MPJE Texas Pharmacy Law + Federal Acts

*Can you make a copy of your license?

NO, you can only have a pocket license card.

What is the ratio of technicians to pharmacists in Class C pharmacies?

None

What is an emergency refill during a Governor declared state of disaster?

"30 Day Rule" If it's during a natural disaster a pharmacist can refill a medication up to a 30 day supply without practitioner authorization.

*What is needed on a CS prescription?

"Caution - Federal Law prohibits transfer of this drug to any other person other than the patient for who it was prescribed" (not required on C-V)

*When substituting a generic for a prescription that was originally written for the brand, what must be included on the prescription LABEL?

"Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where "Brand Name" is replaced with the brand name of the drug (Ex: "Substituted for Tenormin") [Generics dispensed should also have the manufacturer's name]

What is the maximum amount of administrative penalty (fine) for a violation?

$5000 (for EACH violation - each day a violation continues is a separate violation)

*NDC XXXXX-XXXX-XX: Where is the package code?

NDC: XXXXX-XXXX-PACKAGE CODE [Assigned by the manufacturer]

Schedule III-IV invoices must contain

-Name of controlled substance -Dosage form and strength -Number of units or volume in each container -Quantity received -Date of actual receipt -Name, address, and DEA registration number from which controlled substances were received

How can pharmacist be a PIC of more than one pharmacy?

-A pharmacist can be the PIC of more than one pharmacy if the pharmacies are not open to provide pharmacy services simultaneously -A pharmacist can be the PIC of up to two class A pharmacies that open simultaneously as long as they work at least 10 hours per week in each pharmacy

What does a radiopharmaceutical label contain that is not like a normal prescription?

-Amount of radioactive material contained in millicuries (mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that applies to this activity -Date and time of calibration -If liquid, volume in milliliters -Radiation symbol -"Caution-Radioactive Material"

Records Pharmacist should be able to located in a Class A Pharmacy for the past 2 years:

-Annual Inventories -Executed DEA 222 Forms -Controlled substance invoices -Theft and loss reports -Drug destruction reports -All Prescriptions -DEA and DPS registration certificates if they are not posted -Daily dispensing printouts or dispensing logs -Prepackaging records if applicable -Technician training manual and documentation or technician training

What type of drugs are normally (without the expanded formulary exception) allowed in a Class D pharmacy formulary?

-Anti-infective drugs -Musculoskeletal drugs -Vitamins -Obstetrical and gynecological drugs and devices -Topical drugs -Serums, toxoids, and vaccines *Exclusive to injectables administered at the clinic and OTCs

Destruction of CS at the pharmacy (Class A and C)

-At class A can only be done once a year, at class C can be done anytime -Both must get approval from DEA and record it on DEA form 41 which must be kept for 2 years and a copy sent to the DEA divisional office -Destruction must be witness by one of the following: A commissioned peace officer, DEA agent, DPS agent, supervisory member of hospital's security department (Class C only), or agent of TSBP

*In what circumstances can a pharmacist, who is the only pharmacist at the location at the time, be temporarily away from the pharmacy?

-At least one pharmacy technician remains at the pharmacy -The pharmacist remains on site and is immediately available -The pharmacist reasonably believes the security will be maintained -A notice on the pharmacy when the pharmacist will return -At this time only technicians who have full training may do their duties

*When does a CS inventory have to be taken?

-At the initial day the pharmacy opens -A newly scheduled drug or change of schedule on the effective date -Per FCSA amd TCSA inventory every 2 years -Per TSBP inventory annually Exact count only has to be taken for C-II or C-III through C-V if the container contains over 1000 tablets or capsules, must count expired drugs as well

*Things to know about CIII-CV prescriptions

-DEA does not allow CS prescriptions to be transmitted electronically from practitioner's computer to pharmacy's computer -Max of 5 refills within 6 months -CS Rx may only be transferred once between pharmacies with the exception of pharmacies that share a real-time, online database

*The Board (or rep of the Board) may enter and inspect a facility relative to the following...

-Drug storage and stability -Equipment -Components used in compounding, finished and unfinished products, containers, and labeling of any item -Sanitary conditions -Records, reports or other documents required to be kept

*What is a 'New prescription drug order'?

-Has not been dispensed to the patient in the same strength and dosage form within the last year -Is transferred from another pharmacy and/or -Is a discharge (hospital) order *We must counsel on these

*What are the differences in fees for the different time frames when you renew your license?

-If renewed before the license is expired (upon notification by the Board) the pharmacist will pay the renewal fee -If renewed within 90 days after expiring the pharmacist will pay 1 & 1/2 the renewal fee and cannot practice while the license is expired -If renewed after 90 days after expiring but before 1 year the pharmacist will pay twice the renewal fee -If not renewed within 1 year after expiration the pharmacist must apply for a new license

How can a student-internship expire?

-If the student voluntarily or involuntarily ceases enrollement, including suspension, in Pharmacy school -If the student-intern fails the NAPLEX or MPJE -If the student-intern fails to take the NAPLEX or MPJE within 3 calendar months after graduation

Emergency C-II oral prescriptions

-Immediate administration is needed, where no alternative is available, and a written prescription can not be presented prior to emergency -Quantity limited to treatment of emergency -Pharmacist is the transcribe the verbal prescription and receive a written Rx from the practitioner within 7 days or otherwise reported to the DEA if not received.

*What are classifications of an Extended-intern?

-Intern who has successfully passed the NAPLEX and MPJE but does not have enough intern hours to be for licensure -OR has with enough hours and is registered for the NAPLEX and MPJE within 3 months after graduation -OR Applied for the NAPLEX and MPJE within 3 months after obtaining full certification from the Foreign Pharmacy Graduate Equivalency Commission -OR Applied for re-insurance of an expired license for more than 2 years but less than 10 and has successfully passed the MPJE but lack intern hours

General inventory requirements of controlled substances

-Inventories must be done by the PIC (can be delegated) at initial, annual, change of ownership, change of PIC in class A or C pharmacies, and closing inventory and notarized within 72 hours. (Notary not required for change of PIC). Newly scheduled drugs or drugs moved from one schedule to another must be inventoried on the day scheduled. -Make an exact count of all C-I, C-II. For CIII-CV make an exact count only if container >1000 units (also dosage forms containing nalbuphine) -Records are to be kept for 2 years with separate files for both CIIs and CIII-CVs (Same as fed)

*HIPPA Notice of Privacy Practices

-Must be provided and good effort to obtain written acknowledgement is required; it must be provided upon 1st service delivery

What records of the drugs must a pharmacy keep when loading an automatic compounding or counting device?

-Name of the drug, strength, and dosage form -Manufacturer or distributor -Manufacturer's lot number -Expiration date -Date of loading -Name, initials or electronic signature of the person loading the device -Signature or electronic signature of the responsible pharmacist

When labeling a prescription what does it need to have?

-Name, address, and phone number of the pharmacy -Unique prescription number -Date dispensed -Initials or ID code for dispensing pharmacist (not required on label if stored in the computer) -Name of practitioner -Name of patient -Instructions for use -Quantity dispensed -Appropriate ancillary instructions (Do not flush) -If CS, federal transfer caution statement -Name and strength of actual drug dispensed -If a generically equivalent drug is dispensed the statement of substitution on the label -PA or ANP name if signed off by them -Name of pharmacist who delegated dangerous drug if prescribed under the practitioner -Beyond use date

On a C-II prescription what is suppose to be preprinted?

-Prescriber's full name and address, DEA, and DPS

*Exceptions for filling faxed C-II prescriptions

-Prescription faxed for C-II narcotic to be compounded for direct administration parenteral, intravenous, intramuscular, subQ, or instraspinal infusion -Fax to a long-term care facility -For a patient enrolled in a hospice care program certified and/or paid by Medicaid or licensed by the state

*What should a pharmacist-intern not do?

-Present him or herself as a pharmacist -Sign documents pharmacy documents without a cosign of a preceptor -Independently supervise pharmacy technicians

*What are the general requirements of security of the prescription department?

-Shall be locked by key, combination, or other mechanical or electronic means to prohibit unauthorized access -Effective June 1, 2009- Pharmacy's key, combination, or other mechanical or electronic means of locking the pharmacy may not be duplicated without the authorization of the PIC or owner. Also the pharmacy must have a basic alarm system with off-site monitoring and perimeter and motion sensors.

*What are the general requirements of the environment of the pharmacy?

-Shall be orderly and clean -Have a sink with hot and cold running water -Contain an area suitable for confidential patient counseling -Shall be properly lighted and ventilated -Temperature of the pharmacy and refrigerator shall be maintained within a range compatible with proper storage of drugs -No animals in the pharmacy

*What are the rules for when the pharmacist is off-site from a Class A pharmacy?

-The prescription department must be secure -Pharmacy technicians and trainees may not preform any duties -Automated storage and distribution devices can be used -Prescriptions already verified can be delivered -Pharmacist can off-site for only 2 hours in a 24 hours period -Must post a notice that the pharmacist is off-site and can not fill any new prescriptions

What texts are in a Class B pharmacy library?

-USP/NF with supplements -Federal and state laws and rules -Texas Regulations for Control of Radiation -A reference on safe handling of radioactive materials -A minimum of three texts dealing with nuclear medicine science -Reference on sterile product preparation -Code of Federal Regulations (CFR), Title 10 -CFR, Title 49

*FDA requires pharmacists to provide patient package inserts (PPI's) with...(if absent considered misbranded)

1) Oral contraceptives 2) Estrogen containing products 3) Progesterone containing products

*Pharmacies may use and disclose PHI (Protected Health Information, patient identifiable information) without authorization to the patient in order to...

..provide treatment, payment, and for health care operations. Also, to gov't for ADR reporting, law enforcement agencies, TSBP, state drug monitoring programs.

When does a dangerous drug prescription expire?

1 year from the date of issuance

How much experience is required for a pharmacist to become a preceptor?

1 year of experience in the pharmacy practice setting or 6 months as a pharmacy resident. 3 CE hours are needed of preceptor training

*A pharmacist may release confidential records only to:

1) A patient or patient's agent 2) A practitioner or another pharmacist if it is required to protect the patient's health 3) The Board, state/federal agency authorized by law 4) Law enforcement agency engaged in an investigation of a suspected violation 5) A person employed by a state agency that licenses practitioners (as long as working within official duties) 6) Insurance/3rd party carrier authorized by the patient to receive the information

*What is required to use automated pharmacy systems (Pyxis, etc for nursing homes, etc)?

1) Application to the Board 2) Drugs can only be maintained in the automated pharmacy system 3) A pharmacist supervising operation of the system (electronically is okay) and approving the release of the 1st dose after receiving a valid prescription drug order 4) Drugs must be in original manufacturer's container or prepackaged in the provider pharmacy 5) Records maintained of drugs sent to and returned from remote location

*EXEMPTIONS to child-resistant containers requirements

1) At the request of MD or patient 2) *Blanket request for ALL prescriptions from the pt (but NOT from MD --> MD must indicate on each individual Rx) 3) Written request not required, but should be documented 4) Must be the pt's decision, but the RPh may initiate the request 5) Bulk containers shipped to manufacturers, wholesalers, pharmacies (not for household use) 6) Drugs sent to institutions to be administered by the institution's employees 7) One package size of OTC designed for elderly as long as it says "THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN"

A formal disciplinary hearing (public) before an Administrative Law Judge is scheduled due to...

