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Questions and Answers
In a Class D pharmacy, drugs are prepackaged and labeled with________________.
In a Class D pharmacy, drugs are prepackaged and labeled with________________.
name and address of the clinic, name and strength of the drug, quantity, lot number and expiration date, directions for use (may be incomplete), and appropriate ancillary labels.
In a Class D pharmacy, drugs are provided to patients by designated supportive personnel who complete the label with ___________________.
In a Class D pharmacy, drugs are provided to patients by designated supportive personnel who complete the label with ___________________.
name of patient, any information necessary to complete directions for use, date of provision, and practitioner's name.
In a Class D pharmacy, patient counseling is not required.
In a Class D pharmacy, patient counseling is not required.
False
In a Class D pharmacy using an expanded formulary, any supportive personnel may provide drugs.
In a Class D pharmacy using an expanded formulary, any supportive personnel may provide drugs.
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The PIC, consultant pharmacist, or staff pharmacist must personally visit the Class D pharmacy at least _________________.
The PIC, consultant pharmacist, or staff pharmacist must personally visit the Class D pharmacy at least _________________.
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Mail order pharmacy in Wisconsin is an an example of a Class ________ pharmacy.
Mail order pharmacy in Wisconsin is an an example of a Class ________ pharmacy.
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A mail order pharmacy in Texas would have a Class _______ license; a mail order pharmacy outside of Texas would have a Class ________________ license.
A mail order pharmacy in Texas would have a Class _______ license; a mail order pharmacy outside of Texas would have a Class ________________ license.
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Class _______ pharmacies are non-resident (not located in Texas) pharmacies whose primary business is to dispense a prescription or drug device under a prescription drug order and deliver the drug or device to patients in Texas.
Class _______ pharmacies are non-resident (not located in Texas) pharmacies whose primary business is to dispense a prescription or drug device under a prescription drug order and deliver the drug or device to patients in Texas.
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Can Class E pharmacies compound sterile preparations?
Can Class E pharmacies compound sterile preparations?
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A _____________________ is a freestanding facility that is licensed by the Texas Department of State Health Services to provide emergency care to patients.
A _____________________ is a freestanding facility that is licensed by the Texas Department of State Health Services to provide emergency care to patients.
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A Class F pharmacy is licensed by the _______________.
A Class F pharmacy is licensed by the _______________.
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A Class F pharmacy must have ___________ PIC who is employed or contracted at least _______________ -time or on a _________ consulting.
A Class F pharmacy must have ___________ PIC who is employed or contracted at least _______________ -time or on a _________ consulting.
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In a Class F pharmacy, only individuals authorized by the________ may enter the pharmacy or have access to storage areas for prescription drugs.
In a Class F pharmacy, only individuals authorized by the________ may enter the pharmacy or have access to storage areas for prescription drugs.
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Class F pharmacies may not store C2 drugs.
Class F pharmacies may not store C2 drugs.
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In a class F pharmacy when a pharmacist is absent, only a designated _____________ or ________ may remove drugs from the pharmacy in sufficient quantities for the therapeutic immediate needs of a patient.
In a class F pharmacy when a pharmacist is absent, only a designated _____________ or ________ may remove drugs from the pharmacy in sufficient quantities for the therapeutic immediate needs of a patient.
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In Class F pharmacies with a full-time pharmacist, the pharmacist shall verify the withdrawal of drugs from the pharmacy no more than ________ from time of such withdrawal.
In Class F pharmacies with a full-time pharmacist, the pharmacist shall verify the withdrawal of drugs from the pharmacy no more than ________ from time of such withdrawal.
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In Class F pharmacies with a part-time or consultant pharmacist, the pharmacist shall conduct an audit of patient charts at least ______________ that the pharmacy is open.
In Class F pharmacies with a part-time or consultant pharmacist, the pharmacist shall conduct an audit of patient charts at least ______________ that the pharmacy is open.
