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MPJE Texas Pharmacy Law + Federal
Acts,Latest Update
1906 Pure Food & Drug Act - correct answer Which act or amendment was the first to regulate the manufacture or sale of adulterated or misbranded drugs in interstate commerce? 1906 Pure Food & Drug Act - correct answer Which act or amendment was the first to recognize USP/NF as the official compendia? 1938 Food, Drug & Cosmetic Act - correct answer Which act or amendment required manufacturers to prove drug safety prior to marketing? 1938 Food, Drug & Cosmetic Act - correct answer Which act or amendment was the first to regulate medical devices and cosmetics, including COLOR additives? 1938 Food, Drug & Cosmetic Act - correct answer Which act required a warning on all package labeling of habit-forming drugs. 1938 Food, Drug & Cosmetic Act - correct answer Which act required adequate directions for use on all drug product labels 1938 Food, Drug & Cosmetic Act - correct answer Which act required predistribution clearance for safety of new drugs prior to commercial distribution. 1938 Food, Drug & Cosmetic Act - correct answer Which act or amendment granted FDA the authority to inspect factories? 1938 Food, Drug & Cosmetic Act - correct answer Which act established a fast track approval process for drugs approved to treat life-threatening illinesses? 1951 Durham-Humphrey Amendment - correct answer Which amendment established two classes of drugs: Rx (legend) & OTC (non-Rx) and established the first Rx labeling requirements.
1951 Durham-Humphrey Amendment - correct answer Which amendment legalized the use of transmitting Rx's orally and refills as indicated by the prescriber. 1951 Durham-Humphrey Amendment - correct answer Which amendment established minimal label information on the prescription. 1962 Kefauver-Harris Amendment - correct answer Which amendment stated that all new drugs marketed had to be SAFE and EFFECTIVE. 1962 Kefauver-Harris Amendment - correct answer Jurisdiction over drug advertising transferred from FTC to the FDA in this act or amendment. 1962 Kefauver-Harris Amendment - correct answer Good Manufacturing Practices for drugs manufactured in the US in this act or amendment. 1970 Comprehensive Drug Abuse Prevention & Control Act - correct answer Which act repealed the Drug Abuse Control Amendment and established five schedules of controlled substances. 1976 Medical Device Amendments - correct answer Which amendment to the FDCA required safety and efficacy studies on medical devices, including diagnostic & laboratory products, prior to marketing the device. 1984 Drug Price Competition & Patent Term Restoration - correct answer 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. 1988 Prescription Drug Marketing Act - correct answer Which act banned the sale, purchase, or trade of drug samples and drug coupons. 1988 Prescription Drug Marketing Act - correct answer Which act restricted reimportation of prescription drugs.
1984 Patent Protection for New Drugs Act - correct answer 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 MEDWATCH - correct answer A program for reporting ADR's, which became the FDA's Medical Products Reporting and Safety Information Program. MEDMARX - correct answer A data sharing program established by USP that collects medication error & adverse event data from hospital on an anonymous, voluntary basis. Orange Book official name - correct answer Approved Drug Products with Therapeutic Equivalence and Evaluations, published by FDA. Pharmaceutical equivalence definition - correct answer Refers to drug products with the same active ingredients, same dosage form, same route of administration, and identical strength or concentration. Therapeutically euivalent definition - correct answer Refers to drug products that are pharmaceutically equivalent and bioequivalent. Bioequivalent drug products - correct answer Refers to products that are pharmaceutically equivalent that provide the same results of drug delivery with the same pharmacokinetic properties. Class I Medical Device definition - correct answer This class of medical device is very simple by design and has a very low potential to cause harm. Class I Device examples - correct answer Examples of this class include toothbrushes, tongue depressors, bandages, exam gloves, eye pads, ice bags, hand-held surgical instruments. Class II Medical Device definition - correct answer This class of medical device is required to meet performance standards.