1) Licensee declining an informal conference 2) Licensee not consenting to informal disposition of the case through entry of an agreed board order 3) Board rejecting the agreed board order 4) request by licensee for a disciplinary hearing before an Administrative Law Judge

Hazardous Substances Labeling Requirements

1) Name/address of manufacturer 2) Common name 3) "Danger" 4) "Warning" or "Caution" 5) Statement of hazardous properties 6) Precautionary statements 7) First aid instructions followed by "call a physician immediately" 8) "Poison" and the skull/crossbones symbol on HIGHLY TOXIC substances

*Enforcement action by FDA due to raised concerns of a compounding pharmacy's activities mimicking a manufacturer is considered if the pharmacy engages in:

1) Compounding drugs in anticipation of receiving prescriptions (very limited quantities are allowed if they are a response to amounts of drugs compounded after receiving valid prescriptions) 2) Compounding withdrawn or removed drugs from the market for SAFETY reasons. 3) Compounding finished drugs from unapproved bulk active ingredients without a sanctioned investigational new drug application 4) Receiving, storing, or using drugs without first obtaining written assurance from the supplier that each lot has been made in an FDA-registered facility 5) Receiving, storing, or using drugs not guaranteed to meet official compendia requirements 6) Use of commercial scale manufacturing or testing equipment 7) Compounding drugs for 3rd parties to resell to individuals 8) Compounding commercially-available FDA approved drug products (TX allows you to if there is a drug shortage, or MD requests) 9)Failing to operate under statelaw regarding pharmacy practice

*What is required to using telepharmacy systems (monitor dispensing of prescription drugs by electronic methods of audio/video, etc.)?

1) DEA/DPS if controlled substances are to be stored there 2) Application to the Board 3) Drugs dispensed in unit-of-use prepackaged containers with appropriate label, or original manufacturer's container 4) Labels must contain the name, address, and phone number of the provider pharmacy as well as the remote site's name, address, and phone number; Rx number should identify the remote site somehow 5) A record of all the drugs sent to and returned from the remote location 6) Perpetual inventory of all controlled substances (and nalbuphine); inventory of the remote location's CS should be on the same day as the providing pharmacy

After the informal conference, the alleged violations may be...

1) Dismissed 2) Settled by the licensee (consent order - not admitting/denying guilt) by accepting a proposed Agreed Board Order --> this is presented to the Board members who can: a) accept it --> case settled b) reject it --> case is then scheduled for a formal disciplinary hearing before an Administrative Law Judge of the State Office of Administrative Hearings

*OTC drug labels must contain the following...

1) Display panel, including statement of identity of the product 2) Name and address of manufacturer, packer, or distributor 3) Net quantity of contents 4) Cautions and warnings needed to protect the user 5) Adequate directions for safe and effective use (for layperson) 6) "Drug facts" panel must include: active ingredients, purpose, use(s) - indications, warnings, directions, other information, inactive ingredients, Questions? followed by Ph# [OTC's without approved application (monograph drugs) require domestic address or domestic Ph# to receive reports of serious adverse events; drugs with Mg, Ca, Na, or K that might be harmful to certain pts must have stated exact amount]

Who attends the informal conference?

1) Executive Director of the Board 2) Other staff executive director deems necessary 3) Legal counsel of the Board 4) Assistant Attorney General assigned to the Board 5) Affected licensee and/or the authorized representatives 6) One Board member (unless administrate law judge is there --> if so, the judge will tell Board his/her recommendation) 7) The complaintant (optional)

In a pharmacy with a clinical pharmacy program, a tech can check the work of another tech (as long as the checker is a registered tech and is trained) for the following duties:

1) Filling medication carts 2) Distributing routine orders for stock supplies to patient care areas 3) Accessing and restocking automated medication supply systems *The patient's orders must have been previously reviewed and approved by a pharmacist**

Unless the agent in charge of the facility consents in writing, the person authorized to represent the Board in an inspection may not inspect...

1) Financial data 2) Sales data 3) Pricing data

What are requirements to apply for registration as a pharmacy technician trainee?

1) High school or equivalent diploma, or working on getting an equivalent certification (GED) 2) Meet all requirements necessary in order for the Board to access criminal history record information, fingerprint information, and paying fees 3) Complete the Texas application for registration

What are requirements to apply for registration as a pharmacy technician?

1) High school or equivalent diploma, or working to achieve it (GED) 2) Either have: a. Taken and passed the PTCB exam and have a current certification certificate b. granted an exemption by the Board (technicians with experience 10 yrs prior to 9/1/01 or rural techs working in county population of <=50000) 3) Completed Texas application for registration 4) Paid the fee $$$

What is required for a pharmacist to refill a prescription without authorization (emergency refill)?

1) If failure to refill will lead to interruption of therapeutic regimen or create patient suffering 2) Either: a natural or manmade disaster prevents the pharmacist from contacting the prescriber OR the pharmacist is unable to contact the prescriber after reasonable effort. 3) The pharmacist must inform the patient it is an emergency refill

What 3 settings are Class C licenses issued to?

1) Inpatient facility (hospital) 2) Hospice inpatient facility 3) Ambulatory surgical center

What can a person decide to do after the Board by order determines a violation occurred?

1) Pay the administrative penalty (fine) 2) Pay the penalty and file a petition for the judicial review contesting the violation or amount of penalty, or both 3) Without paying the penalty, file a petition for judicial review contesting the violation or amount of penalty or both You have 30 DAYS after the Board's order becomes final to do the above

When is a pharmacist required to review and approve a medication order filled through the automated medication supply system for a... 1) Pharmacist on duty 2) Full-time pharmacist not on duty 3) Part-time/consultant pharmacist not on duty ?

1) Pharmacist on duty - BEFORE the order is filled (except emergency) 2) Full time - within 72 hours 3) Part-time/consultant - within 7 days

*Def'n: Supervision

1) Physically present supervision - pharmacist is physically present to directly supervise pharm tech/trainees 2) Electronic supervision - if the hospital is licensed for <=100 beds, electronic supervision is accepted provided: a) the system allows for monitoring of data entry and filling of orders & the pharmacist verifies accuracy b) there are controls to protect confidential records c) the pharmacy keeps permanent digital records of duties electronically supervised for 2 yrs

In a facility with <= 100 beds, which duties of a technician can be done with electronic supervision?

1) Preparing, packaging, or labeling prescription drugs pursuant to medications orders (RPh must check prior to distribution) 2) distributing routine orders for stock to patient care areas 3) entering medication orders and drug distribution information (as long as judgmental decisions are not required and RPh checks info entered prior to release of order) 4) accessing automated medication supply systems 5) compounding non-sterile preparations 6) compounding low-risk sterile preparations (RPh must check prior to distribution)

*Delivery of controlled substances from physician/pharmacist to users by USPS has the following requirements...

1) Prescription container is labeled in compliance with prescription labeling rules 2) The outer container for the medication cannot have markings that would reveal the contents [Controlled substances can also be mailed to other DEA registrants with plain outer containers]

*When is a pharmacy required to register with the FDA and comply with FDA regulations, inspections, and CGMPs?

1) Repackaging of drugs from one hospital to be distributed to another (in TX, can distribute without registration if under common ownership) 2) Chain repackages drugs to distribute to individual stores 3) Informal buying group repackages to distribute to members 4) Manufacturing is occurring [A pharmacy can repackage for use within its own pharmacy without registration]

*Prescription drug exemptions to FPPPA

1) SL NTG 2) SL and chewable isosorbide dinitrate in strength of <= 10mg 3) Erythromycin ethylsuccinate granules and oral suspensions in packages with <=8g equivalent of erythromycin 4) Erythromycin ethylsuccinate tabs in packages containing <=16g equivalent of erythromycin 5) Anhydrous cholestyramine powder 6) K supplements in unit dose forms containing <= 50 mEq per unit dose 7) NaF drug preparations <= 264mg of NaF per package 8) Betamethasone tabs in manufacturer's dispenser packages containing <=12.6mg betamethasone 9) Mebendazole tabs in packages containing <= 600mg of betamethasone 10) Methylprednisolone in packages containing <= 84mg of drug 11) Colestipol in powder form in packages <= 5g of drug 12) Pancrealipase in tablet, capsule, or powder form 13) Medically administered oral contraceptives in manufacturer's mnemonic dispenser package which rely only on the activity of one or more progestogen or estrogen substances 14) Prednisone tabs in packages <= 105mg of the drug 15) Conjugated estrogen tabs in mnemonic dispenser packages <= 26.5 mg of drug 16) Norethindrone acetate tabs in mnemonic dispenser packages <= 50mg of drug 17) Medroxyprogesterone acetate tabs

*Requirements before entering and inspecting a facility, the person authorized to represent the Board must:

1) State the purpose for the inspection 2) Present the person in charge of the facility with appropriate credentials and written notice of authority for inspection

*What requires immediate notification to the Board?

1) Theft/loss of controlled substances 2) Theft/loss of dangerous drugs 3) Emergency/accident/disaster that may affect the strength, purity, or labeling of drugs or devices in a pharmacy (has up to 10 days) [Everything else is probably 10 days]

*When MUST a PA/APN consult their delegating physician in regards to controlled substance refills and pediatric patients?

1) When refills need to be authorized for a prescription a PA/APN wrote 2) When the patient is <2 years old

*How many days does a pharmacy have to notify the Board of a change of location?

10 days, AND the pharmacy is required to post a sign saying they are changing locations 14 days before they move.

*The training manual for a tech or tech trainee should include...

1) Written procedures and guidelines for use and supervision of techs and trainees - specify how a pharmacist is responsible for actions of techs and what duties techs may or may not perform 2) the following areas: orientation, job descriptions, communication techniques, laws, security/safety, prescription drugs (nomenclature and dosage forms), drug orders and drug order prep, drug product prepackaging, confidential patient medication records

In a facility with <= 100 beds, which duties of a technician MUST be done with physically present supervision?

1) prepacking and labeling unit/multiple dose packages 2) bulk compounding or batch preparation 3) loading unlabeled drugs into an automated compounding or counting device 4) compounding med-high risk sterile preparations pursuant to medication orders

Under PDMA and TSBP Rules, ALL classes of pharmacy are prohibited from selling, purchasing, trading, or possessing prescription drug samples UNLESS...

1) the pharmacy is owned by a charitable organization, city, state or county government AND 2) is part of a health care entity which provides mainly to indigent or low income patients AND 3) gives samples at no cost

*How many days does a pharmacy have to notify the Board about the change in PIC?

10 days. If there is a change in PIC an inventory must be done of all C-II and all dosage forms containing: pentazocine, phentermine, diazepam, phendimetrazine, codeine, hydrocodone, alprazolam, triazolam, butorphanol, nalbuphine, carisoprodol. INVENTORIES may be delegated to another person(s). Does not have to be NOTARIZED.

How many days does a pharmacy have to notify the Board of a change in managing officers?

10 days

How long does a PIC have to notify the Board of a fire or other disaster to the pharmacy?

10 days. If there is a loss of CS it must be reported to the DEA, DPS, and TSBP. If there is a loss of dangerous drugs a list must be reported to the Board in writing.

*How many beds should a facility have to be eligible to have a PIC on a consulting or part-time basis?

100 beds or less

What is the ratio of technicians to pharmacists in an outpatient pharmacy located within a hospital?

1:3 (considered a Class A pharmacy)

What is the ratio of pharmacists to technicians if the pharmacy dispenses <20 different prescription drugs and doesn't compound sterile/IV/IM drugs?

1:5 [At least 4 have to be reigistered, must have policies and procedures that describe supervision and how techs can only be involved in one process at a time (no multitasking)]

How long does a pharmacy technician trainee have to become a pharmacy technician?

2 years

How long must a pharmacy keep records of drug acquisitions or disposals?

2 years

Records for invoices,/inventories, and prescriptions should be maintained for ___ years.

2 years (based on FDCA, TSBP, DPS, and DEA)

How long must a pharmacy retain filled prescriptions?

2 years from initial dispensing or last date of refilling

*If a physician is not part of a narcotic treatment program and his/her patient is having acute withdrawal symptoms, the physician may ADMINISTER narcotic drugs for how long?

3 days

*How many facilities can a pharmacist be a PIC for if they are a PIC on a consulting or part time basis?

3 facilities or 150 beds

*How long are CE records need to be kept?

3 years

*What are the limits on how much PSE can be purchased?

3.6 grams per day (or 2 boxes per Texas law) and 9 grams per 30 days.

*How many ACPE approved CE hours must be obtained for renewal of a pharmacist license?

30 hours

*What is the maximum number of hours a week that a Pharmacist-intern can credit toward their internship?

50 hours

Once a pharmacy is licensed, how long do they have to commence "pharmacy operation" (business) before they can be disciplined for not operating?

