Federal Laws And Rules Flashcards
1938 Federal Food, Drug, and Cosmetic Act
Safety standards only; no efficacy
1951 Durham-Humphrey Amendments
Created OTC and Rx categories
Certain insulins are OTC - humulin/novolin N, R, 70/30, 50/50
1962 Kefauver-Harris
Requires efficacy in addition to safety
1976 Medical Device Amendment
Added regulatory authority over device
1983 Orphan Drug Act
Incentives to create drugs for rare diseases - gives those companies longer patent life
1984 Drug Price Competition and Patent Restoration Act
Patent holders received 5 years of patent life because of the FDAs process to review drug apps
Stopped having to reshow efficacy again
1988 Prescription Drug Marketing Act of 1987
Banned reimportation of Rx drugs
Banned sale, trade, and purchase of Drug samples
- ok to have OTC samples ONLY in pharmacy but cannot sell or trade
1997 FDA Modernization Act
Requires “RX Only” on prescription legend, clarify between compounding/manufacturing
1999 OTC Labeling requirements
Standardized OTC labeling
Define Adultered
Makeup or composition of drug - filthy substance - contamination - unsafe color additive - strength difference (5% ok) Misfilled: drug has been substituted
Define Misbranded
Refers to drug labeling False or misleading Manufacturers requires: - name/address - quantity - strength - information for use - warnings - expiration
Counterfeit drugs
Pharmacist filling without authorization from prescriber
No child resistant caps
Define OTC label requirements
IN QWDP
Identification Name/address Quantity Warnings Directions (laymans) Panel - active/inactive ingredient - purpose - indications - warnings - directions - other - questions?
Prescribed OTC dose higher than OTC limits - what is needed?
Must be written and filled as a prescription
Recalls - does the FDA have authority to recall drugs?
No, only devices
Recall Classes
Class I - reasonable probability to cause serious AE or death
Class II - may cause temporary or reversible AE
Class III - not likely to cause AE
Pregnancy categories
Changing from A, B, C, D, X to three categories
Pregnancy
Lactation
Male/female reproductive capability
Plan B rules - what age group is it available to?
CONSUMERS 17 years or older OTC
WOMEN 16 years and younger by Rx
1906 Pure Food and Drug Act
Purity standards only, no efficacy required
What are exceptions for having Rx samples?
- Charitable organizations - nonprofit
- Hospital/clinic
- Indigent or low income pts at no or reduced costs
What did the Food and Drug Administration Amendment Act of 2007 establish?
REMs program - risky evaluation mitigation strategy
Drugs Requires side effects and toll free number statement
What does the FDA NOT regulate?
Does NOT regulate practice of medicine, pharmacy
Regulates drugs, food, cosmetics, medical devices
Define Biological products
Isolated from natural sources
Define “drug”
Recognized in USP, intended for use in diagnosis, cute, mitigation, treatment, or prevention of disease in man or animal
NOT food
Special warnings: yellow no. 5 tartrazine and no. 6
Must disclose presence and may cause allergic reactions
Special warnings : aspartame
Phenylketonurics: contain phenylalanine
Special warning : sulfite
Disclose and allergy warning
Special warning: mineral oil
Only take at bedtime
No infants unless under physician supervision
Cannot encourage use during pregnancy
Special warnings: wintergreen oil - methyl salicylate
If more than 5%, must include warning that if used other than directed may be dangerous
Keep out of reach of children
Special warning : Ipecac syrup
Must be boxed and red : for emergency use to cause vomiting in poisoning
Only sold in 1 is (30 ml) containers
Warning : keep out of reach of children. Do not use in unconscious persons
Dosage > 1 year old is 1 tablespoon PO
Fluid extract is 14x as potent as syrup
Special warning : phenacetin
Possible kidney damage
Special warning : salicylates
Reye’s syndrome in children
Pediatric ASA 1 1/4 grain (81mg) - no more than 36 tablets in container
Special warning : Tylenol
Prominently displayed
Warnings for potential liver toxicity, use over recommended dose, using multiple APAP products, and with alcohol
Ask doctor before use with liver disease or warfarin
Special warnings: NSAIDs
NSAID must be prominently displayed
Stomach bleeding warning
Ask doctor before use if at increased risk for stomach bleeding
Who regulates prescription drug ads?
FDA
Who regulates OTC drug ads?
FTC - federal trade commission
Who regulates pharmacy advertising and how?
FDA - compounding pharmacies advertising compounded medications cannot advertise therapeutic claims
What is drug price advertising and how can it be exempt from FDA regulations?
“Reminder advertising” - exempt if conditions are met:
- provide price info with no info on safety, efficacy, or indications
- contains brand name if any, generic, strength, form or price charged
- may include availability of professional service as long as not misleading
- price includes all mailing free and delivery but may be stated separately
What must be packaged in tamper-evident packaging?
