Texas MPJE 2018

Only pharmacies allowed to work with drug samples

Pharmacy owned by charitable organization or government serving indigent population

Three constituents of data required to be provided by manufacturer for each product sold

Transaction information, history, and statement

Transaction Information constituents

Drug name strength dose and NDC, container size and count, transaction date, name and address of seller and buyer

Transaction history

Prior transaction information for each prior transaction

Transaction Statement

States seller is authorized for transaction, information and history were provided and are correct, and product is legitimate and has processes to comply with verification requirements, previous seller was legitimate and provided true information

Exceptions to distributing without a license

Distributing between common ownership, patient specific basis, emergency medical reasons, or minimal quantities to a practitioner for office use

Adulteration

Actual contents of product is below standard or is unsafe

Misbranding

Labeling that is misleading or missing required information, non-compliant with PPA

Requirements for manufacturer's label of prescription drugs

Manufacturer name and address, drug name, dose quantity, route for non-PO, lot, and expiration, package insert, storage instructions, Rx only legend

Requirements for OTC drug labels

Manufacturer name and address, drug name, quantity, "Drug Facts" panel: active ingredients, purpose, indication, warning, directions, other info, inactive ingredients

Special warning requirement ingredients

Yellow #5/6, aspartame, sulfites, mineral oil, wintergreen oil, sodium phosphates (90 mL max), isopreterenol, potassium salts, ipecac syrup, phenacetine, salicylates (max 36 tabs of 81mg), alcohol for analgesics/antipyretics, APAP, NSAIDs

FDA Class I Recall

Serious ADE or death possible

FDA Class II Recall

Temporary/reversible ADE or serious ADE remote

FDA Class III Recall

Not likely to cause ADE

When package inserts are required for institutionalized/hospitalized patients

Prior to first administration and every 30 days for OC, estrogen, and progesterone products

iPLEDGE requirements

Doctor, pharmacy, and patient are registered, negative pregnancy test, contraceptive use and pregnancy testing, dispensed as blister packs of no more than 30 day supply, no refills

Requirements to be considered compounding vs manufacturing

Patient specific, done by pharmacist or physician, USP compliance, manufacturer of drug is registered and has certificate of analysis, excipients comply with USP/NF monograph, not a replica of an existing product, drug not withdrawn from market due to safety, no statement from FDA stating difficulty for compounding demonstrating an ADE, 5% rule

FDA Orange book

Generic equivalency book,

A# are drug products the FDA considers to be _______ equivalent and _______ equivalent

pharmaceutical and therapeutically

B# are drug products the FDA considers to ____ be _______ equivalent and _______ equivalent

NOT, pharmaceutical, therapeutically

FDA Purple book

Biologic interchangablity book

Poison Prevention Packaging Act

Requires child-resistant containers for all prescriptions and certain OTC drugs

PPPA exemption request from patient/prescriber

Only patient can provide blanket request for all future prescriptions. Provider can only request for single prescription

PPPA exemptions

OC/estrogens/northindrone in manufacturers package, medroxyprogesterone tablets, nitroglycerin SL, isosorbide chewable up to 10mg, ASA/APAP effervescents, Unit dose potassium supplements, sodium fluoride up to 264mg, anhydrous chloestyramine/colestipol packets, erythromycin granules for PO suspension, erythromycin suspension up to 8g, erythromycin tablets up to 16g, prednisone tabs up to 105mg, methylprednisolone tabs up to 84mg, mebendazole tabs up to 600mg, betamethasone tabs up to 12.6mg, inhalants, pancrelipase, sucrose in glycerol and water

Federal Hazardous Communications Standard, who enforces this standard?

