CSCP Certification Review

Certified Sterile Compounding Pharmacist (CSCP) Review

A Review Guide for the Certified Sterile Compounding Pharmacist (CSCP) Exam

Block 1: Foundations of Sterile Compounding

A-C

  • ACPH: Air Changes Per Hour.
  • ASHP: American Society of Health-System Pharmacists.
  • BOP: Board of Pharmacy.
  • BSC: Biological Safety Cabinet.
  • BUD: Beyond-Use Date.
  • CACI: Compounding Aseptic Containment Isolator.
  • CAI: Compounding Aseptic Isolator.
  • CFU: Colony-Forming Unit.
  • C-PEC: Containment Primary Engineering Control.
  • C-SEC: Containment Secondary Engineering Control.

C-H

  • CSP: Compounded Sterile Preparation.
  • CSTD: Closed System Drug-Transfer Device.
  • DEA: Drug Enforcement Administration.
  • DI: Deionized (Water).
  • DQSA: Drug Quality and Security Act.
  • FDA: Food and Drug Administration.
  • HD: Hazardous Drug.
  • HEPA: High-Efficiency Particulate Air.
  • HVAC: Heating, Ventilation, and Air Conditioning.
  • I.V.: Intravenous.

I-P

  • IFU: Instructions for Use.
  • IM: Intramuscular.
  • ISO: International Organization for Standardization.
  • ISMP: Institute for Safe Medication Practices.
  • IVPB: Intravenous Piggyback.
  • LAFW: Laminar Airflow Workbench.
  • LVP: Large Volume Parenteral.
  • MFR: Master Formulation Record.
  • NIOSH: National Institute for Occupational Safety and Health.
  • PEC: Primary Engineering Control.

P-S

  • PPE: Personal Protective Equipment.
  • PPM: Parts Per Million.
  • QA: Quality Assurance.
  • QC: Quality Control.
  • RABS: Restricted Access Barrier System.
  • SCA: Segregated Compounding Area.
  • SDS: Safety Data Sheet.
  • SEC: Secondary Engineering Control.
  • SOP: Standard Operating Procedure.
  • SVP: Small Volume Parenteral.

T-Z

  • TJC: The Joint Commission.
  • TPN: Total Parenteral Nutrition.
  • TNA: Total Nutrient Admixture.
  • USP: United States Pharmacopeia.
  • WFI: Water for Injection.
  • <71>: USP Chapter on Sterility Tests.
  • <85>: USP Chapter on Bacterial Endotoxins Test.
  • <797>: USP Chapter on Sterile Compounding.
  • <800>: USP Chapter on Hazardous Drug Handling.
  • <1163>: USP Chapter on Quality Assurance in Compounding.

Defining Sterile Compounding

  • Sterile compounding is the process of combining, admixing, diluting, or otherwise altering a drug or bulk drug substance to create a sterile medication.
  • These preparations are intended for administration by injection, infusion, or ophthalmic application.
  • The primary goal is to create a patient-specific medication that is free from microbial and other contaminants.
  • It is a high-risk practice that requires specialized knowledge, training, and facilities.
  • A CSCP is an expert in all aspects of this practice.

The "Why": Patient Safety

  • The entire framework of sterile compounding is built on the principle of patient safety.
  • Contaminated sterile products can cause serious patient harm, including bloodstream infections and death.
  • Inaccurate compounding can result in sub-therapeutic or toxic doses.
  • The rigorous standards outlined in USP <797> are designed to prevent these adverse events.
  • A culture of safety must be the foundation of any sterile compounding practice.
  • A CSCP is a leader in creating and maintaining this culture.

Compounding vs. Manufacturing

  • Compounding: The preparation of a drug for a specific patient based on a prescription. Regulated by state boards of pharmacy and USP.
  • Manufacturing: The mass production of drug products for wholesale distribution. Regulated by the FDA under cGMPs.
  • Compounded products are exempt from the FDA's new drug approval process.
  • A key rule is that a pharmacy cannot compound a product that is essentially a copy of a commercially available FDA-approved product.
  • The Drug Quality and Security Act (DQSA) further clarified these distinctions.

The Role of USP

  • The United States Pharmacopeia (USP) is a non-profit organization that sets public standards for the identity, strength, quality, and purity of medicines.
  • Their standards are published in the USP-NF.
  • The compounding chapters of the USP, especially <797> and <800>, are the national standards for practice.
  • These chapters are often incorporated into state board of pharmacy regulations, making them legally enforceable.
  • A CSCP must have an expert-level knowledge of all relevant USP chapters.

The Role of the CSCP

  • A Certified Sterile Compounding Pharmacist is a specialized practitioner.
  • They have advanced knowledge of the scientific principles of sterile compounding.
  • They are experts in the regulatory and quality standards governing the practice.
  • They are responsible for designing and managing the compounding pharmacy's facilities, personnel, and quality assurance program.
  • They serve as the ultimate resource for ensuring that all compounded sterile preparations (CSPs) are safe, effective, and of high quality.
  • This certification signifies a commitment to the highest level of practice.

Block 2: Regulatory & Quality Standards

Purpose and Scope

  • USP Chapter <797> provides the minimum standards for the compounding of sterile preparations.
  • Its primary purpose is to prevent patient harm, including death, that could result from microbial contamination, excessive bacterial endotoxins, or other preparation errors.
  • The chapter applies to all pharmacies and all personnel who are involved in sterile compounding.
  • State Boards of Pharmacy often incorporate USP <797> into their regulations, making it legally enforceable.
  • A CSCP must be an expert on every detail of this chapter.

Categories of CSPs (Category 1, 2, and 3)

  • The latest version of USP <797> categorizes CSPs based on the conditions under which they are made.
  • Category 1 CSPs: Made in a Segregated Compounding Area (SCA). These have a shorter Beyond-Use Date (BUD).
  • Category 2 CSPs: Made in a formal cleanroom suite (buffer room and ante-room). These can have a longer BUD.
  • Category 3 CSPs: A new category for CSPs made with enhanced sterility assurance measures, allowing for even longer BUDs.
  • The CSCP must understand these categories as they determine the required facilities and assigned BUDs.

Beyond-Use Dating (BUD)

  • A BUD is the date or time after which a CSP must not be stored or transported.
  • It is determined by the risk of microbial contamination and the chemical stability of the drug.
  • The BUDs for Category 1 CSPs are limited to 12 hours at room temperature or 24 hours refrigerated.
  • The BUDs for Category 2 CSPs can be longer, depending on whether a sterility test is performed.
  • The CSCP is responsible for establishing the pharmacy's policies for assigning BUDs in accordance with USP <797>.
  • Assigning an incorrect BUD is a serious safety risk.

The Role of the Designated Person

  • USP <797> requires the designation of one or more individuals to be responsible and accountable for the compounding program.
  • This "designated person" must have the appropriate training and expertise.
  • The CSCP often serves in this role.
  • Responsibilities include developing and implementing all compounding procedures, ensuring staff are properly trained, and overseeing the environmental monitoring program.
  • This is the person with ultimate accountability for USP <797> compliance.

Key Components of the Chapter

  • USP <797> is a comprehensive chapter covering all aspects of the process.
  • Personnel Training and Competency.
  • Facility and Engineering Controls.
  • Environmental Monitoring.
  • Cleaning and Disinfection.
  • Documentation (Master Formulation and Compounding Records).
  • Beyond-Use Dating.
  • Quality Assurance and Control.
  • A CSCP must be an expert in all of these areas.

