Sterile Compounding and Hazardous Drugs

For components that do not have expiration dates assigned by the manufacturer or supplier, the compounder shall label the container with the date of receipt and assign a conservative expiration date, not to exceed __________ after receipt, to the component based on the nature of the component and its degradation mechanism, the container in which it is packaged, and the storage conditions. A. one year B. two years C. three years D. five years

Answer: (c) three years. For components that do not have expiration dates assigned by the manufacturer or supplier, the compounder shall label the container with the date of receipt and assign a conservative expiration date, not to exceed three years after receipt, to the component based on the nature of the component and its degradation mechanism, the container in which it is packaged, and the storage conditions.

The certification process for the sterile compounding facility (hoods and rooms) must follow the guidelines created by: A. Chapter 800 B. Chapter 797 C. CETA D. ASHP E. Remik's Parenteral Guidelines

Answer: (c). The certification process of the sterile compounding facility must follow the guidelines created by Controlled Environment Testing Association (CETA) and the key elements include testing under dynamic/operating conditions (not "at rest").CETA Guidelines include all existing regulations and standards in a document designed for certification.The certification report must document airflow testing, HEPA filter integrity testing, total particle count testing, and for PECs, a dynamic airflow smoke pattern test.

Compounding morphine sulfate suppositories for topical use should be classified as: A. Simple Compounding B. Simple-Moderate Compounding C. Moderate Compounding D. Complex Compounding

Answer: (c) Moderate Compounding. Moderate Compounding: Making a preparation that requires special calculations or procedures (such as calibration of dosage unit mold cavities) to determine quantities of components per preparation or per individualized dosage units; or making a preparation for which stability data for that specific formulation are not available.Examples include morphine sulfate Suppositories, diphenhydramine hydrochloride troches, and mixing two or more manufactured cream products when the stability of the mixture is not known.

Which of the following is/are TRUE ABOUT BUD by types of formulation? I. For non-aqueous formulations, the BUD is not later than the time remaining until the earliest expiration date of any API or 6 months whichever is earlier. II. For water-containing oral formulations, the BUD is not later than 14 days when stored at controlled cold temperatures. III. For water-containing topical formulations, the BUD is not later than 60 days. A. I only B. I and II only C. II and III only D. All

Answer: (b) I and II only. BUD By Types of Formulation: 1. For non-aqueous formulations, the BUD is not later than the time remaining until the earliest expiration date of any API or 6 months whichever is earlier. 2. For water-containing oral formulations, the BUD is not later than 14 days when stored at controlled cold temperatures. 3. For water-containing topical/dermal and mucosal liquid and semisolid formulations, the BUD is not later than 30 days.

Which of the following information is/are TRUE ABOUT Depyrogenation by Dry Heat? I. Dry heat depyrogenation shall be used to render vial or glassware. II. The effectiveness of the dry heat depyrogenation cycle shall be verified using endotoxin challenge vials (ECVs). III. It should be performed by keeping glassware or vials under dry heat for 180 minutes at 125°. A. I only B. I and II only C. II and III only D. All

Answer: (b) I and II only. Dry heat depyrogenation shall be used to render glassware or containers such as vials free from pyrogens as well as viable microbes.A typical cycle would be 30 minutes at 250° (not 180 minutes at 125°) . The effectiveness of the dry heat depyrogenation cycle shall be verified using endotoxin challenge vials (ECVs).The bacterial endotoxin test should be performed on the ECVs to verify that the cycle is capable of achieving a 3-log reduction in endotoxin.

Which of the following references is/are useful for the safe handling of antineoplastic and hazardous drugs? I. OSHA Technical Manual—Section VI II. NIOSH Alert III. MSDSs A. I only B. I and II only C. II and III only D. All

Answer: (b) I and II only. Hazardous drugs shall be stored, prepared, and handled by appropriately trained personnel under conditions that protect the healthcare workers and other personnel. The following are references for the safe handling of antineoplastic and hazardous drugs in healthcare settings: 1. OSHA Technical Manual—Section VI: Chapter 2, Controlling Occupational Exposure to Hazardous Drugs. 2. NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings (DHHS (NIOSH) Publication No. 2004-165) and updates.