Requires pharmacies to have a plan including list of hazardous chemicals with SDSs, and to train workers, OSHA

Federal Hazardous Substances Act

Requires labeling of hazardous materials including manufacturer, type of danger, "Keep out of reach of children", handling and storage instructions

Frequency of CMS medication regimen reviews required for long term care patients

Every 30 days

Alcohol and Tobacco Tax Trade Bureau (TTB)

Issues permits for tax free alcohol for pharmacies

TTB ________ tax free alcohol for pharmacies while the _______ enforces

regulates, ATFE

HIPAA requirement for new patients

Obtain written acknowledgement of receipt of Notice of Privacy Practices

Allowed PHI disclosures

Providing treatment, receiving payment, health care operations, government functions including FAERs, AWARxE. Marketing purposes must have singed authorization from patient

Time limit for patient request of PHI

30 days, may extend by no more than 30 additional days

Time limit for patient request to amend PHI

60 days, may extend by no more than 30 additional days

HIPAA's required pharmacy personnel

Privacy Official and contact person for complaints

Time limit to notify individuals of PHI breach

60 days after discovering

Requirement for PHI breach of <500 individuals

maintain log of breaches and notify breaches to HHS annually

Requirement for PHI breach of >500 individuals

Report to HHS and local media within 60 days

C-I list

Opiate derivatives (heroin, dihydromorphine), marijuana, LSD, peyote, mescaline, methaqualone

C-II list

Narcotics, cocaine, stimulants, amobarbital, secobarbital, pentobarbital

C-III list

Anabolic steroids, ketamine, C-II barbituate suppositories, buprenorphone, codeine up to 90mg/dose, opium combo up to 25mg/dose

C-IV list

BZDs, carisoprodol, modafinil, phentermine, phenobarbital, tramadol

C-V list

Codeine up to 200mg/100ml, opium less than 50mg/100ml, pregabalin, lacosamide

DEA from 224

Registration for dispensing controlled substances

Time limit to obtain DEA permit upon sale of pharmacy

45 days

Concentration limit for compounded narcotics

20%, with non-narcotic therapeutic ingredient

Concentration limits for codeine

C-V: 200mg/100mlC-III: 1.8g/100mL or 90mg/dose

Concentration limits for opium

Texas C-V: 50mg/100mLC-III: 500mg/100mL or 25mg/dose

DEA from 222

Ordering C-IIs

Where each copy of DEA-222 goes

1 Brown: supplier2 Green: DEA3 Blue: buyer

Drugs that have to be alone on DEA-222

Etorphine HCl and Diprenorphine

Controlled Substances Ordering System (CSOS)

Electronic C-II ordering

Non C-II CS invoice requirements

Signature of receiving pharmacist, distributor name address and DEA, date of receipt, Drug name, dosage form, strength, units per container, container quantity recieved

5% rule

Pharmacies can distribute 5% of annual controlled substance doses dispensed without registering with DEA as a distributor

Controlled substance storage requirements for Class A

Locked cabinet or dispersed throughout pharmacy

Controlled substance storage requirements for Class C

C-IIs locked, others dispersed. Class F also required to lock C-IIs

Time limit to report significant loss or theft of controlled substances to DEA and TSBP

1 day

DEA From 106

CS theft/significant loss form

Schedules requiring "Caution... prohibits the transfer of this drug to any person other than the patient...

C-II-IV

DEA Form 41

Onsite controlled substance destruction. Must be submitted 2 weeks before destruction date

When controlled substances inventories are required

First day pharmacy is open, annually, change in PIC, change in ownership

Counts for inventories

Exact for C-II, estimated for C-III-V unless container holds more than 1000 tablets

Circumstances for required perpetual inventory

Class C and C-IIAll controls in remote pharmacy, Class C-ASC, Class F

Time limit for signature of PIC for CS inventories

3 days excluding weekends and federal holidays

Required time of keeping CS records

2 years

CS records required to be in pharmacy

DEA-222 copy 3, prescriptions, inventories

Requirements for controlled substance prescription

Patient full name address and age/birthdate, drug name strength dose quantity (## and word) and intended use, practitioner name address phone number and DEA number, earliest fill date for C-II