Scope and Purpose

  • USP Chapter <800> provides standards for the safe handling of hazardous drugs (HDs).
  • Its primary purpose is to protect healthcare workers, patients, and the environment from exposure to HDs.
  • It applies to all personnel who handle HDs and all entities where they are handled.
  • It covers the entire lifecycle of an HD, from receipt to disposal.
  • Many sterile compounded preparations, especially chemotherapy, involve hazardous drugs.

The NIOSH List of Hazardous Drugs

  • The National Institute for Occupational Safety and Health (NIOSH) maintains a list of all drugs that are considered hazardous.
  • A pharmacy must maintain its own list of the HDs it handles, based on the NIOSH list.
  • This list must be reviewed at least every 12 months.
  • The list is organized into groups based on the type of toxicity.

Engineering Controls for Sterile HDs

  • Sterile HD compounding requires specific engineering controls to contain aerosols and vapors.
  • The Primary Engineering Control (C-PEC) must be a Biological Safety Cabinet (BSC) or a Compounding Aseptic Containment Isolator (CACI).
  • The C-PEC must be located in a Containment Secondary Engineering Control (C-SEC).
  • The C-SEC must be externally vented and have a negative pressure relative to the surrounding areas.
  • This is a key difference from a non-hazardous cleanroom.
  • A CSCP must ensure their facility meets these requirements.

Personal Protective Equipment (PPE)

  • Strict PPE is required for handling HDs.
  • This includes two pairs of chemotherapy-tested gloves.
  • A disposable gown that is resistant to chemotherapy is required.
  • Eye protection is required when there is a risk of splashes.
  • For some activities, respiratory protection is also needed.
  • The CSCP is responsible for selecting the appropriate PPE and for training all staff on how to don and doff it correctly.

Safe Handling and Disposal

  • USP <800> details safe handling practices for all stages of the lifecycle.
  • This includes procedures for receiving, storing, compounding, and dispensing HDs.
  • Closed System Drug-Transfer Devices (CSTDs) are required for the administration of chemotherapy and recommended for compounding.
  • All waste contaminated with HDs must be disposed of in a designated hazardous waste container.
  • A CSCP is the leader responsible for implementing all aspects of a USP <800> compliant program.

The Quality Assurance (QA) Program

  • USP <797> requires every compounding pharmacy to have a formal Quality Assurance program.
  • The QA program is the set of all activities designed to ensure that the compounding processes are under control and that the final products meet their quality specifications.
  • It is a proactive program focused on preventing errors.
  • The CSCP, as the designated person, is responsible for the overall design and implementation of the QA program.

Standard Operating Procedures (SOPs)

  • SOPs are the foundation of any QA program.
  • They are detailed, written instructions for how to perform every key task in the pharmacy.
  • There must be SOPs for personnel training, facility cleaning, equipment maintenance, compounding procedures, and documentation.
  • All staff must be trained on the SOPs relevant to their job.
  • The SOPs must be reviewed and updated on a regular basis.
  • The CSCP is responsible for writing and maintaining the pharmacy's SOP manual.

Environmental Monitoring

  • This is a core component of the QA program.
  • This includes the certification of the facilities every six months.
  • It includes the viable air and surface sampling.
  • It also includes the daily monitoring of temperatures and pressures.
  • The QA program must have a clear plan for what to do if any of these results are outside of the acceptable limits.

Personnel Competency

  • The QA program includes the initial and ongoing assessment of staff competency.
  • This includes the documented training program.
  • It also includes the gloved fingertip testing and the media-fill testing.
  • The QA program must have a clear policy for what happens if an employee fails one of these tests (e.g., they must be retrained and re-tested before they can compound again).

End-Product Testing

  • For certain high-risk and batched preparations, the QA program includes testing of the final product.
  • For sterile batches with long BUDs (Category 3), this includes sending a sample of the batch for sterility and endotoxin testing.
  • The batch must be quarantined and cannot be released until the test results are confirmed as negative.
  • The QA program may also include sending samples for potency testing.
  • The CSCP is responsible for developing and overseeing this QA program.

Block 3: Sterile Compounding Facilities & Equipment

Primary Engineering Controls (PECs)

  • The PEC is the device that provides the ISO Class 5 environment where sterile compounding takes place.
  • Laminar Airflow Workbench (LAFW): Provides clean, HEPA-filtered air that moves in a unidirectional (laminar) flow.
  • Biological Safety Cabinet (BSC): A containment hood used for hazardous sterile compounding.
  • Compounding Aseptic Isolator (CAI): A "glovebox" system for non-hazardous compounding.
  • Compounding Aseptic Containment Isolator (CACI): A "glovebox" for hazardous compounding.
  • The CSCP must ensure the correct PEC is used for each type of compounding.

Secondary Engineering Controls (SECs)

  • The SEC is the room in which the PEC is located.
  • Buffer Room: The main cleanroom where the PECs are located. Must be at least ISO Class 7.
  • Ante-Room: The room adjacent to the buffer room, used for garbing and staging. Must be at least ISO Class 8.
  • The ante-room must have a line of demarcation separating the "clean" and "dirty" sides.
  • The entire cleanroom suite must have specific temperature, humidity, and pressure requirements.

Pressure Differentials

  • The pressure relationship between the rooms is critical for preventing contamination.
  • For non-hazardous compounding: The buffer room must be under positive pressure relative to the ante-room. This ensures that air flows out of the cleanroom, preventing contaminants from entering.
  • For hazardous compounding: The buffer room must be under negative pressure relative to the ante-room. This is a containment strategy to prevent hazardous drug aerosols from escaping.
  • A CSCP must be an expert on these pressure requirements.

Segregated Compounding Area (SCA)

  • An SCA is an alternative space for making Category 1 CSPs.
  • It is a designated space with a visible perimeter, but it does not have to be a full cleanroom.
  • It must contain a PEC (e.g., an isolator).
  • The air in the SCA does not need to meet a specific ISO class, but it should be away from high-traffic areas.
  • This option provides more flexibility, but the BUDs of CSPs made in an SCA are much shorter.

Certification and Airflow Testing

  • The entire cleanroom suite and all PECs must be certified by a qualified, independent certifier every 6 months.
  • The certifier performs tests to ensure that the airflow, pressures, and HEPA filters are all working correctly.
  • This includes measuring the air changes per hour (ACPH) and performing smoke pattern tests to visualize the airflow.
  • The CSCP is responsible for coordinating this certification and for reviewing the final report.

The Importance of Cleaning

  • A robust cleaning and disinfection program is a cornerstone of USP <797> compliance.
  • The goal is to reduce the bioburden (the number of microorganisms) in the compounding environment to a safe level.
  • This is a daily, weekly, and monthly process.
  • The CSCP is responsible for developing the SOPs and for training the staff on these critical procedures.
  • Inadequate cleaning can lead to environmental monitoring failures and patient harm.

Cleaning Agents

  • Several different types of agents are used.
  • Germicidal Detergent: Used for the initial cleaning step to remove dirt and organic matter.
  • Disinfectant: An agent that destroys bacteria, fungi, and viruses. Sterile 70% isopropyl alcohol (IPA) is the most common disinfectant.
  • Sporicidal Agent: A special type of disinfectant that is effective against bacterial and fungal spores (e.g., sterile hydrogen peroxide, peracetic acid).
  • The CSCP must select appropriate, EPA-registered agents.