A component for internal or external use that is used as a carrier or diluent in which liquids, semisolids, or solids are dissolved or suspended is known as: A. Levigation B. Vehicle C. Co-surfactant D. Emulsifying agent

Answer: (b) Vehicle. A component for internal or external use that is used as a carrier or diluent in which liquids, semisolids, or solids are dissolved or suspended. Examples include, but are not limited to, water, syrups, elixirs, oleaginous liquids, solid and semisolid carriers, and proprietary products.

Which of the following is best described CSTDs? A. Every compounding pharmacy should record controlled system transfer data. B. System that allows no venting or exposure of hazardous substance to the environment. C. Managing compounding sterile tristatic drawers. D. Guidelines for Environmental Infection Control in facilities.

Answer: (b) Vial-transfer system that allows no venting or exposure of hazardous substance to the environment. CSTD is defined as the closed-system vial-transfer device - vial-transfer systems that allow no venting or exposure of hazardous substance to the environment. The use of a CSTD is preferred because of their inherent closed system process.In facilities that prepare a low volume of hazardous drugs, the use of two tiers of containment (e.g., CSTD within a BSC or CACI that is located in a non-negative pressure room) is acceptable

Which of the following shall be included on the dispensing label of every prescription prepared for food-producing species? A. ASD B. WDT C. MDK D. EMC

Answer: (b) WDT or Withdrawal Time. A compounder's responsibility for providing patients with high-quality compounded preparations extends beyond the human species. All portions of this chapter apply to compounded preparations formulated for animal patients. Intended use of any animal patient (e.g., companion, performance, food) shall be determined before compounding for that patient.Because humans can consume animal patients as food, care must be taken to prevent drug residues from entering the human food chain when compounded preparations are used in animal patients.For this reason, all compounders preparing formulations for animals shall possess a functional knowledge of drug regulation and disposition in animal patients. Veterinarians are required by law to provide food producing animal caregivers with an accurate length of time to withhold treated animal tissues (e.g., meat, milk, eggs) from the human food supply.This length of time is referred to as a withdrawal time (WDT) and must also, by law, be included on the dispensing label of every prescription prepared for a food-producing species.

Which of the following is TRUE regarding sterile gloves when compounding in a compounding aseptic isolator or compounding aseptic containment isolator? A. Sterile gloves are donned on the hands, which are placed in the gauntlet sleeves and gloves. B. Sterile gloves are donned inside the compounding isolator chamber, and placed over the glove sleeves. C. Sterile gloves are not required when working in a compounding isolator. D. The sterile gloves on the gauntlet sleeves must be changed when the gauntlet sleeves are changed. E. Sterile gloves are donned inside the BSC, and placed over the glove sleeves.

Answer: (b). In compounding aseptic isolator/compounding aseptic containment isolator devices, sterile gloves must be donned over the gauntlet gloves. The gloves that touch a sterile preparation during compounding must be sterile gloves.

Which of the following primary engineering controls are designed for compounding nonhazardous sterile preparations? A. Containment-ventilated enclosure and laminar air flow workbench. B. Laminar air flow workbench and compounding aseptic isolator. C. Containment aseptic containment isolator and biological safety cabinet. D. Containment-ventilated enclosure and biological safety cabinet. E. Containment-ventilated enclosure and laminar air flow workbench.

Answer: (b). 1. Containment-ventilated enclosures are used only for nonsterile preparations. 2. Laminar air flow workbenches and compounding aseptic isolators are designed for compounding nonhazardous drugs. 3. Biological safety cabinets and compounding aseptic containment Isolators are designed for compounding hazardous drugs.