Class II Device examples - correct answer Examples of this class include insulin syringes, BP guages, diagnostic reagents, electric heating pads, electronic thermometers, power wheel chairs, infusion pumps, & surgical drapes. Class III Device examples - correct answer Examples of this class include heart pacemakers, replacement heart valves, SCS, silicone gel-filled breast implants Class III Medical Device definition - correct answer This class of medical device applies to life- supporting or life-sustaining and requires premarket approval. Consumer or User product recall affects? - correct answer This product recall affects the patient or the physician. Retail level product recall affects? - correct answer This product recall affects the pharmacy, physicians, clinics, hospitals, & LTCF Wholesale level product recall affects? - correct answer This product recall is limited to manufacturers and retailers. Class I recall - correct answer Class "X" recalls have a reasonable probability that use of the product will cause serious, adverse health consequences or death. Class II recall - correct answer Class "X" recalls involve products that the use of the product may cause temporary or medically reversible health issues, i.e. subpotent drug. Class III recall - correct answer Class "X" recalls involve products that are not likely to cause adverse health consequencs, i.e. dirt, plastic or animal parts. 1912 Shirley Amendment - correct answer Which amendment prohibited false or misleading claims about the therapeutic effects of a drug.
1997 FDA Modernization Act - correct answer 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. A. FDA - correct answer Which federal agency determines whether drugs are safe and effective for intended uses? A. FDA B. DEA C. DHHS D. State & federal governments concurrently - correct answer 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 - correct answer 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 1976 Medical Device Amendments - correct answer Which amendment to the FDCA required better classification of medical devices, established performance standards, & pre-market approval requirements. Hatch-Waman Amendment aka - correct answer 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.
1987 Prescription Drug Marketing Act - correct answer Which act required that prescription drug wholesalers be licensed by states under federal guidelines? 1997 FDA Modernization Act - correct answer Which act clarified pharmacy extemporaneous compounding guidelines, replaced Federal Caution with "Rx only" & eliminated the statement, "Warning
- May be habit forming". 1997 FDA Modernization Act - correct answer 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. 2010 Patient Protection & Affordable Care Act (Health Care Reform Act) - correct answer Which act required all individuals have health insurance, required timely payment of electronic claims, & phasing out the "donut hole" by 2020. Who is the PIC for a Class B pharmacy? - correct answer 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. Who do nuclear pharmacist receiving their training requirements from? - correct answer The Texas Regulations for Control of Radiation of the Bureau of Radiation Control, Texas Department of Health. How many hours of training must a nuclear pharmacist have to be registered with the Board? - correct answer 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 ratio of pharmacist to technicians in a class B pharmacy? - correct answer No greater than 1:3 provided one technician is registered and only one may be engaged in the compounding of a sterile radiopharmaceutical What kind of laminar flow hood do nuclear pharmacist use, vertical or horizontal? - correct answer Vertical What texts are in a Class B pharmacy library? - correct answer -USP/NF with supplements
-Musculoskeletal drugs -Vitamins -Obstetrical and gynecological drugs and devices -Topical drugs -Serums, toxoids, and vaccines *Exclusive to injectables administered at the clinic and OTCs What type of drugs are not allowed on a Class D pharmacy formulary (no exceptions)? - correct answer Drugs containing: -Nalbuphine (Nubain) -Carisoprodol (Soma) -Drugs to treat erectile dysfunction -Schedule I-V controlled substances How can a Class D pharmacy petition for an expanded formulary? - correct answer 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 Do out of state Class E pharmacist have to be licensed with Texas? - correct answer No, they don't have to be licensed with Texas but their pharmacy must have a Class E license with Texas. How soon before a license application for a Class E pharmacy is received does a pharmacy need to send in an inspection report? - correct answer 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. *If a Class C pharmacy has an outpatient pharmacy do they also have to have a Class A pharmacy license? - correct answer No, but they do have to follow Class A rules What does 'Accurately as prescribed' mean? - correct answer When dispensing, delivering and/or distributing a prescription order that it as the correct patient, drug, and labeling.
