Non-Sterile Compounding

Regulatory Context

Regulatory framework for non-sterile compounding in pharmacy:

Schedule II

High abuse potential with accepted medical use. Examples: oxycodone, fentanyl, morphine, amphetamine, methylphenidate. Storage: Double-locked, perpetual inventory, no refills, written/electronic Rx only

Schedule III

Moderate abuse potential. Examples: testosterone, ketamine, Tylenol with codeine. Storage: 5 refills in 6 months, written/oral/electronic Rx

Calculation Methods

Calculations relevant to non-sterile compounding in pharmacy:

body weight dosing: dose (mg/kg) * weight (kg) = total dose. Example: Vancomycin 15mg/kg * 80kg = 1200mg

alligation: Parts of each concentration to reach desired concentration. Example: Mix 10% and 2% to get 5%: high minus desired = 5 parts of 2%, desired minus low = 3 parts of 10%

Practical Example

Related Procedures

Preparation of oral, topical, and rectal medications from bulk ingredients per USP 795 standards. Non-sterile compounding principles and documentation tested on PTCB exam.

Related drug class: Fluoroquinolones includes ciprofloxacin, levofloxacin, moxifloxacin. Mechanism: Inhibit bacterial DNA gyrase and topoisomerase IV, bactericidal.

Patient Communication

Clear communication about non-sterile compounding with patients, families, and the healthcare team is essential. Use standardized handoff tools (SBAR) for shift changes and transfers. Verify understanding by asking the patient to repeat key information back to you.

Historical Context

Pharmacy regulation in the U.S. began with the Pure Food and Drug Act of 1906. The Federal Food, Drug, and Cosmetic Act of 1938 required proof of safety. The 1962 Kefauver-Harris Amendment added efficacy requirements. Understanding non-sterile compounding within this regulatory history helps pharmacy technicians appreciate why current standards exist, as each major regulation was prompted by a public health crisis.