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MPJE review
CH4: Texas Pharmacy Act and Board rules
| Question | Answer |
|---|---|
| How many members of the TSBP? What is the makeup? | 11 memebers: 7 pharmacists (including at least one class A and C pharmacist) 1 tech 3 public members |
| TSBP requirements for board memeber pharmacists? | Lives in TX, licensed for 5 years prior to appointment, good standing with TSBP, actively practices |
| What are the the big DONT's for pharmacist members and member spouses? | Cant be lobbyist, cant be paid by lobbying/professional advocacy groups in healthcare |
| What are the DONT rules for for public members and their spouses? | Cant be liscensed as a nurse/doc/etc, part of business(es) that are regulated by the board, more than 10% interest in business regulated by the board, paid by lobbying/professional advocacy groups |
| Term of office for TSBP board member? Who appoints them? | 6 years, max of 2 terms Appointed by governor with consent of senate |
| What is the general role of the Texas State Board of Pharmacy under the Texas Pharmacy Act? | To administer and enforce the Texas Pharmacy Act and rules Issue/renew pharmacy liscenses and training Intern/tech training/registration needs Can make rules needed to carry out the TPA |
| What are the 5 requirements to be a pharmacist in TX? | 18+ years old Completed internship Graduated and got professional degree Passed board exams Hasnt had a RPh liscense revoked/surrendered/suspended in other state |
| Can Texas grant pharmacist licensure by reciprocity? | Yes, when the applicant meets Texas reciprocity requirements and the other jurisdiction’s standards are acceptable. But must satisfy texas requirements |
| What is an extended intern? | A registered graduate or former student whose intern registration continues for specified circumstances such as awaiting examination or licensure. |
| What event can terminate a *student* pharmacist-intern registration? | leaving the pharmacy program, failing required examinations more than once, not taking the exam within 6 months of graduation |
| Does an intern need pharmacist supervision to perform pharmacist duties? | Obviously yes. But they CAN perform tech duties without preceptor supervision |
| Does an intern count toward the RPh;tech ratio? | No |
| What is the max RPh:tech or RPh:trainee ratio for class A in texas? | 1:6 and 1:3 for trainees. So a pharmacist could supervise 3 techs plus 3 trainess. |
| What internship-hour structure does Dr. C identify for Texas pharmacist licensure? | The required internship experience corresponds to ACPE requirements, including 300 IPPE hours and 1,440 APPE hours. *max of 50 hours per week* |
| How long may internship hours remain usable toward Texas licensure? | Generally no more than 3 years from the date the internship hours are fully completed |
| What is generally required for a pharmacist to serve as a Texas pharmacist preceptor? | Active license, 1 year experience or 6 months residency training, 3 hours of preceptor training through ACPE (renew every 2 years), no disciplinary issues, |
| What is the max preceptor to intern ratio? Are there exceptions? | 1:1, unless the intern is a student in a texas pharmacy school program |
| How often are RPh lisences renewed? | Every 2 years |
| When does a Texas pharmacist license expire? Is there a grace period? | On the last day of the pharmacist’s assigned birth month. No grace period, they cant practice if it expires |
| What does Dr. C mean by timely receipt of a pharmacist renewal application? | Receipt by TSBP before the applicable expiration deadline. |
| What happens if a pharmacist license has been expired for less than 90 days? | It may generally be renewed by paying 1.5x the required renewal fee. |
| What are the timelines for renewals/penalties after a liscense expires for RPh? | <90 days 90 days to 1 year > 1 year |
| What happens if a pharmacist license has been expired for more than 90 days but less than 1 year? | The pharmacist may renew subject 2x the renewal fee requirements. |
| What happens if a Texas pharmacist license has been expired for 1 year or longer? | The pharmacist generally cannot simply renew it and must pursue the applicable re-licensure pathway. |
| What is the required CE for pharmacists? How often is it needed? | 30 hours every 2 years |
| What materials must be covered in CE? | 1 hour or more of pharmacy law/rules Human trafficking course |
| What special CE requirement applies to certain newly licensed pharmacists? | At least 2 contact hours concerning prescribing and monitoring controlled substances by the first anniversary of initial licensure, as described by Dr. C. |