Cleaning Procedures

  • The cleaning process must be done in a specific sequence, from cleanest to dirtiest.
  • This means cleaning the buffer room first, then the ante-room.
  • Within a room, cleaning should proceed from top to bottom, and from back to front.
  • A specific, overlapping stroke should be used to ensure complete coverage.
  • Low-linting wipes and mops must be used.
  • The CSCP must ensure that staff are competent in these specific techniques.

Cleaning Frequency

  • USP <797> specifies the minimum frequency for cleaning.
  • Beginning of each shift: All surfaces in the PEC.
  • Daily: Floors, counters.
  • Monthly: Walls, ceilings, storage bins.
  • A sporicidal agent must be used at least monthly.
  • The CSCP is responsible for creating a detailed cleaning schedule and for documenting that all cleaning has been completed.

Cleaning for Hazardous Drugs

  • For areas where HDs are handled, USP <800> requires a more rigorous, four-step process.
  • 1. Deactivation: Using an agent like bleach or peroxide to break down the HD.
  • 2. Decontamination: Removing the deactivated residue.
  • 3. Cleaning: Removing any organic and inorganic material.
  • 4. Disinfection: Destroying microorganisms.
  • This four-step process is required for all C-PECs and C-SECs.
  • A CSCP must be an expert on this specific procedure.

The Purpose of Environmental Monitoring (EM)

  • EM is the program for sampling and testing the cleanroom environment to ensure it is meeting its required state of microbiological control.
  • It is a key part of the Quality Assurance program.
  • It provides an objective measure of the effectiveness of the facility design, cleaning procedures, and personnel practices.
  • The CSCP is responsible for the overall design and management of the EM program.

Viable Air Sampling

  • This involves sampling the air for the presence of viable microorganisms (bacteria and fungi).
  • It is performed using a microbial air sampler that impacts a specific volume of air onto a plate of growth medium.
  • The plates are then incubated, and the number of colony-forming units (CFUs) is counted.
  • This sampling must be performed at least every 6 months.
  • USP <797> sets specific "action levels" for the number of CFUs allowed in each ISO class of air.

Surface Sampling

  • This involves testing key surfaces in the compounding environment for microbial contamination.
  • It is performed using contact plates or swabs.
  • Sampling should be done at the end of a compounding shift to represent the dirtiest state.
  • Key sites to be sampled include the interior of the PEC, equipment, and surfaces in the ante- and buffer rooms.
  • This sampling must be performed monthly.
  • USP <797> also sets action levels for surface contamination.

Non-Viable Particle Counting

  • This is the testing that is done as part of the semi-annual certification of the cleanroom.
  • It is performed using a laser particle counter.
  • The counter measures the number of particles of a certain size (e.g., ≥ 0.5 microns) per cubic meter of air.
  • This is how the ISO class of the air is determined.
  • For example, ISO Class 7 air must have no more than 352,000 particles/m3.

Responding to Action Levels

  • If any of the EM results are above the action level, a formal investigation must be conducted.
  • The goal is to identify the cause of the contamination.
  • The microorganisms that are recovered should be identified to the genus level.
  • Corrective actions must be implemented, which may include re-cleaning the facility or re-training staff.
  • The area must be re-sampled to confirm that the corrective action was effective.
  • The CSCP is responsible for managing this entire investigation and remediation process.

Block 4: Compounding Practices & Procedures

The Importance of Training

  • The single most important factor in preventing contamination is the skill and technique of the compounding personnel.
  • Therefore, a robust training and competency program is the cornerstone of a safe sterile compounding practice.
  • All personnel involved in compounding must complete this program before they are allowed to compound independently.
  • The CSCP is responsible for the design and oversight of this program.

Didactic Training

  • The training program must include a didactic (knowledge-based) component.
  • This includes reading the relevant USP chapters and the pharmacy's own SOPs.
  • It should also include training on topics like aseptic technique, cleanroom procedures, and basic calculations.
  • Competency in this knowledge must be demonstrated through a written test.

Skills Training

  • The program must also include hands-on skills training.
  • This involves demonstrating the correct procedures for hand hygiene, garbing, and aseptic technique.
  • This training should be done under the direct supervision of an experienced compounder.
  • The trainee must be able to demonstrate proficiency in these core skills.

Gloved Fingertip and Thumb Sampling

  • This is a key skills assessment used to evaluate an employee's hand hygiene and garbing competency.
  • After garbing, the employee presses their gloved fingertips onto a plate of sterile growth medium.
  • The plate is then incubated to see if any bacteria grow.
  • A passing result is zero CFUs for both hands.
  • This test must be passed three times initially before an employee can compound.
  • It must then be re-evaluated periodically (every 6 months).

Media-Fill Testing

  • This is a skills assessment used to evaluate an employee's overall aseptic technique.
  • The employee performs a simulation of the most complex compounding procedure they do, but they use a sterile growth medium instead of actual drugs.
  • The final "product" is then incubated to see if it remains sterile.
  • Any sign of microbial growth constitutes a failure.
  • This test must be passed initially and then annually thereafter for low- and medium-risk compounding.
  • It is the ultimate test of an individual's ability to compound safely.

Defining Aseptic Technique

  • Aseptic technique is a set of practices and procedures used to prevent contamination from microorganisms.
  • It involves applying the strictest rules to minimize the risk of contamination of a sterile product.
  • It is the most important skill for any sterile compounding professional.
  • Mastery of aseptic technique is a non-negotiable requirement.

First Air

  • First air is the clean, HEPA-filtered air that comes directly out of the filter of the PEC.
  • It is considered the cleanest air in the compounding environment.
  • A core principle of aseptic technique is that all critical sites must be in the path of first air at all times.
  • This means that the operator's hands or any other object should never pass between the HEPA filter and a critical site.
  • This is known as "shadowing."

Critical Sites

  • A critical site is any location that is at risk of direct contact with the sterile product and therefore represents a pathway for contamination.
  • Examples include:
  • The tip of a syringe.
  • The hub of a needle.
  • The rubber stopper of a vial.
  • The injection port of an IV bag.
  • These sites must never be touched by anything that is not sterile.

Working in the PEC

  • All aseptic manipulations must be performed at least 6 inches inside the outer edge of the LAFW.
  • This ensures that the work is being done in the cleanest air.
  • All items should be placed in the hood in a way that does not obstruct the flow of first air to the critical sites.
  • The number of items in the hood should be minimized.
  • The operator should avoid any unnecessary or rapid movements.

Key Aseptic Manipulations

  • Disinfection of Surfaces: All vial stoppers and injection ports must be disinfected with a sterile 70% IPA wipe and allowed to dry.
  • Handling Needles and Syringes: The cap of the needle should not be removed until just before use. The needle should never be recapped.
  • Vial Technique: When withdrawing from a vial, a small amount of air is often injected first to prevent a vacuum from forming.
  • Ampule Technique: A filter needle or filter straw must be used when withdrawing from a glass ampule to remove any glass particles.
  • A CSCP must be a master of all of these core techniques.

Block 5: Sterile Compounding Formulations & Calculations

Physical and Chemical Stability

  • Chemical Stability: The active ingredient retains its chemical integrity and labeled potency. Key degradation pathways include hydrolysis and oxidation.
  • Physical Stability: The original physical properties (e.g., appearance, uniformity) are retained. Instabilities include precipitation or color change.
  • Microbiological Stability: The preparation remains free from microbial contamination.
  • A CSCP must consider all three types of stability when compounding and assigning a BUD.

