PharmLaw 6

smoore020390's version from 2015-09-07 21:55


Question Answer
What branch of gov is FDA under?Executive
What branch of gov is DEA under?Executive
What does the executive branch do? Enforce laws
What does the legislative branch do?Make laws
What is an administrative agency?Part of the executive branch. Created by legislature. Yields power to administrative agencies and allows them to implement changes in policies or to administer law when legislature cannot perform
CMSCenter for Medicare and Medicaid Services. Federal admin agency.
Requirements for administrative agency regulations Within scope of agency's authority, for public health, safety, welfare, and base on statute that give authority


Question Answer
DrugArticles regonized in the US Pharmacopeia, Homeopathic Pharmacopeia of US, or official National formulation. Intended for use in the diagnosis, cure, mitigation, tx, or prevention of disease in man or other animals. Articles (other than food) intented to affect the structure or any function of the body. All included.
Is dispensing a counterfit drug a strict liability crime ?Yes! Even if contains active ingredient. No excuse of not knowing.
How is device different vs drug?Does not achieve primary intended purpose through chemical action in body and not dependent on being metabolized for its principle purpose
Is soap a cosmetic?No
What are adequate directions for use under FDCA that all manufacturers must provide?Qty or dose for each intended use and for persons of diff ages and physical conditions. Frequency, duration, time of administration or application, route or method, preparation necessary for use (shaking etc). Must also include indication, SEs, contraindications and other warnings
Who issues drug recalls?Can be done by FDA but manufacture should inform wholesalers then they notify pharmacy then consumers
What is difference between label and labelling?Label is what on outside of stock bottle. Labelling is label AND package insert (anything accompanying drug)
What does NDC mean?11 digit number, 1st 5 are the manufacturer, next 4 are drug product, last 2 are package size
Does it matter if you enter one NDC but then dispense another generic brand with a different NDC?YES! Correct brand not on label, MISBRANDING
What are the major offenses under FDCA?Adulteration and misbranding. Both strict liability


Question Answer
What is an adulterated drug under FDCA?Even if pure, if it may have been contaminated (if insulin kept out of fridge), container may have contaminated (fell on floor), manufacture didn't comply with CGMP, contains unsafe color additive, strength/quality/purity different from standards unless stated on label
Does adulterated drugs apply to pharmaciesPrimarily effects wholesalers (FDA mostly effects wholesalers) However, If pharmacy repackages or compounds meds for sale under certain conditions
MisbrandingFDA must approve exact wording of drugs label/labelling. If it is the wrong drug, wrong strength, wrong NDC. Needs to provide established name of drug, adequate directions for use, and adequate info for use.
What does CGMP (current good manufacturing practice) meanRegulations that establish minimum requirements for methods facilities or controls used to manufacture, process, package, or hold drug product
Tamper resistant packagingAn indicator or barrier to entry which if breached/missing, indicate to customers (not same as tamper proof)
To get new drug approved submit new drug application (NDA)Must submit substantial evidence that it is effective. Also adequate info that it is safe.
New Drug definitionFDCA - a drug not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drugs labelling
Drugs marketed before when are exempt from providing safety or efficacy data?1938 if marketed in accordance with labelling requirement that existed then
How does an approved drug become new drug?New substance (inactive active anything), new combo of prev app drugs, different proportion of ingredients in combo drug, new intended us of drug, dose, method, or duration of admin changed (IR to XR etc)
Investigation New Drug Application (IND)Manufacturer submits to FDA. Name and composition of drug. How manufactured/qlty control and info from preclinical (animal investigations). List experience/qualifications of investigators and study protocol. Want to ensure safety of humans
Phase I TrialHealthy volunteers. Determine ADRs
Phase II TrialSmall number with disease. Determine efficacy and safety
Phase III TrialDetermine efficacy and safety in large number
NDA is submittedAfter phase III of trial
How long does FDA have to act on NDA?180 days under PDUFA (doesn't usually happen)
After NDA approved, if manufacturer wants to make change to production of drugFDA must approve BEFORE change is made


Question Answer
After NDA approved, if manufacturer wants to make labelling changes (strength warnings or dose/admin info)Manufacturer can do a change being effected supplement. Can implement before FDA approves.
How are OTC-drugs regulated?Rule-making
Class I OTCsafe/effective
Category III OTCtake off market
Do biologics need an NDA?Yes! But licensed by PHSA
Medwatchreporting to FDA ADRs or probs with drugs