| Does passing the NAPLEX during the preceding licensing period count toward pharmacist CE? | Yes, taking and passing the NAPLEX can count to 30 contact hours of CE |
| Does completing accredited pharmacy-school coursework during the licensing period potentially count toward CE? | Yes |
| How are CEUs related to contact hours? | 0.1 CEU = 1 contact hour. |
| What organization accredits pharmacy continuing-education providers? | ACPE |
| May CPR coursework count toward Texas pharmacist CE? | Yes within certain limits |
| How long must pharmacists retain CE documentation? | 3 years from the date that the CE was reported with the renewal |
| Does each pharmacy location need its own license? | Yes |
| Is a Texas pharmacy license transferable from one owner to another? | No, a new application is needed |
| How soon must a newly licensed pharmacy actually begin operating before its license may become subject to cancellation? | Within 6 months of the date the license/application process is completed |
| What special inspection requirement applies to pharmacies that compound sterile products? | They cannot be licensed by TSBP until the pharmacy has been inspected. |
| What is a pharmaceutically equivalent drug product? | A product containing the same active ingredient(s), strength/concentration, dosage form, and route as the comparison product. |
| Who has professional responsibility for deciding whether an allowable generic/interchangeable substitution should be made? | The pharmacist, subject to prescriber and patient restrictions. |
| May a pharmacist substitute a generic product if it costs more than the prescribed brand product? | No; the substituted product must cost less than the brand product under the Texas rule described. |
| Can the patient object to a substituion? | Yes, and the pharmacy must not violate that |
| For ordinary small-molecule drugs, what Orange Book rating does Dr. C emphasize for substitution? | An A-rated therapeutically equivalent product. |
| For biologics, what FDA status is required for pharmacy-level substitution in Texas? | FDA designation as interchangeable. It cant just say biosimilar. |
| May a preprinted “dispense as written” notation alone prohibit substitution if Texas requires the prescriber to personally indicate the restriction? | No, it must say “brand necessary” or “brand medically necessary” and be handwritten if it is on written prescription |
| May checkboxes or other preprinted markings alone automatically prohibit substitution? | No, where Texas requires the prescriber’s own notation. |
| How may a prescriber prohibit substitution on a verbal prescription? | By communicating the appropriate “brand necessary” or “brand medically necessary” instruction. |
| What special follow-up does Dr. C discuss when a prescriber prohibits substitution for a Medicaid patient by verbal or electronic prescription? | A signed/faxed written dispensing directive must generally reach the pharmacy within 30 days. |
| Must a Texas pharmacist inform the patient when a generic drug or interchangeable biological product is substituted? | Yes |
| What information must the patient generally receive concerning an interchangeable biologic substitution? | Information identifying the product dispensed and appropriate counseling/notification. |
| What additional prescriber-notification requirement applies after dispensing an interchangeable biological product? | The pharmacist must communicate information about the product dispensed to the prescriber within 3 days |
| : May a pharmacist substitute a different dosage form of a drug without prescriber authorization? | Only under the circumstances permitted by Texas law and with patient consent. |
| What clinical circumstance generally must exist for an emergency refill without prescriber authorization? | Failure to refill would interrupt therapy or create patient suffering/risk. |
| What is the usual maximum emergency refill quantity under ordinary circumstances? | A 72-hour supply. |
| What emergency-refill quantity may be allowed when the governor declares a disaster and TSBP authorizes expanded emergency dispensing? | Up to a 30-day supply |
| Must the pharmacist notify the prescriber that an emergency refill was dispensed? | Yes and it must be labeled as a prescription |
| Which drugs cannot be auto-refilled under texas law? | C2 and C3 drugs |
| Can emergency refills be done for C3-5s? | Yes, but with rules attached |
| Can pharmacies do auto-refill programs? | Yes, but must affirmatively enroll in the programs and must be able to stop the program if aske |