Which of the following tests assesses an individual's competency in garbing and hand hygiene? [Select ALL THAT APPLY] A. Media fill test B. Gloved fingertip test C. Thumb sampling test D. Van-d-ussan test E. Mac fill test

Answer: (b,c). The gloved fingertip/thumb sampling has two purposes. Initially, it must be passed before personnel are allowed to compound independently. Direct touch contamination is the most likely source of introducing microorganisms into CSPs. This test assesses an individual's competency in garbing and hand hygiene.The initial gloved fingertip test is performed immediately after the compounding employee completes the hand hygiene and garbing procedures. The evaluator will conduct this test to determine if any colony forming units (CFUs) are on the operator's gloved fingertips.This test must be performed on three separate occasions with absolutely no CFU growth within the required incubation period. Compounding personnel must requalify every 6 months.For the retesting, the gloved fingertip test is performed following the media fill inside the PEC. Ideally, there will be no CFU growth for the fingertip sample retest; it is failed if more than 3 CFUs are found.A skilled compounder must also observe proper garbing and hand hygiene of personnel every 6 months.These simulation tests are critical in determining that personnel are garbed to compound aseptically.

An ISO class 5 is equivalent to U.S. FS 209E A. Class 1 B. Class 10 C. Class 100 D. Class 1000

Answer: (c) An ISO class 5 is equivalent to U.S. FS 209E Class 100

Sterile filters used to sterilize CSPs shall have a nominal pore size of: A. 0.2 or 0.22 micrometer B. 0.2 or 0.22 nanometer C. 0.02 or 0.10 micrometer D. 0.5 or 0.10 micrometer

Answer: (a) 0.2 or 0.22 micrometer. Commercially available sterile filters shall be approved for human-use applications in sterilizing pharmaceutical fluids. Sterile filters used to sterilize CSPs shall be pyrogen free and have a nominal pore size of 0.2 or 0.22 μm. They shall be certified by the manufacturer to retain at least 10^7 microorganisms of a strain of Brevundimonas (Pseudomonas) diminuta on each square centimeter of upstream filter surface area under conditions similar to those in which the CSPs will be sterilized

Which of the following information is/are TRUE about immediate use CSPs? I. The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP. II. Preparations that are medium-risk level and high-risk level CSPs may be prepared as immediate-use CSPs. III. Immediate-use CSPs can be stored in advance for anticipated needs. A. I only B. I and II only C. II and III only D. All

Answer: (a) I is true. The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP. Such situations may include cardiopulmonary resuscitation, emergency room treatment, preparation of diagnostic agents, or critical therapy where the preparation of the CSP under conditions described for Low-Risk Level CSPs subjects the patient to additional risk due to delays in therapy.Immediate-use CSPs are not intended for storage for anticipated needs or batch compounding. Preparations that are medium-risk level and high-risk level CSPs shall not be prepared as immediate-use CSPs.Immediate-use CSPs are exempt from the requirements described for Low-Risk Level CSPs only when all of the following criteria are met: 1. The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products or diagnostic radiopharmaceutical products from the manufacturers' original containers and not more than two entries into any one container or package (e.g., bag, vial) of sterile infusion solution or administration container/device. For example, anti-neoplastic shall not be prepared as immediate-use CSPs because they are hazardous drugs. 2. Unless required for the preparation, the compounding procedure is a continuous process not to exceed 1 hour. 3. During preparation, aseptic technique is followed and, if not immediately administered, the finished CSP is under continuous supervision to minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or biological fluids, mix-ups with other CSPs, and direct contact of outside surfaces. 4. Administration begins not later than 1 hour following the start of the preparation of the CSP. 5. Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the CSP shall bear a label listing patient identification information the names and amounts of all ingredients, the name or initials of the person who prepared the CSP, and the exact 1-hour BUD and time. 6. If administration has not begun within 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly, and safely discarded.

For a sterilized high-risk level preparation, in the absence of passing a sterility test, the storage periods of CSPs cannot exceed: I. more than 24 hours at controlled room temperature. II. not more than 7 days at a cold temperature. III. not more than 60 days in solid frozen state between −25° and −10°. A. I only B. I and II only C. II and III only D. All

Answer: (a) I only. For a sterilized high-risk level preparation, in the absence of passing a sterility test, the storage periods cannot exceed the following time periods:Before administration, the CSPs are properly stored and are exposed for not more than: 1. 24 hours at controlled room temperature. 2. 3 days at a cold temperature. 3. 45 days in solid frozen state between −25° and −10°.

The Critical Area requires which of the following ISO class environment? A. ISO 5 B. ISO 6 C. ISO 7 D. ISO 8

Answer: (a) ISO 5 class. The Critical Area requires ISO 5 (Class 100) environment.

