Pharmacy Law Flashcards
1
Q
Pure Food and Drug Act
A
- 1906
- Prohibits the interstate transportation/sale of adulterated/misbranded food/drugs
2
Q
Food Drug and Cosmetic Act
A
- 1938
- Creates the Food and Drug Administration
- All new drug applications must be filed with the FDA
- Defines adulteration and misbranding
3
Q
State vs. Federal Law
A
- Federal law takes precedence unless state law is stricter
4
Q
Adulteration
A
- Composed in whole or part of any filthy, putrid, or decomposed substance
- Prepared, packed, or held in unsanitary conditions
- Prepared in containers composed in whole or part of any poisonous or deleterious substance
- Containing unsafe color additives
- Claimed/represented to be a drug recognized in an official compendium, but differing in strength, quality, or purity
5
Q
Misbranding
A
- Containing any false/misleading info
- Failure to have the name and place of business of the manufacturer/packer/distributor, accurate quantity of contents, or any other required info clearly and conspicuously displayed
- Failure to have warning “Warning: may be habit forming”
- Failure to have the established name of the active ingredients and quantities if there are multiple ingredients, quantity of alcohol, and established name and quantity of any other required substance
- Failure to have adequate directions for use or warning against use in certain pathological conditions
- If the drug is hazardous to health due to the manner of use, dosage, or duration recommended/prescribed/suggested by the label
6
Q
Durham-Humphrey Act
A
- 1951
- All drugs must have directions for use or warning “Caution: Federal law prohibits dispensing without a prescription”
- Separates legend and non-legend drugs
- Prescriptions may be verbally received via phone
- Refills may be called in by physician’s office
7
Q
Kefauver-Harris Act
A
- 1962
- All meds must be safe, pure, and effective
8
Q
Comprehensive Drug Abuse Prevention and Control Act
A
- 1970
- Creates the Drug Enforcement Agency under the Department of Justice
- Places controlled substances in 5 schedules based on accepted medical use and potential for abuse
9
Q
Schedule I
A
- No medical use, very high abuse potential
- Crack cocaine
- Crystal methamphetamine
- Ecstasy
- Hashish
- Hash oil
- Heroin
- Marijuana
- Mescaline
- Opium
- Phencyclidine Palmitate
- Peyote
- Psilocybin
- Rohypnol
10
Q
Schedule II
A
- Accepted medical use, high psychological or physical abuse potential
- Adderall
- Amytal
- Cocaine
- Codeine
- Demerol
- Dexedrine
- Dilaudid
- Dolophine
- Duragesic
- Morphine Sulfate
- Numorphan
- OxyContin
- Percocet
- Percodan
- Ritalin
- Seconal
- Tylox
11
Q
Schedule III-V
A
- III - lower abuse potential
- IV - even lower abuse potential
- V - lowest abuse potential, includes exempt narcotics
12
Q
DEA Registration
A
- Must be registered with DEA to dispense controlled substances
- Use DEA form 224
- Must be renewed every 3 years
13
Q
Schedule II Ordering
A
- Person registered with DEA must fill out DEA form 222 with typewriter/pen/indelible pencil
- DEA form 222 is valid for 60 days
- Must be one item per line, max of 10 per form, totaled at bottom
- Unused forms to be kept in secure location in pharmacy
- Upon receipt, number or packages to be recorded on retained copy of form which is also to be signed and dated
- Invoice and form kept for 2 years in secure location
14
Q
Schedule III-V Ordering
A
- Can be ordered by fax, telephone, writing
- Invoice must be signed, dated, stamped with red C
- Must be kept in secure location for 2 years
15
Q
DEA Records
A
- Must be kept for 2 years and readily retrievable
- Readily retrievable = separate from other business records or designated with a visual indication (red line/asterisk), a red C must be stamped on schedule III-V invoices if filed with others
- Must be given to DEA agent within 72 upon request
16
Q
Defective DEA forms
A
- Incomplete, illegible, or showing signs of alteration, erasure, or change
- Must be readily retrievable and kept for 2 years
17
Q
Controlled Substance Inventories
A
- Initial - taken before the opening of the first business day, a complete and accurate count of all controlled substances
- Biennial - taken every two years, an exact count of schedule II and estimate of schedules III-V, records must be kept for 2 years
- Perpetual - records drugs received, supplied to other locations, returned to pharmacy, and dispensed to patient, shows the actual number of units of a drug at a particular time
18
Q
Return of Controlled Substances
A
- Can be returned only between DEA registrants
- Use DEA form 222 for schedule II
- Cannot be returned from long-term care facilities which don’t have DEA numbers
19
Q
Destruction of Outdated/Damaged Controlled Substances
A
- Use DEA form 41 to record name, strength. and quantity of the drug, as well as, date and method of destruction and witness
- Retail pharmacies have one form 41 per year
- Hospitals may have blanket authorization
20
Q
Theft of Controlled Substances
A
- Must be reported to the nearest DEA division office and local police
- Use form 106 and retain a copy
21
Q
Filling of Schedule II
A
- Computer generated or handwritten, signed by physician in pen
- No refills
- Can be partially filled if remaining amount is available within 72 hours, but a new prescription is needed for additional quantities after 72 hours, pharmacist should notify physician if unavailable
- Can have emergency filling, can be an oral prescription, good faith attempt must be made to identify the physician, only the amount required to treat the patient at that time, reduced to writing by pharmacist, physician must write a prescription that is received within 7 days
22
Q
Filling of Schedule II in Long-Term Care Facilities
A
- Prescription may be faxed and treated as original, but must be retained
- Partial filling is allowed for patients in a long-term care facility or diagnosed with a terminal illness for 60 days unless prescription is discontinued sooner
- Note must be made on prescription that it’s for a long-term care facility/terminally ill patient or it violates federal law