| May a Texas pharmacist dispense up to a 90-day supply of a dangerous drug when the original prescription specifies a smaller quantity? | Yes, if the patient consents, it doesnt exceed the total quantity of the Rx, and physician is notified, and its not a psych med, and the patient is 18+ |
| Which meds cannot be changed up to a 90 day supply (assuming it was written for less than 90 days per refill)? | Psych meds |
| What situations would prevent an accelerated refill? | Patient isnt 18+ years old, physician forbids it, its a psych med |
| What is an accelerated refill? | When the pharmacy dispenses more than what was written per each fill on a prescription (ie filling for 90 days at a time when the script was written for 30 at a time) |
| What must a pharmacist report to Texas health authorities regarding possible bioterrorism, epidemic, or pandemic activity? | Unusual or increased prescription rates or trends that may indicate such an event. |
| May a Texas pharmacist administer epinephrine through an auto-injector in an emergency? | Yes, and must call 911 afterwards |
| What liability protection does Dr. C describe for pharmacists who administer epinephrine in good faith under the statute? | Statutory protection when acting in accordance with the applicable requirements. |
| If the pharmacist administers a epipen, do they need to report it? | Yes, it must be reported to the patient's Dr within 72 hours |
| May Texas physicians or delegated APRNs/PAs issue non-patient-specific orders for epinephrine auto-injectors to qualifying entities for pharmacy dispensing? | Yes |
| What is required for these special epipen scripts? | Name/signature of physician prescriber, name of the entitiy to which it is for, quantitiy of epipens, date of issue |
| What entities can these special epipen orders be written for? | Law enforcement, day cares, child cares, day camps, higher education, amusement parks, resturaunts, sports venues, etc. |
| Aside from epipens, what other drug(s) can be dispensed without a specific patient? | Drugs like albuterol for schools |
| How quickly must a pharmacist report a change of pharmacist name or address to TSBP according to the chapter’s notification table? | Within 10 days |
| How quickly must termination/change of pharmacist employment be reported when required? | Within 10 days |
| How quickly must permanent closing of a pharmacy be reported to TSBP? | Within 10 days, in addition to the separate advance pharmacy-closing requirements. |
| How quickly must a change in pharmacy ownership be reported? | Within 10 days |
| How much advance notice is generally required for a pharmacy location change? | New lisence filed 30 days prior to change |
| How quickly must a pharmacy report a pharmacy-name change? | 10 days PRIOR to change |
| : How quickly must a change in pharmacist-in-charge generally be reported? | Within 10 days |
| Who is responsible for reporting a pharmacist-in-charge change when a new PIC assumes the role? | The new/incoming PIC and the pharmacy itself |
| How quickly must a fire or other disaster/emergency affecting pharmacy security, drugs, records, or operations be reported? | Within 10 days |
| How quickly must a pharmacy report a significant loss of controlled substances or dangerous drugs? | Right away upon discovery |
| How quickly must a significant loss of pharmacy computer data be reported? | Within 10 days |
| When must a pharmacy report discovering that a licensee/registrant obtained dangerous drugs or controlled substances from a forged prescription? | Right away upon discovery |
| How quickly must a pharmacy report a final disciplinary order from another pharmacy licensing authority? | Within 10 days |
| After loss of the pharmacist-in-charge, how soon must a temporary pharmacy closure be reported? | By the next business day |
| Does Texas generally allow physicians to operate as routine dispensing pharmacies? | No; physician dispensing is generally restricted. |
| What limited quantity may a physician provide directly to a patient in the physician’s office to meet an immediate therapeutic need? | Up to 72 hours assuming an exception is met |
| In what situations is a physician allowed to dispense to a patient directly? | 1) a 72-hour supply (no controls) to meet immediate medical needs 2) In rural areas with no nearby pharmacy (no 72 hour rule here) |
| Which pharmacies have no required RPh:tech ratio? | Class C and Class G |
| What are the rules for children getting shots by a pharmacist? | Cant give shots to a child under 14 without a reference by a doctor unless it is a flu shot, then the minimum age is >7. Unless the pharmacy has a physician issued protocol. |