All OTC except for dermatological, dentifrice, insulin, or lozenges for retail sale
Any two-piece hard gelatin capsule must be sealed
All repackaging and resale are subject to same labeling requirements
Describe the three FDA enforcement methods
- Civil procedure - seizure
- Civil procedure - injunction or restraining
- Administrative action - regulatory letter to cease distribution and notify health professionals and users
Describe patient package inserts and when they are required
Written for patient to understand
- oral contraceptives
- estrogen products
- progesterone products
- for both new and refill prescriptions
- failure to provide = misbranding
In hospital - same as community or prior to 1st administration AND every 30 days after
Which drug classes and biologicals require Medication Guides?
Accutane - isotretinoin Antidepressants in children/teens Long acting opioids Coumadin Forteo - teriparatide - osteosarcoma Lindane Lotronex - alosetron - constipation Nolvadex - tamoxifen NSAIDS Remicade - infliximab Trizivar - abacavir, lamvudine, zidovudine Actiq - IR fentany
Which drugs have REMs?
Mifepristone - mifeprix Accutane - isotretinoin Clozapine - clozaril Lotronex - alosetron Thalomid - thalidomide Tikosyn - dofetilide Tracleer - bosentan Xyrem - GHB Tysabri - natalizumab
REMs for Mifepristone
Should not be dispensed from pharmacies
REMs for Accutane
IPLEDGE
“Responsible pharmacist registered”
Auth to dispense via phone or web
Rx picked up within 7 days of pregnancy test
If not, must be reversed by accessing iPLEDGE
30 day supply
No refill
REMs Clozaril - clozapine
Monitor for fatal rxn of agranulocytosis
May only dispense enough until next blood test
REMs Lotronex - alosetron
Only for women with severe D-prominent IBS
- requires sticker affixed
REMs for Thalomid - thalidomide
STEPs program
REMs Tikosyn - dofetilide
Only available to retail pharmacists in TIPs
- verify physician participated in educational program
- stamp
REMs Tracleer - bosentan
For pulmonary arterial hypertension
Monitor for liver toxicity through TAP
REMs Xyrem - GHB
Only processed through centralized pharmacy
Med guide required
REMs Tysabri - natalizumab
TOUCH program
- only available to those who register
- MRI required
- status report to manufacturer
What is the time frame for record keeping ?
2 years - FDA, DPS/DEA, TSBP
3 years - exception for CE ACPE certs, Medicare part D original copy (electronic for 10 years)
What is the difference between compounding and manufacturing?
Compounding is a process done by the pharmacy and manufacturing is done by the manufacturer and regulated by the FDA
What is the primary source for determining generic equivalency?
FDA Orange Book - Approved Drug Products with Therapeutic Equivalence Evaluations
Describe the coding system of FDA Orange Book
A = equivalent B = not equivalent AB = necessary bioequivalent only to other drugs coded as AB AA = conventional dosage forms (Oral) AN = aerosolization AO = injectable oils AP = injectable aqueous AT = topical
When is a substance considered highly toxic?
When a single oral dose of 50mg or less per kg body weight will kill half of rats
Who administers and enforces the Poison Prevention Packaging Act?
Consumer Product Safety Commission CPSC
What is the purpose of the Poison Prevention Packaging Act? What are the requirements? Does it cover dietary supplements?
Child resistant containers
No more than 20% of child test group can open package after demonstration and/or if more than 10% of adults cannot
Cannot be reused
No to dietary supplement
What are general exceptions to child resistant containers?
Patient or physician can request (does not need in writing)
Patient can request as a blanket, physician cannot
Bulk containers
Institutionalized patients
One OTC size to elder with label “not for households with children”
What are OTC drug exceptions to child safety caps
ASA/APAP effervescent
Which OTC need child resistant caps?
Methyl salicylate > 5% Methanol > 4% unless in pressurized can spray Iron > 250mg Benadryl > 66 mg NSAIDs
All Rx drugs require child safety caps except for:
SL NTG
SL/chewable isosorbide dinitrate
What are US postal regulations?
Non controlled may be mailed by physician or pharmacist
- no alcoholic beverage, poisons, flammable
Controlled (narcotic/nonnarcotic II-V)
- can’t identify contents (no names)
What is PHI?
Protected health information (TPO)
Treatment
Payment
Operations
Cannot release for marketing purpose
What are patient rights associated with PHI?
Access - right to inspect/obtain PHI, 30 days
Amend - right to amend PHI, 60 days
Accounting - accounting of disclosures except for TPO, authorization figure, national security, correctional facility, law enforcement
- exempt: HITECH- must disclose all entities that maintain electronic records
What does “minimum necessary” not apply to?
Treatment purposes - Rx transfers, Rx information to physicians
If authorization was signed by patient
What is OBRA90?
Expansion of Medicaid
Mandatory prospective DUR and patient counseling
What are the penalties for HIPAA Violations?
If entity did not know: $100; $25,000
If reasonable/not negligent: $1000; $100,000
Willful neglect
- corrected
What does HIPAA Security pertain to?
Electronic information
HITECH Act pertains to?
Includes Business Associates
How many days must covered entities provide patients EHR that have a written request?
15 days