How often shall ISO-Class 5 compounding area shall be cleaned and disinfected? a. No longer than 30 minutes following the previous surface disinfection when ongoing compounding activities are occurring. b. No longer than 10 minutes following the previous surface disinfection when ongoing compounding activities are occurring. c. No longer than 60 minutes following the previous surface disinfection when ongoing compounding activities are occurring. d. No longer than 15 minutes following the previous surface disinfection when ongoing compounding activities are occurring. A. a only B. b only C. c only D. d only

Answer: (a) No longer than 30 minutes following the previous surface disinfection when ongoing compounding activities are occurring. ISO-Class 5 Primary Engineering Control Area (e.g. LAFW, BSC, CAI, CACI) shall be cleaned and disinfected at the beginning of each shift, before each batch, not longer than 30 minutes following the previous surface disinfection when ongoing compounding activities are occurring, after spills, and when surface contamination is known or suspected.The counters and easily cleanable work surfaces and floors shall be cleaned and disinfected daily. The walls, ceilings and storage shelving of ISO Class 5 area shall be cleaned and disinfected monthly.

Reconstituted Amoxicillin Suspension with sterile water should be classified as: A. Simple Compounding B. Simple-Moderate Compounding C. Moderate Compounding D. Complex Compounding

Answer: (a) Simple Compounding. Simple Compounding: Making a preparation that has a United States Pharmacopeia (USP) compounding monograph or that appears in a peer-reviewed journal article that contains specific quantities of all components, compounding procedure and equipment, and stability data for that formulation with appropriate BUDs; OR reconstituting or manipulating commercial products that may require the addition of one or more ingredients as directed by the manufacturer. Examples include Captopril Oral Solution, Indomethacin Topical Gel, and Potassium Bromide Oral Solution.

Potable water for compounding shall meet the standards prescribed in the Environmental Protection Agency's National Primary Drinking Water Regulations. A. True B. False

Answer: (a) True. Potable water shall be supplied for hand and equipment washing. This water meets the standards prescribed in the Environmental Protection Agency's National Primary Drinking Water Regulations.Purified Water shall be used for compounding nonsterile drug preparations when formulations indicate the inclusion of water. Purified Water should be used for rinsing equipment and utensils. In those cases when a water is used to prepare a sterile preparation, follow the appropriate monographs and general included in Water for Pharmaceutical Purposes.

Water-containing compounded sterile preparations (CSPs) that are nonsterile during any phase of the compounding procedure MUST be sterilized within 6 hours after completing the preparation in order to minimize the generation of bacterial endotoxins. A. True B. False

Answer: (a) True. Water-containing compounded sterile preparations (CSPs) that are nonsterile during any phase of the compounding procedure MUST be sterilized within 6 hours after completing the preparation in order to minimize the generation of bacterial endotoxins.

In the Negative Pressure Room, the net flow of air is: A. into the room B. out of the room C. unchanged D. None of the above

Answer: (a) into the room. In the Negative Pressure Room, the room is at a lower pressure than the adjacent spaces and, therefore, the net flow of air is into the room. In the Positive Pressure Room, the room is at a higher pressure than the adjacent spaces and, therefore, the net airflow is out of the room.

For compounding areas, chapter 797 requires daily cleaning and disinfecting of each: [Select ALL THAT APPLY]. A. PEC B. all floors C. all counters D. work surfaces in the buffer rooms E. refrigerator handles

Answer: (a,b,c,d,e). For compounding areas, chapter 797 requires daily cleaning and disinfecting of each PEC, all floors, counters, and easily cleanable work surfaces in the buffer rooms and anterooms and any SCA/C-SCA; this includes high-touch areas such as telephones, pass-throughs, and refrigerator handles.For nonhazardous areas, the compounding suite or SCA must be cleaned with a detergent.For the hazardous compounding area, chapter 797 and chapter 800 require deactivation and decontamination with an oxidizer intended for use with HDs before cleaning. The area must then be cleaned with a detergent.Only compounding personnel can clean PECs, but others who are appropriately trained and have documented competency can clean the floors.Appropriate cleaning and disinfecting solutions and dilutions must be used. Ready-to-use solutions are preferred, since they eliminate the need to mix different concentrations. After cleaning with a detergent, sterile 70% isopropyl alcohol must be applied to the work surface inside the PEC. Sterile alcohol is used since it has been filtered and irradiated to remove spores.Clean and disinfect all other surfaces (including walls, storage shelving, and ceilings) in the cleanroom suite and SCA/C-SCA at least monthly.At least monthly, also use a sporicidal agent