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In Class F pharmacies, drugs may be supplied for outpatient use only in prepackaged quantities not to exceed a _________________ supply; At the time of delivery of the drug, the _______ or ______ under the practitioner's supervision must complete the label.
In Class F pharmacies, drugs may be supplied for outpatient use only in prepackaged quantities not to exceed a _________________ supply; At the time of delivery of the drug, the _______ or ______ under the practitioner's supervision must complete the label.
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A retrospective drug regimen review must be completed at least once every _____________ in a Class F pharmacy to verify proper usage of drugs.
A retrospective drug regimen review must be completed at least once every _____________ in a Class F pharmacy to verify proper usage of drugs.
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A Class _____________ pharmacy license is issued to a facility established for the primary purpose of processing prescription or medication drug orders on behalf of another pharmacy, a health care provider, or a payor.
A Class _____________ pharmacy license is issued to a facility established for the primary purpose of processing prescription or medication drug orders on behalf of another pharmacy, a health care provider, or a payor.
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A Class G pharmacy does not possess, store, or dispense drugs, but may perform ___________.
A Class G pharmacy does not possess, store, or dispense drugs, but may perform ___________.
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What is the max ratio of pharmacists to pharmacy technicians and technician trainees in a Class G pharmacy? How many may be pharmacy technician trainees?
What is the max ratio of pharmacists to pharmacy technicians and technician trainees in a Class G pharmacy? How many may be pharmacy technician trainees?
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Match the pharmacy types with their appropriate designations:
Match the pharmacy types with their appropriate designations:
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In a Class C pharmacy, a facility with _________ shall be under the continuous on-site supervision of a pharmacist when the pharmacy department is open for services.
In a Class C pharmacy, a facility with _________ shall be under the continuous on-site supervision of a pharmacist when the pharmacy department is open for services.
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A facility with _____________ shall have the services of a pharmacist but may be at least ____________ time or on a ________ basis, but the pharmacist must be on-site at least once every ____________ days.
A facility with _____________ shall have the services of a pharmacist but may be at least ____________ time or on a ________ basis, but the pharmacist must be on-site at least once every ____________ days.
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In a Class C pharmacy, the pharmacist to technician ratio is?
In a Class C pharmacy, the pharmacist to technician ratio is?
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In a Class C pharmacy, when must a pharmacist be accessible and how is 'accessible' defined?
In a Class C pharmacy, when must a pharmacist be accessible and how is 'accessible' defined?
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Facilities with 101 or more beds must have _____________ full-time PIC who can be the PIC for how many facilities?
Facilities with 101 or more beds must have _____________ full-time PIC who can be the PIC for how many facilities?
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Facilities with 100 beds or fewer must have a PIC how must be employed or under contract as a consultant and may be part time. 1 pharmacist may be the PIC of no more than ______ such facilities or _____ beds.
Facilities with 100 beds or fewer must have a PIC how must be employed or under contract as a consultant and may be part time. 1 pharmacist may be the PIC of no more than ______ such facilities or _____ beds.
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In facilities with 100 beds or fewer, pharmacy technicians may perform which of the following under physically present pharmacist supervision? (Select all that apply)
In facilities with 100 beds or fewer, pharmacy technicians may perform which of the following under physically present pharmacist supervision? (Select all that apply)
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What is 'Tech Check Tech?' Can pharmacy technician trainees participate?
What is 'Tech Check Tech?' Can pharmacy technician trainees participate?
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Rural hospitals are those that have _____________ beds or fewer and are located in a county with a population fewer than __________.
Rural hospitals are those that have _____________ beds or fewer and are located in a county with a population fewer than __________.
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If a practitioner orders a Rx drug for a patient in a rural hospital when a pharmacist is not present or the pharmacy is closed, a _____ or _____ may withdraw the drug from the pharmacy in sufficient quantity to fulfill the order.
