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ZFederal Law1

ZFederal Law

A few exemptions from DEA registration Public Health Service Practitioners, Bureau of Prisons Practitioners, Military Service Practitioners (AG can deny)
Which form is used for new pharmacy and physician registration? DEA 224
Change of address requires new registration, T/F? True
If there is a transfer of business how many days prior to the move must the DEA be notified? 14 (name address, and DEA # of old business AND new business)
DEA # verification AB1357210 1+5+2=8; 3+7+1 =11x2=22 +8 =30; the zero at end is verified by the zero at end of DEA #
T/F Records for CII must be kept separate from other records True
3 types of records Inventory, drugs received( invoices for C3-C5 and DEA222 for C2), and drugs dispersed
Which form is used if theft or loss occurs? DEA 106
Form for drugs surrendered for disposal DEA 41
Requires all OTC and prescription drugs be subject to special packing requirements Poison prevention packaging
Established 2 classes of drug, prescription and OTC Durham Humphrey
Required drugs be proven safe and effective Kefauver harris
Mandates increased recordkeeping for physicians and pharmacists who dispense narcotics harrison narcotic act
Individually identifiable health info addressed under the privacy rule PHI
Established a formal definition of dietary supplements using several criteria DSHEA
Official compendia of active ingredients USP
Established a fast track approval process for srugs intended for serious life threatening diseases FDAMA
A key component in OBRA 90 that pharmacists must offer counseling to patients Prospective DUR
Act that provides storage, handling, and recordkeeping for drug samples Prescription drug marketing
Act regarding safety and efficacy of medical devices according to their function Medical devices
Intent was cost savings and better fiscal mgmt of medicare/ Medicaid
Provide tax incentives for manufacturers to develop drugs for rare disease Orphandrug
Established to ensure security and dprivacy of patients medical records when electronically transmitted HIPPA
Authorized batch certification on insulin and penicillin FDCA
Dept of health and human services is an example of what kind of agency? Federal administrative; responsible for Health Care Financing Admin and FDA
Fair Trade Commission is what kind of agency? Federal administrative; drug advertising
US Justice Department Fed admin agency; DEA
State Board of Pharmacy puts in details for legislatures framework No answer
4 types of law Criminal (person vsgov) ; civil (person vs person);administrative (created/ enforced by gov agencies); common law( no specific statute)
A pharmacist who unintentionallyharms a patient through inattentiveness or carelessness can be considered legally negligent “tort”; civil or criminal? Civil
Failing to do something that a reasonable person would do omission
doing something that a reasonable person would not do Commission
a violation of the legal obligation to an individual; ex: misfilling a prescription Breach of duty
a reasonable standard of care while performing any acts that could potentially harm others Duty owed
Proof that pharmacists misconduct caused the alleged damage Causation
Loss or injury to a person or property Damage
4 elements of negligence (all 4 needed to be legally liable) Duty owed, breach of duty, causation, damage
Definition of “drug” Habit forming OR not safe w/o supervision OR is limited by application to be used under supervision
cGMP Current good manufacturing practices
Drugs recognized among experts to be safe and effective OTC drugs; must contain adequate directions for use and comply with cGMP
Obtaining FDA Pre-marketing drug approval; new use for previously approved drugs New Drug Application
once the patent on an approved parent drug product expires, the FDA allows manufacturers of generic products to submit a what? ANDA ANDA
ANDA Abbreviated New Drug Application; no safety or efficacy data required; have to prove it’s the same bioequivalence
Formulation change or change to written material of product goes thru what process? SNDA (Supplemental New Drug Application)
OTC monograph OTC’s broken down into categories instead of making each go thru FDA process; list of safe products that can be used in a new product
11 digit, 3 segment number identifying all drug products NDC (National Drug Code); required on all OTC AND prescription labels
First section of National Drug Code manufacturer or distributor
Second section of NDC “product”
Third section of NDC “packaging”
Concerned with physical condition of drug or device Adulteration; unsanitary, etc
Concerned with representation made by the manufacturer regarding drug or device misbranding
False or misleading label, inadequate directions for use, doesn’t warn of possible habit forming misbranding
Not in conformance with GMP, poisonous container, unsafe color additives, not tamper resistant Adulteration
Insulin or antibiotic that is not batch certified is an example of what? Misbranding; every batch tested for strength and quality
Label vs labeling Label is attached to actual container and labeling refers to all accompanying info; package inserts etc
