TX MPJE REVIEW 2023
mailing rx drugs through USPS - regulations
-DD: can be mailed to ultimate user as long as meds are not alcoholic beverages, poisons, or flammable substances -CS if: >prescription labeled correctly >outer wrapper free of markings, name of pharmacy >no markings indicating contents >can be mailed to other DEA registrants if kept in plain outer container and recordkeeping requirements are met
special warning requiremens for OTC: -Yellow No. 5 (tartrazine) and No. 6 -Aspartame -Sulfite -Mineral Oil -Wintergreen oil (methyl salicylate) -sodium phophates -isoproternenol inhalation preparations -potassium salt preparations for oral ingestions -ipecac syrup -phenacetin (acetophenetidin) -salicylates - minor sore throats -alcohol wanring -vaginal contraceptive and spermicide w/ nonoxynol 9 -APAP - NSAID -Iron in solid dosage form
-Yellow No. 5 (tartrazine) and No. 6: allergic rxn -Aspartame: Phenylketonurics: contains phenylalanine __ mg per __ (dosage unit) -Sulfite: allergy (used as preservative) -Mineral Oil: taken at bedtime and not used in infants. not for pregnancy -Wintergreen oil (methyl salicylate): >5% must include warning that any other use is dangerous and kept out of children reach (used as flavoring agent) -sodium phophates: 90 ml/container -isoproternenol inhalation preparations: not to exceed dose and contact prescriber if difficulty breathing -potassium salt preparations for oral ingestions: nonspecific bowel lesions consisting of stenosis, with or w/o ulceration associated w/ enteric coated thiazide w/ potassium salts -ipecac syrup: emergency use to cause vomitting in poisoning. keep out of children reach. do not use unconcious person. 15 ml for >1 yo. only sold in 30 ml container. -phenacetin (acetophenetidin): kidney damage when taken large amount for long period of time -salicylates: reye's syndrome in children. 1 1/4 grain (pediatric) hold only 36 tablets - minor sore throats: for temporary relieve. severe sore throat w/ sx contact doctor. do not use >2d or give to <3 yo -alcohol wanring: internal analgesic and antipyretic - >3 alcohol/day talk to doctor -vaginal contraceptive and spermicide w/ nonoxynol 9: does not protect aginst HIV/AIDS or STD -APAP: must have APAP displayed. liver damage. warn not to use other products w/ APAP and talk to doctor if taking warfarin - NSAID: stomach bleed. NSAID on label -Iron in solid dosage form: accidental overdose leading cause of fatal poisoning <6yo. keep out of reach
Prescription Drug Marketing Act of 1987
-bans reimportation of rx drugs and insulin made in the US (except by the manufacturer) -ban sale, trade, purchase of drug samples (except charitable organization) -prohibit resale of rx drugs purchased by hospital (since hospital has lower price than community)
pharmacies do not have register as a distributor if:
-distributing under common ownership -dispenser is providing product to another dispenser on pt specific basis -distributing under emergency response -distributing minimal quantities to a licensed practitioner for office use (ie must be <5%)
federal tax free regulations
-pharmacies using 95% ethanol (190 proof) for compounding purposes -when used for scientific, medicinal, or mechanical purposes or to treat patients, it is tax free -user permit must be acquired from TTB + recordkeeping -cannot be resold or used in beverage prodcut
what should be done if completed order form is lost or stolen?