If a practitioner orders a Rx drug for a patient in a rural hospital when a pharmacist is not present or the pharmacy is closed, a _____ or _____ may withdraw the drug from the pharmacy in sufficient quantity to fulfill the order.
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In a rural hospital, pharmacy technicians may perform what duties WITHOUT the direct supervision of the pharmacist?
In a rural hospital, pharmacy technicians may perform what duties WITHOUT the direct supervision of the pharmacist?
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In facilities licensed for 101 beds or more, a designated licensed nurse or practitioner may remove drugs for the patient's immediate therapeutic needs. A pharmacist must verify withdrawal ASAP but no more than _________________ after withdrawal.
In facilities licensed for 101 beds or more, a designated licensed nurse or practitioner may remove drugs for the patient's immediate therapeutic needs. A pharmacist must verify withdrawal ASAP but no more than _________________ after withdrawal.
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Class C pharmacy floor stock records must be reviewed by a pharmacist at least every _______.
Class C pharmacy floor stock records must be reviewed by a pharmacist at least every _______.
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In a Class C pharmacy, how often must an inventory of C2 prescriptions be taken?
In a Class C pharmacy, how often must an inventory of C2 prescriptions be taken?
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When a pharmacist is on duty in the facility, any drugs dispensed for outpatient use including to the emergency room must be dispensed by a pharmacist.
When a pharmacist is on duty in the facility, any drugs dispensed for outpatient use including to the emergency room must be dispensed by a pharmacist.
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Under what conditions may dangerous drugs and controlled substances be dispensed to patients admitted to the emergency room when a pharmacist is not on duty?
Under what conditions may dangerous drugs and controlled substances be dispensed to patients admitted to the emergency room when a pharmacist is not on duty?
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What is an example of an automated medication supply system?
What is an example of an automated medication supply system?
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How often must an automated medication supply system be tested for accuracy?
How often must an automated medication supply system be tested for accuracy?
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How often must an automated medication supply system be monitored via a quality assurance program?
How often must an automated medication supply system be monitored via a quality assurance program?
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Records in a Class C pharmacy must be maintained for _________ and be supplied within _____ for request.
Records in a Class C pharmacy must be maintained for _________ and be supplied within _____ for request.
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Class C-ASC must keep a perpetual inventory of ____________.
Class C-ASC must keep a perpetual inventory of ____________.
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Class B pharmacies must meet federal Department of Transportation (DOT) regulations.
Class B pharmacies must meet federal Department of Transportation (DOT) regulations.
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Planned Parenthood is an example of a Class ____________ pharmacy.
Planned Parenthood is an example of a Class ____________ pharmacy.
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Define a 'Clinic.'
Define a 'Clinic.'
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What is required as part of the license application for a Class D pharmacy license?
What is required as part of the license application for a Class D pharmacy license?
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The PIC of a Class D pharmacy is employed or under written agreement as a consultant to the facility and may be the PIC for a max of 3 clinics.
The PIC of a Class D pharmacy is employed or under written agreement as a consultant to the facility and may be the PIC for a max of 3 clinics.
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What are some responsibilities of the PIC for a Class D pharmacy?
What are some responsibilities of the PIC for a Class D pharmacy?
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What are the responsibilities of 'Supportive Personnel' for a Class D pharmacy?
What are the responsibilities of 'Supportive Personnel' for a Class D pharmacy?
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Can the Class D pharmacy formulary include ant-infective drugs?
Can the Class D pharmacy formulary include ant-infective drugs?
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Can the Class D pharmacy formulary include sildenafil?
Can the Class D pharmacy formulary include sildenafil?
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Can the Class D pharmacy formulary include musculoskeletal drugs?
Can the Class D pharmacy formulary include musculoskeletal drugs?
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Can the Class D pharmacy formulary include vitamins?
Can the Class D pharmacy formulary include vitamins?
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Can the Class D pharmacy formulary include C5 drugs?