6 months - Also, if a pharmacy is licensed and commences business on time but suddenly ceases business for 6 months or more, they can also be penalized.

When does a controlled substance prescription expire?

6 months or after 5 refills, whichever is sooner

*How long does the supplier have to send a partial fill for C-II?

60 days

Can you refill a prescription of a practitioner who has died?

A prescription dies with the practitioner. Emergency refills may be used.

How many hours of training must a nuclear pharmacist have to be registered with the Board?

700 hours: 200 hours of didatic training in a program approved by the Bureau of Radiation Control, Texas Department of Health and 500 hours of supervised experience in a nuclear pharmacy

What is the maximum days supply that can be dispensed from the ER in the absence of a pharmacist?

72 hour supply

What is the maximum quantity of drug allowed to be dispensed if it is an "emergency refill?"

72 hour supply

*How long do you have to complete a partial filling of a C-II prescription?

72 hours, after that no further quantity can be dispensed Exception: Terminally ill patients or an LTCF patient which must be documented on the Rx, can be partially filled up to 60 days after being issued.

*Emergency Refills: What is the difference between the 72 hour rule and the 30 day rule?

72-hour rule: the pharmacist can dispense a 72-hour supply for a prescription other than a CII without authorization from a prescriber if interruption of therapy may harm/affect the health of the patient and the pharmacist is unable to contact the prescriber after reasonable effort OR a natural/manmade disaster prohibits the pharmacist from contacting the prescriber 30-day rule: the pharmacist can dispense a 30 day supply (other than a CII) with the provisions of the 72 hour rule AND the governor has declared a state of disaster and the executive director of the board has notified pharmacies that pharmacists may dispense up to a 30 day supply

*Who makes up the TSBP?

9 members - 6 Pharmacist and 3 public residents. The 6 pharmacist must include pharmacist from Class A and C.

MEDMARX

A data sharing program established by USP that collects medication error & adverse event data from hospital on an anonymous, voluntary basis.

What happens if you don't respond to a Preliminary Board Letter by attending the Informal Conference or in writing?

A default Order will be entered by the Board

*What are the requirements for a facility to only need services of a pharmacist on a part-time or consulting basis?

A facility licensed for <= 100 beds; the pharmacist must be on-site at least once every 7 days A consultant/part-time pharmacist must have a written agreement with the facility

*Def'n: Pharmacy

A facility where prescription drug or medication orders are received, processed, or dispensed [NOT a narcotic drug treatment program]

MEDWATCH

A program for reporting ADR's, which became the FDA's Medical Products Reporting and Safety Information Program.

*Def'n: Revoke

A license is void and may not be reissued However, upon expiration of 12 months from the effective date of the order revoking a license an application may be made by the former licensee for the issuance of a license upon the successful completion of any examination required by the Board

*When the pharmacy is closed and the practitioner orders a drug for a patient, who is allowed to withdraw drugs from the pharmacy?

A licensed nurse or practitioner only (in a facility with any # of beds)

*Def'n: Dangerous Drug

A non-controlled prescription item. [Required to bear the legend: "Rx only" or "Caution Federal law prohibits dispensing without prescription" or "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian]

*How often should the controlled substances be inventoried for emergency medication kits?

A perpetual inventory of controlled substances (and nalbuphine) must be maintained for each remote location; Inventories should be done on the same day as the provider pharmacy's inventory.

*How often must inventories be made for controlled substances using automated pharmacy systems in remote locations?

A perpetual inventory should be made for controlled substances (and nalbuphine) for EACH remote location; CS inventories should be done on the same day as the provider pharmacy's inventory

Def'n: Patient

A person who is admitted to the facility; INCLUDES a person confined in a correctional institution!

*What is an intern-trainee?

A pharmacist intern, registered with the board, who is enrolled in the first year of Pharmacy school

Who can load Automatic Compounding and Counting devices?

A pharmacist or technician supervised by a pharmacist

*What is a student-intern?

A pharmacist-intern registered with the board who is enrolled in the professional school and obtained a minimum of 30 credit hours

*When transferring CS what is the "Distributor rule"?

A pharmacy does not have to register as a distributor if the amount of CS transferred does not exceed 5% of the total quantity of all CS dispensed during that same 12-month period. This is based on dosage units (# of tablets, etc). Transferring of C-II, transferee must execute a DEA 222

*Distribution of CS to ambulances or EMS units (not affiliated with the hospital)

A physician must order the CS for the ambulance to use and will be placed under the physician's DEA

*How many interns can a preceptor supervise?

A preceptor may only supervise 1 pharmacist-intern at any given time, except if the student-interns are not engaging in dispensing activities, patient counseling, or any activities requiring independent judgment.

When the pharmacy is closed and the practitioner orders a drug for a patient, what is required to record what is being taken?

A record of the name of the patient, name of the drug, strength and dosage form, dose prescribed, quantity taken, time and date, signature of the person making the withdrawal (or an original/direct copy of the order can be substituted if it contains all of this information) --> for a facility with any # of beds

*Def'n: Administrative penalty

A term meaning fine

*Def'n: Pharmaceutically equivalent

A term that describes a drug that has identical amounts of the same active chemical ingredients in the same dosage form (same drug)

*Def'n: Generically equivalent

A term that describes a drug that is pharmaceutically equivalent and therapeutically equivalent

*Def'n: Therapeutically equivalent

A term that describes a drug that is pharmaceutically equivalent that, if administered in the same amounts, produces identical therapeutic effect in duration and intensity (same bioavailability)

*What are the limits on the days supply a PA/APN can write for a controlled substance?

A total of 90 day supply (including refills) of a C-III to C-V

*Do all codeine products require a Rx?

Under Texas law all codeine products require Rx

What are the 5 (A-E) Classes of pharmacy?

A-Community, B-Nuclear, C-Institutional, D-Clinic, E-Nonresidential Pharmacy

*Non-prescription exemptions to FPPPA

ASA containing effervescent tablets (other than ped use) with <10% ASA or ASA powders with <13 grains of ASA/unit (provided there is no other substance requiring special packaging) Methyl alcohol if packaged in a pressurized spray container APAP effervescent tablets < 10% APAP or powders with <13 grains of APAP/unit dose (provided there is no other substance that requires the special packaging requirements)

*Storage of CS drugs

Acceptable - Storage of CS in a secure locked cabinet or dispersed throughout the non-controlled drug stock to deter theft Unacceptable - storing all CS on one unsecure shelf C-II are not required to be secured in a locked cabinet in a community pharmacy but are required in a Class C pharmacy (Hospital)

*Define Schedule IV (C-IV)

Accepted medical use and an abuse potential less than those in Schedule III. abuse may lead to LIMITED physical or psychological dependence Ex. Propoxyphene, butorphanol, pentazocine, 25mcg of atropine, diazepam, lorazepam, phenobarbital, phentermine SOMA is C-IV under Texas law

*Define Schedule V (C-V)

Accepted medical use and an abuse potential less than those in Schedule IV. Abuse may lead to limited physical or psychological dependence relative to C-IV. Ex. Robitussin AC, diphenoxlate and atropine (lomotil), pregabalin (lyrica)

*Define Schedule III (C-III)

Accepted medical use and an abuse protential less than those in schedule I and II. Abuse may lead to MODERATE or Low physical or HIGH psychological dependence Ex. includes many C-II in combination with another ingredient, aspirin with codeine, APAP with codeine, pentobarbital, ketamine, anabolic steroids NOT human growth hormones!

*Federal Hazardous Substances Act

Act's purpose was the protect the consumer (esp children) from household and non-household substances

*How to confirming a DEA number

Add 1st, 3rd, and 5th digits. Then add 2nd, 4th, and 6th digits and multiply by 2. Add the two resulting numbers and the last digit or the one's column digit corresponds to the 7th digit of the DEA number. The first letter of the DEA number is an A, B, or F. The second letter corresponds to the first letter of the practitioner's last name or first letter of a pharmacy's name Mid-lvl practitioners (PA, ANP, etc) have DEA numbers that start with the letter M. (Those without independent prescribing authority)

*Poison Prevention Packaging Act (FPPPA) - who administers it, and what was the purpose?

Administered by the Consumer Product Safety Commission (CPSC) Purpose: required child resistant containers for all prescription and nonprescription drugs (household substances also included)

*Def'n: Adulteration

Affects the purity, quality, or strength of the drug; If the drug contains a filthy substance, packed under unsanitary conditions, methods of manufacture don't comply with CGMPs, if any type of contaminant is possible, unsafe color additive, strength differs from purported compendium standards, strength differs from what it represents, mixed with substance which decreases strength

When can a person whose license has been canceled, revoked, or restricted petition the Board for reinstatement or removal of the restriction?

After the 1st anniversary of the effective date of revocation or restriction - the petition must be in writing; if denied, the person must wait another 12 months before re-petitioning

*Writing CS prescriptions

All CS prescriptions must be signed not dated by the physician issuing the Rx and dated for the date given. The prescription must include the patients name and address, drug name, strength, dosage form, the quantity prescribed in number and written, DEA and DPS, DOB, and practitioner's telephone number

Def'n: Labeling

All labels and other written, printed, or graphic matter on the container or accompanying the container (package insert), any advertising, and anything verbally stated by a manufacturer's representative

When does a dispensing container not require everything a usual prescription label should have?

All of the following together: -Drug is administered to an ultimate user who is institutionalized -No more than 34-day supply or 100 dosage units -The PIC has determined the institution will keep clear records -The label will contain: Pharmacy name and address, prescription number, name and strength of the drug, name of the patient, name of the practitioner, and beyond use date

Optometric Glaucoma Specialists may prescribe and administer...

All that a Therapeutic Optometrist can prescribe PLUS antiglaucoma drugs, one 10-day supply of oral antibiotics, one 72-hour supply of oral antihistamines, one 7-day supply of oral NSAIDs, and one 3-day supply of any analgesic in Schedule III-V

*Def'n: Tech-check-tech

Allows a pharm tech to verify the accuracy of the work of another pharm tech relating to filling floor stock and unit dose distribution systems (pyxis) for a patient admitted to the hospital if the patient's orders have previously been reviewed and approved by the pharmacist. *must complete training for this*

The Drug Enforcement Administration (DEA)

An agency of the Department of Justice, is the lead federal law enforcement agency charged with the responsibility for combating controlled substance abuse

*What is required to provide an emergency medication kit (for nursing homes, intermediate care facilities, convalescents, etc) to provide drugs to a resident that would otherwise be unable to supplied in reasonable time?

An application to the Board of Pharmacy, limitation of access to the kit to the pharmacists and healthcare personnel at the facility, stocking of drugs by a pharmacist, pharm tech, or pharm tech trainee, records kept of all drugs sent to and returned to the providing pharmacy

Who is the PIC for a Class B pharmacy?

An authorized nuclear pharmacist which is a pharmacist who has completed the specialized training requirements for preparation and distribution of radiopharmaceuticals. The PIC can only be PIC of ONE pharmacy at a given time.

What is an emergency temporary pharmacist license used for and how is it obtained?

An emergency temporary pharmacist license is used during emergency situations in which the TSBP grants a license pharmacist from another state a temporary license in Texas, but must be sponsored by a pharmacy with an active license in Texas

What are required for an annual controlled substance inventory for a Class A and C pharmacy?

Annual inventory in Class A and C pharmacies of all controlled substances and dosage forms contain nalbuphine are required by TSBP (more stringent than DPS/DEA). Must be taken within 4 days of date specified for annual inventory

If a pharmacy has a pharmacy balance used for weighing ingredients how often do they need to have it registered?

Annually or biannually. The Board may inspect the accuracy of the balance periodically.

Who can request prescription drug samples under PDMA in Texas?

Any practitioner (MD, OD, DM) INCLUDING nurse practitioners and physician assistants. NOT pharmacists.

What practitioners can possess OTC drug samples?

Any practitioner (MD, OD, DM, ANP, PA, PharmD). They can be kept in pharmacies!