Things pharmacists can't change on C-IIs

Patient name, drug name, physician name, prescription date

Requirement for faxed C-III-V

Prescriber's original signature

Time limit to dispense C-II

21 days from prescription date

Exceptions to facsimile restriction

C-II for home infusion/IV pain therapy patient, LTCF patient, hospice patient

Quantity restriction for verbal emergency C-II

Amount needed to treat patient during emergency period

Time limit to provide official prescription after emergency C-II

7 days, marked "Authorization for Emergency Dispensing

Time limit to complete partial fill

30 days after prescription issue date

Time limit to complete emergency partial fill

72 hours

Time limit to complete partial fill for treminally ill/LTCF patients

60 days

Refills allow for C-III-V

5 times or 6 months

OTC controlled substance dispensing requirements

Up to 8oz or 48 doses of opium, up to 4 oz or 24 doses of anything else, not same person within 48 hours, buyer is 18 years old, ID required, record book entry

Time limit for transmitting CS prescription information to TSBP

7 days from fill

Information needed for TSBP regarding CS prescriptions

Prescription control number, patient name, age, and address, Rx issue and fill date, dispensed drug NDC, quanitity, pharmacy's prescription number, pharmacy's DEA number

Short term detox length

30 days or less

Long term detox length

30-180 days

Drugs dispensable under Drug Addiction Treatment Act

Subutex, Suboxone

DATA-waived physician requirement for prescription

DEA number with an X

Meth precursor limits

3.6g daily9g every 30 days

Meth precursor log book requirements

Product name and quantity, buyer name and address, sale date and time, buyer signature

Exception to meth precursor rules

Convenience package of pseudoephedrine 60mg or less

Mail pharmacy/mobile retail vendor meth precursor sales limit

7.5g in 30 days

Controls able to be auto-refilled by TSBP

C-IV-V

TSBP requirements for prescription records

Three file system (C-II, other controls, non-controls)

Requirement to sell meth precursors

Certificate of Authority from TDSHS for non-pharmacy retailers

Practitioners that can prescribe under own license

Physicians (MD, DO), Dentists (DDS, DMD), Podiatrist (DPM), Veterinarians (DVM)

Practitioners with dependent prescriptive authority

Physician's assistant, Advanced Practice Nurses

Controlled substance prescription amount limit for family members of physician

72 hour supply

How drugs are ordered for office use by practitioner

DEA-222 or invoice, not prescription

Day supply given for patient after prescriber dies

30 day supply

Dangerous drugs Nurses of Home and Community Support Agencies can carry

Sterile water/saline, vaccines, 5 doses of certain drugs

Additional requirement for prescriptions from an APRN or PA

Supervising physician name, address, phone number, identifying number

Setting in which APRN or PA can prescribe C-IIs

Hospital based under medical staff policy, for patient with intended LOS of 24 hours or greater/in ED/hospice/terminal illness

Supply limit for controlled substance prescription from APRNs/PAs

90 day supply

Products Therapeutic Optometrists can prescribe

Ophthalmic devices, OTC PO meds, topical ocular products approved by Optometry Board

Products Glaucoma Specialists can prescribe

10 days of PO antibx, 72 horus of PO antihistamines, 7 day supply of NSAIDs, 3 day supply of scheduled analgesic, products approved by Optometry Board and Texas Medical Board

Cocaine eye drop concentration and supply limit

2 vials of 10% prepackaged

Letter which Therapeutic Optometrist licenses end in

T

Letter which Glaucoma Specialist licenses end in

TG

Composition of TSBP

7 pharmacists, 1 pharmacy technician, 3 public members

Allowed retakes of MPJE or NAPLEX

4 each (5 attempts)

Requirements for licensure by exam

18 years old, good moral character, 1500 hours internship, professional practice degree, NAPLEX and MPJE 75, no restriction/suspension from another state

Requirements for licensure by reciprocity

Proof of initial licensure by exam, current license, Texas MPJE 75

Restrictions to intern duties

No signatures, cannot introduce self as pharmacist, supervise technicians

Preceptor requirements

Active license, 1 year experience/6 months residency training, 3 hours ACPE preceptor training (then every 2 years)

