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