Def'n: Biological Products

Any product isolated from natural sources (human, animal microorganism) and that may be produced by biotechnology methods. Ex: vaccines, blood, allergenics, genetherapy, tissues, recombinant therapeutic proteins

*Def'n: Designated agent

Anyone authorized by the practitioner to communicate prescription drug orders; May also be an APN or PA who can sign a prescription drug order for dangerous drugs.

What drugs may dispensed in the ER to outpatients in the absence of a pharmacist?

Anything on a LIST that is put together by the PIC and the ER committee

Orange Book official name

Approved Drug Products with Therapeutic Equivalence and Evaluations, published by FDA.

Def'n: Drug

Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal; intended to affect the structure or function of the body of man or animal (other than food)

Def'n: Cosmetic

Articles intended to be rubbed/poured into the body for the purpose of cleansing, beautifying, or altering appearance of it

*In a facility with >100 beds, when the pharmacy is closed and the practitioner orders a drug for a patient, when does a pharmacist have to verify what was withdrawn while the pharmacy was closed?

As soon as possible, but no later than 72 hours after withdrawal

What must a pharmacy do when closing?

At least 14 days prior the pharmacy must post a sign notifying consumers they are closing and notify the DEA if they possess CS. On the day of closing the pharmacy must take an inventory, removal all prescription drugs (return, transfer, or destroy). Within 10 days of closing they must notify the board. All DEA order forms (222) must have VOID written on them and all Copy 2 of C-II transfers must be sent to the DEA. Emergency closing is exempt from the 14 day tasks.

How often must a QA test be done for an automated medication supply system?

At least every 6 months and whenever an upgrade to the system is made

If a pharmacy is using an automated pharmacy dispensing system how often are they required to test the accuracy and who is responsible for its supervision?

At least every 6 months or whenever they upgrade and the PIC of the pharmacy.

If a pharmacy has an automated pharmacy dispensing system, how often does the PIC have to inspect the medication?

At least monthly, for expiration date, misbranding, physical integrity, security, and accountability

*Ryan Haight online pharmacy consumer protection act of 2008 (FCSA)

Bans, delivery, distribution or dispensing of controlled substances over the internet without a valid prescription. Online pharmacies must notify the US attorney general and state board of pharmacy 30 days of offering sell, distribution, or dispensing of CS.

*What are the ways in which a pharmacist must supervise a technician or technician-in-training when entering prescription data into a pharmacy's data processing system?

By physically present supervision in which the pharmacist verifies at the time of data entry OR By Electronic supervision in which the pharmacist must be on-site, have immediate access to any original document containing prescription information, and verifies the accuracy of the data entered prior to release of the information into the system

*Which form is used to return CS or sending them to the DEA to dispose of?

C-II DEA form 222 - Copy 3 is kept by the supplier and copies 1 and 2 are sent to the pharmacy, the pharmacy records the date sent (returned) of package and keeps copy 1 while sending copy 2 to the DEA divisional office by the end of the month. Transfer of CS to the DEA for disposal also uses the DEA form 222. C-III through C-V are handled like dangerous drugs returns.

*What are the TSBP rules on filing prescriptions?

C-II, C-III through C-V, and Dangerous drugs and OTC drugs TSBP requires 3 files

*What training is required by the TSBP to administer immunizations and vaccinations?

CDC and prevention training, basic life support training, and hands-on training in techniques for administering immunizations and vaccinations. Also must maintain documentation of initial training and 3 hours of CE every 2 years which are designed to maintain competency in the disease states, drugs, and administration of immunizations and vaccinations.

What is a Satellite Pharmacy (not decentralize in hospital)?

Can be established by a Class A and Class C pharmacy (needs separate license). They cannot store bulk drugs and only store prescription medications that have been previously verified and dispensed be provider pharmacy. Licensure and notification of ownership and common records with Pharmacy is required biannually to the Board with the original pharmacy's renewal. Records are to be kept for 2 years and able to provide within 72 hours

What is a DEA Form 223?

Certificate of registration

In what situations will a Class A pharmacy have 10 days to notify the Board of?

Change of ownership, change of location or name, change of managing officers (ex. corporation), change in PIC, theft or significant loss of dangerous drugs or CS, disasters/accidents/emergencies affecting drugs or devices, significant loss of information from data processing system of a pharmacy, and closing of the pharmacy

Class I recall

Class "X" recalls have a reasonable probability that use of the product will cause serious, adverse health consequences or death.

Class III recall

Class "X" recalls involve products that are not likely to cause adverse health consequencs, i.e. dirt, plastic or animal parts.

Class II recall

Class "X" recalls involve products that the use of the product may cause temporary or medically reversible health issues, i.e. subpotent drug.

What classes of pharmacy can use centralized prescription dispensing?

Class A, C, and E. Both must keep a common electronic file or appropriate technology to allow access to info. Records of shipping and delivery need to be kept.

*Who is required to have a perpetual inventory?

Class C pharmacies are required to have a perpetual inventory of their C-II drugs.

*Schedule III Max Allowable Concentration Limits under Federal Law

Codeine - 1.8gm/100mL OR 90mg/unit dose Morphine - 50mg/100mL or 100gm Opium - 500mg/100mL or 100gm OR 25mg/unit dose

*Schedule V Max Allowable Concentration Limits under Federal Law

Codeine - 200mg/100ml or 100gm Opium - 100mg/100mL or 100gm (50mg/100ml in TCSA rules!)

Destruction of drugs dispensed in a nursing home can be witnessed by who?

Commissioned peace officer, agent of the TSBP, agent of the Texas health and Human Services Commission, agent of the Texas Department of State Health Services, any two individual (facility administrators, director of nursing, acting director of nursing, or licensed nurse)

*Who determines the contents of an emergency medication kit?

Consultant pharmacist, PIC of the provider pharmacy, medical director, director of nursing

*How often must a pharmacist provide services to a hospital with >100 beds?

Continuously - techs may distribute prepackaged and prelabeled drugs from a drug storage area of the facility without physical supervision if the distribution is under control of the pharmacist and the pharmacist is on duty in the facility

What are the definitions of storage (Part 2): Controlled room temperature, Warm, Excessive Heat, Dry place

Controlled room temperature - 15C-30C (59F - 86F) Warm - 30C-40C (86F-104F) Excessive Heat - Above 40C (>104F) Dry place - A place that does not exceed 40% average relative humidity at controlled room temperature

If a triplicate prescription form for a C-II is use, which copy must the pharmacist receive to fill the prescription?

Copy 1

*What happens to the copies of DEA Form 222?

Copy 1 - retained by supplier Copy 2 - Sent by supplier to divisional DEA administrator *Do not separate copy 1 and 2 when sending to supplier Copy 3 - Retained by pharmacy

What books must a pharmacy have in its library?

Current copies of: -Texas Pharmacy Act and rules -Texas Dangerous Drug Act and rules -Texas Controlled Substance Act and rules -Federal Controlled Act and rules -One current or updated reference from the categories: Patient information, drug interactions, and a general information reference text. -Basic antidote information and telephone number of the nearest regional poison control center

*Define Schedule II (C-II)

Currently accepted medical use and a high abuse potential. Abuse may lead to SEVERE physical or psychological dependence. Ex. morphine, codeine, dihydrocodeine, hydrocodone, oxycodone, cocaine, amphetamine, methylphenidate

Physicians self-prescribing or to family members of CS

DEA does not specifically address this, but the Texas Medical Board's rules mention that the physician must have a history, proper examination, or maintaining records to prescriptions.

*What form is used to order C-II?

DEA form 222 or use the Controlled substances ordering system (CSOS)

Who enforces the CS laws?

DEA under the federal. DPS and TSBP under Texas state. TSBP has the authority to take disciplinary action against the license of a pharmacist, pharmacy, or registration of a pharmacy technician or trainee

*Which CS registration form is used for dispensers (pharmacies, hospitals, practitioners)?

DEA-224 form, must be renewed every 3 year. (DPS every year)

Which CS registration form is used for manufacturers, distributors, researchers, etc?

DEA-225 form, must be renewed every year

Which CS registration form is used for narcotic treatment facilities?

DEA-363 form

*What is required to house controlled substances at a remote location using an automated pharmacy system?

DEA/DPS registration for EACH MACHINE in the name of the providing pharmacy

*What is the difference between direct and general supervision?

Direct supervision is required while the student-intern is preparing and delivering prescription medications or medication orders, otherwise general supervision is enough.

1992 Prescription Drug User Fee

Drug & biological manufacturers were required to pay fees for product applications which were used to subsidize the review process at the FDA and shorten the review time.

*FDA Orange Book Code: B

Drug products that the FDA considers NOT to be pharmaceutically equivalent and therapeutically equivalent

*FDA Orange Book Code: A

Drug products that the FDA considers to be pharmaceutically equivalent and therapeutically equivalent (generic equivalent); only rating that can be substituted in TX

Def'n: New Drug

Drug that contains new chemical substance for medical use OR established drug offered in new dosage form, new medical claims, new dosage levels, or new/novel packaging material.

Def'n: Prescription Drug

Drug which is habit-forming, toxic, or having potential for harm or NDA limits its use to under the supervision of a physician

What type of drugs are not allowed on a Class D pharmacy formulary (no exceptions)?

Drugs containing: -Nalbuphine (Nubain) -Carisoprodol (Soma) -Drugs to treat erectile dysfunction -Schedule I-V controlled substances

Drug Efficacy Study Implementation (DESI)

Drugs marketed from 1938-1962 were reviewed for efficacy after Kefaufer-Harris was passed. Legend drugs were examined individually and OTC's were examined by therapeutic category.

Def'n: OTC Drug

Drugs recognized to be safe and effective for self-use

Def'n: Direct copy

Electronic copy or carbonized copy of a medication order (ex: fax, scan, etc)

Food and Drug Administration Amendments Act (FDAAA)

Established conflict of interest policies ofr FDA advisory committees, expanded clinical trials registry (clinicaltrials.gov) to include all trials past the Phase I stage, established REMS, requires toll free number info given to patient (via sticker on vial, cap, separate paper, med info sheet or med guide) for reporting adverse effects

*Def'n: Tax-free alcohol

Ethyl alcohol or ethanol with a proof of 190 degrees or more when withdrawn from bonded premises of a distilled spirits plant -Use for scientific, medicinal, mechanical purposes; cannot be sold or used in MD's private practice (hospital is okay, but not office in hospital) -Must apply for an industrial alcohol user permit, keep recordkeeping and storage requirements [Denatured alcohol - ethyl alcohol with denaturants used for external-use only medicines NOT consumption]

How often do you renew a pharmacist license?

Every 2 years and usually expires at the end of the holder's birth month

Who must register for CS and when?

Every person or firm who manufacturers, distributes, or dispenses any controlled substances. Must register with DEA every 3 years and in Texas with DPS every year

Class III Device examples

Examples of this class include heart pacemakers, replacement heart valves, SCS, silicone gel-filled breast implants

Class II Device examples

Examples of this class include insulin syringes, BP guages, diagnostic reagents, electric heating pads, electronic thermometers, power wheel chairs, infusion pumps, & surgical drapes.

Class I Device examples

Examples of this class include toothbrushes, tongue depressors, bandages, exam gloves, eye pads, ice bags, hand-held surgical instruments.

True or False: The NDC is required on the manufacturer's label

FALSE

True or False: Results of any informal/formal disposition (agreed board order/board order) will appear in the Board's newsletter.

FALSE - Any disposition after an informal conference/public hearing will appear in the Board's newsletter EXCEPT for those concerning a pharmacist impaired by chemical abuse or mental/physical illness

*True or False: A PA/APN can write a prescription for Vicodin with a 90 day supply and 1 refill

FALSE - PA/APNs can only write prescriptions for controlled substances that will last 90 days or less (including refills)

*A physician has the authority to delegate the carrying out or signing of a prescription to 4 PA or APNs at their primary site and 4 PA/APNs at their alternate site.

FALSE - The physician may only delegate to 4 PA or APNs total AND must establish or will establish a physician-patient relationship

*True or False: Delivery of medication by common carrier (UPS, FedEx) must abide by the same rules USPS goes by

FALSE - They can send all schedules of controlled drugs and dangerous drugs without subjecting to postal regulations

*True or False: You must publicly display your pharmacist's license to practice pharmacy, and you can make copies of both the license and renewal certificate when you practice at multiple sites.