Can the Class D pharmacy formulary include C5 drugs?
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Can the Class D pharmacy formulary include obstetrical and gynecological drugs?
Can the Class D pharmacy formulary include obstetrical and gynecological drugs?
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Can the Class D pharmacy formulary include serums, toxoids, and vaccines?
Can the Class D pharmacy formulary include serums, toxoids, and vaccines?
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Can the Class D pharmacy formulary include tramadol?
Can the Class D pharmacy formulary include tramadol?
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Can the Class D pharmacy formulary include topical drugs?
Can the Class D pharmacy formulary include topical drugs?
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Can the Class D pharmacy formulary include nalbuphine (Nubain)?
Can the Class D pharmacy formulary include nalbuphine (Nubain)?
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Can the Class D pharmacy formulary include carisoprodol?
Can the Class D pharmacy formulary include carisoprodol?
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A Class D pharmacy may petition the Board for an expanded formulary if serving at least ____________ indigent patients.
A Class D pharmacy may petition the Board for an expanded formulary if serving at least ____________ indigent patients.
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True or False? Expanded formulary may provide for other drugs including those to treat erectile dysfunction.
True or False? Expanded formulary may provide for other drugs including those to treat erectile dysfunction.
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What are the additional requirements of a Class D pharmacy if using an expanded formulary?
What are the additional requirements of a Class D pharmacy if using an expanded formulary?
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If a Class D pharmacy uses an expanded formulary, how often must retrospective drug regimen reviews of a random sample of clinic patients be done?
If a Class D pharmacy uses an expanded formulary, how often must retrospective drug regimen reviews of a random sample of clinic patients be done?
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If a Class D pharmacy uses an expanded formulary including psychotropic drugs, how often must a patient be examined physically by a physician?
If a Class D pharmacy uses an expanded formulary including psychotropic drugs, how often must a patient be examined physically by a physician?
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Study Notes
Classifications of Pharmacies
- Community, Nuclear, Institutional/Hospital, Clinic, Non-Resident/Remote, Freestanding Emergency Medical Care Facility classified as Class A, B, C, D, E, F respectively.
- Central Prescription Drug Order or Medication Order Processing and Limited Prescription Delivery also play roles in pharmacy classification.
Class C Pharmacy Regulations
- Facilities with 101+ beds require continuous on-site pharmacist supervision; those with 100 beds or fewer need a pharmacist present at least once every 7 days.
- Pharmacist to technician ratio is no limit for Class C; ratio is 1:4 for outpatient pharmacies, similar to Class A.
- Access to a pharmacist must be available at all times, either physically or through a 24/7 telephone service.
Pharmacist-in-Charge (PIC) Guidelines
- Facilities with 101+ beds must have one full-time PIC.
- For facilities with 100 beds or fewer, a PIC can oversee up to three facilities or a total of 150 beds.
- A PIC of a Class D pharmacy can oversee a maximum of three clinics, with no specified limit on the number of clinics for the PIC.
Pharmacy Technician Duties in Class C
- Under supervision, pharmacy technicians in facilities with 100 beds or fewer can compound low-risk and non-sterile preparations.
- Tech Check Tech allows technicians to verify the work of other technicians regarding filling floor stock and unit dose systems after orders are reviewed by a pharmacist.
Rural Hospital Regulations
- Rural hospitals have 75 beds or fewer and are located in counties with populations under 50,000.
- In urgent situations, a nurse or practitioner can withdraw drugs from the pharmacy if a pharmacist is unavailable, but pharmacists must verify within specific timeframes.
- Pharmacy technicians can operate various duties, including preparing and distributing medications without immediate pharmacist supervision.
Record Keeping and Inventory
- Class C pharmacies must maintain records for 2 years, with specific timeframes for providing records upon request.
- A perpetual inventory of Controlled Substances (C2) is mandatory, and audits of distribution records must occur regularly.
