | Sch 4 |
diazepam | Valium | Sch 4 |
clorazepate | Tranxene | Sch 4 |
pentazocine-naloxone | Talwin NX | Sch 4 |
pentazocine | Talwin | Sch 4 |
temazepam | Restoril | Sch 4 |
clonazepam | Klonopin | Sch 4 |
triazolam | Halcion | Sch 4 |
phentermine | Fastin | Sch 4 |
Are C2's allowed to be refilled? | no, they require a new prescription each time. |