Question Answer
With new drugs, how classified as Rx (vs OTC?)If they have 1/3 - toxicity/potential for harmful effect, or the method of its use, or collateral measures make it not safe unless under supervision
How to make OTC to RxFDA must prove that toxicity, method of use and collateral measures make it necessary
Labeling requirements under federal lawName, address of dispenser, serial # of rx and date or Rx or its filling, name of prescriber and if stated on Rx name of pt, directions for use and cautionary statements if any included in the Rx (no mention of drug name)
Beyond use dateper USP not later than manufacturer exp or one yr from when dispensed
Beyond use date for insulin24 mos from date of manufacturer
What specifies the labelling with OTC drug review?Monograph
How can an Rx become OTC?Manufacturer requests switch (supplemental app for ONLY its NDC, only for that product and manufacturer), manufacturer may petition FDA, or can be switched through OTC drug review process
Fed gov req patient package inserts fororal contraceptives, estrogen drugs, IUD, albuterol etc. Must get before 1st dose adminstered and 30 days thereafter
Do medication guides require FDA approval?Yes! Any changed need to be approved
Why are med guides given out for certain drugs?Prevent serious ADR, serious risk relative to benefit, pt adherence to directions crucial for effectiveness
Meds where give medication guideaccutane, SSRI, NSAID, ambien, epogen, coumadin


Question Answer
Is it legal to prescribe drug for off label use?Yes!
Narrow Therapeutic IndexLess than 2-fold difference in median lethal dose and median effective dose
NTI Drug ExamplesCarbamaepine, clonidine, levothyroxine, lithium, phenytoin, warfarin, theophylline
Tax Free ETOHmust be stored in securely locked storeroom with labels and markings intact. After containers empty labels and markings must be obliterated before discarding
Exemptions to child resistant packagingSL nitroglycerin, SL/chewable isosorbide dinitrate 10mg or less dsg form, sod fluoride containing not more than 264 mg per PACKAGE, anhydrous cholestyramine in powder form, methylpred not more than 84mg PER PACKAGE. EES for oral susp not more than 8mg
Who is able to schedule drugs federally?Attorney general
Sched IIIMod to low physical dep or high psych dep
Sched IISever physical or psych dependance
Scheduled list of chemical productsknown to be used in manufacturer of controlled subs. Meth act added ephedrine, pseudoephedrine, and phenylproanolamine,
Daily sales limit of ephedrine, pseudo, or phenylpropanolamine3.6 grams
30 day sales limit of ephedrine, pseudo, or phenylpropanolamine9 g. If mail order 30 day max is 7.5 g


Question Answer
Who has to be registered with DEAPharmacies, hospitals, wholesalers, manufacturers, anyone writing control substance.
How long does each DEA registration last?3 years
Can DEA inspections be done under CSA?Yes. Exam and copy all records, reports, inspect, take inventory of CS
Does the DEA inspector need consent to search pharmacyTechnically yes, pharmacist incharge must sign a written statement of informed consent to search
Administrative Inspection WarrantIf PIC or owner refuses consent, inspector can get AIW. Easy to get. AIW may only be served during regular business hrs. Must allow.
Opioid Tx ProgramsRun by Substance Abuse adn Mental Health Services Adminstration (SAMHSA). Only 2 drugs - methadone and LAAM
How long are OTP certifications good for3 years. Must reaply to SAMHSA
Drug Addiction Treatment ActAllows for office based tx of opioid dependent pts by qualified physicians to prescribe and dispense CII, CIV, CV FDA app for detox maintanence. - Suboxone or subutex
Qualified DATA physicianBC in addiction psych or addiction med or at least 8 hrs training in tx and mngmt. Special DEA number
Controlled Substance Registration Protection Act of 1984Fed investigation occurs if replacement of CS >$500, someone killed or suffers signif injury, interstate or foreign commerce involved
Compat methamphetamine of 2005Ephedrine, psuedoephedrine, phenylpropanolamine. If nonliquid form must be blister packs with max 2 dose in each blister and sales limits.
To buy ephedrine, pseudoephedrine, and phenylpropanolamineseller must maintain written or e-log book of product name, qty sold, name and addresses of purchasers, date and time of sales
Sales of pseudoephedrine under how much do not need logbook or ID60 mg
Max sales limit for mobile sellers of pseudoephedrine7.5gm in 30 days
How long must sellers maintain their combat meth logbookMinimum 2 year


Question Answer
To prescribe a CS a provider mustBe authorized to prescribe CS in THE STATE IN WHICH HE IS LICENSED TO PRACTICE - dea reg and licensed and reg for practice
Do CII Rxs expire under federal lawNo! But 30 days in NYS!
Under federal law do faxed CII rx ever count as originalYes! If for direct admin by parenteral rt, resident of LTCF, or enrolled in hospice pt ( if not hospice on rx). Not for NYS!!! Can do CII rx's this way only for this pt pop but need hardcopy in 72 hrs!
Under federal law, how many refills for a CV can be filled?Technically no limit. Under NYS law, can do 5 refills up to 6 mos.
Fed hard script requirements for oral CIII - CVRequires hard copy
Fed hard script requirement for fax CIII-CVDOES NOT req hard copy.
Hold long must CS records be kept under federal law2 years