Which of the following statements is TRUE? [Select ALL THAT APPLY]. A. Section 503A relates to traditional compounding pharmacies B. Section 503B relates to compounding pharmacies in hospice care. C. Section 503C relates to outsourcing facilities. D. Section 503D relates to compounding and nuclear pharmacies. E. Section 503B relates to outsourcing facilities.

Answer: (a,e). The Compounding Quality Act of DQSA established two sections that established clearly differentiated types of compounding facilities: Section 503A describes "Traditional Compounders" (such as pharmacies) and Section 503B established "Outsourcing Facilities."

To terminally sterilize aqueous preparations that are NOT thermolabile shall be sterilized using: A. Filtration B. Autoclaving C. Dry Heat D. Addition of Antimicrobial agent

Answer: (b) Autoclaving. The process of thermal sterilization employing saturated steam under pressure, or autoclaving, is the preferred method to terminally sterilize aqueous preparations that have been verified to maintain their full chemical and physical stability under the conditions employed.To achieve sterility, all materials are to be exposed to steam at 121° under pressure of about 1 atmosphere or 15 psi for the duration verified by testing to achieve sterility of theitems, which is usually 20 to 60 minutes for CSPs. An allowance shall be made for the time required for the material to reach 121° before the sterilization exposure duration is timed.

The date after which a compounded preparation should not be used is defined as: A. API B. BUD C. Added Substance D. Compounding

Answer: (b) Beyond Use Date or BUD. The date after which a compounded preparation should not be used is defined as Beyond Use Date or BUD.

In which of the following areas is the primary engineering control (PEC) physically located? A. Ante Area B. Buffer Area C. Critical Area D. Clean Room area

Answer: (b) Buffer Area.Buffer Area: An area where the primary engineering control (PEC) is physically located. Activities that occur in this area include the preparation and staging of components and supplies used when compounding CSPs.

The master formulation record shall include: I. official or assigned name, strength, and dosage form of the preparation. II. description of all ingredients and their quantities. III. compatibility and stability information, including references when available. A. I only B. I and II only C. All D. None of the above

Answer: (c) All. The master formulation record shall include: 1. official or assigned name, strength, and dosage form of the preparation. 2. calculations needed to determine and verify quantities of components and doses of active pharmaceutical ingredients. 3. description of all ingredients and their quantities. 4. compatibility and stability information, including references when available. 5. equipment needed to prepare the preparation, when appropriate. 6. mixing instructions that should include:a. order of mixingb. mixing temperatures or other environmental controls.c. duration of mixingd. other factors pertinent to the replication of the preparation as compounded. 7. sample labeling information, which shall contain, in addition to legally required information: a. generic name and quantity or concentration of each active ingredient. b. assigned BUDc. storage conditionsd. prescription or control number, whichever is applicable 8. container used in dispensing 9. packaging and storage requirements 10. description of final preparation 11. quality control procedures and expected results.

An ISO Class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high-particulate generating activities are performed is defined as: A. Buffer area B. Clean room C. Ante area D. Critical area

Answer: (c) Ante area. An ISO Class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high-particulate generating activities are performed is defined as Ante Area. It is also a transition area that: (1). provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas and (2). reduces the need for the heating, ventilating, and air conditioning (HVAC) control system to respond to large disturbances.

Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs shall be used within 6 hours if opened in worse than ISO Class 5 air quality. A. True B. False

Answer: (b) False. 1. Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5 air quality and any remaining contents must be discarded. 2. Single dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture. 3. Opened single-dose ampules shall not be stored for any time period. 4. Multiple-dose containers (e.g., vials) are formulated for removal of portions on multiple occasions because they usually contain antimicrobial preservatives. 5. The BUD after initially entering or opening (e.g., needle-punctured) multiple-dose containers is 28 days unless otherwise specified by the manufacturer.