FALSE - You can only make copies of your "pocket" card, not license or renewal certificate. It is true that you have to publicly display your pharmacist's license.

*True or False: Assignment of the NDC number means the product has an approved NDA

FALSE - it also doesn't determine it is a drug, or that it is covered by 3rd party payors

*True or False: A pharmacy can transfer a prescription filled out-of-state that was written by a practitioner in Canada or Mexico.

FALSE - must have the original written prescription

True or False: In Ambulatory Surgical Centers, like ER's, practitioners or licensed nurses may create labels for outpatient dispensed medications for less than a 72 hours supply (unless it's a cream)

FALSE - only a practitioner can make the label in an ambulatory surgical center

Manufacturing is regulated by...

FDA

What is the Orange book?

FDA publication of approved drug products with therapeutic evaluations.

*Prescription drug advertising is regulated by...

FDA regulates this advertising

True or False: An agreed board order may be appealed through the courts.

False

True or False: It is legal for a dentist to prescribe a hypertension drug

False

True or False: It is legal for a podiatrist to prescribe a hypertension drug

False

True or False: It is legal for a veterinarian to prescribe a hypertension drug to a human

False

True or False: It is legal for an optometrist to prescribe a hypertension drug

False

True or False: It is not possible to dispense a CII prescription WITHOUT an Official Prescription Form to an admitted patient upon discharge from the hospital.

False - A 7 day supply can be dispensed without an official prescription form if the prescription is manually signed by the practitioner and dispensed by the hospital pharmacy before the patient is discharged (file in outpatient records)

True or False: All drugs in a Class C pharmacy may be kept together as long as it meets temperature requirements for each drug.

False - External use drugs, antiseptics, and disinfectants must be kept separately from internal and injectable medications

*True or False: If the institution operates an outpatient pharmacy and has <=100 beds, only a consultant or part-time pharmacist is required, so an absence of a pharmacist onsite is acceptable.

False - There must be a full-time pharmacist on site when the OUTPATIENT pharmacy is open, no matter how many beds there are

True or False: A clinic secretary is authorized to be a designated agent for a physician assistant or nurse practitioner

False - must have the education equivalency of an LVN or greater

*True or False: Any prescription written by a PA/APN out-of-state may be filled in Texas.

False - only DANGEROUS DRUG prescriptions from out-of-state PA/APNs may be filled, NOT controlled substances

*True or False: A pharmacy can obtain a refill authorization on a prescription written by a Canadian or Mexican practitioner.

False - only refills on the original prescription may be dispensed

True or False: Oral and faxed prescriptions from Canada or Mexico can be filled legally in Texas

False - the pharmacist must have the original written prescription

True or False: The signature of the physician is required in a prescription that is signed by a PA/APN to be filled in a pharmacy

False - the signature is not required

*Def'n: Misbranding

False, misleading statements about the drug on the label (Ex: indications/superiority claims without data) If the manufacturer fails to contain required info for a prescription drug (name/address, quantity, generic and brand name, strength, adequate info for use, warnings, expiration date), prescription filled without authorization from practitioner, OTC without all required info, container is misleading, drug imitates another drug exactly but different name, if dangerous to health when given in suggested labeling dose, packaging is in violation or poison prevention packaging act

True or False: A pharmacist may delegate to pharmacy technicians and pharmacy technician trainees any judgmental technical duty associated with the preparation and distribution of prescription drugs.

False: They can only do NONjudgmental duties

*OTC advertising is regulated by...

Federal Trade Commission regulates this advertising

*What are the age limits at which pharmacists can give a flu shot and other vaccines?

Flu shots can be given to children older than 7 years of age without an established patient-physician relationship. Other vaccines can be given to children 14 years and older.

*When is counseling for a prescription necessary?

For each new prescription which means prescriptions that have not been dispensed to the patient in the same strength and dosage form by the pharmacy within the past year; prescriptions that have been transferred from another pharmacy, and/or discharged prescriptions from hospitals. Also needs to include written information. Offer counseling on refills. Effective on June 1, 2010 the pharmacist must document counseling on the original prescription or in data processing system.

Use of anabolic steroids

For use and dispense in valid and professional medical purposes only. NOT to be used in bodybuilding or muscle enhancement in persons with good health. Doesnt not apply to livestock or poultry

What are the definitions of storage (Part 1): Freezer, Cold, Cool, Room temperature

Freezer - a place where the temp is maintained between minus 25C and minus 10C (minus 13F and 14F) Cold - Any temperature not exceeding 8C (46F) Cool - Any temperature between 8C and 15C (46F - 59F) Room temperature - temperature prevailing in a working area

*In a facility with <=100 beds, when the pharmacy is closed and the practitioner orders a drug for a patient, when must a pharmacist verify what was taken?

Full time pharmacists: ASAP but no longer than 72 hrs after withdrawn Part time/consultant pharmacists: no more than 7 days

*Def'n: Automated checking device

Fully automated system that confirms the accurate drug/strength is labeled with the correct label. (Placement is after drug is prepared for distribution and before delivery to the patient)

*What is the identification letter on the license for an optometric glaucoma specialist?

G

1962 Kefauver-Harris Amendment

Good Manufacturing Practices for drugs manufactured in the US in this act or amendment.

*After how many years of not practicing do you need to gain 500 hours of internship hours to practice again?

Greater than 4 and less than 5 years (4-5 years). Amount of internship hours increases by 200 hours year thereafter up to 10 years not practicing.

What is the only acceptable way(s) for a prescriber to institute a dispensing directive on a WRITTEN prescription?

Handwriting "brand necessary" or "brand medically necessary" on the face of the prescription (no rubber stamps, check boxes, etc.)

*In what situations are there exceptions to the use of an official prescription form?

Hospital inpatient med orders that include admitted to the hospital, hospital clinic, hospital ER, licensed ambulatory surgical center, surgical suite in a dental office or vet medical school. Also hospitals inpatients requiring an emergency quantity of C-II but is limited to 7 days supply, labeled correctly, and while the patient is admitted.

*What is the duty to report?

If a complaint or claim letter (misfill, etc) is filed against an ensured pharmacist (or tech) seedamages related to the insured's conduct in providing or failing to provide appropriate service within pharmaceutical care, the liability insurance company has the DUTY TO REPORT the incident to the Board. If the pharmacist is not insured, the pharmacist has a DUTY TO REPORT the information to the Board; the settlement of the claim should also be reported

In what circumstance can the disciplinary panel temporarily suspend the license or registration without notice or hearing?

If a hearing before the panel on whether disciplinary proceedings should be initiated against the license holder is initiated and scheduled to be held not later than the 14th day after the date of suspension

What is an emergency refill? ("72 Hour Rule")

If a pharmacist is unable to contact the prescribing practitioner after a reasonable effort, a pharmacist may refill the prescription (not control) for a 72 hour supply if they feel there might be a possible interruption in therapy. They must also inform the patient that they are refilling without doctors authorization.

If a disciplinary board temporarily suspends a license/registration, what happens if a second hearing held by the State Office of Administrative Hearings doesn't hold the hearing until 80 days after the date of suspension?

If the second hearing isn't held by the 60th day after date of suspension, the license is automatically reinstated

*For what reason can a pharmacist not have access to CS?

If they have been convicted of a felony relating to CS. Exception: DEA Waiver policy - the employer must apply for it for the employee It is the employer's responsibility to screen the applicant/employee for their background

1960 Color Additive Law

In which act did the FDA establish additional conditions for the safe use of color additives in food, drugs, & cosmetics. Mfg were required to perform scientific investigations to establish safety for intended use.

1984 Drug Price Competition & Patent Term Restoration

In which act was the FDA granted the authority to accept ANDA for generic versions of drugs and brand manufacturers could apply for patent extension for up to 5 additional years.

1990 Safe Medical Device Act

In which act were manufacturers of medical devices required to conduct post marketing surveillance on all permanently implanted devices whose failure might cause serious harm or death.

*Who are classified as CS dispensers?

Individual practitioners, institutional practitioners and pharmacies; not pharmacist unless state law grans them prescriptive authority for CS

*How long does a pharmacy have to transmit CS prescription information to DPS?

Information must be transmitted no later than the 15th day after the last day of the month in which the prescription was completely filled.

*Dispensing directive:

Instructs pharmacists how to dispense a drug according to the contents of a prescription. It must: 1) Require the use of the phrase "brand necessary" or "brand medically necessary" in practitioner's handwriting to prohibit generic substitution 2) Be in a format that protects confidentiality as required by HIPAA 3)Includes an exemption for electronic prescriptions (these are regulated in the manner provided by federal law)

Def'n: Medical Device

Instrument/apparatus intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease without using chemical or biological action within or on the body

*What is a Pharmacist Intern?

Intern-trainee, a student-intern, or an extended-intern

*How many facilities can a pharmacist be a PIC for if they are currently one in a facility with 125 beds?

It depends on the size of the 2nd facility. A pharmacist must be full time at a location with >100 beds, but may also be in charge of another facility with <100 beds as long as the total number of beds doesn't exceed 150.

Does a pharmacist have to perform a final check of a prescription dispensed by an automated medication supply system?

It depends: 1) If it is used for storage and recordkeeping outside the pharmacy, then NO 2) If it is located in the pharmacy department, then YES

What is the policy and procedure manual of a Class B pharmacy?

It is a manual that is a compilation of written policy and procedure statements for operation of the pharmacy. It should reflect the technical operations of the nuclear pharmacy functions with current changes in technique and organization.

*Can prescription drug be returned to the pharmacy?

It is generally illegal for a pharmacist to accept a return of a prescription after dispensing for the purposes of resale or redispensing. Dangerous drugs, but not CS, can be return to be destroyed. Exception: returns can only be made by a health care facility regulated under Chapter 242 Health and Safety Code (primarily nursing homes). Drugs must be basically unused, original packaging, not compounded, and not less than 120 days from expiration.

What is the exception to the monthly requirement to check automated medication supply systems for expiration dates, misbranding, physical integrity, security, and accountability?

It may be performed quarterly if the system monitors expiration dates and the security system is checked at regularly defined intervals (daily, weekly)

If a prescription drug order is electronically submitted (escript) to the pharmacist and is for a Medicaid patient, how does a practitioner institute a dispensing directive?

It must be specified in the order that it is "brand necessary" or "brand medically necessary" BUT the practitioner is required to fax a copy of the original prescription drug order within 30 days (if it's not for Medicaid, the prescriber doesn't need to fax in a copy)

1962 Kefauver-Harris Amendment

Jurisdiction over drug advertising transferred from FTC to the FDA in this act or amendment.

*When doing a Drug Regimen Review (DRR) what is to be considered clinically?

Known allergies, rational therapy-contraindications, reasonable dose and route of administration, reasonable directions for use, duplication of therapy, drug-drug interactions, reasonable directions of use, drug-food interactions, drug-disease interactions, adverse drug reactions, and proper utilization, including overutilization or underutilization

If a Class A pharmacy also operates as a Class B pharmacy do they need both licenses?

No, they only need the Class A license but must comply with all Class B rules (procedures, record keeping, etc)

*What are the qualifications for license by examination?

License fee, at least 18 years old, good moral character, completed a minimum of a 1,000-hour internship (1,500 hours are required by rule of the board), has graduated and received a professional practice degree (accredited), has by the NAPLEX and MPJE, and has not had a pharmacist license granted by another state restricted, suspended, revoked, or surrendered for any reason.

Can you automatically substitute a prescription written for a brand name (but not notating "brand necessary" or "brand medically necessary) from a practitioner in Canada/Mexico, a state other than Texas, or a federal facility?

NO - you must dispense the brand unless you obtain verbal/written authorization from the prescriber, or the pharmacist obtains written documentation of the state board rules from the prescriber's state that allows substitution.

Can a Pharmacist share or offer money received from filing a prescription with the practitioner?

NO!

Can products be exempted for schedules?