Automated Systems in Pharmacy
- Automated medication supply systems must be tested for accuracy at least every 6 months and continuously monitored under quality assurance programs.
- TPN Compounding machines may be loaded by pharmacy technicians but need verification by pharmacists prior to use.
Class D Pharmacy Characteristics
- Class D (Clinic) pharmacies dispense limited drugs to outpatients, requiring a supportive structure and policy adherence.
- Formulary includes provisions for certain drugs, with restrictions on controlled substances.
- Retrospective drug regimen reviews must occur quarterly when an expanded formulary is utilized.
Non-Resident (Class E) Pharmacies
- Class E pharmacies are non-resident pharmacies that operate with licenses in good standing in their respective home states.
- Texas has specific licensing requirements for mail order pharmacies, while non-resident pharmacies must comply with their state regulations.
Additional Pharmacy Standards
- Class C and D pharmacies must ensure patient counseling is provided at the time of drug provision.
- Policy manual and formulary submission are necessary for Class D pharmacy license applications.
Special Considerations
- Special monitoring must be in place for drugs requiring it, especially in expanded formularies involving psychotropic drugs and ongoing physician evaluations for patients.### Class E-S Pharmacy
- Class E-S pharmacies are required to register to operate.
- They are authorized to compound sterile preparations.
Patient Counseling in Class E Pharmacy
- Mandatory patient counseling for all new prescription drug orders.
- Counseling includes providing written information and a toll-free number for pharmacist access.
Class F Pharmacy Overview
- Class F, or Freestanding Emergency Medical Care Facility (FEMCF) Pharmacy, is licensed by the Texas Department of State Health Services.
- These facilities provide emergency care to patients.
Licensing and Regulation
- Class F pharmacies are regulated by the Texas Department of State Health Services (TDSHS).
- Class B pharmacies also fall under TDSHS regulation via the Radiation Control Program.
Pharmacist in Charge (PIC) Requirements
- A Class F pharmacy must employ or contract with at least one PIC, who works part-time or on a consulting basis.
Access Regulations
- Only individuals authorized by the TDSHS may access storage areas for prescription drugs in a Class F pharmacy.
Controlled Substances Storage
- False statement: Class F pharmacies cannot store Schedule II (C2) drugs.
- C2 drugs must be kept in locked storage.
Drug Removal Protocols
- In the absence of a pharmacist, only designated licensed nurses or practitioners can remove drugs for patient needs.
Verification of Drug Withdrawal
- In Class F pharmacies with a full-time pharmacist, drug withdrawals must be verified within 72 hours.
Audit Requirements
- Class F pharmacies with part-time pharmacists must conduct patient chart audits at least once every calendar week.
Outpatient Drug Supply Limits
- Drugs provided for outpatient use are limited to a 72-hour supply.
- Labels must be completed by a practitioner or licensed nurse under a practitioner's supervision at the time of delivery.
Retrospective Drug Regimen Review
- Reviews for proper drug usage must occur at least every 31 days in Class F pharmacies.
Class G Pharmacy License
- A Class G pharmacy license is designated for facilities that process prescription or medication orders for other pharmacies, healthcare providers, or payors.
Class G Pharmacy Functions
- Class G pharmacies do not store or dispense drugs but can handle various pharmacy-related tasks, including:
- Receiving, interpreting, and clarifying prescription orders
- Data entry and transferring prescriptions
- Performing drug regimen reviews and obtaining refills or authorizations
- Interpreting clinical data for prior authorization
- Conducting therapeutic interventions
- Providing drug information regarding a patient's prescription
Staffing Ratios in Class G Pharmacy
- Maximum ratio of pharmacists to pharmacy technicians and technician trainees is 1:8, with only one allowed to be a technician trainee.
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Test your knowledge of different pharmacy classes with these flashcards. Match the terms such as Community, Institutional, and Clinic to their definitions. Perfect for students studying pharmacy or anyone interested in the field.