Pharmacist to intern ratio

1:1

Pharmacist to intern ratio exception

Hours part of school of pharmacy program

When direct supervision is required

Preparation or delivery of drug order

Frequency of license renewal

Biennially

Date of license expiration

Last day of birth month

Payment due to renew expired license

<90 days: 1.5 times fee90 days to 1 year: 2 times fee

Total CE hour requirements for renewal

30 contact hours (3.0 continuing education units (CEUs), 1 hour of Texas Laws and Rules

Contact hours for passing NAPLEX

30 hours

Contact hours for CPR course

1 hour

Contact hours for ACLS initial certification

12 hours

Contact hours for ACLS recertification

4 hours

Contact hours for TSBP meeting

3 hours

Contact hours for participation in TSBP appointed Task Force

3 hours

Contact hours for passing specialty exam

3 hours

Required time to keep CE records

3 years

Generic Equivalent

Therapeutically and pharmaceutically equivalent

Pharmaceutical equivalent

Same amount of drug in same dosage form

Therapeutic equivalent

Pharmaceutical equivalent that produces same effect when given in equal amounts

Interchangeable

Biosimilar that is therapeutically equivalent

How physicians can prevent generic substitution

Write "brand necessary" or " brand medically necessary" by hand on prescription

Additional requirement for verbal/electronic prescriptions with dispensing directive for Medicaid patients

Must mail/fax written prescription within 30 days

Practitioners who must authorize generic substitution

Out-of-state, federal facilities

Communication requirement for biologics after dispensing

Must provide prescriber with name and NDC within 3 days

Labeling requirement for generic equivalents

substituted for brand name

Exceptions to dispensing dosage form other than prescribed without authorization from prescriber

EC, time release

Display requirements for pharmacies

Pharmacy" in front of pharmacy, license in public view, how to file complaint to TSBP sign

Quantity of emergency fills

72 hour supply

Exceptions to emergency fill limit

Governor declared disaster and TSBP notification, OC, inhalers, ophthalmic solutions

Exceptions to 90 day supply for dangerous drugs

Psychotropic drugs, patient <18 years old

Department to report epidemic or bioterrorism

Texas Department of State Health Services

Reporting requirements for emergency epinephrine administration

To PCP within 72 hours

Time limit to report change of name/address to TSBP

10 days

Time limit to report closing of pharmacy to TSBP

10 days

Time limit to change in pharmacy name or location

30 days before change, new license application

Time limit to change managing officers

10 days

Time limit to change PIC

10 days

Time limit to report sale/transfer of drugs due to change in ownership

10 days

Time limit to report event that could affect drugs (fire, accident)

Immediately (10 days)

Time limit to report significant loss/theft of drug

Immediately

Time limit to report significant loss of data

10 days

Time limit to report final order against license holder

10 days

Allowable physician dispensing

72 hour supply of dangerous drug, rural areas, veterinarians

Time limit to report legal claim if not insured

30 days

Time limit to report disposition of legal claim

105 days

Length of technician trainee license

2 years, non-renewable

Technician renewal requirements

20 hours CE, 1 hour law every 2 years

Pharmacist to tech ratio

1:4 in Class A. 1:3 if all trainees

Age limit for vaccines

14, unless referred by physician or 7 for flu

Pharmacist certification requirements

BCLS training, 20 hours CDC training, 3 hours CE every 2 years relating to immunizations

Time limits for immunization reporting

24 hours to physician who issued protocol14 days for PCP

Settings in which pharmacists may sign drug orders under physician protocol

Hospital, hospital-based clinic, academic institution

Requirements to perform DTM

Notify TSBP, complete 6 hours of drug therapy annually

Length of keeping DTM records

2 years

Length of keeping inventory

2 years

Reporting requirements for closing pharmacy

14 days beforehand to DEA, have sign for patients showing where records will be

Three places drugs can be stored/dispensed without pharmacist

Nursing home emergency medication kit, Automated Pharmacy Systems in certain facilities, Telepharmacy Systems in rural health care clinics

Additional labeling requirements for prescriptions at a telepharmacy

Providing pharmacy name, address, number

Possible witnesses of drug destruction

Peace officer, agent of the Board, agent of Texas Human Services, agent of Texas State Health Services2 of: Facility administrator, director of nursing, licensed nurse