-purchaser must prepare another DEA form 222 -statement containing the serial number and date of the lost form -state that the goods covered by the first order were not recieved because the form was lost
advertising is exempt from FDA regulations if:
-purpose is only to give price, not info on drug's safety, efficacy, or indications -contains brand/generic name, strength, dosage form, price -can include services (compounding) -price stated should include all charges
exemptions: a prescription for a CS is not required to be issued electronically and may be issued in writing (not verbally) for the following:
-rx written by veterinarian -electronic prescribing not available -to be dispensed by a pharmacy outside of tx -when prescriber and dispenser are in same location or under same license -required elements not possible with electronic prescribing -non specific pt pursuant to standing order, protocol, collab drug management, in response to public health emergency -research protocol -waiver (valid one yr and can be renewed) -delay in pt medical condition if electronic rx was submitted -med order written for a pt who is admitted to hosptial at time the order is written and filled
what are ways to handle patients bringing CS from home to the hospital
-secure in pt hospital room -turn over to pt family member -hospital modified DEA as an authorized collector -empty mail back packages (no modification of DEA required) -give to DEA registered reverse distributor -contact local law enforcement
what are the two types of Controlled substance ordering system
1. CSOS administrative certificate: used to digitally sign communications with DEA. only issued to CSOS coordinators and not valid for electronic ordering. 2. CSOS signing certificates: used to digitally sign CS orders. only issued to registrant and POA
Durnham-Humphrey Amendment of 1951
1. created OTC and rx class 2. verbal rx and rx refills
when are child resistant containers exempt: (exempt from the Poison Prevention Packaging Act)
1. request of pt or prescriber 2. bulk contianers not intended for household use 3. rx for LTCF or any facility administering 4. drugs distributed to institutionalized patients 5. one package size of otc designed for elderly 6. rx drugs that are exempted: -oral contraceptives -medroxyprogesterone tablets -sublingual nitroglycerin and sublingual and chewable isosorbide dinitrate of <10mg -asa and apap in effervescent tablets or granules -potassium supplements in unit dose -sodium fluoride containing <264 mg/package -anhydrous cholestyramine and colestipol packets -erythromycin ethylsuccinate granules for oral suspension an oral suspensions containing <8g -erythromycin ethylsuccinate tablets containing <16 g -prednisone tablets <105 mg/package -methylprednisolone tablets <84 mg/package -mebendazole tablets <600 mg/package -betamethasone tablets <12.6 mg/package -aerosol inhalation -pancrelipase -sucrose preparations in a solution of glycerol and water -hormone replacement therapy
NDC configurations and meaning billing/claims submission NDC
10 character number: 4-4-2, 5-3-2, 5-4-1 a. first 4-5 digits: labeler code b. next 3-4 digits=specific drug, strength, dosage form c. last 1-2 digits=package size billing/claims: 11 digit NDC insert 0: first segment if its 4 number, second segment if its 3 numbers, or added to begining of the third segment if its only one number
what is the qty limit for opioids (not just CII) for acute pain? what does acute pain not include?
10d, no refills. does not limit how many times it can occur acute pain does not include: -cancer -hospice -palliative -chronic -substance addiction
in LTCF, how many days are medications dispensed
14day cycle to reduce medication waste
how to verify DEA registration
1st letter is A,B,F: practitioners, or M: mid level 2nd letter: first letter of practitioner last name Step 1: Add 1st, 3rd, and 5th digit Step 2: Add 2nd, 4th, and 6th digit and then multiply by 2 Step 3: Add the sum of the steps 1 and 2 and the last digit of the sum should correspond to the last digit of the DEA number EX: DEA AB1234563 Total: 33
single DEA form 222 features
20 order lines vs 10 (triplicate) make copy of original form, send original to supplier purchaser have to enter supplier DEA # (vs supplier had to fill it out in triplicate) after products recieved, purchaser date and record number of containers recieved on ea item on the copy of form
what is max qty isotretinon dispensed? how many refills ?
30 day supply, no refills
patients have a right to access their PHI and obtain it, pharmacies need to comply within __ patients can ask to amend their PHI and must comply within __
30 days, but can extend no more than additional 30 days if notify individual reason for delay TBSP is stricter and requires 15 days to respond to a request for confidential record amend: comply within 60 days, but may extend no more than 30 days if notify indiviual reason for delay
how many days can the previous owner let the new owner of the pharmacy use his DEA registration
45 days
interstate distribution of compounded drugs from a 503A pharmacy is limited to:
5% unless compounder is in a state entered into a memorandum of understanding with FDA if MOU: drugs distributed interstate during any calendar year is >50% of sum of: 1. rx orders sent out 2. rx p/u by pt
pharmacies should notice individuals when their is a breach within __ who should be notified?