Air sampling of compounding area shall be performed at least every: A. Month B. 3-Month C. 6-Month D. 12-Month

Answer: (c) Every six months. Evaluation of airborne microorganisms using volumetric collection methods in the controlled air environments (LAFWs, CAIs, clean room or buffer areas, and ante-areas) shall be performed by properly trained individuals for all compounding risk levels.For low-, medium-, and high-risk level compounding, air sampling shall be performed at locations that are prone to contamination during compounding activities and during other activities such as staging, labeling, gowning, and cleaning.Air sampling shall be performed at least semiannually (i.e., every 6 months) as part of the re-certification of facilities and equipment. If compounding occurs in multiple locations within an institution (e.g., main pharmacy, satellites), environmental sampling is required for each individual compounding area.A sufficient volume of air shall be sampled and the manufacturer's guidelines for use of the electronic air sampling equipment followed.

When assigning a BUD to a compounded product, compounders should consider: I. the nature of the drug and its degradation mechanism. II. the dosage form and its components. III. the container in which it is packaged. A. I only B. I and II only C. II and III only D. All

Answer: (d) All. BUDs should be assigned conservatively. When assigning a BUD, compounders shall consult and apply drug-specific and general stability documentation and literature when available and should consider: a. the nature of the drug and its degradation mechanism b. the dosage form and its components c. the potential for microbial proliferation in the preparation d. the container in which it is packaged e. the expected storage conditions f. the intended duration of therapy

Criteria used to determine categories of nonsterile compounding may include: I. stability information and warnings. II. level of risk to the compounder. III. complexity of calculations. A. I only B. I and II only C. II and III only D. All

Answer: (d) All. Criteria used to determine categories of nonsterile compounding may include: 1. degree of difficulty or complexity of the compounding process. 2. stability information and warnings 3. packaging and storage requirements 4. dosage forms 5. complexity of calculations 6. local versus systemic biological disposition 7. level of risk to the compounder 8. potential for risk of harm to the patient

Which of the following is/are recommended source(s) of ingredients for compounding? I. United States Pharmacopeia (USP) approved. II. National Formulary (NF) approved. III. Food Chemicals Codex (FCC) approved. A. I only B. I and II only C. II and III only D. All

Answer: (d) All. A United States Pharmacopeia (USP), National Formulary (NF), or Food Chemicals Codex (FCC) substance is the recommended source of ingredients for compounding all preparations.

The training to compound hazardous drugs shall include: I. safe aseptic manipulation practices. II. negative pressure techniques when utilizing a BSC or CACI. III. correct use of CSTD devices. A. I only B. I and II only C. II and III only D. All

Answer: (d) All. All personnel who compound hazardous drugs shall be fully trained in the storage, handling, and disposal of these drugs. This training shall occur prior to preparing or handling hazardous CSPs, and its effectiveness shall be verified by testing specific hazardous drugs preparation techniques.Such verification shall be documented for each person at least annually. This training shall include didactic overview of hazardous drugs, including mutagenic, teratogenic, and carcinogenic properties, and it shall include ongoing training for each new hazardous drug that enters the marketplace.Compounding personnel of reproductive capability shall confirm in writing that they understand the risks of handling hazardous drugs.The training shall include at least the following:(1). safe aseptic manipulation practices; (2). negative pressure techniques when utilizing a BSC or CACI; (3). correct use of CSTD devices; (4). containment, cleanup, and disposal procedures for breakages and spills; and (5). treatment of personnel contact and inhalation exposure.

Which of the following is/are criteria to define a new drug as hazardous drug? a. The new drug is carcinogenic. b. The new drug is teratogenic. c. The new drug is genotoxic. d. The new drug causes organ toxicity at low doses. A. a, b and d B. c and d C. a and c D. All

Answer: (d) All. Any drug identified by at least one of the following six criteria is defined as hazardous drug. 1. Carcinogenicity 2. Teratogenicity or developmental toxicity 3. Reproductive toxicity in humans INTRODUCTION 4. Organ toxicity at low doses in humans or animals 5. Genotoxicity 6. New drugs that mimic existing hazardous drugs in structure or toxicity [for examples see current National Institute for Occupational Safety and Health (NIOSH) publications].