Factors Affecting Stability

  • pH: Many drugs are only stable within a narrow pH range. The pH of the final solution can have a major impact on stability.
  • Temperature: Most reactions proceed faster at higher temperatures. Refrigeration is often used to extend stability.
  • Light: Exposure to light can cause photodegradation of sensitive drugs. Amber bags and tubing are used for protection.
  • Concentration: The stability of a drug can be concentration-dependent.
  • Container: Some drugs can adsorb to the plastic of an IV bag.

Beyond-Use Dating (BUD)

  • A BUD is the date after which a CSP shall not be used.
  • It is determined by the risk of microbial contamination (per USP <797>) and the chemical stability of the drug.
  • The BUD is whichever of these two dates is shorter.
  • For example, if USP <797> would allow a 14-day BUD but the drug is only chemically stable for 24 hours, the BUD must be 24 hours.
  • A CSCP must be an expert on determining the correct BUD.

Using Stability Resources

  • It is essential to use reliable, evidence-based resources to determine the stability of a CSP.
  • Package Insert: The manufacturer's official prescribing information.
  • Trissel's Handbook on Injectable Drugs: The most comprehensive and authoritative reference for IV compatibility and stability.
  • Primary Literature: Published stability studies from peer-reviewed journals.
  • A CSCP must be skilled at finding and critically appraising this information.

Incompatibilities

  • An incompatibility is an undesirable reaction that can occur between drugs, or between a drug and its container or diluent.
  • Physical Incompatibility: Often visible, such as the formation of a precipitate or a color change.
  • Chemical Incompatibility: A chemical reaction that causes degradation of the drug. This is often not visible.
  • A common example is the precipitation of calcium and ceftriaxone.
  • Another is the precipitation of phenytoin in a dextrose solution.
  • A CSCP is an expert at identifying and preventing these incompatibilities.

Ratio and Proportion

  • This is the most fundamental calculation skill in pharmacy.
  • It is used to solve for an unknown quantity when three other quantities are known.
  • For example, if you know the amount of drug in a certain volume, you can calculate the volume needed to get a specific dose.
  • A CSCP must be able to perform these calculations quickly and accurately.
  • Using dimensional analysis is a key technique for preventing errors.

Percentage Strength and Ratio Strength

  • These are ways to express the concentration of a solution.
  • Percentage Strength (% w/v): Grams of solute in 100 mL of solution.
  • Ratio Strength (e.g., 1:1000): 1 gram of solute in 1000 mL of solution.
  • A CSCP must be able to easily convert between these different expressions of concentration.

Dilution and Concentration

  • This involves calculating the amount of a stock solution needed to prepare a more dilute solution.
  • The key formula is: (Q1)(C1) = (Q2)(C2).
  • Where Q1 is the quantity of the stock solution, C1 is the concentration of the stock solution, Q2 is the final quantity, and C2 is the final concentration.
  • This is a fundamental calculation used daily in compounding.

Milliequivalents (mEq) and Millimoles (mmol)

  • These are units used to express the concentration of electrolytes.
  • A mEq is a measure of the chemical activity of an electrolyte.
  • A mmol is a measure of the number of particles of a substance.
  • A CSCP must be able to perform calculations involving electrolytes for parenteral nutrition and other IV admixtures.
  • This includes converting from mg to mEq using the molecular weight and valence of the ion.

Infusion Rate Calculations

  • A core competency is the ability to calculate the infusion rate for an IV medication.
  • This is typically calculated in mL/hour.
  • The formula is: Rate (mL/hr) = Total Volume (mL) / Total Time (hr).
  • For critical care drips, the dose is often ordered in mcg/kg/min.
  • A CSCP must be able to perform the multi-step calculation to convert this dose into a final infusion rate in mL/hr.
  • This is a high-risk calculation where errors can have serious consequences.

Defining SVPs

  • An SVP is a parenteral preparation that is 100 mL or less in volume.
  • They are typically used for intermittent infusions of medications.
  • This is the most common type of sterile product compounded in a hospital pharmacy.
  • The most common SVP is an "IV piggyback" (IVPB).
  • This involves a small bag of a drug solution that is infused through the same line as a primary, continuous infusion.

Common SVP Therapies

  • Antibiotics: The most common category of drugs prepared as SVPs.
  • Electrolytes: Potassium, magnesium, and phosphorus are often given as intermittent infusions.
  • Antiemetics.
  • H2-Receptor Antagonists.
  • A CSCP must be familiar with the standard concentrations and diluents for all of these common preparations.

Standardization

  • Standardization is a key safety strategy for SVPs.
  • The pharmacy should develop a set of standard concentrations for all commonly used infusions.
  • This reduces the risk of calculation errors and makes the process more efficient.
  • The Institute for Safe Medication Practices (ISMP) provides guidance on standard concentrations.
  • The CSCP is a leader in developing and implementing these standards.

Batch Compounding

  • Because many SVPs are standardized, they are often prepared in batches.
  • This is much more efficient than making each dose individually.
  • However, it also carries a higher risk, as an error in a batch can affect many patients.
  • Therefore, the QA procedures for batching must be extremely robust.
  • This includes the use of a Master Formulation Record and a detailed Compounding Record for each batch.
  • A CSCP is responsible for the policies and procedures governing batch compounding.

Ready-to-Use (RTU) Products

  • Many common SVPs are now available from the manufacturer as pre-mixed, ready-to-use products.
  • Using these RTU products is a major safety advantage, as it bypasses the need for manual compounding and reduces the risk of errors.
  • While they may be more expensive, the safety benefits often outweigh the cost.
  • A CSCP is an advocate for the use of commercially available RTU products whenever possible.

Defining LVPs

  • An LVP is a sterile preparation of 101 mL or greater in volume.
  • They are typically used for continuous infusions to provide hydration, electrolytes, or medications.
  • Common base solutions include 0.9% Sodium Chloride (Normal Saline), Dextrose 5% in Water (D5W), and Lactated Ringer's.
  • Compounding an LVP involves adding one or more drugs to one of these base solutions.
  • A CSCP must be an expert in the compatibility and stability of these admixtures.

Common LVP Therapies

  • Electrolyte Repletion: Potassium chloride, magnesium sulfate, and calcium gluconate are often added to LVPs.
  • Continuous Medication Infusions: Many critical care medications, such as vasopressors and antiarrhythmics, are given as continuous infusions.
  • Hydration Fluids: Dextrose and saline solutions.
  • Parenteral Nutrition: The most complex type of LVP.

Osmolarity and Tonicity

  • Tonicity: A measure of the effective osmotic pressure gradient.
  • Isotonic solutions (like Normal Saline) have the same tonicity as blood and are safe for peripheral administration.
  • Hypertonic Solutions: Have a higher tonicity than blood. If they are highly hypertonic (e.g., >900 mOsmol/L), they can damage peripheral veins and must be administered through a central line.
  • Parenteral nutrition is a highly hypertonic solution.
  • A CSCP must be able to calculate the osmolarity of a compounded LVP to determine the appropriate route of administration.

Stability Considerations

  • The stability of a drug in an LVP can be affected by many factors.
  • pH of the base solution: Some drugs are only stable in dextrose, while others are only stable in saline.
  • Container Material: Some drugs, like insulin, can adsorb to the plastic of the IV bag.
  • Light Exposure: Some drugs must be protected from light during infusion.
  • A CSCP uses resources like Trissel's Handbook to determine the stability of these admixtures.