60 calendar days breaches <500 individuals, entities must maintain a log and notify HHS of these breaches annually >500 individuals: secretary of HHS and local media must be notified + individuals within 60 days
how long is the authorization numbers valid for thalomid? how long is the confirmation number valid prior to dispensing?
7 days from date of last pregnancy test for females 30 days from the date issued for other patients confirmation number: must be dispensed within 24 hr of obtaining the number
FDA orange book -products with no known or suspected bioequivalence issues: -products with potential bioequivalence problems: -products that are pharmaceutically equivalent but not bioequivalent (therapeutic):
AA: conventional dosage forms AN: solutions and powders for aerosolization AO: injectable oil solutions AP: injectable aqueous solutions AT: topical products AB: potential bioequivalence problems AB1, AB2, AB3: pharmaceutical equivalent, but not bioequivalent
can a prescriber of the US armed services prescribe a CS to be filled off base?
CII cannot be filled off base because it requires a tx official prescription form, which are only given to DEA registrants (US armed forces are not DEA registrants) CIII-CV may be filled off base
what pharmacies are required to have a perpetual inventory
CII in class C all CS in Class F, C-ASCs all CS in remote locations
what is the federal transfer warning on CS, and which CS class is it required on
CII-CIV (not required for CV) Caution: Federal law prohibits the transfer of this drug to any person other that the patient for whom it is prescribed
CIII CIV CV
CIII tylenol #3 pentobarbital suppositories fiornal (butalbital, APAP, caffeine) anabolic steroids (testosterone) ketamine buprenorphine buprenorphine/naloxone CIV zolpidem tramadol benzos phenterimine phenobarbital carisprodol CV pregabalin lacosomide brivaracetam antitussive w/ codeine antidiarrheal w/ opium
tamper resistant prescriptions
CMS requires that all written rx have them prevent copying of completed or blank prevent erasure or modification of info written on pad prevent use of counterfeit rx forms
concentration limits for narcotis -codeine -dihydrocodeine -opium -morphine
Codeine CV: 200 mg/100 ml CIII: 1.8 mg/100 ml and 90 mg/dosage unit dihydrocodeine CV: 100 mg/100 ml CIII: 1.8 mg/100 ml and 90 mg/dosage unit opium CV (federal): 100 mg/100 ml CV (TX): 50 mg/100 ml CIII: 500 mg/100 ml and 25 mg/dosage unit morphine CV: none (either CIII or CII) CIII: 50 mg/100 ml
poison prevention packaging act is administered by
Consumer Product Safety Commission (CPSC)
form for ordering CII
DEA form 222
DEA form for applying as a registrant
DEA form 224
CHAPTER 1
FDCA, PPPA, OTHER
CHAPTER 2
FEDERAL & TEXAS CONTROLLED SUBSTANCE ACTS
FDA drug/device recall classification
I: serious AE on health or death II: temporary or reversible AE on health III: not likley to cause AE
FDA purple book official name
Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
who is responsible for ensuring all inventory is taken and that the inventory count of CS
PIC
Drug Quality and Security Act of 2013
Regulates compounding pharmacies (Drug Compounding Quality Act) and establishes framework for track and trace system (Drug Supply Chain Security Act) *new england compounding meningitis outbreak
Poison Prevention Packaging Act of 1970
Requires use of child-resistant containers for prescription and nonprescription drugs: -ASa -methyl salicylate: >5% liquid preparations (not pressurized spray) -methyl alcohol: >4% liquid form (not pressurized spray) -iron (including supplements) : >250 mg in single package -APAP: >1 g in single package >exemptions: effervescent tablets/granules <10% apap, unflavored powder form -diphenhydramine: >66 mg in single package -ibuprofen: >1 g in single package -loperamide: >0.045 mg in single package -lidocaine: >5 mg in single package (all dosage forms) -dibucaine: >0.5 mg in single package (all dosage forms) -naproxen: >250 mg in single package -ketoprofen: >50 mg in single package -fluoride: >50 mg elemental or >0.5% fluoride in single package -minoxidil: >14 mg in single package (must meet it after applicator installed by consumer) -imidazolines: >0.08 mg in single package (includes tetrahydrozolilne, naphazoline, oxymetazoline, xylometazoline in nasal/ophthalmic -any drugs switched from rx to otc
