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MPJE Review
Chapter 7: Class B-G Pharmacy Rules
| Question | Answer |
|---|---|
| When must a class C facility require continuous onsite pharmacist supervision whenever the pharamcy is open/operating? | Any class C facility with 101 beds or more |
| What pharmacist-service requirement applies to a facility with 100 beds or fewer? | It must have pharmacist services at least part-time or on a consulting basis, with the pharmacist on site at least once every 7 days. |
| If an class C institution opens/operates an *outpatient pharmacy, what pharmacist-presence rule applies? | A pharmacist must be on site whenever the outpatient pharmacy is open, just like a Class A requires |
| If an institutional outpatient pharmacy is operated, what rules generally apply to that outpatient operation? | Pharmacist onsite at all times when open, and all other class A rules (including the RPh:tech ratio rules |
| Must a pharmacist be accessible at all times in a Class C pharmacy? | Yes, even if it is remote for smaller places, a pharmacist must be reachable either physically or by phone/pager 24/7 |
| How may pharmacist accessibility be provided when the pharmacist is not physically present? | Through telephone service answered 24 hours a day, a paging service, or a list of phone numbers where a pharmacist can be reached. |
| When is a full time PIC required for a Class C? | If the Class C facility has 101+ beds |
| May a Class C PIC simultaneously serve as PIC of a Class A or Class B pharmacy? | No |
| What PIC arrangement may be used in a Class C facility with 100 beds or fewer? | The PIC may be employed or contracted as a consultant on a part-time basis. |
| Can class C PIC serve as a PIC at more than one Class C facility? | Only for 100 or less beds and a max of 3 facilities |
| May a pharmacist serve as PIC of one facility with 101 or more beds and also PIC of smaller facilities under the small-facility exception? | No, if they are going to serve multiple Class C pharmacies, all of the facilities must have 100 beds or fewer |
| Who bears responsibility for the distribution pharmacist’s duties associated with preparing and distributing medications? | The pharmacist involved in the preparation process. |
| What dispensing-process functions should the pharmacy computer system be able to identify? | Each pharmacist involved in functions such as data entry, preparation, distribution, and labeling. |
| In a facility with 101 beds or more, what technician activities may be performed under physically present pharmacist supervision? | Preparing/labeling package/drug orders, nonsterile compounding, trained sterile compounding in Class C-S, bulk compounding, distributing stock supplies, entering medication orders/data, loading automated devices, and resupply orders |
| In a facility with 100 beds or fewer, may technicians perform certain duties with electronic rather than physically present pharmacist supervision? | Yes, but still needs electronic supervision |
| In a facility with 100 beds or fewer, may technicians prepare/package/compound/label prescription drugs under electronic pharmacist supervision? | Yes, but with electrronic supervision |
| Do class C pharmacies have a RPh:tech ratio by law? | No |
| Do tech responsibilities/duties change depending on bed count of the class C facility? | No, they have the same allowed duties, the only difference is whether RPh supervision is electronic or physical. The only difference is for sterile compounding duties |
| Can trained techs do sterile/nonsterile compounding even in small bed facilities? | Yes, but without physical pharmacist supervision, they can only do low-risk sterile compounding if a pharmacist is not physically present. |
| What special Class C process may allow one pharmacy technician to check another technician’s work? | A Board-approved tech-check-tech program. |
| What types of medication-distribution systems can tech-check-tech involve? | Floor-stock and unit-dose distribution systems. |
| What condition must generally be met before tech-check-tech may be used? | The patient’s orders must previously have been reviewed by a pharmacist. |
| *For these special Class C rules, what is a rural hospital? | A hospital with 75 beds or fewer located in a COUNTY with a population fewer than 50,000, OR designated as a critical-access hospital, rural-referral center, or sole-community hospital. |
| May a practitioner order a prescription drug/device for a patient in a rural hospital when the pharmacist is not on duty? | Yes, under the rural-hospital rules. |
| When the pharmacist is not on duty or the pharmacy is closed, who may withdraw drugs needed for a patient in a rural hospital? | A nurse or practitioner. But only a quantity needed for immediate patient needs |
| : How much medication may generally be withdrawn when the pharmacist is absent? | A quantity sufficient for the patient’s immediate therapeutic needs. |
| What must the hospital pharmacist do after medication is withdrawn while the pharmacist is absent? | Verify the withdrawal and perform a drug-regimen review. |
| How soon must that pharmacist verification/drug-regimen review occur in a rural hosptial if they were absent? | Within 7 days of the withdrawal |
| In a rural hospital, may pharmacy technicians perform certain duties when the pharmacist is not physically present? | Yes, under direct electronic supervision of a pharmacist. |
| May a technician enter medication orders and drug-distribution information into the computer system under remote pharmacist supervision? | Yes |
| Can techs perform all of their normal duties when RPh supervision is remote/electronic? | Yes, with the exception of higher risk sterile compounding |