Which of the following information is/are TRUE ABOUT Biological Safety Cabinet (BSC)? I. It has an open front with inward airflow for personnel protection. II. It has a downward high-efficiency particulate air (HEPA)-filtered laminar airflow for product protection. III. It has a HEPA filtered exhausted air for environmental protection. A. I only B. I and II only C. II and III only D. All

Answer: (d) All. Biological Safety Cabinet (BSC) is a ventilated cabinet for CSPs, personnel, product, and environmental protection. It has an open front with inward airflow for personnel protection, downward high-efficiency particulate air (HEPA)-filtered laminar airflow for product protection and HEPA filtered exhausted air for environmental protection.

For a low-risk level preparation, in the absence of passing a sterility test the storage periods cannot exceed more than: I. 48 hours at controlled room temperature II. 14 days at a cold temperature III. 45 days in solid frozen state between −25° and −10° A. I only B. I and II only C. II and III only D. All

Answer: (d) All. CSPs compounded under all the following conditions are at a low risk of contamination. 1. The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 or better air quality using only sterile ingredients, products, components, and devices. 2. The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or package (e.g., bag, vial) of sterile product or administration container/device to prepare the CSP. 3. Manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing. 4. For a low-risk level preparation, in the absence of passing a sterility test, the storage periods cannot exceed the following time periods: before administration, the CSPs are properly stored and are exposed for not more than 48 hours at controlled room temperature, for not more than 14 days at a cold temperature, and for 45 days in solid frozen state between −25° and −10°.

Which of the following information is/are TRUE ABOUT compounding a drug preparation? I. A Master Formulation Record should be created before compounding a preparation for the first time. II. The dose, safety, and intended use of the preparation or device has been evaluated for suitability in terms of dosage form. III. Only one preparation is compounded at one time in a specific workspace. A. I only B. I and II only C. II and III only D. All

Answer: (d) All. Criteria When Compounding Drug Preparation: 1. The dose, safety, and intended use of the preparation or device has been evaluated for suitability in terms of: a. the chemical and physical properties of the components. b. dosage form c. therapeutic appropriateness and route of administration, including local and systemic biological disposition.d. legal limitations, if any. 2. A Master Formulation Record should be created before compounding a preparation for the first time. This record shall be followed each time that preparation is made. In addition, a Compounding Record should be completed each time a preparation is compounded. 3. Ingredients used in the formulation have their expected identity, quality, and purity. If the formulation is for humans, ingredients are not on a list of federally recognized drugs or specific drug products that have been withdrawn or removed from the market for safety or efficacy reasons.If the formulation is for food-producing animals, ingredients are not on a list of components prohibited for use in food-producing animals. Certificates of Analysis, when applicable, and MSDSs have been consulted for all ingredients used. 4. Compounding is done in an appropriately clean and sanitized area dedicated to this activity. 5. Only one preparation is compounded at one time in a specific workspace. 6. Appropriate compounding equipment has been selected and inspected for cleanliness and correct functioning and is properly used. 7. A reliable BUD is established to ensure that the finished preparation has its accepted potency, purity, quality, and characteristics, at least until the labeled BUD. 8. Personnel engaged in compounding maintain good hand hygiene and wear clean clothing appropriate to the type of compounding performed (e.g., hair bonnets, coats, gowns, gloves, facemasks, shoes, aprons, or other items) as needed for protection of personnel from chemical exposures and for prevention of drug contamination. 9. The preparation is made in accordance with the USP 795, other official standards referenced in the USP 795, and relevant scientific data and information. 10. Critical processes (including but not limited to weighing, measuring, and mixing) are verified by the compounder to ensure that procedures, when used, will consistently result in the expected qualities in the finished preparation. 11. The final preparation is assessed using factors such as weight, adequacy of mixing, clarity, odor, color, consistency, pH, and analytical testing as appropriate; and this information is recorded on the Compounding Record. 12. The preparation is packaged as recommended in the Packaging and Drug Preparation Containers section of the USP 795. 13. The preparation container is labeled according to all applicable state and federal laws. The labeling shall include the BUD and storage and handling information. The labeling should indicate that "this is a compounded preparation." 14. The Master Formulation Record and the Compounding Record have been reviewed by the compounder to ensure that errors have not occurred in the compounding process and that the preparation is suitable for use. 15. The preparation is delivered to the patient or caregiver with the appropriate consultation.