Patient information program ( 2 parts of program) MedGuides and Consumer Medication Information (CMI)
Manufacturers are required to provide these for drugs that pose a “serious and significant” concern to the public, Requires FDA approval MedGuides of Patient Info Program; Manufacturer provides to dispenser, dispenser provides to patient
Mandated that written information is provided to the patient for every drug every time a new prescription is dispensed Consumer medication Information (CMI); Patient Information Program
Which class of product recall is most serious? Class I, irreversible damage/ death; class II reversible damage; class III often mislabeling; FDA does tell public which class
T/F; Pharmacists have to know which products have been recalled? True
Product recall withdrawal process Manufacturer contacts seller; seller contacts consumer- manufacturer or FDA may initiate recall
set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packing, or holding of a drug product GMP
The intent of the GMP is to do what? Ensure safety of drug and that it meets quality and purity requirements; adulterated if not in accordance with GMP
Manufacturers are inspected by FDA how often? Every 2 years
“Approved Drug Products with Therapeutic Equivalence Evaluations” Orange book
Two-letter coding system for the therapeutic equivalence; first letter is either an A or a B First letter=A; equivalent- first letter B; not equivalent
In the A/B equivalence coding system, the second letter means what? Gives info about dosing- ex: oil or aerosol
MedWatch and VAERS (Vaccine Adverse Event Reporting System) are part of what? Voluntary Reporting Programs
Pharmacists must provide: “Call your doctor for medical advice about side effects; You may report side effects to the FDA at 1-800-FDA-1088” Voluntary Reporting Programs
Clinical trials Phase I healthy patients; detect adverse side effects; doesn’t determine efficacy
Clinical trials phase II Written consent from patients who have the disease; determine efficacy and dosage
Clinical trials phase III Verbal consent; large studies; strict criteria; risk to benefit analysis
Clinical trials phase IV Post marketing surveillance; FDA can rescind NDA approval
1820 first group of physicians gathered info about drugs, created a compendia standard of drugs US Pharmacopia
Monographs of inactive ingredients NF (National Formulary)
USP and NF joined into 1 compendium for drug standards USP/NF; meet every 5 years to review
HPUS is what? Homeopathic pharmacopeia of the US; compendium for homeopathic (natural) products
Prohibited the adulteration/ misbranding of drugs; not required to list ingredients; no authority to ban drugs Pure Food and Drug Act of 1906;misleading claims were not prevented; only prevented false statements about drugs identity
Required prescriptions for narcotics and mandated record keeping for physicians and pharmacists Harrison Narcotic act of 1914
Authorized batch certification AND required new drugs to be proven safe before marketed Food, drug, and cosmetic act of 1938
Established 2 classes of drugs; required drugs to be labeled durham- Humphrey; must contain “ federal law prohibits dispensing without prescription
Adequate info vs adequate directions OTC require adequate directions for use (clear and specific), prescription meds require adequate information in health care provider lingo
Required drugs to be SAFE and EFFECTIVE; established GMP Kefauver- Harris
Established advertising procedures Kefauver- Harris; legend (prescription drugs)=FDA ; OTC= Federal trade commission
Special packaging and child resistant packaging Poison prevention packaging act (not required if patient request or physician prescribes)
Medical Devices Act: 3 classes according to function Class I, low risk (bandaids, no testing); Class II,must be evaluated (hearing aids); Class III, life supporting devices(pacemaker) pre-market approval
Tax/ licensing incentives for manufacturers to develop and market drugs for rare diseases Orphan drug act
Extended patent to 5 years after FDA approval; streamlined generic drug approval process Drug Price Competition and Patent Term Restoration Act
Requirements for samples Prescription Drug Marketing Act
Intent was cost saving/ better mgmt of Medicaid and medicare; required drug use review OBRA 90 (Omnibus Budget Reconciliation Act)
3 components of OBRA90 Rebates, innovation, drug utilization review
3 components of DUR Screening prescriptions prior to dispense, patient counseling, and pharmacist documentation of relevant info (allergies etc)
Annual Fees on manufacturers; allowed more FDA employees and faster drug approval Prescription Drug User Fee Act
Definition of dietary supplement (Dietary Supplement Health and Education); product other than tobacco; vitamin, mineral, herb, amino acid orcombo of these
Required labels to say “This statement has not been evaluated by the FDA, not intended to diagnose etc DSHEA
Fast track approval for life threatening disease; data base for clinical trials; panel review; “off-label”uses FDAMA (Food and Drug Administration Modernization Act
Incentives for creating PEDIATRIC clinical studies FDAMA; also regulates pharmacy coumpounding