| How quickly must the initial professional-liability claim report be submitted after notice is received? | Within 30 days. |
| How quickly is the follow-up report due after final disposition of the claim? | Within 105 days after disposition. |
| How long is a Texas pharmacy technician trainee registration valid? | 2 years and it is not renewable. |
| How quickly must the physician who issued the vaccination protocol be notified after vaccine administration? | Within 24 hours. |
| How quickly must the patient’s primary-care physician be notified of vaccination, when applicable? | Within 14 days. |
| What types of records must be kept for pharmacists operating under DTM? | Copy of the written protocol(s), document all interventions, review protocols annuals. Keep records for 2 years |
| Can a DTM pharmacist change drug therapy without any physician protocol? | No |
| Does a DTM give a pharmacist indepedent authority? | No |
| How frequently must the physician review the DTM protocol and deviations from it? | Annually |
| Must the physician be geographically available to be physically present when necessary for a DTM agreement? | Yes |
| What special CE requirements are needed for DTM pharmacists? | 6 hours of DTM related CE |
| Is there a max ratio for physicians:DTM pharmacists? | Currently no, a pharmacist may have a DTM with unlimited doctors and doctors may have DTMs with unlimited pharmacists |
| How long must pharmacy inventory records generally be maintained? | 2 years. |
| Must controlled substances that are out of date or expired still be included in the controlled-substance inventory? | Yes |
| Does C2 inventory have to be seperate from other drugs during inventory reports? | Yes |
| Who is responsible for an exact count of Schedule II controlled substances? | The PIC |
| May Schedule III–V inventory counts be estimated when permitted? | Yes, subject to the >1,000-tablet/capsule exact-count rule discussed in Chapter 2. |
| If a pharmacy maintains a perpetual inventory, does that eliminate the required annual controlled-substance inventory? | No |
| What must occur on the opening day of a pharmacy if no controlled substances are present? | A record indicating there are no controlled substances should be created. |
| How often does Texas require a controls inventory? | Annually |
| What inventory is required when ownership of certain Texas pharmacies changes? | An inventory on the date of the change of ownership. |
| Must the seller and buyer each have an inventory when ownership changes? | Yes |
| What inventory is required when the PIC changes in specified pharmacy classes? | Controls inventory is needed by law |
| Which pharmacy classes must maintain perpetual inventory of all controlled substances? | Class C ambulatory surgical center and Class F pharmacies among those requiring broader perpetual inventory. |
| Which pharmacy types does Dr. C identify as requiring perpetual Schedule II inventory? | Class C and class C-S (does not include class C ambulatory surgery centers, which require perpetualjust for C2s) |
| What inventory is required for drugs stored at remote locations? | Perpetual inventory for all controls |
| How much advance notice does Dr. C state a pharmacy generally must provide before permanently closing? | At least 14 days |
| What must the PIC do at least 14 days before planned pharmacy closure? | Notify DEA and post/provide patient notice including information about where records will be transferred. |
| What must occur with prescription records and patient medication records on the closing day? | They must be transferred or otherwise handled according to TSBP requirements. |
| How soon after closing must the PIC provide TSBP with required information concerning closure and disposition of records/drugs? | Within 10 days. |
| What controlled-substance documentation must generally be surrendered when a pharmacy closes? | The pharmacy’s DEA registration certificate and unused DEA Form 222s, as applicable. |
| Can a pharmacy remain open if it doesn't have a PIC? | NO, cannot operate with a PIC |
| If a pharmacy closes suddenly because of fire, destruction, eviction, disaster, or similar emergency, must it still give the normal 14-day advance notice? | No; notice should be provided as soon as circumstances permit. |
| What happens when a pharmacy temporarily closes solely because it has no pharmacist-in-charge? | The pharmacy may temporarily close under the limited TSBP procedure but cannot operate without a PIC. |
| If a pharmacy temporarily closes for lack of a PIC, who may access the prescription department? | Only another pharmacist |