Manufactures may apply to DEA to exempt a product if the product is not to be abused. Include non-narcotic products containing small amounts of controlled substances, primarily testosterone and estradiol products

*Can narcotic-dependent patients who are being maintained or detoxified receive narcotic prescriptions for this purpose?

NO, Narcotic prescriptions are only valid for treating pain. Administering and dispensing (not prescribing) is allowed by a narcotic treatment program registered with the DEA, FDA, and licensed in Texas by the Texas Commission on Alcohol and Drug Abuse and possessing a permit issued by the Texas Department of Health. However physcians who are not part of a narcotic treatment program can administer narcotic drugs for the individual's acute withdrawal symptoms but for only 3 days.

How long are board members' terms?

Members of the board are appointed for staggered six-year terms. The terms of members expire every other year at midnight on the last day of the state fiscal year in the last year of the member's term. No member may serve more than two consecutive full terms

*C-II multiple prescriptions

Multiple prescriptions can be written for up to 90 days supply. Although there is no limit on amount of C-II that can be prescribed. Original prescriptions must be filled within 21 days of the date issued with day 1 the day after the Rx was issued. Rx to be filled at a later date are yet to be determined how long they have but can be filled later than 21 days that it was issued (TCSA). C-II prescriptions for a LTCS or terminally ill patient must be filled withing 60 days of date issued

*How to report a theft or Significant loss of CS

Must be reported in 1 business day and Complete DEA form 106 (within 60 days) There are particular factors constituting a significant loss such as the quantity in relation to the type of business, pattern of losses, likely candidates for diversion, or local trends. Breakage or spillage of CS does not constitute as a loss. It is responsibility of the employee to report any drug diversion.

Destruction of dispensed drugs at health care facilities or institutions (nursing homes)...

Must be signed off by the consulting pharmacist and all information about the drug must be recorded.

Def'n: Approved Drug

NDA was approved by the FDA or drug in use prior to effective date of the 1938 FDCA

*NDC XXXXX-XXXX-XX: Where is the labeler code?

NDC: LABELER CODE-XXXX-XX [Assigned by the FDA]

*NDC XXXXX-XXXX-XX: Where is the drug product code?

NDC: XXXXX-DRUG PRODUCT CODE-XX [Assigned by the manufacturer]

*Define narcotic

Narcotic refers to drugs that are derivatives of opium, poppy, straw, cocaine, or ecgonine. While all narcotics are controlled substances, not all controlled substances are narcotics

*When changing ownership of a pharmacy the DEA of the previous owner can be temporarily used by the new owner under what conditions?

New owner must apply for a DEA and previous owner provides a Power of Attorney to the new owner. All activities will be done under the previous owner's DEA. Temporary use will last for 45 days.

Can a nuclear prescription be refilled?

No

Is PTCB Certification required for renewal of a pharmacy technician license?

No - all that is required is: 1) completing the the Texas application for registration 2) paying the renewal fee 3) completing 20 contact hours of CE during the renewal period (1 hr should be law)

Can you renew your pharmacy technician trainee registration?

No - registrations for pharmacy tech trainees are only good for 2 years and you cannot renew a current license or reapply for a new one

*Can you open a telepharmacy in a rule-defined rural community that has an independent pharmacy open?

No - rules state that if a Class A or Class C pharmacy dispenses drugs to outpatients in the same community (within 10 miles if not located in an MSA or within the same Metropolitan Statistical Area (MSA) as defined by the US Census Bureau), a pharmacy can't provide remote pharmacy services

*Define Schedule I (C-I)

No accepted medical use in the US and having a high abuse potential Ex. heroin, dihydromorphine, marujuana, LSD, MDMA (Ecstasy)

What is the ratio of pharmacist to technicians in a class B pharmacy?

No greater than 1:3 provided one technician is registered and only one may be engaged in the compounding of a sterile radiopharmaceutical

How soon before a license application for a Class E pharmacy is received does a pharmacy need to send in an inspection report?

No more than 2 years before turning in the application. For renewals, the inspection report can be sent in not more than 3 years of renewal.

*How many telepharmacies can a pharmacist supervise?

No more than 3 that are open simultaneously

Can an automated storage and distribution device be used to deliver new prescriptions or CS?

No to both, only refill prescriptions and dangerous drugs. No counseling is required because they are refills. Technicians are allowed to store drugs. The device must be located in the pharmacy building.

*If a Class C pharmacy has an outpatient pharmacy do they also have to have a Class A pharmacy license?

No, but they do have to follow Class A rules

Filling prescriptions from practitioners such as physicians, dentist, veterinarian, or podiatrist from other states are filled in the same rules as in-state practitioners, but is that the same for prescriptions from Canada or Mexico?

No, prescriptions from Mexico and Canada can only be filled if it is an original prescription.

Can someone who previously applied to be a pharmacy technician apply to be a pharmacy technician trainee?

No, regardless of the technician registration status - if you apply for both, you won't be considered for the trainee application

Do out of state Class E pharmacist have to be licensed with Texas?

No, they don't have to be licensed with Texas but their pharmacy must have a Class E license with Texas.

You receive a prescription on a single page with three drugs: Tenormin, Zestril, and HydroDiuril. The physician has hand-written "Brand Necessary" on the the page. Which medication(s) MUST you fill with the brand name?

None - if the practitioner doesn't specify which medication the dispensing directive applies, the pharmacist may substitute on all listed medications

*Who in the pharmacy can verify receiving of controlled substances by initialing and dating invoices of controlled substances received in the pharmacy?

ONLY the pharmacist.

Therapeutic optometrists may prescribe and administer...

OTC oral medications, opthalmic devices, and certain topical ocular pharmaceutical agents

Harrison Narcotic Act

Old regulation that exerted control over narcotic drugs by imposition of a tax and covered only narcotic drugs. Federal controlled substances act (FCSA) covers both narcotic and non-narcotic, stimulant, depressant, and hallucinogenic drugs

How often does floor stock records have to be reviewed by a pharmacist to verify proper usage?

Once every 30 days

How often must a PIC or staff pharmacist verify the records of ER medications that were dispensed to outpatients in the absence of a pharmacist?

Once every 7 days

How many medications per C-II prescription form?

Only 1. If the physician writes another lower schedule drug or a dangerous drug on the C-II prescription the pharmacist can just cross it out and transfer it to a pharmacy prescription pad.

In a facility with >100 beds, when the pharmacy is closed and the practitioner orders a drug for a patient, what is the amount of medication that can be taken?

Only enough for immediate therapeutic needs

What types of optometrists can prescribe?

Only therapeutic optometrists and optometric glaucoma specialists NOT optometrists

Which type of optometrist may prescribe controlled substances?

Optometric Glaucoma Specialists

Which type of optometrist can a pharmacy distribute a 10% solution of cocaine in a prepackaged liquid form?

Optometric Glaucoma Specialists AND Therapeutic Optometrists

1984 Patent Protection for New Drugs Act

Patent life is 20 years from the date of the first filing of the patent application. This act provided mfgs a 5-year extension, however the patent life of the drug cannot exceed 14 years from the approval date of the drug

Confidential records are privileged and may be released to who?

Patient or the patient's agent, practitioner or another pharmacist, board or state or federal agency authorized by law, law enforcement engaged in investigation, person employed by state agency that licenses a practitioner, or insurance carrier or third party payor. Records must be sent within 30 days or in a case of emergency 24 hours if records kept in pharmacy (72 hours if kept off-site)

How often must a CII inventory be done in a Class C pharmacy?

Perpetually

*Special Warning Requirements in FDCA: Phenacetin (acetophenetidin)

Special Warning Requirements in FDCA: must contain warning about possible kidney damage when taken in large amounts or for long period of time.

*HIPPA Business Associate

Person other than pharmacy's workforce who performs a service on behalf of the pharmacy which requires the use of PHI - they must have a business associate contract (Ex: auditors, software vendors, lawyers)

*How does Power of Attorney work?

Person who signed the most recent registration can execute a power of attorney authorizing anyone at the pharmacy and as many as they want. Power of attorney can be revoked at anytime by executing a Notice of Revocation.

When can a Pharmacist administer medication?

Pharmacist can administer vaccines and if necessary must have physician written protocol. Usually when medication is needed and a practitioner is not available. Pharmacist can not administer medication at a patient's home, except at a licensed nursing home or hospital.

*What is the "Corresponding Responsibility" or the pharmacist in prescribing CS?

Pharmacist have the responsibility to make sure the prescription is valid and was issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his/her professional practice

Def'n: Full time pharmacist

Pharmacist who works in a pharmacy from 30-40 hrs per week. If the pharmacy is open <60 hrs/wk, a pharmacy who works 1/2 the time the pharmacy is open

*Who is exempt from CS registration requirements?

Pharmacist, pharmacy technician, nurse, delivery persons or any other agents acting in the usual course of business or employment under a registrant (ex. Pharmacy). OR An individual practitioner working under a registered practitioner may dispense and administer CS but can not issue a prescription. OR An individual practitioner (Ex. Med intern/resident) under employment of a hospital or other institution may administer, dispense, or prescribe CS using the institutions DEA number with a suffix identification

*Prescription Drug Marketing Act (PDMA)

Piece of legislature that bans the sale, trade, or purchase of drug samples and the trafficking in and counterfeiting of drug coupons; required drug pedigrees and licensing of drug wholesale distributors as well as banning reimportation of prescription drugs made in the US in an effort to eliminate risk of subpotent or adulterated drug distribution

Federal Food, Drug, and Cosmetic Act (FDCA)

Piece of legislature that created the FDA and required purity (NOT efficacy) of food, drinks, drugs, cosmetics, and devices.

*Durham Humphrey Amendment

Piece of legislature that created the OTC and prescription drug categories

*Kefauver-Harris Amendment

Piece of legislature that required new drug products to be proven BOTH safe and effective.

*What information on a CS Rx is not allowed to be completed or changed by the pharmacist even after calling?

Practitioner's name, name of drug, date or Rx, and/or name of patient

What is the 1st step to the adjudication procedure to discipline a licensee?

Preliminary Notice Letter: Licensee notified of Board's intent to institute disciplinary action, list of alleged violations, and right to schedule a non-public informal conference

Def'n: Floor stock

Prescription drugs or devices not labeled for a specific patient and maintained at the nursing station or other hospital department

Def'n: Controlled substances

Prescription drugs that have a high abuse potential with psychological or physical dependency liability

*FDA Orange Book Code: AB

Products with actual or potential bioequivalence problems where adequate scientific evidence has established bioequivalence

What kind of research projects can be approved by the TSBP?

Projects for innovated applications in the practice of pharmacy complying to the Pharmacy Act. The project may not include therapeutic substitution or substitution of a medical device in patient care because that may be out of a pharmacist's scope of practice.

What is one of the main goals of pharmacy law?

Protecting the public health and interest

*Who must the DEA form 106 be sent to?

Provide a copy of the form to: -DEA, DPS, TSBP, and the local police

*What are the ratios of pharmacist to technician and technician trainees

Ratio of pharmacists to technicians and technician trainees may be 1:3 provided that at least one of the three technicians is a pharmacy technician not a trainee. The ratio of pharmacist to trainee may not exceed 1:2.

*Class II Recall

Recall class where the use/exposure to a violative product may cause temporary or medically reversible adverse effects on health, or where the probability of serious adverse effects on health is remote

*Class III Recall

Recall class where the use/exposure to violative product is not likely to cause adverse health consequences

*Class I Recall

Recall class where there is a reasonable possibility that the use/exposure to a violative product will cause serous adverse effects on health or death

*What can't be kept in central record keeping?

Records maintaining used DEA order forms (222), prescriptions, or CS inventories, which must be kept at the pharmacies. Invoices and financial data can be kept at a central storage for keeping

Therapeutically euivalent definition

Refers to drug products that are pharmaceutically equivalent and bioequivalent.

Pharmaceutical equivalence definition

Refers to drug products with the same active ingredients, same dosage form, same route of administration, and identical strength or concentration.

Bioequivalent drug products

Refers to products that are pharmaceutically equivalent that provide the same results of drug delivery with the same pharmacokinetic properties.