Automated Compounding Devices (ACDs)

  • ACDs, or "compounders," are robotic devices used to prepare complex multi-ingredient LVPs, especially TPNs.
  • They use multiple channels to pump the correct volume of each ingredient into the final container.
  • The use of an ACD can improve the accuracy and efficiency of the compounding process.
  • However, they must be properly calibrated and validated.
  • The CSCP is responsible for the management and quality assurance of these devices.

Ophthalmic Compounding

  • Ophthalmic preparations (eye drops) must be sterile to prevent serious eye infections.
  • Compounded ophthalmic preparations are considered high-risk.
  • They are often prepared for conditions like severe dry eye or for fortified antibiotics for corneal ulcers.
  • A CSCP must be an expert in the specialized requirements for ophthalmic compounding.

Key Formulation Requirements for Ophthalmics

  • Sterility: This is the most critical requirement.
  • Isotonicity: The solution should be isotonic with the tears to prevent irritation. This requires calculations using sodium chloride equivalents.
  • pH: The solution should be buffered to a pH that is close to the natural pH of tears (around 7.4).
  • Particulate Matter: The solution must be free of any particulate matter. Filtration is often used.

Intrathecal Preparations

  • Intrathecal administration involves injecting the drug directly into the cerebrospinal fluid.
  • This is an extremely high-risk route of administration.
  • A compounding error can have devastating neurological consequences.
  • The most critical requirement is that all intrathecal preparations must be PRESERVATIVE-FREE.
  • Preservatives are neurotoxic and can cause paralysis and death if injected into the spinal canal.
  • A CSCP must have a robust system to ensure that only preservative-free ingredients are ever used for these preparations.

Compounding with Non-Sterile Ingredients

  • Any CSP that is compounded using a non-sterile ingredient (e.g., a bulk drug powder) is considered a high-risk preparation.
  • This is because the starting component is not sterile.
  • These preparations must undergo terminal sterilization before they can be dispensed.
  • The most common method of terminal sterilization in a pharmacy is filtration through a 0.22-micron filter.
  • The final preparation should also undergo sterility testing.

Quality Assurance for High-Risk CSPs

  • High-risk compounding requires the most stringent level of quality assurance.
  • The compounding must be done in an ISO Class 5 environment.
  • The personnel must be specially trained and demonstrate competency through more rigorous media-fill testing.
  • The final product must undergo sterility and endotoxin testing before it is dispensed.
  • A CSCP is responsible for designing and overseeing this high-level QA program.

Block 6: Complex & High-Risk Compounding

Indications for PN

  • PN is a life-saving therapy for patients who are unable to absorb nutrients through their gastrointestinal tract.
  • This is known as intestinal failure.
  • Common indications include short bowel syndrome, severe Crohn's disease, and bowel obstruction.
  • The goal is to provide all of the patient's nutritional needs intravenously.
  • A central venous catheter is required for long-term PN.

Macronutrient and Micronutrient Management

  • The CSCP is often the expert responsible for designing the PN formulation.
  • This is a complex process that involves calculating the patient's individual needs for:
  • Macronutrients: Dextrose (carbohydrates), amino acids (protein), and intravenous fat emulsion (lipids).
  • Micronutrients: Electrolytes, vitamins, and trace elements.
  • The formulation is tailored to the patient's specific clinical condition and lab results.

Compounding PN Formulations

  • PN is one of the most complex sterile products to compound.
  • It is considered a medium- or high-risk preparation under USP <797>.
  • The formulation is often a "3-in-1" or Total Nutrient Admixture (TNA), where the dextrose, amino acids, and lipids are all in one bag.
  • Automated compounding devices are used to prepare these complex admixtures.
  • The CSCP must be an expert in the use and calibration of these devices.

Calcium-Phosphate Compatibility

  • The most significant and dangerous incompatibility in PN is between calcium and phosphate.
  • If they are mixed improperly, they can form an insoluble precipitate.
  • Infusion of a precipitate can cause a fatal pulmonary embolism.
  • The risk of precipitation is dependent on the concentration of the electrolytes, the amino acid product used, the pH of the solution, and the order of mixing.
  • A CSCP must be an expert on the complex physical chemistry of calcium-phosphate compatibility and use specialized software to ensure the safety of every TNA they compound.

Clinical Monitoring

  • Patients on PN require intensive clinical monitoring.
  • This includes regular monitoring of a wide range of laboratory parameters.
  • Electrolytes, glucose, and triglycerides are checked frequently.
  • Liver function tests must be monitored, as long-term PN can cause liver damage.
  • The CSCP is a key member of the nutrition support team that is responsible for this monitoring and for making adjustments to the PN formula.

The High-Risk Nature of Chemotherapy

  • Chemotherapy agents are hazardous drugs with a narrow therapeutic index.
  • A compounding error with a chemotherapy drug can have devastating consequences for the patient.
  • The process also poses a significant occupational exposure risk to the pharmacy staff.
  • Therefore, chemotherapy compounding requires the highest level of safety and quality assurance.
  • A CSCP working in oncology is an expert in this high-risk area.

Compliance with USP <800>

  • All aspects of chemotherapy compounding are governed by USP <800>.
  • This includes the requirement for a negative pressure cleanroom and the use of a Biological Safety Cabinet (BSC).
  • Strict use of all required PPE is mandatory.
  • Closed System Drug-Transfer Devices (CSTDs) are recommended for compounding and required for administration.
  • The CSCP is responsible for ensuring full compliance with this chapter.

The Chemotherapy Order

  • Chemotherapy orders are complex and must be written on a standardized, pre-printed or electronic order set.
  • The order must include the patient's height, weight, and BSA (Body Surface Area), as many doses are based on BSA.
  • The pharmacist is responsible for independently double-checking all dose calculations.
  • This is a critical safety step to prevent catastrophic dosing errors.

The Compounding Process

  • The compounding of chemotherapy requires meticulous aseptic technique and specific manipulations to prevent exposure.
  • This includes using techniques to avoid pressurizing vials, which can cause the drug to spray out.
  • All chemotherapy waste is considered hazardous and must be disposed of in a designated container.
  • Chemotherapy workflow management systems are often used to enhance safety.

The Final Verification

  • The final verification of a chemotherapy product is one of the most high-stakes tasks a pharmacist can perform.
  • It requires an independent double check of the original order, the dose calculation, the compounded product, and the label.
  • Many institutions require two pharmacists to independently perform this final check.
  • The CSCP is responsible for designing and overseeing this critical final verification process.

The Vulnerability of the Pediatric Population

  • Pediatric patients, especially neonates, are at a very high risk for medication errors and harm from contaminated sterile products.
  • Their immune systems are immature.
  • Their ability to metabolize and clear drugs is different from adults.
  • Dosing errors that might be minor in an adult can be fatal in a neonate.
  • Therefore, pediatric sterile compounding requires an exceptional level of care and precision.

Weight-Based Dosing and Calculations

  • Almost all pediatric doses are weight-based (mg/kg).
  • This requires careful and accurate calculations for every single dose.
  • An independent double-check of all calculations is the standard of care.
  • The small volumes involved also require the use of specialized equipment, like low-volume syringes, to ensure accuracy.
  • A CSCP specializing in pediatrics is an expert in these calculations.