| Who must ultimately verify the accuracy of pharmacy-technician activities performed while the pharmacist is off site in a rural hospital? | A nurse or practitioner at the hospital or a pharmacist through electronic supervision, as applicable. |
| If a facility has a full-time pharmacist and the pharmacy is closed, who may remove drugs for a patient’s immediate therapeutic needs? | A designated licensed nurse or practitioner, but they must keep records for withdrawals |
| What info MUST be included in a withdrawal record when the pharmacist was absent? | Patient name, drug name/strength/dose/route, quantity, time/date of withdrawal, signature of authorized agent |
| In a facility with a full-time pharmacist, how quickly must the pharmacist verify a withdrawal made during absence? | ASAP, but no more than than 72 hours for NON-rural |
| How does this withdrawal verification rule differ from the rural-hospital rule and non-rural hospital rule? | The ordinary full-time-pharmacist absence rule uses 72 hours, while the rural-hospital provision allows pharmacist verification/drug-regimen review within 7 days. |
| If a facility uses only a part-time or consultant pharmacist, who may withdraw medication when the pharmacist is absent? | Same rules apply as a full time pharamcist, only a designated nurse or practitioner for immediate need |
| How quickly must a part-time/consultant pharmacist verify such withdrawals? | Within 7 days |
| So when does the 7 days rule apply to withdrawals during pharmacist absence? | 7 days applies when there is no full-time pharmacist If a rural/nonrural hospital has a full-timer, then 72 hour rules kicks in |
| So when does the 72 hour rule apply to withdrawals during pharmacist absence? | In non-rural hospitals that have a full time pharmacist |
| When does the 7 day rule get shortened for a absence of a part time pharmacist? | If the facility bed census averages more than 10 per day |
| So what is the withdrawal review timeline for a hospital with a part time pharmacist but averages 13 filled beds per day? | Since there are more than 10/day, the rule shrinks from 7 days to 96 hours that the pharmacist must review the withdrawal records and perform the DRR |
| Must a Class C pharmacy maintain a pharmacy-reference library? | Yes, either physical or electronic |
| What Texas pharmacy-law references MUST the library contain in Class C? | Current Texas Pharmacy Act/rules, Texas Dangerous Drug Act/rules, Texas Controlled Substances Act/rules, and applicable federal controlled-substance law/rules. As well as drug interaction and information/resources |
| Must the class C library include injectable-drug information? | Yes, as well as drug info, antidotes, and interaction checkers |
| Must the library include a metric/apothecary conversion reference? | Yes |
| Must a Class C pharmacy have a formulary? | Yes |
| May prepackaging occur within the class C facility? | Yes |
| May prepackaging for distribution to other Class C pharmacies occur? | Yes, but the facilities must be under a common owner |
| Is prospective drug-regimen review required in Class C? | Yes, unless pharmacist is off duty, then it must be retrospective after withdrawal is performed |
| When does a Class C pharmacy require constant onsite pharmacist supervision? | 101+ beds |
| How often must floor-stock records generally be reviewed by a pharmacist? | every 30 days at least |
| What perpetual-inventory requirement applies drugs in a Class C pharmacy? | Only required by law for C2s |
| When a pharmacist is on duty in the facility, who must dispense drugs for outpatient use, including emergency-room patients? | A pharmacist |
| If the pharmacist is not on duty, may dangerous drugs and controlled substances be supplied to emergency-room patients? | Yes, under certain conditions |
| What formulary restriction applies to emergency-room drug supplies when no pharmacist is present? | Only drugs on the emergency-room drug list may be provided. |
| What is the maximum supply that may generally be provided from an emergency-room drug supply? | a 72 hour supply, only applies when no pharmacist is on duty |
| How must ER medications be supplied? | In prepackaged quantities. |
| What pharmacy-identifying information must appear on the ER medication label? | Pharmacy name, address, and telephone number. Along with all other class A label requirements |
| How often must a pharmacist verify the contents of the emergency-room drug list/supply? | At least once every 7 days. |
| Must automated compounding or counting devices be calibrated and tested for accuracy? | Yes |
| May a pharmacy technician load an automated compounding/counting device? | Yes, but a pharmacist must verify it. |
| How frequently must that QA program test system accuracy for automated dispensing machines? | At least every 6 months, and when an upgrade or change is made. |
| Must the pharmacy have a backup plan if an automated system becomes unavailable? | Yes |
| How long must ordinary Class C pharmacy records generally be maintained? | 2 years |
| How quickly must requested pharmacy records generally be supplied? | Within 72 hours of request |
| Must Schedule II records be maintained separately from other records? | Yes. |
| How may Schedule III–V records be maintained? | Separately or in a manner that makes them readily retrievable. |
| Must outpatient-pharmacy records in a Class C facility comply with Class A requirements? | Yes |
| Must a separate patient medication record be maintained for each patient? | Yes |
| What audit capability must the pharmacy computer system have? | : It must be capable of producing a hardcopy audit trail of drugs distributed in the facility, including required patient, location, prescriber, drug, quantity, and request-date information. |
| If a Class C-ASC has a full-time pharmacist, how often must withdrawals be reviewed? | At reasonable intervals, but at least once each calendar week. |