On the entry of an initial order against an applicant or holder of a pharmacy/pharmacist license, the Board may...

Refuse to issue a license or suspend the license holder's license

When does DEA registration terminate?

Registration terminates if registrant dies, ceases legal existence, or ceases business or professional practice (must notify DEA 14 day prior to termination)

1990 Omnibus Budget Reconcilliation Act (OBRA)

Requires pharmacist to offer counseling to Medicaid patients.

*What are the requirements of a pharmacist to be a board member?

Resident of the state, licensed for 5 years preceding appointment, be in good standing to practice pharmacy in this state, and be practicing pharmacy in this state

*What responsibilities does an 'Owner' of a Class A Pharmacy have?

Responsibility for all administrative and operation functions, but if they are not a Texas licensed pharmacist they must consult one.

On final conviction of an applicant or holder of a pharmacy/pharmacist license, the Board may...

Revoke the license holder's license

*How to schedule Compounded CS

Rx narcotics containing greater than the max allowed for C-V becomes a C-III (never a C-IV). If the concentration exceeds the max allowable for C-III, it becomes a C-II. Narcotics must be compounded with other non-narcotic, active ingredients in recognized therapeutic amounts. Any narcotics compounded with non-active ingredients or therapeutic amounts of active ingredients or by itself will be a C-II.

What are the procedures for dispensing prescriptions from a radiology department?

Same as ER

According to the sunset act when does the TSBP expire?

September 1, 2017

*HIPPA Transactions and Code Set Regulations - What was the purpose?

Set standards for electronic standards and codes to use for transactions; NCPDP is the retail pharmacy drug claim standard (National Council for Prescription Drug Programs)

Medical Marijuana laws

Several states have passed laws to legalize the use and/or sell of medical marijuana. However, marijuana remains a Schedule I controlled substance under federal law, therefore is a violation of federal law

*Def'n: FDA Orange Book

Source for determining generic equivalency of drugs; aka "Approved Drug Products with Therapeutic Equivalence Evaluations"

*Special Warning Requirements in FDCA: Sulfites

Special Warning Requirements in FDA: allergy warning in "warnings" section

*Special Warning Requirements in FDCA: Ipecac Syrup

Special Warning Requirements in FDCA: "for emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital ER immediately for advice," "Warning: keep out of reach of children. do not use in unconscious persons," The dosage (1 tblspn in those >1 yr), can only be sold in 1 oz containers

*Special Warning Requirements in FDCA: FD&C Yellow No. 5 and No. 6

Special Warning Requirements in FDCA: "precautions" section must say may cause allergic reaction in susceptible persons

*Special Warning Requirements in FDCA: Aspartame

Special Warning Requirements in FDCA: "precautions" section must say: Phenylketonurics: Contains phenalalanine __mg per __ (dosage unit)

*Special Warning Requirements in FDCA: alcohol warning

Special Warning Requirements in FDCA: acetaminophen, asa, nsaids are required to have warning for those consuming >2 alcoholic beverages per day to consult with MD before taking

*Special Warning Requirements in FDCA: Wintergreen oil

Special Warning Requirements in FDCA: if > 5% methyl salicylate, must include warning that use other than directed may be dangerous and it should be kept out of reach of children

*Special Warning Requirements in FDCA: Sodium Phosphates

Special Warning Requirements in FDCA: limits the amount of sodium phosphates oral solution to not more than 90ml per OTC container.

*Special Warning Requirements in FDCA: potassium salt preparation for PO ingestion

Special Warning Requirements in FDCA: nonspecific small-bowel lesions consisting of stenosis w/ or w/out ulceration; d/c if abdominal pain, distention, nausea, vomiting, or gi bleed occur; coated K tabs should be used only when adequate dietary supplementation is not practicable

*Special Warning Requirements in FDCA: Isoproterenol inhalation preparations

Special Warning Requirements in FDCA: not to exceed dose prescribed and contact physician if difficulty breathing persists

*Special Warning Requirements in FDCA: Mineral oil

Special Warning Requirements in FDCA: only taken at bedtime and don't use in infants unless under the advice of a physician; label cannot encourage use during pregnancy

*Special Warning Requirements in FDCA: NSAIDs

Special Warning Requirements in FDCA: prominent display of ingredient & NSAID, stomach bleeding warning

*Special Warning Requirements in FDCA: APAP

Special Warning Requirements in FDCA: prominent displaying of ingredient, liver toxicity, ask MD if liver disease or warfarin

*Special Warning Requirements in FDCA: salicylates

Special Warning Requirements in FDCA: warning regarding Reye's syndrome in children; containers of 1 1/4 gr (pediatric) ASA tablets can't be distributed in containers > 36 tabs

1996 Health Insurance Portability and Accountabillity Act (HIPPA)

Stringent regulations to protect patients' right to privacy.

Def'n: Toxic Substance

Substance (other than radioactive) that can cause personal injury or illness to man through ingestion, inhalation, or absorption through any body surface

Def'n: Highly Toxic

Substance in which a single oral dose of <=50mg/kg body weight would kill >=1/2 of white rats it is fed to

Def'n: Hazardous Substance

Substance that can cause injury or illness through handling and that can cause potential danger, especially to children, if misused

Def'n: Automated medication supply system

System that collects, controls, and maintains all transaction information for storage and distribution of medications (Pyxis)

*What is the identification letter on the license for a therapeutic optometrist?

T

*A pharmacist must display in a prominent place in clear public view where prescription drugs are dispensed, a sign in block letters not less than 1 inch in height that reads in both English and Spanish:

TEXAS LAW REQUIRES A PHARMACIST TO INFORM YOU IF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG IS AVAILABLE FOR CERTAIN BRAND NAME DRUGS AND ASK YOU TO CHOOSE BETWEEN THE GENERIC AND THE BRAND NAME DRUG. YOU HAVE A RIGHT TO ACCEPT OR REFUSE THE GENERICALLY EQUIVALENT DRUG

Compounding is regulated by...

TSBP

How do therapeutic optometrist know what they are able to prescribe?

TSBP sends a list of drugs to each therapeutic optometrist annually

*Def'n: Retire

Term meaning a license has been withdrawn and is of no further force and effect

*Def'n: Suspend

Term meaning a license is of no further force and effect for a period of time as determined by the Board You can probate a suspension

*Def'n: Reprimand

Term meaning a public and formal censure against a license

Def'n: Initial order

Term meaning order by a state or federal court granting deferred adjudication of a suspended or probated sentence based either on a finding that a person is guilty or on the entry of a plea of nolo contendere or a plea of guilty of a person

*Def'n: Probation

Term meaning suspension of a sanction imposed against a license during good behavior, for a term and under conditions as determined by the Board

Def'n: Final conviction

Term meaning the entry of an order by a state or federal court imposing a punishment of imprisonment or fine

Hatch-Waman Amendment aka

The 1984 Drug Price Competition and Patent Term Restoration Act is also know as _____, streamline the drug approval process for generic products by use of ANDA.

*How many internship hours are required for licensure?

The Board requires 1500 hours (The pharmacy act requires 1000 hours)

When do meetings occur of the Board?

The Board shall meet at least once every 4 months to transact business and twice each year for the examination of applicants. The Board may also meet if the presidents or two-thirds of the Board's members call a meeting.

*Who schedules CS for TCSA?

The Commissioner of the Texas Department of Health may add, delete, or reschedule substances with the approval of the Texas Board of Health. The Commissioner can on add any substance that has been deleted, or proposed and failed to pass.

What kind of electronic prescription drug orders for control substances do they not allow?

The DEA does not currently allow for 'electronic' (computer to computer) prescriptions, but they do allow faxed prescriptions.

Who designates a member of the Board as president?

The Govenor of Texas

*Training for pharmacy technicians and pharmacy technician trainees:

The PIC must document the completion of the initial and subsequent training with the following information: 1) Name of person receiving training 2) Date of training 3) Description of topics covered 4) Statement that certifies the tech or tech trainee is competent to perform duties assigned 5) Name of person supervising training 6) Signature of tech or tech trainee and PIC or other pharmacist designated as responsible for training of techs and tech trainees

Who do nuclear pharmacist receiving their training requirements from?

The Texas Regulations for Control of Radiation of the Bureau of Radiation Control, Texas Department of Health.

*Who schedules CS for FCSA?

The U.S Attorney General may add, delete, or reschedule substances but must consult with the secretary or US Department of Health and Human Services

What must an applicant obtain if they fail either examinations 3 times?

The applicant must provide documentation form a college of pharmacy that the applicant has successfully completed additional college course work in each examination

What is an executive director and how are they elected?

The executive director is an ex officio member of the Board without a vote and shall serve as the secretary of the Board and full-time member of the TSBP. They are elected by the board and must be a pharmacist and are not part of the 9 members of the Board.

*What can't be inspected by the DEA?

The financial, sales, and pricing data can't be inspected without consent of the registrant. Otherwise the inventory and rest of the CS documents can be inspected.

Follow state or federal law?

The more stringent law or regulation is to followed in all cases unless the two canon consistently stand together, then the state law must yield to the federal

What is an ultimate user?

The person who obtains or possess a prescription drug for their own use or others

How many hours must a pharmacist provide in ACPE approved CEs when doing drug therapy management?

The pharmacist complete 6 hours of CE realated to drug therapy offered by ACPE and continued 6 hours of CE annually

What must a pharmacist do to substitute a generic for an original drug order that stated "brand necessary?" (Pretend the patient wanted generic due to costs)

The pharmacist must obtain verbal or written authorization by a prescriber and document it on the original. (If the patient wasn't the initiator of the change, they would have to be notified about the change)

*How does 'physician delegation to a pharmacist' work?

The pharmacist practices in a hospital, hospital-based clinic, or an academic health care institution, and the place has bylaws and medical staff policy that permits pharmacist management of a patient's drug therapy. The pharmacist must also update the board annually and send in their information and protocol granted to them.

*Physicians may dispense dangerous drugs and receive reimbursements under what circumstances?

The physician's office is located in a county with a population <=5000 or in amunicipality or an unincorporated town with a population <=2500 within a 15 mile radius where a pharmacy is not located [DOESN'T apply to a municipality or unincorporated town adjacent to a municipality of 2500 or more]

*If a prescription drug order is called in to the pharmacist, how does a practitioner institute a dispensing directive?

The practitioner must specify verbally that the order is "brand necessary" or "brand medically necessary."

How is the disciplinary panel chosen by the Board?

The president of the Board appoints 3 members to the disciplinary panel (determines whether a license should be temporarily suspended or restricted) A majority vote decides the fate of a license

What are the limits on the quantity of C-II drugs prescribed by a physician?

There are no limits for a physician

How many Class D pharmacies can a pharmacist be PIC for?

There is NO limit to the amount of class D pharmacies a pharmacist can be PIC for

What is the pharmacist to supportive personnel ratio in a Class D pharmacy?

There is no ratio in a Class D pharmacy. A pharmacist must visit the clinic at least every month to ensure the clinic if following established policies and procedures.

*If a prescription drug order is called in to the pharmacist and is for a Medicaid patient, how does a practitioner institute a dispensing directive?

They also must specify that the order is "brand necessary" or "brand medically necessary" BUT the practitioner is also required to mail or fax a written prescription which complies with the dispensing directive rules for written prescriptions within 30 days

The pharmacist my customize patient medication packages, what are these called and what are they for?

They are patient med-paks that are patient specific who have two or more solid oral prescriptions in which the pharmacist designs the container so it labels the day and time or period of time the contents are to be taken. This is done only with the consent of the patient, the patient's care give or the prescriber and must follow all of the same labeling requirements of regular prescriptions (expiration date up to a year)

What are the inventory requirements for a remote pharmacy?

They must keep a perpetual inventory of CS and other drugs required to be inventoried under board rule 291.17

How can a Class D pharmacy petition for an expanded formulary?

They're patient population has to consist of at least 80% indigent patients. The expanded formulary will allow the pharmacy to use other dangerous drugs not normally allowed but not controlled substances or nubain. Must be submitted every 2 years to continue expanded formulary. If using an expanded formulary they can only be dispensed by a licensed nurse or practitioner

Class III Medical Device definition

This class of medical device applies to life-supporting or life-sustaining and requires premarket approval.