who regulates tax free alcohol
The Alcohol and Tobacco Tax and Trade Bureau with the federal Bureu of alochol, tobacco, firearms, and explosives (ATF). ATF responsible for enforcement
examples of medications requiring medication guides:
accutane antidepressant in children/teenager coumadin epogen (epoetin alfa) lindane shampoo/lotion lotronex (alosetron) nolvadex (tamoxifen) NSAID remicade (infliximab) trizivar (abacavir, lamivudine, zidovudine) forteo (teriparatide, rDNA origin) opioid analgesic and cough products benzos
adulterated vs misbranded acts
adulterated -counting pills on tray w/ residue -incorrectly storing drug -temp wrong (not in range) -OTC no tamper evident (also misbrand) misbrand -misfill wrong drug, directions, strength (adulterated if wrong strength) -REMS not met -false advertise -filling expired drug (the exp drug is adulterated) -no child resistant cap -no Med guide or PPI (if required) -dietary supplement, or medical device w/ NDC (medical devices have unique device identifiers, not NDC) -a product that implies it is an FDA approved drug -dispensing rx without authorization
Who are exempted from DEA registration?
agent/employee of any registered manufacturer, distributor or dispenser common/contract carrier or warehouseman patient who possess a controlled substance for a lawful purpose officials of the U.S. armed services, public health service, or Bureau of Prisons acting in the course of their official duties (can issue electronic CII on site, but not issue written CII to fill off site because they do not have TX official Prescription form since they are not DEA registrants)
what does inventories include
all stock on hand of CS (including expired drugs)
delivering drugs through common carrier
any rx drug can be delivered and not subjected to postal regulations
outsourcing facilities can compound bulk substance if: what are the requirements of compounding bulk substances
appears on list for clinical need appear on FDA shortage must have valid certificate of analysis comply with monograph if drug has one
FDA orange book official name
approved drug products with therapeutic equivalence evaluations
medical device class meaning which medical device needs premarket approval?
based on risk on using device I: low risk, least regulatory control (ie dental floss) II: higher risk, regulatory controls (ie syringe) III: highest level of regulatory control, pose risk of illness or injury (ie replacement heart valve). Requires premarket approval by FDA Certain class I and II are exempt from premarket approval and GMPs, but still must comply with regulatory requirements
biosimilar meaning
biologic product is highly similar to reference product, no clinical meaningful difference in terms of safety, purity, potency
what drugs are exempted from track and trace?
blood radioactive IV products for fluid replacement dialysis medical gases compounded drugs medical convenience kit
what happens when supplier cannot fill an order entirely
can partial and supply the balance within 60d
what are the duties of designated agent? what are they not allowed to do?
communicate a rx for CIII-CV (NOT CII) cannot authorize or prescribe
What are 503A Facilities? who regulates them
compounding pharmacies that may only compound products pursuant to an individual prescription. do limited anticipatory compounding, regulated by states, subject to USP 797
which listed chemicals were removed from market by FDA due to safety reasons
ephedrine and phenylpropanolamine
FDCA 1938
established FDA (deal w/ food, cosmetic, drug, medical safety) after sulfanilmide elixir that caused death - new drugs need to be safe
inventory counts for controls
exact count for CII estimate count for CIII-CV unless container holds >1000
True or False: drugs with NDC mean they are FDA approved drugs
false
who has the authority to schedule CS from the federal and state level
federal: US attorney general - can add, delete, or reschedule substances but must obtain a scientific and medical recommendation from fda state: the commissioner of the tx dept of state health services - can add, delete, or reschedule substances but cannot override actions by the legislature
FDA orange book 2 letter coding system, what does it indicate?
