CPhT PTCE Book

Incompatibility in a nonsterile compound can be identified through various physical, chemical, and therapeutic changes.An unexpected change in odoris a key indicator of chemical instability, contamination, or degradation of a compounded preparation. Some ingredients may break down into volatile compounds, leading to noticeable odor changes.

A. A clear solution→ Incorrect; clarity alone does not indicate incompatibility.Some solutions may be clear but still chemically unstable.

B. The use of a pH buffer system→ Incorrect; buffer systems are used to maintain pH stability and prevent incompatibility rather than indicate it.

D. Suspension particles settling to the bottom of a container→ Incorrect; suspensions naturally settle and require shaking before use.This is not necessarily a sign of incompatibility.

Other Answer Choices Explained:References:

USP <795> Pharmaceutical Compounding—Nonsterile Preparations

PTCB PTCE Exam Content Outline (Medication Safety & Quality Assurance)

Remington: The Science and Practice of Pharmacy

Handling and internal transport of hazardous waste in the workplace require compliance with OSHA standards, including Hazard Communication and HAZWOPER (29 CFR 1910.120) training for personnel involved in hazardous waste operations. While external shipment of hazardous materials involves DOT/EPA rules, within pharmacy and healthcare settings, technicians moving hazardous waste containers to storage must have OSHA-mandated training. DEA pertains to controlled substances, FDA regulates drug approval/labeling, and ISMP is a safety organization but does not mandate training.

References (Pharmacy Technician documents / Study Guides):

• USP <800> Hazardous Drugs—Handling in Healthcare Settings: personnel training expectations and references to OSHA standards for safe handling.

• OSHA Hazard Communication Standard and HAZWOPER training requirements as cited in pharm tech safety modules.

• PTCB/ExCPT study materials on hazardous drugs/waste handling and applicable regulatory bodies

AMaster Formulation Record (MFR)is adetailed document used in compounding pharmaciesto ensureconsistency, accuracy, and quality controlin preparing compounded medications.

An MFR includes:

Ingredients & amounts required.

Compounding procedures.

Stability and beyond-use dating (BUD).

Storage and labeling instructions.

This ensures that each compounded preparationmeets quality standardsand ismade correctly every time.

B. Prevent drug diversion❌→Incorrect

Drug diversion prevention involves security measures, inventory control, and trackingcontrolled substances, not MFRs.

C. Eliminate patient profiles❌→Incorrect

Patient profiles are essential for tracking medication history; MFRs are unrelated.

D. Guarantee drug availability❌→Incorrect

MFRs do not affect drug supply; they ensure accurate compounding.

USP <795> (Non-Sterile Compounding Guidelines)– RequiresMaster Formulation Records for all compounded preparations.

PTCB PTCE Exam Content Outline– Covers compounding procedures and quality control measures.

Why Not the Other Options?Key References:

To determine the correct volume of amoxicillin suspension per dose, use the given concentration and dose.

Prescription dose:150 mg per dose

Suspension concentration:250 mg per 5 mL

Formula to calculate volume needed:Volume (mL)=Prescribed dose (mg)Concentration (mg/mL)\text{Volume (mL)} = \frac{\text{Prescribed dose (mg)}}{\text{Concentration (mg/mL)}}Volume (mL)=Concentration (mg/mL)Prescribed dose (mg)​

Step 1: Identify Given InformationStep 2: Calculate150 mg250 mg/5 mL=150×5250=750250=3 mL\frac{150 \text{ mg}}{250 \text{ mg/5 mL}} = \frac{150 \times 5}{250} = \frac{750}{250} = 3 \text{ mL}250 mg/5 mL150 mg​=250150×5​=250750​=3 mL

Thus, the patient should take3 mL per dose.

B. 4 mL→ Incorrect; this would correspond to a different strength.

C. 5 mL→ Incorrect; this would deliver250 mg, which is incorrect.

D. 6 mL→ Incorrect; this would deliver300 mg, exceeding the prescribed dose.

Other Answer Choices Explained:References:

PTCB PTCE Exam Content Outline (Pharmaceutical Calculations – Dosage & Volume Calculations)

USP <795> Guidelines for Nonsterile Compounding & Drug Dilution

Lexicomp Drug Monograph for Amoxicillin Suspension