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LAws and regulations

PTCB laws and stuffs

LawDefinitionYear
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.
Created by: PanKrepe
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