The Challenge of Small Volumes

  • Compounding very small volumes of potent medications is a major challenge.
  • It is difficult to measure these small volumes accurately.
  • It may be necessary to perform a serial dilution to create a more dilute concentration of a drug that can be measured more accurately.
  • This is a complex process that introduces additional opportunities for error if not performed carefully.

Excipient Toxicity

  • Many excipients (inactive ingredients) that are safe for adults can be toxic to neonates.
  • Benzyl Alcohol: Can cause a fatal "gasping syndrome" in neonates.
  • Propylene Glycol: Can cause hyperosmolality.
  • The CSCP must be an expert on toxic excipients.
  • They must ensure that all compounded preparations for neonates are free from these harmful ingredients.

Standardization and Technology

  • Standardization of concentrations for common pediatric infusions is a key safety strategy.
  • This reduces the need for complex, one-off calculations.
  • The use of technology, such as smart pumps with pediatric-specific drug libraries, is also essential.
  • The drug library can provide a hard stop for a dose that is dangerously high for a child's weight.
  • The CSCP is a leader in developing and implementing these pediatric-specific safety technologies.

The Role of Compounding in Pain Management

  • Sterile compounding is essential for providing advanced pain management therapies.
  • This includes the preparation of patient-controlled analgesia (PCA), epidurals, and continuous nerve blocks.
  • These are high-risk preparations that require the highest level of accuracy and quality.
  • A CSCP is the expert responsible for the safe preparation of these critical medications.

Patient-Controlled Analgesia (PCA)

  • PCA is a method of pain control that allows the patient to self-administer small doses of an opioid via a programmable pump.
  • The pharmacy is responsible for compounding the PCA syringes or bags.
  • This must be done with extreme accuracy, as a concentration error could be fatal.
  • Standardized concentrations and a robust independent double-check process are essential safety measures.

Epidural Analgesia

  • Epidural analgesia involves the infusion of a local anesthetic and/or an opioid into the epidural space.
  • It is commonly used for labor and post-operative pain.
  • All medications intended for epidural use must be preservative-free.
  • This is an absolute requirement, as preservatives are neurotoxic.
  • The CSCP must be vigilant in ensuring that only preservative-free ingredients are used.
  • The final product must be clearly labeled "For Epidural Use Only."

Intrathecal Analgesia

  • Intrathecal administration involves injecting the drug directly into the cerebrospinal fluid.
  • This is used for severe, refractory pain, often with an implanted pump.
  • The doses are extremely small (micrograms).
  • This is a very high-risk type of compounding that requires specialized expertise and equipment.
  • Preservative-free formulations are also required.

Safety and Quality Assurance

  • Because these are high-risk preparations, the QA program must be extremely robust.
  • Standardized concentrations should be used whenever possible.
  • An independent double-check of all calculations and ingredients is mandatory.
  • The use of IV workflow technology can provide an extra layer of safety.
  • The CSCP is responsible for designing and overseeing this high-reliability compounding process.

The Nature of Biologics

  • Biologics are complex products derived from living organisms.
  • This includes vaccines, blood products, and monoclonal antibodies.
  • They are often much more fragile and sensitive to handling than small-molecule drugs.
  • A CSCP must have a special understanding of the handling requirements for these products.

Allergen Extracts

  • Allergen extracts are used for both the diagnosis and treatment (immunotherapy) of allergies.
  • The preparation of patient-specific allergy immunotherapy vials is a form of sterile compounding.
  • It involves making a series of dilutions of concentrated allergen extracts.
  • This is a specialized area of practice that requires specific training.
  • USP <797> has specific guidelines for the compounding of allergen extracts.

Monoclonal Antibodies

  • Many monoclonal antibodies require reconstitution and dilution before administration.
  • These are large, complex protein molecules.
  • They can be damaged by excessive agitation (shaking). Vials should be gently swirled, not shaken.
  • They are often very expensive, so minimizing waste is a key concern.
  • The CSCP must ensure that staff are trained on the proper handling of these delicate and high-cost drugs.

Gene Therapies and Cell-Based Therapies

  • This is a new and rapidly evolving area of medicine.
  • These are living therapies that require extremely specialized handling.
  • They often have ultra-cold chain requirements (e.g., stored in liquid nitrogen).
  • The preparation and administration process is highly complex and protocol-driven.
  • A CSCP working at a major academic medical center may be involved in this cutting-edge area of practice.

Handling and Stability

  • The CSCP must be an expert on the specific handling requirements for each biologic they compound.
  • This includes the correct diluent, the final concentration, and the stability of the final product.
  • They must ensure that the cold chain is maintained throughout the storage and preparation process.
  • This is a critical part of ensuring that these fragile and expensive medications are delivered to the patient safely and effectively.

Block 7: Practice Management & Advanced Formulation

Cleanroom Design and Certification

  • The CSCP is often involved in the design of a new or renovated cleanroom.
  • This requires a deep understanding of the engineering controls and workflow requirements of USP <797> and <800>.
  • They work with architects and engineers to ensure the design is compliant.
  • The CSCP is responsible for the semi-annual certification of the facility.
  • This involves coordinating with an independent certifier and reviewing the final report.

Equipment Selection and Validation

  • The CSCP is responsible for the selection of all compounding equipment.
  • This includes Primary Engineering Controls (hoods), automated compounders, and other key equipment.
  • Before any new piece of equipment is used for patient care, it must be formally validated.
  • Validation is the process of documenting that the equipment is installed correctly, operates correctly, and performs correctly.
  • This is a critical part of the QA program.

Equipment Maintenance and Calibration

  • All equipment must be on a regular maintenance and calibration schedule.
  • This is essential for ensuring that the equipment continues to operate accurately and reliably.
  • The CSCP is responsible for developing this schedule and for maintaining all of the documentation.
  • This includes the daily cleaning of the PECs and the periodic calibration of automated compounders.

Environmental Monitoring Program

  • The CSCP is the leader of the environmental monitoring program.
  • This includes overseeing the performance of the viable air and surface sampling.
  • They are responsible for interpreting the results and for leading the investigation if any action levels are exceeded.
  • They are also responsible for the daily monitoring of temperatures, humidity, and pressure differentials.

Managing Downtime

  • The CSCP must have a formal contingency plan for what to do if a key piece of equipment fails.
  • What is the backup plan if the primary LAFW is out of service?
  • What is the procedure for a power outage?
  • This EOP must be documented and all staff must be trained on it.
  • This is a key part of ensuring business continuity.

State vs. Federal Regulation

  • Traditional sterile compounding (503A) is primarily regulated by the state boards of pharmacy.
  • The FDA also has authority, especially as defined by the Drug Quality and Security Act (DQSA).
  • A CSCP must be an expert on both their state's specific compounding laws and the federal framework.
  • This is a complex and overlapping regulatory environment.

The Drug Quality and Security Act (DQSA)

  • The DQSA, passed in 2013 in response to the NECC tragedy, clarified the FDA's authority over compounding.
  • It created a new category of "outsourcing facilities" (503B) that can compound sterile drugs in large quantities without a prescription.
  • It also affirmed that traditional 503A pharmacies must compound based on a patient-specific prescription.
  • A key provision is the prohibition on compounding products that are "essentially a copy" of a commercially available drug.