Designed to stimulate additional research into pediatric data for pharmaceuticals Best pharmaceuticals for children act
FDA requires research on certain drugs before licensing;ex:Pediatric studies prior to marketing Pediatrics Research Equity Act
Gives FDA more authority to remove unsafe dietary supplements (DS) and OTC products Dietary Supplement and nonprescription drug protection act; also requires manufacturer to submit reports of serious adverse effects
Examples of individually identifiable health info Name, address, ss#, or a combo of things: zip code +DOB+unusual diagnosis
Organizations privy to patient PHI covered entities
Covered entities: health plans, clearing houses(billing etc), electronic transmission by health care provider
Enforces HIPPA Office of Civil Rights; civil penalties 25k,criminal penalties 50k, intent to sell 250k and prison
CSA Controlled Substance Act; enforces by DEA (agency of US dept of Justice)
Goal of this act is to trace controlled substances and prevent diversion CSA
Controlled drugs/ scheduled drugs: Potential for addiction and abuse
Narcotic controlled substance is defined as? Natural or synthetic opium or opiate and any derivative, poppy straw, coca leaves, cocaine; narcotic CS and CS are regulated same way
Who has the authority to place a schedule on a drug? US attorney general
Used in research; high potential for abuse; no current accepted medical use C I (Schedule I)
Manufacturers and distributors register with the DEA how often? Annually
Dispensers (doctors and pharmacies) are required to register with the DEA how often? Determined by AG; 1-3 years. nevada is 2 years
Dispense: to deliver a controlled substance to the ultimate user (patient)
Inventory of CII is required how often? perpetual; actual physical count
inventory of CS's is done how? initial and then every 2 years; doesn't need to be submitted to DEA but needs to be kept in records
Estimation can be made of CS inventory if? opened bottle holds less than 1000 units; must be counted if bottle holds more than 1,000 units
Disposal of CS DEA Form 41; DEA will instruct registrant how to dispose; transfer, deliver to DEA, destroy in presence of DEA, other DEA authorized means
If DEA allows, pharmacies can destroy outdated, damaged, unwanted CS; witnesses to destruction can be? pharmacist, licensed physician, midlevel practitioner, nurse or state/ local law enforcement
New pharmacy initially registers to order CS with which form? DEA form 224
DEA form 222 CI CII drugs, triplicate, serial #, states which schedules registrant is allowed to handle
Ordering CS CI and CII- DEA 222; CIII-V- invoice or packing slip with drug name, dosage and strength, number of units/containers; supplier info
Form 222 copies pharmacy keeps copy 3; forward copy 1 & 2 to supplier; supplier sends copy 2 to DEA; valid for 60 days
POA power of attorney designated by person who signed DEA registration; can sign 222 on behalf of the signer (requires 2 witnesses)
Pharmacist needs to mark if something not received or can face huge fine no answer
Can still use form 222 if minor error misspelled drug name, no date, package size (if only 1 package size available), strength (if only 1 strength). Supplier cannot fill in "last line completed"
Electronic ordering of CI-CV is allowed if? Digital certificate
CII must be hand written; III-V can be verbal or written State law more detailed
Oral Emergency CII prescription limited to unspecified period;must have written script from prescriber within 7 days or report dr. to DEA. Check State law
Fax requirements III-V is original as fax
CII can be a faxed "original" under what conditions? compounded for direct admin, LTCF, hospice
State Board determines if electronic prescribing is allowed not allowed for CII
Labeling requirements for CII-V date of dispense, pharmacy name/ address (phone not req), script #,patient/physician name, directions for use, cautionary statements
Partial filling: must be able to supply full amount within 72 hours or do what? notify prescriber, write on script how many were dispensedno further quantity may be supplied w/o a new script
partial filling of CII for LTCF patient; script is good for how mong? 60 days form date of issue
No refills allowed for CII no expiration under Federal Law p.61
CIII-IV expires? 6 months, no more than 5 refills
CV expires? 12 months, can prescribe as needed for refills
Multiple CII rx issued if? not more than 90 day supply; if 3 separate scripts are written for 30 days each, they must have instructions on fill dates
CII-CV must be stored where in a pharmacy? In Dr. office? pharmacy- locked cabinet or mixed in with other meds to deter theft. Dr office must have them in a locket cabinet
CII cannot be transferred; no refills CIII-CV can be transferred 1 time
Can a CS be mailed? Which classes? Any CS can be mailed as long as the package doesnt state whats in it
Can CS's be delivered or shipped out of country? Not without DEA "exporter" registration and export permit
OTC ephedrine etc is limited to how much? 3.6 g/ day or 9 g/ month; less if mail order
Created by: angieryx



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