| If a Class C-ASC has a part-time or consultant pharmacist, how often must withdrawals be verified? | Still needed once every week |
| What are the inventory requirements for Class C-ASC pharmacies? | Need perpetual inventory of all controls |
| How are controlled-substance invoices handled in a Class C-ASC pharmacy? | They must be dated and initialed by the person receiving the drugs, and the pharmacist verifies entry into the perpetual inventory. Basically the same invoice rules as Class A pharmacies |
| How frequently must retrospective random drug-regimen review be conducted in the ASC? | At least every 31 days |
| What quantity restriction applies to drugs supplied for outpatient use from the ASC? | They may generally be supplied only in prepackaged quantities not exceeding a 72-hour supply. |
| What additional requirements are needed for C-ASC pharmacists when it comes to drug regimen reviews? | The law requires restrospective quality control DRRs every 31 days, this is not related to patient-specific withdrawal reviews. |
| What additional Texas regulatory license is required for a Class B nuclear pharmacy? | Authorization through the Texas Department of State Health Services Radiation Control Program. |
| What professional qualification must an authorized nuclear pharmacist have? | The pharmacist must be a BPS-certified nuclear pharmacist or meet the specified education/training requirements. |
| What training pathway does Dr. C list as an alternative to BPS certification? | At least 200 hours of didactic (course work/classes) training approved by the TDSHS Radiation Control Program and 500 hours of supervised experience. |
| Which classes of pharmacy have the 1:6 rule with max of 3 trainees per RPh? | Class A and B |
| Must a Class B nuclear pharmacy have a policy-and-procedure manual? | Yes |
| What identifying information must appear on the outer container of a radiopharmaceutical? | Pharmacy name, address, phone #, date dispensed, directions, Rx #, patient/prescriber, radiation warnings, drug information, activity information, preparation/checker identification, volume, calibration date/time, and expiration information as applicable. |
| What radiation warning appears on the inner container of nuclear prescriptions? | The standard radiation symbol and “Caution—Radioactive Material” or “Danger—Radioactive Material.” |
| Must the prescription number appear on the inner container for class B? | Yes |
| Are ordinary sterile-compounding rules always applied identically to sterile radiopharmaceutical preparation? | : No. Dr. C notes that nuclear pharmacies have special exemptions/provisions for certain sterile-compounding requirements. |
| What is a Class D pharmacy? | A pharmacy associated with a clinic where limited dangerous drugs/devices are used under an approved clinic formulary. |
| Must the clinic’s pharmacy policies and procedures be included in the pharmacy license application? | Yes |
| How may the pharmacist serve the Class D clinic? | As a consultant under a written agreement. |
| Is there a limit on how many Class D clinics a pharmacist may serve as PIC for? | No, there is no limit, they can PIC at as many class D pharmacies as they want under the law. |
| What type of supervision does the Class D pharmacist provide to nurses, physician assistants, and others carrying out pharmacy-related functions? | Must be continuous supervision |
| What types of drugs are commonly included in a basic Class D formulary? | Anti-infectives, musculoskeletal drugs, vitamins, obstetrical/gynecological drugs, topical drugs, and serums/toxoids/vaccines. |
| What drugs may NOT be included in the ordinary basic Class D formulary? | Nalbuphine, erectile-dysfunction drugs, and controlled substances. |
| What is an expanded formulary for Class D? | A formulary allowing additional drugs beyond the basic list when statutory conditions are met. |
| What is the requirement for a class D to create/use an extended formulary? | The clinic must serve at least 80% indigent patients. |
| If an expanded formulary is used, who may supply drugs to the clinic? | Licensed nurses or practitioners under the required policies and procedures. |
| What additional monitoring accompanies an expanded formulary? | Policies for special monitoring, retrospective random drug-regimen review at least quarterly, and annual physician examination of patients receiving certain psychotropic therapy as specified. |
| If a mail order pharmacy location was located in Texas, would Texas law classify it as a Class E? | No, it would then be classified as class A. Its only Class E if it serves texas while located outside the state |
| What are the rules for class G pharmacies? | These pharmacies can only process orders on behalf of another pharmacy, but they cannot possess, fill, store, or dispense medications, they only do informtion processing |
| Do class G pharmacies have a legal max ratio for RPh:techs? | No, this was changed recently, so the answer is now NO |
| Do larger Class C pharmacies (101+ beds) have to be open 24/7 by law? | No, they just need continuous pharmacist supervision WHILE OPEN |
| Which pharmacy classes CANNOT carry controls at all? | Class D and G *G cant possess ANY drugs* |
| Which pharmacy classes must have perpetual control inventory for ALL controls? | Class C-ASC and Class F |
| Does class F need a full-time pharmacist? | No, just needs consultant or part time pharmacist |
| Can meds be removed from a Class F pharmacy without a pharmacist supervision? | Yes, but only by nurse or practitioner |
| What are the rules for ER dispensing without a pharmacist? | Only ER approved drug list prepackaged max 72 hour supply pharmacist must verify at least q7 days (or 72 hours if full time) |
Created by:
cdaughtry