| How quickly must TSBP be notified of such a temporary closure in the loss of a PIC due to an *emergency situation when advanced notice cant be given? | Promptly/by the next business day under the applicable notification rule. |
| How quickly must a pharmacy reopen after an emergency situations such as fire, natural disaster, death, etc? | Within 30 days, although a single extension may be available |
| Within what time must the pharmacy generally reopen with a new PIC to avoid moving toward permanent closure? | Within 48 hours |
| Who remains responsible for problems in delivery when the pharmacy itself selects and uses a common or contract carrier? | The pharmacy |
| Is it legally required that delivered meds be in tamper evident packaging and packaged to maintain integrity of contents? | Yes, as well as making sure temperature controlling packaging is used when needed |
| What must the pharmacy do if a delivery is delayed or the integrity of the drug may have been compromised? | Assess the condition and replace/redistribute the drug when necessary. |
| May the pharmacy refuse to use a delivery method that could clinically compromise the medication? | Yes |
| Must counseling requirements still be satisfied for delivered prescriptions? | Yes |
| Must a pharmacy notify the patient or patient’s agent that the prescription has been delivered? | Yes |
| If a delivered prescription is compromised in transit, what must the pharmacy do? | Replace it or arrange appropriate replacement. |
| What type of delivery records does Dr. C say pharmacies must retain for specified events such as patient complaints or compromised delivery? | Documentation of the delivery event and corrective action, retained for the required period. |
| How long must a pharmacy keep delivery records? | 2 years, must document each change of custody between entities |
| May a pharmacy use unmanned drones or vehicles to deliver scripts? | Yes, but subject to pharmacy/aviation requirements |
| Who is always liable for prescriptions that have been delivered regardless of the delivery mechanism? | The pharmacy |
| What four broad types of remote pharmacy practice does Dr. C identify? | Emergency medication kits, automated pharmacy systems, telepharmacy systems, and automated dispensing/delivery systems at remote locations. |
| Must TSBP generally approve remote pharmacy services before operation? | Yes |
| May a provider pharmacy supervise unlimited numbers of remote dispensing sites? | No, there are specific limits. |
| Which pharmacy classes are not allowed to stock controls? | Class D, G, and H |
| What is a class H pharmacy? | A local "pharmacy" that acts as a delivery point for drugs to/from another facility, but does not store bulk drugs and does not fill medications |
| What are the rules for having C2s in a class C-ASC facility? | They CANNOT maintain floor stock of C2s, drugs must be ordered from another supplier for specific upcoming patient/surgery purposes. And they must only be given inside the facility (so no take home C2s for patients) |
| Which pharmacy classes can have C2s but under serious restrictions? | Class C-ASC (cant have floor stock C2s, has to order for specific upcoming operations) Class F (can stock C2s, but can only give 72 hour outpatient supply) |
| What is the maximum number of remote dispensing sites a provider pharmacy may generally supervise under the rules discussed? | 2 remote dispensing sites |
| Is a remote dispensing site required to register as a pharmacy class (A-H)? | No, unless it averages over 125 scripts per day in dispensing, then it must register as a class A |
| Can remote dispensing sites carry controls? | Yes, but require perpetual inventory |
| May an emergency medication kit be used as a routine source of drugs for ordinary dispensing? | No |
| What does a pharmacy have to do in order to provide emergency med kits services? | Must obtain TSBP approval |
| Who determines which drugs may be stocked in an emergency medication kit? | The consultant pharmacist, pharmacist-in-charge, and appropriate facility medical/nursing leadership as specified. |
| Who may access an emergency medication kit? | Pharmacists and authorized healthcare personnel employed by the facility. |
| If a facility carries an emergency med kit that contains a control, does that facility need DEA registration? | No, since the kit is not used for regular dispensing |
| What are the rules for what meds can be in a emergency med kit? | Limited to drugs needed when delay in obtaining them from a pharmacy would be harmful |
| May drugs in an automated pharmacy system (like an Omni-cell) be stocked by technicians or trainees? | Yes, under pharmacist supervision and system safeguards. |