indicates equivalency, with first letter being: A=pharmaceutically equivalent and therapeutically equivalent B=NOT pharmaceutically equivalent and therapeutically equivalent
after recieving invoice, what must be done
initialed by recieving pharmacist (excepct in Class C-ASC and class F pharmacies, these can be signed by person recieving it)
what are the limits in compounding a narcotic controlled substance for a prescription?
limits compounding of aqueous or oleaginous solutions or solid dosage forms to no more than 20% concentration if greater will have to be manufacturing
which pharmacies are required to lock their CS
locked storage for CII -class c -class c-s -class c-asc -class f
what activities require seperate registrations
manufacturing (CI-CV) distributor (CI-CV) reverse distributor dispensing (CII-CV) conducting research/chemical analysis (CI-CV) narcotic treatment program (CII-CV) importing/exporting (CI-CV)
what must an CIII-CV invoice contain
name of drug dosage form and strength # units/container qty recieved date of reciept name, address, DEA# of registrant from where CS was recieved
manufacturer label contains:
name/address manufacturer brand/generic name net qty wt of active ingredient/dosage unit Rx only if not taken PO, specific route special storage instructions exp date lot # adequate info for use (package insert and med guide or PPI if required) does NOT require NDC, although it helps facilitate processing
for CS rx, after obtaining verbal authorization from prescriber, a pharmacist can change/add? what can be corrected on rx without prescriber notification/authorization
need verbal authorization to change: -earliest fill date if multiple CII rx at same time -drug strength -drug dosage form -directions for use -drug qty (number and alpha) w/o authorization/notification: -mispelled name -obvious date error -add pt address
when is PPI are given to pt? they are required for what drugs?
new and refills if hospitalized/institutionalized: PPI given prior to the first admin and q30 days thereafter required for: oral contraceptives estrogen containing products
outsourcing facilities are exmpt from
new drug provisions adequate directions for use drug track and trace provisions
what is max qty and refills can thalomid be prescribed?
no more than 4 week (28 day supply), no automatic refills or telephone rx subsequent rx may be dispensed only if there are <7 days less remaining on existing rx
what are prescription drug preparations are exempted from controlled substnace provisions
nonnarcotic prodcuts containing small amounts of phenobarbital, butalbital, chlordiazepoxide, or meprobamate (ie. Fiorcet >butalbital, apap, caffiene)
what happens if a collector of a mail back program recieves a package thats not theirs
notify DEA w/in 3 business days of reciept
when can biological products be substituted
only if they are interchangeable and require prescriber intervention in order to substitute
what records can be moved to a central location and who must be notified? when can it be moved? what records have to stay within the registered location?
only shipping and financial records but must notify the DEA (then after 14days can move it) prescriptions, DEA order forms, inventories must be kept at pharmacy
how are CS disposed and destroyed (2 ways)
onsite (authorized collector): rarely used DEA form 41 -drug name -NDC -strength -dosage form -package size -qty destroyed -two employees signatures transfer to registered reverse distributor: preferred -invoice for CIII-CV -DEA form 222 for CII
what are 503B pharmacies? who regulates them
outsourcing facilities can compound sterile w/o pt specific rx regulated by FDA and GMP
how are transfers of CS between registrants conducted
pharmacy does not have to register with DEA as distributor as long as total quantities of CS distributed during calendar year do not exceed 5% of the total quantity of all CS dispensed and distributed transfers for CII: DEA form 222 required transfers for CIII-V: invoice transfers only made to address listed on DEA registration
who needs to report to DEA's Automation of Reports and Consolidated Orders Systems (ARCOS)
pharmacy or practitioners acting under 5% rule must mail or email copy to DEA pharmacy that act as suppliers under 5% rule must have a system to identify an suspicous orders and to report online to DEA's Suspicious orders Report System
practitioners who can prescribe CS
physicians (DO or MD) veterinarian therapeutic optometrist optometric glaucoma specialist dentist podiatrist APRN/PA (CIII-CV, CII in some settings)
plan b one step (generic single dose levonorgestrel) age restriction? w/ or w/o rx? next choice (two pill) age restriction? w/ or w/o rx?