Information required for documenting destruction of dangerous drugs returned to pharmacy

Dispensing pharmacy name and address, prescription number, drug name and strength, pharmacy signature

Conditions for centralized prescription dispensing

Written contract/common ownership, common database/technology to share information, notice to patients, name of outsourcing pharmacy on prescription label

Conditions for centralized prescription processing

Common ownership/written contract, common database/technology, notice to patients/sign

Time to comply with written warning from inspection

10 days or more unless immediate danger to public

License suspension

License not in effect for a specific amount of time

License Revocation

License is void and no longer in effect

License Restriction

Limit, confine, or restrict a license with certain terms or conditions

Max administrative penalty

$5000 per violation per day$1000 per violation per day for civil penalties

License Reprimand

Public and formal censure of license

Time before re-issuance or removing a restriction on a license can be requested

12 months

Requirement for a pharmacist to be PIC for 2 Class-A pharmacies

Emergency, works 10 hours/week at each pharmacy, no more than 30 days

PIC responsibilities

Legal operation of pharmacy, educating/training technicians

Pharmacist only duties

Receiving oral prescriptions, interpreting prescriptions, selecting drug products, performing final check of dispensed prescription, patient counseling, assuring records are received/kept, drug regimen reviews, DTM, controlled substance invoices, prescription transfers

Drug regimen review minimum

Allergies, CIs, dose and route, therapy duplication, DDIs, ADRs, over/underutilization

Label requirements of prescriptions

Pharmacy name, address, phone number, prescription number, dispensing date, initials of dispensing pharmacist, prescriber name, name of pharmacist who signed prescription, patient name, instructions for use, quantity, ancillary instructions, drug name and strength, beyond use date, "do not flush

Required equipment in Class-A

Computer and printer, refrigerator, child/light resistant containers, precriptions/poison labels, metric-apothecary conversion chart

Required Class-A Library

Laws and Rules, Patient drug information text/leaflets, Drug interaction reference, general drug information reference, basic antidote information and poison control center number

Frequency of testing automated dispensing system

6 months

Information required to be kept by prescription pickup kiosk

Digital image of person picking up prescription for 2 years

Information required for Patient Medication Record

Patient name, address, number, age, gender, allergies, drug reactions, chronic conditions, other drugs used within last 2 years

Frequency of backing up Class-A computer

Monthly

Two ways prescription records may be produced

Daily hard copy printouts, pharmacist log book

Length of keeping log book of pharmacy employee IDs

7 years

Time limit of transferring prescription upon request

4 hours

Number of beds of Class-C where pharmacist has to be present at all times

101 or more

Frequency of onsite pharmacist for Class-C <101 beds

7 days

Max number of facilities/beds under a PIC of Class-Cs

3 facilities or 150 beds

Tech Check Tech

Tech may verify work of another relating ot filling floor stock/unit dose distribution systems

Requirements to be a rural hospital

75 beds or fewer, either in county of <50k people or in designated as critical access hospital, rural referral center or sole community hospital

Time limit for pharmacist to verify orders in rural hospital

7 days

Duties available to tech in rural hospital without pharmacist

Entering orders into computer, preparation of prescription drugs pursunat of orders, filling medication carts, distributing stock to floor, restocking automated medication supply cabinets

Time limit for pharmacist to verify drug withdrawal in hospital >100 beds

72 hours

Time limit for full time pharmacist to verify drug withdrawal in hospital <101 beds

72 hours

Time limit for part time pharmacist to verify drug withdrawal in hospital with <101 beds

7 days

Required library of Class-C

Law and Rules, DDI reference, general drug reference, injectable drug products reference, basic antidote and phone number of poison control, metric-apothecary conversion chart

Frequency of Class-C floor stock review by a pharmacist

30 days

Supply of prepackaged prescriptions that can be filled without a pharmacist by an emergency room

