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88 Cards in this Set

  • Front
  • Back
Pure Food & Drug Act of 1906
can't sell or transport impure food or drugs
Food, Drug, and Cosmetic Act of 1938 (FCDA 1938)
FDA - new drugs must be filled with the FDA
FCDA - rectify adulterated or misbranded drugs
Durham-Humphrey Act of 1951
-All drugs must contain directions of usage unless if it is a legend, federal drug
-Legend-need prescription
-Non legend OTC (no prescription)
-Allow refilles on teh phone
-Allow Doctor's prescription on the phone
Kefauver-Harris Amendment of 1962
All medications must be safe, pure, and effective
Comprehensive Drug Abuse Prevention and Control Act of 1970
The DEA (Department of Enforcement Agency) was created by the Department of Justice to ensure that all controlled substances are placed in 5 categories for potential abuse and accepted medical use in the US.
Schedule I Drugs
Not accepted as medical use in US because of high abuse potential
Schedule II Drugs
Has medical use but high drug abuse potential or psychological physical dependency
Adderall
amphetamine & dextramphetamine II
Amytal
amobarbital II
Cocaine
cocaine II
Codeine
codeine II
Demerol
meperidine II
Dexedrine
Dextramphetamine II
Dilaudid
hydromorphone II
Dolophine
methadone II
Duragesic
fentanyl II
Morphine Sulfate
morphine II
Numorphan
oxymorphone II
Oxycontin
oxycodone II
Percocet
acetaminophone & oxycodone II
Percodan
acetaminophan & oxycodone II
Ritalin
methyphenidate II
Seconal
secobarbital II
Tylox
acetaminophen & oxycodone II
Schedule III
accepted medical use with potential drug abuse (less than schedule I & II)
Schedule IV
Drug abuse is less than Schedule III but may lead to limited physical & psychological dependency
Schedule V
Less than IV with the exception of narcotics
Drug Enforcement Agency Registration
Pharmacy must register with Form 224 with the DEA every 3 years when they deal with controlled substance
Schedule II (Ordering and receipt)
Form 222
Valid for 60 days
Copies of drugs be stored in a min of 2 years
Retention of Drug Enforcement Agency Records
Be readily retrievable
For records III to V, must be marked with a red C
Must be available within 72 hours after a DEA representative ask for it
Defective Forms
Incomplete or illegible
Has been altered
Keep for a min of 2 years
Initial Inventory
Complete inventories before the first business day of the pharmacy store
Perpetual Inventory
actual number of drugs at a particular store
Ambien
zolpidiem IV
Anexia
acetaminophan & hydrocodone III
Ativan
lorazepam IV
Bontril
phendimetrazine III
Butisol
butabarbital IV
Cylert
pemoline IV
Dalmane
flurazepam IV
Davocet
acetaminophen & propoxyphene IV
Dravon
propoxyphene III
Empirin with Codeine
aspirin with codeine III
Equanil
meprobamate IV
Fastin
phentermine IV
Fiorcet with Codeine
acetaminophen
butalbital
caffeine
codeine
IV
Fiorinal
aspirin
butalbital
caffeine
IV
Fiorinal with Codeine
aspirin
butalbital
codeine
caffeine
IV
Halcion
triazolam IV
Hycodan
hydrocodone III
Hycomine Compound
hydrocodone
chlorphenramine
phenylephrine
acetaminophen
caffeine
III
Hycotuss
guaifenesin
hydrocodone
III
klonopin
clonazepam IV
Lorcet
acetaminophen & hydrocodone III
Lortab
acetaminophen & hydrocodone III
Noctec
chloral hydrate IV
Phenobarbital
phenobarbital IV
Restoril
temazepham IV
Soma with Codeine
carisoprodol & codeine III
Sonata
zaleplon IV
Stadol
butorphanol IV
Talwin
pentazocine IV
Talwin Nx
pentazocine & Naloxone IV
Tenusate
diethypropion IV
Tranxene
chlorazepate IV
Valium
diazepam IV
Xanax
alprazolam IV
Return of Controlled Substance
DEA registrants only
Form 222 for transferring medicine
Long term facilities cannot accept these medications
Destruction of Outdated or Damaged Controlled Substances
Form 41, once a year with regular pharm facilities
Hospitals use blanket authorization
Theft of Controlled Substances
Form 106, own copy and other copy for DEA
Filling of Controlled Substances
Schedule II Only
Within 72 hours = refills only
After 72 hours = new prescription
Emergency Filling of Schedule II Drug Prescriptions
Pharm must be notified within 7 days
Oral Prescription
Must be in writing
Schedule II Drugs in Long Term Care Facilities
Must be in written form (even fax)
May provide up to 60 days
Labeled as "terminally ill patients" or "long term facility patient"
Schedule III to V Drugs Prescription
Doctor's Signature
5 refills in the next 6 months
Exempt Narcotics
Must be at least 18 years or older
May only order cough or anti-diarrhea pills
Narcotics Exempt Form
-Date
-Name of purchaser
-Address of purchase
-Name & quantity of product
-Pharm's signature & price of transaction
Only 1 bottle within 48 hours
Prescription Monitoring Programs
II, III, IV drugs are not used by computers
Transferring of Controlled Sub Prescriptions
VOID & Transfer
-Include name, address, DEA # of pharmacy, date, and pharmacist's name
-Keep in records for 2 years (original and transfer)
Poison Prevention Packaging Act of 1970
Child Resistant Containers
Children Under 5 = 80% can open
Adults = 90% can open
Exceptions for Child Resistant Containers
Non-compliant size or one time dispensers
Occupational Safety and Health Act (OSHA) of 1970
Health & safety
Orphan Drug Act of 1983
Less than 200,000 case studies
Exclusive licensing and tax incentives
Drug Price Competition and Patent Term Restoration Act of 1984
Streamlining between generic and new drugs by extending patent licenses
Omnibus Budget Reconciliation Act of 1987 (OBRA-87)
-extensive revision of Medicaid and Medicare of long term facility and hospitals
-patients must be free of unnecessary drug prescription
-anti psychotic drug must be given gradually
-Long term and emergency drugs must be granted
-Pharm to be there for long term facilities
-Correctly labeled
-Correct temp
Prescription Drug Marketing Act of 1987
Vet & licensed individuals can prescribe
No reimported drugs back to the US
Anabolic Steroid Control Act of 1990
Harsher punishment for athletes for use the steroid drugs
Omnibus Budget Reconciliation Act of 1990 (OBRA-90)
-Provide the lowest price possible to Medicaid patient (price should be between average to lowest price)
-Provide "offer to counsel" to patients
-Participate in gov-sponsored projects
FDA Safe Medical Devices Act of 1990
Track and recorded to see if they are durable `
Americans with Disabilities Act (ADA) of 1990
employers must have reasonable accommodation for employee