Compounding from Bulk Drug Substances

  • The FDA maintains a list of bulk drug substances that can be used for 503A compounding.
  • If a substance is not on this list, it generally cannot be used for compounding.
  • The bulk substance must also be manufactured by an FDA-registered facility and be accompanied by a valid Certificate of Analysis (COA).
  • A CSCP is responsible for ensuring that all bulk substances used in their pharmacy are compliant with these regulations.

Ethical Principles

  • The pharmacist's primary ethical obligation is to act in the best interests of the patient (beneficence) and to do no harm (non-maleficence).
  • This means that all compounded preparations must be made to the highest possible quality standards.
  • It also requires respecting the patient's autonomy and their right to make informed decisions.
  • The principle of veracity (truthfulness) requires the pharmacist to be honest about the evidence and risks associated with a compounded product.

Liability and Risk Management

  • Sterile compounding is a high-risk practice with significant professional liability.
  • An error can cause serious patient harm or death.
  • Thorough documentation (MFRs, Compounding Records, training records) is the best protection against liability.
  • Adherence to all USP standards is the standard of care.
  • Professional liability insurance is essential and should be reviewed to ensure it provides adequate coverage for sterile compounding.

Developing a Niche

  • A successful compounding practice often focuses on a specific clinical niche.
  • For sterile compounding, this could be pain management, hormone replacement, or ophthalmology.
  • Developing a niche allows the pharmacy to build deep expertise and market its services more effectively to a specific group of prescribers.
  • The CSCP is a key leader in identifying and developing these clinical niches.

Marketing to Prescribers

  • The primary marketing focus for a sterile compounding pharmacy is the local prescriber community.
  • This involves academic detailing, where a pharmacist visits prescribers to provide education on the pharmacy's compounding capabilities.
  • The goal is to position the pharmacy as a high-quality, reliable, and expert partner.
  • Building strong, collaborative relationships with prescribers is the key to generating referrals.

Marketing to Patients

  • Direct-to-patient marketing must be done carefully to comply with regulations.
  • Marketing cannot make specific disease claims for compounded products.
  • It should focus on the pharmacy's problem-solving capabilities and its commitment to quality and safety.
  • A professional website and patient education materials are effective strategies.

Pricing Compounded Prescriptions

  • Pricing is a complex process that must account for multiple factors.
  • This includes the cost of the ingredients and all the disposable supplies.
  • It must also account for the significant labor cost (pharmacist and technician time).
  • A professional fee should be included to cover the substantial overhead of the cleanroom and the QA program.
  • The CSCP is responsible for developing a fair and sustainable pricing model.

Insurance Billing and Audits

  • Billing insurance for compounded sterile prescriptions is a major challenge.
  • PBMs have very strict and often complex rules for compound billing.
  • Sterile compounds are a major target for PBM audits.
  • A CSCP must be an expert on the billing and audit landscape to ensure compliance and to avoid massive recoupments.

USP Chapters

  • The USP-NF itself is the primary assessment tool. A CSCP must be able to navigate and apply the standards within key chapters.
  • <797>: For sterile compounding processes.
  • <800>: For hazardous drug handling.
  • <71>: Sterility Tests.
  • <85>: Bacterial Endotoxins Test.
  • <1163>: Quality Assurance in Pharmaceutical Compounding.

Environmental Monitoring Action Level Tables

  • These tables within USP <797> are a critical rating scale.
  • They provide the specific action levels (in colony-forming units, or CFUs) for viable air and surface sampling.
  • For example, for ISO Class 7 air, the action level is >10 CFU/m3.
  • A CSCP must have these levels memorized or readily available and must use them to interpret their EM results.

ISO Classification of Particulate Matter in Air

  • This is the international standard used to classify the cleanliness of the air.
  • The classification is based on the number of particles of a certain size per cubic meter of air.
  • ISO Class 5: The cleanest air, required for the PEC.
  • ISO Class 7: Required for the buffer room.
  • ISO Class 8: Required for the ante-room.
  • A CSCP must understand this rating scale and its implications for cleanroom design.

The NIOSH List of Hazardous Drugs

  • This is the primary assessment tool for determining which drugs require handling according to USP <800>.
  • The list is updated periodically.
  • The CSCP is responsible for using this list to create their pharmacy's own, customized list of HDs.
  • This is a foundational step for USP <800> compliance.

Competency Assessment Forms

  • These are the tools used to document the training and competency of compounding personnel.
  • This includes checklists for hand hygiene and garbing.
  • It also includes the log forms for documenting the results of gloved fingertip sampling and media-fill testing.
  • A CSCP is responsible for developing and maintaining these critical assessment tools.

IV Drip Rate Calculations

  • A fundamental calculation to determine the infusion rate in mL/hour or drops/minute for gravity infusions.

\( \text{Rate (mL/hr)} = \frac{\text{Total Volume (mL)}}{\text{Total Time (hr)}} \)

Days Supply Calculation

  • A simple but critical calculation for infusions. It determines how many days a specific compounded bag or device will last for a patient.

\( \text{Days Supply} = \frac{\text{Total Volume in Bag (mL)}}{\text{Infusion Rate (mL/day)}} \)

Body Surface Area (BSA) - Mosteller Formula

  • The Mosteller formula is the most common method for calculating BSA. This is a critical calculation for chemotherapy compounding, as most chemotherapy doses are based on a patient's BSA (mg/m²).

\( \text{BSA (m}^2\text{)} = \sqrt{\frac{\text{Height (cm)} \times \text{Weight (kg)}}{3600}} \)

Isotonicity Calculations (Sodium Chloride Equivalent)

  • This calculation is essential for compounding ophthalmic and other sensitive sterile preparations. It is used to determine the amount of a substance needed to make a solution isotonic with body fluids, preventing irritation.

E-value = \( \frac{\text{MW of NaCl}}{\text{i-factor of NaCl}} \times \frac{\text{i-factor of drug}}{\text{MW of drug}} \)

Molar and Millimole Calculations

  • Essential for preparing solutions of a specific molarity and for electrolyte calculations in parenteral nutrition.

Moles = \( \frac{\text{Weight (g)}}{\text{Molecular Weight (g/mol)}} \)

Block 8: Advanced Topics & Final Review

USP Chapters

  • The USP-NF itself is the primary assessment tool. A CSCP must be able to navigate and apply the standards within key chapters.
  • <797>: For sterile compounding processes.
  • <800>: For hazardous drug handling.
  • <71>: Sterility Tests.
  • <85>: Bacterial Endotoxins Test.
  • <1163>: Quality Assurance in Pharmaceutical Compounding.

Environmental Monitoring Action Level Tables

  • These tables within USP <797> are a critical rating scale.
  • They provide the specific action levels (in colony-forming units, or CFUs) for viable air and surface sampling.
  • For example, for ISO Class 7 air, the action level is >10 CFU/m3.
  • A CSCP must have these levels memorized or readily available and must use them to interpret their EM results.

ISO Classification of Particulate Matter in Air

  • This is the international standard used to classify the cleanliness of the air.
  • The classification is based on the number of particles of a certain size per cubic meter of air.
  • ISO Class 5: The cleanest air, required for the PEC.
  • ISO Class 7: Required for the buffer room.
  • ISO Class 8: Required for the ante-room.
  • A CSCP must understand this rating scale and its implications for cleanroom design.

The NIOSH List of Hazardous Drugs

  • This is the primary assessment tool for determining which drugs require handling according to USP <800>.
  • The list is updated periodically.
  • The CSCP is responsible for using this list to create their pharmacy's own, customized list of HDs.
  • This is a foundational step for USP <800> compliance.