72 hours

Frequency of emergency room drug list records review by pharmacist

7 days

Frequency of required accuracy testing of Automated Medication Supply Systems

6 months

Time for Class-C to provide records upon request

72 hours

Time limit for full time pharmacist to review drug withdrawal in Class-CASC

72 hours

Time limit for part time pharmacist to review drug withdrawal in Class-CASC

Every calendar week

Frequency of distribution vs med order audit by pharmacist in Class-CASC

30 days

Requirements to be an authorized nuclear pharmacist

BPS Certified Nuclear Pharmacist OR complete 700 hours of structured education program, 200 hours of didactic training, 500 hours supervised experience

Pharmacist to tech ratio for Class-B

1:4

Additional labeling requirements for Class-B outer container

Radiation symbol, "Caution - Radioactive Material", name of radiopharmaceutical, amount of radioactivity in curies or bequerels, corresponding time to activity if differing from calibration date, volume if liquid, calibration date and time

Labeling requirements for inner container

Radiation symbol, "Caution/Danger- Radioactive Material", name of readiopharmaceutical, prescription number

Class-D pharmacy

Clinic pharmacy

Products allowed in Class-D formulary

Anti-infectives, musculoskeletal drugs, vitamins, OB-G drugs, topical drugs, serums/toxioids/vaccines

Products restricted from Class-D formularies

nalbuphine (Nubain), ED drugs, controlled substances

Condition to expand Class-D formulary

Serves 80% indigent patients

Frequency of visit by pharmacist to Class-D facility

Monthly

Class-E pharmacy

Non-resident pharmacy

Time limit for Class-E pharmacies to produce records for TSBP

72 hours

Class-F Pharmacy

Freestanding Emergency Medical Care Facility

Those able to access the prescription drug storage area in a FEMCF

Those authorized by PIC

Pharmacists working for Class-E required to have Texas license

Only PIC

Those able to remove drugs from Class-E pharmacy in absence of pharmacist

Designated licensed nurse or practitioner

Time limit for full time pharmacist to review drug removal

72 hours

Time limit for part time pharmacist to review drug removal

Every calendar week

Frequency of retrospective DRRs in Class-F pharmacies

31 days

Class G Pharmacy

Central order processing pharmacy

Pharmacist to tech ratio for Class-G

1:8, only one trainee allowed

Class H pharmacy

Limited prescription delivery pharmacy

Purpose of Class-H pharmacy

Deliver non-control prescriptions to county without a pharmacy for a Class-A pharmacy

When commercially available products can be compounded

When the product cannot be obtained in a timely manner and the practitioner requested the drug be compounded

Additional required material for compounding pharmacy

Class-A balance or analytical balance with weights

Additional labeling requirements of compounded prescriptions

That is has been compounded, active ingredients

Requirements for sterile compounding pharmacists

Trained 20 hours in school or ACPE accredited program, on the job training at compounding facility

CE required for sterile compounding license renewal

2 hours

CE required for license renewal with high risk sterile compounding

4 hours

Sterile compounding tech training requirements

40 hour ACPE accredited course, 40 hours on the job structured training

Frequency of media-fill tests for sterile compounding

Annually

Frequency of media-fill tests for high risk sterile compounding

Semi-annually

Time limit of media-fill test upon pharmacist working on sterile preparations

7 days

Time limit of media-fill test upon technician working on sterile preparations

None, must pass first

Low risk ISO Class requirement

Class 5

Max number of products for low risk sterile compound

3 products

Time limit of room temp storage of low risk sterile product

48 hours

Time limit of cold storage of low risk sterile product

14 days

Time limit of frozen low risk sterile product

45 days

Medium risk sterile compounding

Multiple end products from one container, anything more than single volume transfer

Time limit room temp storage of medium risk sterile products

30 hours

Time limit cold storage of medium risk sterile products

7 days

Time limit frozen storage of medium risk sterile products

45 days

High risk sterile compounding

Non-sterile ingredients used, ISO inferior to Class 5

Time limit room temperature storage of high risk sterile products

24 hours

Time limit cold storage of high risk sterile products

3 days

Time limit frozen storage of high risk sterile products

45 days

Frequency of certification of Laminar air flow hoods

6 months

Additional labeling requirements of sterile prescriptions

Beyond use date, active ingredient