plan b: available any age to anyone w/o rx next choice: w/o rx for women >17 yo; women <17 yo need rx
OTC label contains:
principal display panel name/address manufacturer net qty of contents caution and warnings adequate directions for use Drug facts: -active ingredients -inactive ingredients (alphabet) -purpose -use-indications -warnings -directions -other info -questions (optional) & phone #
how often should dispensers (practitioners and pharmacies) register with the DEA
q3years
who must sign the DEA form 222
registrant (individual, partner, or officer) and by the person authorized to execute DEA form 222 registrant can authorize individuals to execute by creating POA (does not need to be sent to DEA but must maintain at pharmacy)
who does outsourcing pharmacy report to ? what do they report and how often
report to secretary of HHS upon registering and q6mo thereafter, the drugs sold in previous 6 mo
how should theft or loss of CS be reported
reported in writing to DEA w/in one business day. rec reporting to police board upon discovery complete DEA form 106
when are medication guides required? when are they given to the pt?
required for all new and refill rx in community: 1. The drug product is one for which patient labeling could help prevent serious adverse effects 2. The drug product is one that has serious risk/s (relative to benefits) 3. The drug product is important to health and patient adherence and directions for use is crucial to drug's effectiveness
Federal Hazardous Substances Act of 1966
requires label on HD product: name/address manufacturer chemical name of ea HD ingredient "Danger" for corrosive, flammable, toxic "Caution" or "warning" for all other HD products statement of the principal hazard precautionary statments: what to avoid and protect first aid treatment "Poison" and "Danger" for highly toxic special care/handling "Keep out of reach of children"
who regulates rx advertising? otc advertising?
rx: FDA otc: federal trade commission (FTC)
what is a product identifier? what are they used for
standardized numerical identifier (contains NDC and serial number, lot #, exp date) pharmacies may only recieve drugs with product identifiers, but not required to scan them
what must supplier do if order cannot be filled at all
statement from supplier of reason to purchaser if supplier refused at all - can have statement that order is not accepted
where can the side effects statement appear? when is it required to give to pt? what is the purpose of it?
sticker attached to pharmacy container, preprinted pharmacy rx vial cap, separate sheet of paper, found within CMI or med guides required for all new and refill rx in outpatient setting to enable consumers to report SE
who is required to initial inventories? when is it required to be initialed?
the person taking it (sign/date/time) and PIC w/in 3D (excluding weekend and holidays) notarized (except for initial inventory and change in PIC inventory)
manufacturers may apply to DEA to exempt a product from certain provisions of the CS act (labeling and inventory) if ____
the products are not likely to be abused products may still be considered CS for certain criminial violations even though they are not labeled as CS
what is transaction data
transaction hx: ea transaction prior back to manufacturer transaction statement: by the seller that they are authorized, got product from authorized person, got transaction info/hx from prior owner, did not ship illegitmate, systems to comply with verification, did not provide flase info transaction info: product name/strength/dosage form ndc date of transaction container size and # containers name/address of person from and to being transferred serialized numerical identifier (SNI)
how long until the digital certificates for the controlled substance ordering system expire
until expiration of the DEA registration of the facility - 3 years
how does a pharmacy investigate a suspect/illegitamate product? who must be notify and what must be done after once realized product is illegitimate?
verify the product identifier of at least 3 products or 10% of suspect product (whichever is greater), or all packages if <3 FDA form 3911 and notify trading partners w/in 24 hr
in LTCF, what is the rule for psychotropic drugs
when used PRN, must be limited to 14D unless prescriber has rationale documentation on why extending beyond it
how should loss of listed chemicals (pseudophedrine) be reported
written report of description to DEA w/in 15d using DEA form 107
can purchaser fax dea form 222?
yes and can start the prepare, but purchaser may not ship order until the orignal form is recieved and verified
Kefauver-Harris Amendment of 1962
• drugs need to prove effectiveness and safety of their drugs (thalidomide-birth defects) • GMPs for manufacturing • FDA control drug advertising