Competency Assessment Forms

  • These are the tools used to document the training and competency of compounding personnel.
  • This includes checklists for hand hygiene and garbing.
  • It also includes the log forms for documenting the results of gloved fingertip sampling and media-fill testing.
  • A CSCP is responsible for developing and maintaining these critical assessment tools.

The OPO Business Model

  • Organ Procurement Organizations (OPOs) are non-profit entities.
  • Their revenue is generated by charging transplant centers a fee for each organ procured.
  • This is known as the Organ Acquisition Charge (OAC).
  • The OAC is a bundled payment that covers all costs associated with the procurement process.
  • This includes staff salaries, donor hospital charges, and medication costs.
  • A CTPP must understand this business model to manage resources effectively.

Cost Management

  • The OPO must carefully manage its costs to remain financially viable.
  • The CTPP is responsible for managing the significant pharmaceutical costs associated with donor management.
  • This includes negotiating pricing with suppliers for key medications like vasoactive drips and preservation solutions.
  • It also involves developing cost-effective treatment protocols that do not compromise organ quality.
  • Minimizing drug waste is another key cost-containment strategy.

The Role of the CTPP in Financial Management

  • The CTPP is a key steward of the OPO's financial resources.
  • They are responsible for developing the annual pharmacy budget.
  • They perform variance analysis to compare actual spending to the budget.
  • They are constantly looking for opportunities to reduce costs without compromising the quality of the organs.
  • This financial acumen is a key leadership skill for a CTPP.

Vendor Relationships

  • The CTPP is responsible for managing the OPO's relationships with pharmaceutical wholesalers and manufacturers.
  • This includes negotiating pricing and ensuring a reliable supply of critical medications.
  • This is a key part of the OPO's supply chain management.
  • A strong relationship with vendors is essential, especially during drug shortages.

Strategic Planning

  • The CTPP is a member of the OPO's leadership team and is involved in the strategic planning process.
  • This includes identifying new technologies and clinical practices that could improve the OPO's performance.
  • It also involves developing the business case to justify these new investments.
  • This strategic thinking is what elevates the role beyond just clinical practice.

State vs. Federal Regulation

  • Traditional sterile compounding (503A) is primarily regulated by the state boards of pharmacy.
  • The FDA also has authority, especially as defined by the Drug Quality and Security Act (DQSA).
  • A CSCP must be an expert on both their state's specific compounding laws and the federal framework.
  • This is a complex and overlapping regulatory environment.

The Drug Quality and Security Act (DQSA)

  • The DQSA, passed in 2013 in response to the NECC tragedy, clarified the FDA's authority over compounding.
  • It created a new category of "outsourcing facilities" (503B) that can compound sterile drugs in large quantities without a prescription and must follow cGMPs.
  • It also affirmed that traditional 503A pharmacies must compound based on a patient-specific prescription.
  • A key provision is the prohibition on compounding products that are "essentially a copy" of a commercially available drug.

Compounding from Bulk Drug Substances

  • The FDA maintains a list of bulk drug substances that can be used for 503A compounding.
  • If a substance is not on this list, it generally cannot be used for compounding.
  • The bulk substance must also be manufactured by an FDA-registered facility and be accompanied by a valid Certificate of Analysis (COA).
  • A CSCP is responsible for ensuring that all bulk substances used in their pharmacy are compliant with these regulations.

Ethical Principles

  • The pharmacist's primary ethical obligation is to act in the best interests of the patient (beneficence) and to do no harm (non-maleficence).
  • This means that all compounded preparations must be made to the highest possible quality standards.
  • It also requires respecting the patient's autonomy and their right to make informed decisions.
  • The principle of veracity (truthfulness) requires the pharmacist to be honest about the evidence and risks associated with a compounded product.

Liability and Risk Management

  • Sterile compounding is a high-risk practice with significant professional liability. An error can cause serious patient harm or death.
  • Thorough documentation (MFRs, Compounding Records, training records) is the best protection against liability.
  • Adherence to all USP standards is the standard of care.
  • Professional liability insurance is essential and should be reviewed to ensure it provides adequate coverage for sterile compounding.

The Importance of a Formal Process

  • Every compounding pharmacy must have a formal, written procedure for handling patient complaints and adverse event reports.
  • This is a key part of the Quality Assurance program.
  • The goal is to investigate every report thoroughly and to use the findings to improve the process.
  • A CSCP is responsible for developing and managing this process.

Receiving the Complaint

  • The first step is to listen to the patient with empathy and respect.
  • All complaints should be taken seriously.
  • A standardized intake form should be used to document all the key information.
  • This includes the patient's name, the prescription number, and a detailed description of the problem.

The Investigation

  • Every complaint must be thoroughly investigated.
  • The first step is to review the Master Formulation Record and the Compounding Record for that specific prescription.
  • This is to verify that the product was made correctly.
  • The pharmacist may also need to speak with the staff who were involved in the compounding process.
  • A sample of the returned product may be sent for quality testing.

Root Cause Analysis (RCA)

  • If the investigation determines that an error did occur, an RCA should be performed.
  • The goal of the RCA is to identify the underlying system-level causes of the error, not to place blame on an individual.
  • This is a key part of a "just culture."
  • The findings from the RCA are used to develop a Corrective and Preventive Action (CAPA) plan.

Follow-Up and Communication

  • The pharmacy must follow up with the patient who made the complaint.
  • They should be informed of the results of the investigation.
  • If an error was made, the pharmacy should apologize and explain what steps are being taken to prevent it from happening again.
  • This transparent communication is key to rebuilding trust.
  • The event should also be reported to any relevant external bodies, such as the FDA's MedWatch program.

Patient Safety is the Absolute Priority

  • The single most important concept is that the entire practice of sterile compounding is built on a foundation of patient safety.
  • Every standard, policy, and procedure is designed to prevent patient harm from contaminated or incorrectly prepared medications.
  • A CSCP must have an unwavering commitment to a culture of safety.
  • There are no shortcuts in sterile compounding.

The Compounding Environment is a System

  • A successful sterile compounding practice relies on a system of overlapping controls.
  • This includes the facility (engineering controls), the procedures (SOPs), and the people (training and competency).
  • A failure in any one part of this system can compromise the sterility of the final product.
  • A CSCP is a systems thinker who is responsible for the integrity of this entire system.

The Designated Person is Accountable

  • USP <797> places a great deal of responsibility on the "designated person."
  • This person is ultimately accountable for the performance and compliance of the entire compounding program.
  • The CSCP is the ideal professional to serve in this leadership role.
  • This requires both deep technical expertise and strong management skills.

Aseptic Technique is a Skill and a Mindset

  • Aseptic technique is more than just a set of mechanical skills; it is a mindset.
  • It requires a constant state of awareness and a commitment to preventing contamination at every step.
  • A CSCP is a master of this technique and a role model for their team.
  • They are responsible for instilling this mindset in all compounding personnel.

A Commitment to Lifelong Learning and Continuous Improvement

  • The field of sterile compounding is constantly evolving.
  • The USP standards are regularly updated to reflect new science and best practices.
  • New technologies and new equipment are always emerging.
  • A CSCP must be a lifelong learner with a commitment to staying at the forefront of their field.
  • They must also be a leader of continuous quality improvement, always looking for ways to make their practice safer and more effective.
  • This certification represents a commitment to this high level of professional practice.
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