Class II Medical Device definition

This class of medical device is required to meet performance standards.

Class I Medical Device definition

This class of medical device is very simple by design and has a very low potential to cause harm.

*True or False: No matter how many beds there are in the facility, a pharmacist must always be accessible to answer other health professional's questions and needs 24 hours a day.

True

1984 Drug Price Competition and Patent Term Restoration Act

Which act allowed extension of drug patent terms and quicker introduction of lower cost generic drugs, aka Hatch-Waxman

Transfer of CS to a DEA register disposal firm (Reverse distributor)

This is the preferred method. Invoices must be used for CIII-CV and DEA 222 forms for CII

Consumer or User product recall affects?

This product recall affects the patient or the physician.

Retail level product recall affects?

This product recall affects the pharmacy, physicians, clinics, hospitals, & LTCF

Wholesale level product recall affects?

This product recall is limited to manufacturers and retailers.

Define administer and delivery.

To administer is to give to the body, while delivery is giving from person to person

*Def'n: Restrict

To limit, confine, abridge, narrow, or restrain a license for a term and under conditions determined by the Board

Def'n: Approved use

To prescribe or or administer a drug within the limits of the package insert information

*True or False: Any prescription (controlled and non-controlled) issued by a Texas Dentist, Veterinarian or Podiatrist can have their refills transferred between Texas pharmacies.

True

True or False: A board can enter a Board Order as a result of the hearing before the Administrative Law Judge and is appealable through the courts.

True

True or False: A clinic secretary is authorized to be a designated agent for a physician

True

True or False: A licensed vocational nurse is authorized to be a designated agent for a physician assistant or nurse practitioner

True

True or False: An LVN is authorized to be a designated agent for a physician.

True

True or False: It is not legal to operate a pharmacy in a personal residence

True

True or False: Written prescriptions from Canada or Mexico can be filled legally in Texas

True

*True or False: the Board has grounds to discipline pharmacists, pharmacies, pharmacy technicians, pharmacy technician trainees, and applicants under the Texas Pharmacy Act

True - Pharmacy technicians/tech trainees have been recently added to those that the Board may discipline

True or False: It is legal for a dermatologist to prescribe a hypertension drug.

True - Physician practitioners can legally prescribe a drug to treat any disease or illness.

True or False: If a pharmacist is on duty at a facility, any prescription drugs given to an outpatient in the ER can ONLY be dispensed by a pharmacist.

True - if the pharmacist is NOT on duty, there are special procedures to be done to dispense drugs from the ER

True or False: Prescriptions may not be written "For Office Use"

True - prescriptions may only be issued to a patient

True or False: The signature of the physician is required in a prescription that is carried out by a PA/APN

True - signature is required from a physician if the prescription is to be CARRIED OUT by a PA/APN (not required if a prescription is written to be filled in a pharmacy)

*True or False: Any prescription (controlled and non-controlled) issued by an out-of-state Dentist, Veterinarian, or Podiatrist can be filled, called in, and refills can be transferred from an out-of-state pharmacy to a Texas pharmacy

True!

True or False: A Class C PIC must submit an application to the board if they decide to have tech-check-tech services

True!

True or False: A Class C pharmacy does NOT need to obtain a separate license for a Class A AND Class B license if they are wanting to do outpatient/nuclear pharmacy services.

True!

True or False: A prescription for a controlled substance written by a PA/APN requires BOTH the DEA/DPS of the PA/APN and the DEA/DPS of the supervising physician

True!

*What is required when providing an emergency medication kit that contains controlled substances?

Tx DPS registration, NOT DEA as long as DEA emergency kit requirements are met

*Why is a Schedule V drug not available over the counter in Texas?

Under the TCSA the Schedule V limit is 50mg/100mL or half the concentration under federal law. The stricter requirement means that most of the C-V commercially available products containing opium canon be purchased without a prescription. They are C-III under Texas law

What kind of laminar flow hood do nuclear pharmacist use, vertical or horizontal?

Vertical

1988 Prescription Drug Marketing Act

Which act banned the sale, purchase, or trade of drug samples and drug coupons.

What does 'Accurately as prescribed' mean?

When dispensing, delivering and/or distributing a prescription order that it as the correct patient, drug, and labeling.

1997 FDA Modernization Act

Which act clarified pharmacy extemporaneous compounding guidelines, replaced Federal Caution with "Rx only" & eliminated the statement, "Warning - May be habit forming".

1970 Controlled Substances Act (CSA)

Which act classified 5 levels of drugs (controlled substances) that have potential for abuse and restricts their distribution. Establishes the DEA, under the Justice Department, to enforce its regulations.

1997 FDA Modernization Act

Which act covered the dissemination of information of new/off-label uses, pharmacy compounding, compliance policy guidelines, drugs intended to treat serious & life thretening conditions, and beyon-use-dating of compounds.

1997 FDA Modernization Act

Which act eliminated the requirement for the Legend statement, provided the labeling contained the words "Rx only."

1997 FDA Modernization Act

Which act encouraged manufacturers to conduct research for new uses of drugs and submit SNDAs for these uses and encouraged manufacturers to perform pediatric drug studies by providing them with an additional 6 months of drug exclusivity.

1938 Food, Drug & Cosmetic Act

Which act established a fast track approval process for drugs approved to treat life-threatening illinesses?

1988 Prescription Drug Marketing Act

Which act established requirements for drug sample distribution, record keeping, storage, and handling.

1997 FDA Modernization Act

Which act helped to speed up the approval process for new drugs and devices. Also implemented inactive ingredient labeling requirements for OTC drugs.

1938 Food, Drug & Cosmetic Act

Which act or amendment granted FDA the authority to inspect factories?

1938 Food, Drug & Cosmetic Act

Which act or amendment required manufacturers to prove drug safety prior to marketing?

1906 Pure Food & Drug Act

Which act or amendment was the first to recognize USP/NF as the official compendia?

1938 Food, Drug & Cosmetic Act

Which act or amendment was the first to regulate medical devices and cosmetics, including COLOR additives?

1906 Pure Food & Drug Act

Which act or amendment was the first to regulate the manufacture or sale of adulterated or misbranded drugs in interstate commerce?

1970 Comprehensive Drug Abuse Prevention & Control Act

Which act or legislation created the DEA

1988 Prescription Drug Marketing Act

Which act prohibited the sale, purchase, or trade of Rx drugs that were purchased by hospitals or other health care entities, or donated or supplied at a reduced price to charities.

1983 Orphan Drug Act

Which act provided tax & licensing incentives for the research & marketing of drugs for rare diseases, which affects less than 200,000 people in the US.

1983 Orphan Drug Act

Which act provided tax credits and grant provisions to encourage the development of drugs intended for rare diseases and manufacturers were given 7 year exclusive marketing of the product.

1990 Safe Medical Device Act

Which act provided the FDA with the authority to order medical device recalls.

1970 Comprehensive Drug Abuse Prevention & Control Act

Which act repealed the Drug Abuse Control Amendment and established five schedules of controlled substances.

1938 Food, Drug & Cosmetic Act

Which act required a warning on all package labeling of habit-forming drugs.

1938 Food, Drug & Cosmetic Act

Which act required adequate directions for use on all drug product labels

2010 Patient Protection & Affordable Care Act (Health Care Reform Act)

Which act required all individuals have health insurance, required timely payment of electronic claims, & phasing out the "donut hole" by 2020.

1990 Safe Medical Device Act

Which act required manufacturers to report to DHHS any device that caused to contributed to the death, illness, or serious injury of a patient.

1938 Food, Drug & Cosmetic Act

Which act required predistribution clearance for safety of new drugs prior to commercial distribution.

1987 Prescription Drug Marketing Act

Which act required that prescription drug wholesalers be licensed by states under federal guidelines?

1988 Prescription Drug Marketing Act

Which act restricted reimportation of prescription drugs.

1994 Dietary Supplement Health & Education Act (DSHEA)

Which act stated manufacturers of dietary supplements do NOT need to establish safety or efficacy, that the FDA must prove an unreasonable risk of illness or injury.

1951 Durham-Humphrey Amendment

Which amendment established minimal label information on the prescription.

1951 Durham-Humphrey Amendment

Which amendment established two classes of drugs: Rx (legend) & OTC (non-Rx) and established the first Rx labeling requirements.

1951 Durham-Humphrey Amendment

Which amendment legalized the use of transmitting Rx's orally and refills as indicated by the prescriber.

1912 Shirley Amendment

Which amendment prohibited false or misleading claims about the therapeutic effects of a drug.

1962 Kefauver-Harris Amendment

Which amendment separated controlled substances from other drugs?

1962 Kefauver-Harris Amendment

Which amendment stated that all new drugs marketed had to be SAFE and EFFECTIVE.

1976 Medical Device Amendments

Which amendment to the FDCA required better classification of medical devices, established performance standards, & pre-market approval requirements.

1976 Medical Device Amendments

Which amendment to the FDCA required safety and efficacy studies on medical devices, including diagnostic & laboratory products, prior to marketing the device.

1951 Durham-Humphrey Amendment

Which amendment was the first to established the first Rx labeling requirements.

A. FDA

Which federal agency determines whether drugs are safe and effective for intended uses? A. FDA B. DEA C. DHHS

D. State & federal governments concurrently

Which governmental agencies have authority to regulate controlled substances? A. Exclusively the federal government B. Exclusively state governments C. World Trade Federation D. State & federal governments concurrently

C. U.S. Attorney General

Who determines which schedule a drug desinated as a controlled substance will be placed in? A. Secretary of Health & Human Services B. FDA Commissioner C. U.S. Attorney General

How soon does a pharmacist need to notify the physician about the immunization?

Within 24 hours after administering the immunization and notify the PCP of the patient within 14 days.

Do pharmacies have to be licensed by the Board?

YES! All pharmacies who plan to distribute, advertise, and deal medication/prescription in this state needs to be registered with the Board. Exception: If a pharmacy has isolated transactions with a resident of the state the Board can grant an exemption

Can nonpharmacy trained employees (not technicians and not the pharmacist) take refill numbers from patients?

Yes

*Can ANP/PAs write controlled prescriptions?

Yes (NOT CII's - only III-V's)

*Can a veterinarian administer dangerous drugs?

Yes - it can be administered in the office or on the patient's premises if the drugs are used or required to meet the needs of the veterinarian's patients

*Are separate CS registrations needed for separate locations?

Yes, a separate registration is required for each general physical location *EXCEPTIONS: DEA does not require emergency kits at nursing homes to be registered but DPS does! Each pharmacy must have their own DEA registration but NOT satellite pharmacies WITHIN a hospital (off site clinics need to be registered)

Does a pharmacy have to notify the Board when changing owners?

Yes, and they have to submit a new/completed pharmacy application

*Is a perpetual inventory of CS required?

Yes, but only of C-II in Class C (Institutional) pharmacies

*Can a licensed nurse/practitioner remove items needed for floor stock from a pharmacy?

Yes, it must be a licensed nurse/practitioner removing drugs in the original manufacturer's or prepackaged container and must record the following: 1) name of drug 2) strength 3) dosage form 4) quantity removed 5) location of floor stock 6) date and time 7) signature

Can pharmacist destroy stock dangerous drugs?

Yes, they can on their own to a point where the drugs are unfit for human consumption, but must take inventory of nalbuphine prior to destruction.

*Delivery of noncontrolled prescriptions by USPS from physician/pharmacist to the user is acceptable provided that they are not...

alcoholic beverages, poisons, or flammable substances. [Manufacturers may send highly toxic substances to the pharmacist/physician]

*Advertising by pharmacists is considered...

reminder advertising (mainly just the price of the drug)

*When must a pharmacist verify withdrawal of floor stock from the pharmacy in the absence of a pharmacist?

no later than 7 days

*An APN/PA may practice at an alternate site away from the delegating physician provided...

the services are similar to the delegating physician's primary practice site AND it is located within 60 miles of the physician's primary practice site