*What is a 'New prescription drug order'? - correct answer -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 How can pharmacist be a PIC of more than one pharmacy? - correct answer -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 If a pharmacy has an automated pharmacy dispensing system, how often does the PIC have to inspect the medication? - correct answer At least monthly, for expiration date, misbranding, physical integrity, security, and accountability *What responsibilities does an 'Owner' of a Class A Pharmacy have? - correct answer Responsibility for all administrative and operation functions, but if they are not a Texas licensed pharmacist they must consult one. *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? - correct answer 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 *Who in the pharmacy can verify receiving of controlled substances by initialing and dating invoices of controlled substances received in the pharmacy? - correct answer ONLY the pharmacist. 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. - correct answer False: They can only do NONjudgmental duties
*In what circumstances can a pharmacist, who is the only pharmacist at the location at the time, be temporarily away from the pharmacy? - correct answer -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 *What are the rules for when the pharmacist is off-site from a Class A pharmacy? - correct answer -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 *When is counseling for a prescription necessary? - correct answer 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. *When doing a Drug Regimen Review (DRR) what is to be considered clinically? - correct answer 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 When labeling a prescription what does it need to have? - correct answer -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 When does a dispensing container not require everything a usual prescription label should have? - correct answer 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 What books must a pharmacy have in its library? - correct answer 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
What kind of electronic prescription drug orders for control substances do they not allow? - correct answer The DEA does not currently allow for 'electronic' (computer to computer) prescriptions, but they do allow faxed prescriptions. What is an emergency refill? ("72 Hour Rule") - correct answer 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. Can you refill a prescription of a practitioner who has died? - correct answer A prescription dies with the practitioner. Emergency refills may be used. What is an emergency refill during a Governor declared state of disaster? - correct answer "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. Records Pharmacist should be able to located in a Class A Pharmacy for the past 2 years: - correct answer -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 3 settings are Class C licenses issued to? - correct answer 1) Inpatient facility (hospital)
- Hospice inpatient facility
- Ambulatory surgical center
Def'n: Automated medication supply system - correct answer System that collects, controls, and maintains all transaction information for storage and distribution of medications (Pyxis) Def'n: Direct copy - correct answer Electronic copy or carbonized copy of a medication order (ex: fax, scan, etc) Def'n: Floor stock - correct answer Prescription drugs or devices not labeled for a specific patient and maintained at the nursing station or other hospital department Def'n: Full time pharmacist - correct answer 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 Def'n: Patient - correct answer A person who is admitted to the facility; INCLUDES a person confined in a correctional institution! *Def'n: Supervision - correct answer 1) Physically present supervision - pharmacist is physically present to directly supervise pharm tech/trainees
- 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 *What are the requirements for a facility to only need services of a pharmacist on a part-time or consulting basis? - correct answer 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 *How often must a pharmacist provide services to a hospital with >100 beds? - correct answer Continuously - techs may distribute prepackaged and prelabeled drugs from a drug storage area of the
be performed quarterly if the system monitors expiration dates and the security system is checked at regularly defined intervals (daily, weekly) 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: - correct answer 1) Filling medication carts
- Distributing routine orders for stock supplies to patient care areas
- Accessing and restocking automated medication supply systems The patient's orders must have been previously reviewed and approved by a pharmacist* In a facility with <= 100 beds, which duties of a technician MUST be done with physically present supervision? - correct answer 1) prepacking and labeling unit/multiple dose packages
- bulk compounding or batch preparation
- loading unlabeled drugs into an automated compounding or counting device
- compounding med-high risk sterile preparations pursuant to medication orders In a facility with <= 100 beds, which duties of a technician can be done with electronic supervision? - correct answer 1) Preparing, packaging, or labeling prescription drugs pursuant to medications orders (RPh must check prior to distribution)
- distributing routine orders for stock to patient care areas
- 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)
- accessing automated medication supply systems
- compounding non-sterile preparations
- compounding low-risk sterile preparations (RPh must check prior to distribution) What is the ratio of technicians to pharmacists in Class C pharmacies? - correct answer None What is the ratio of technicians to pharmacists in an outpatient pharmacy located within a hospital? - correct answer 1:3 (considered a Class A pharmacy)
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. - correct answer True! True or False: A Class C PIC must submit an application to the board if they decide to have tech-check- tech services - correct answer True! True or False: All drugs in a Class C pharmacy may be kept together as long as it meets temperature requirements for each drug. - correct answer False - External use drugs, antiseptics, and disinfectants must be kept separately from internal and injectable medications When the pharmacy is closed and the practitioner orders a drug for a patient, what is required to record what is being taken? - correct answer 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 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? - correct answer Only enough for immediate therapeutic needs *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? - correct answer As soon as possible, but no later than 72 hours after withdrawal *When the pharmacy is closed and the practitioner orders a drug for a patient, who is allowed to withdraw drugs from the pharmacy? - correct answer A licensed nurse or practitioner only (in a facility with any # of beds) *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? - correct answer Full time pharmacists: ASAP but no longer than 72 hrs after withdrawn Part time/consultant pharmacists: no more than 7 days