| Must drugs sent to a remote automated system be packaged/labeled appropriately before leaving the provider pharmacy? | Yes |
| Must remote controlled-substance inventory be maintained separately from the provider pharmacy’s on-hand inventory? | Yes |
| May a remote system dispense Schedule II controlled substances in every remote-pharmacy configuration? | No; some remote dispensing systems specifically may not dispense Schedule II controlled substances. |
| What supervision requirement applies to a remote dispensing site staffed by a pharmacy technician? | Continuous supervision by a pharmacist employed by the provider pharmacy through an approved telepharmacy system. |
| What minimum experience does Dr. C list for a technician working at certain remote dispensing sites? | At least 1 year working in a retail pharmacy during the preceding 3 years, plus required system training. |
| May pharmacy technicians at a remote dispensing site perform sterile compounding? | Yes, within the limited scope permitted. |
| *How often must a pharmacist employed by the provider pharmacy PHYSICALLY visit certain remote dispensing sites? | At least monthly, but must provide remote supervisions daily for things like perpetual inventory |
| What must the visiting pharmacist reconcile during a remote-site visit? | control inventory and reconciliations |
| Must the remote dispensing/delivery system provide a way for a patient to contact a pharmacist? | Yes |
| How must dangerous drugs that were dispensed to patients in healthcare facilities be destroyed? | In a manner that renders them unfit for human consumption and complies with applicable environmental and legal requirements. |
| Does destruction of controlled substances have to follow DEA controlled-substance destruction rules in addition to state requirements? | Yes |
| Who must witness destruction of certain dangerous drugs in a healthcare facility? | Authorized personnel such as the consultant pharmacist and specified nursing/administrative personnel |
| Must a record be made when certain dangerous drugs are transferred to a waste-disposal service? | Yes |
| What should the destruction/transfer record include? | The date of transfer, identities/signatures of appropriate personnel, and information identifying the waste-disposal service. |
| What may a pharmacy do with dangerous drugs returned to it when destruction is required? | Destroy them in a manner rendering them unfit for human consumption and document destruction as required. |
| What additional requirement applies when returned drugs are controlled substances? | The pharmacy must be an authorized collector or otherwise follow DEA-controlled-substance return/destruction requirements. |
| May a Texas pharmacy destroy expired or unusable dangerous-drug stock itself? | Yes, if destruction makes the drug unfit for human consumption and complies with applicable law. For controls, they must follow DEA rules |
| Are detailed destruction records required for every destruction of noncontrolled stock dangerous drugs? | Dr. C notes that records of destruction are not required for certain stock dangerous-drug destruction situations. |
| May a business establish a general prescription pickup/drop-off location at any site it chooses? | No; Texas generally prohibits prescription pickup locations outside licensed pharmacies except authorized arrangements. |
| May a pharmacy pick up prescription orders from a patient at the prescriber’s office, home, residence, employment site, hospital, or medical facility? | Yes, under the permitted arrangements described by Dr. C. |
| What additional limitation does Dr. C emphasize for delivering a controlled-substance prescription to a prescriber’s office? | It is more restrictive and generally tied to administration to the patient at the prescriber’s office under applicable controlled-substance rules. |
| How quickly must the pharmacy generally remove a recalled drug from active inventory after receiving recall notice? | Within 24 hours |
| May a pharmacy accept a prescription drug that has already been dispensed to a patient and return it to normal stock for resale? | Usually no, there is an exception for scripts dispensed to nursing home patients |
| What pharmacy classes can use central fill systems? | Class A, C, and E |
| Rules for central fill pharmacies? | Must be under common ownership, must share common database, must provide notice to patients once, no controls, and CANNOT deliver directly to patient |
| Are remote pickup locations for class A/c pharmacies allowed? | Genernally no, unless its a satellite pharmacy, which falls under the license of the filling pharmacy |
Created by:
cdaughtry