Dry heat sterilization shall be used for: I. Moisture sensitive material II. Materials impermeable to steam sterilization III. Oily materials A. I only B. I and II only C. II and III only D. All

Answer: (d) All. Dry heat sterilization is usually done as a batch process in an oven designed for sterilization. Heated filtered air shall be evenly distributed throughout the chamber by a blower device.The oven should be equipped with a system for controlling temperature and exposure period. Sterilization by dry heat requires higher temperatures and longer exposure times than does sterilization by steam.Dry heat shall be used only for those materials that cannot be sterilized by steam, when either the moisture would damage the material or the material is impermeable. During sterilization, sufficient space shall be left between materials to allow for good circulation of the hot air.Dry or Moist Heat Sterilization is useful for:a. glasswareb. most metal instrumentsOnly Moist Heat Sterilization is useful for:a. culture mediab. flammable and heat-sensitive itemsc. liquidsd. dense loadsOnly Dry Heat Sterilization is useful for: a. anhydrous fats b. oils c. powders d. metal instruments at risk for corrosion

Which of the following information is/are TRUE ABOUT storing hazardous drugs? I. They shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure. II. They should be stored in the area with the negative pressure. III. They should be stored in area with sufficient general exhaust ventilation with at least 12 air changes per hour (ACPH). A. I only B. I and II only C. II and III only D. All

Answer: (d) All. Hazardous drugs shall be prepared for administration only under conditions that protect the healthcare workers and other personnel in the preparation and storage areas.Hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure.Many hazardous drugs have sufficient vapor pressures that allow volatilization at room temperature; thus storage is preferably within a containment area such as a negative pressure room.The storage area should have sufficient general exhaust ventilation, at least 12 air changes per hour (ACPH) to dilute and remove any airborne contaminants.

Compounding includes which of the following? A. Preparation of drug dosage forms for both human and animal patients B. Reconstitution or manipulation of commercial products ingredients C. Preparation of drugs and devices for prescriber's office use where permitted by federal and state law. D. Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic), teaching, or chemical analysis. A. a, b and d B. c and d C. a and c D. All

Answer: (d) All. The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following: 1. Preparation of drug dosage forms for both human and animal patients. 2. Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. 3. Reconstitution or manipulation of commercial products ingredients. 4. Preparation of drugs and devices for prescriber's office use where permitted by federal and state law. 5. Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic), teaching, or chemical analysis.

The existence of which of the following conditions may increase the medium risk contamination of CSPs? I. Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP that will be administered either to multiple patients or to one patient on multiple occasions. II. The compounding process includes complex aseptic manipulations other than the single volume transfer. III. The compounding process requires unusually long duration, such as that required to complete dissolution or homogeneous mixing. A. I only B. I and II only C. II and III only D. All

Answer: (d) All. When CSPs are compounded aseptically under Low-Risk Conditions and one or more of the following conditions exists, such CSPs are at a medium risk of contamination. 1. Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP that will be administered either to multiple patients or to one patient on multiple occasions. 2. The compounding process includes complex aseptic manipulations other than the single volume transfer. 3. The compounding process requires unusually long duration, such as that required to complete dissolution or homogeneous mixing. 4. For a medium-risk preparation, in the absence of passing a sterility test, the storage periods cannot exceed the following time periods: before administration, the CSPs are properly stored and are exposed for not more than 30 hours at controlled room temperature, for not more than 9 days at a cold temperature, and for 45 days in solid frozen state between −25° and −10°.

CSPs compounded under which of the following conditions are at a high risk to become contaminated? I. Compounding personnel are improperly garbed and gloved. II. Nonsterile water-containing preparations are stored for more than 6 hours before being sterilized. III. Sterile contents of commercially manufactured products are exposed to air quality worse than ISO Class 5 for more than 1 hour. A. I only B. I and II only C. II and III only D. All

Answer: (d) All. CSPs compounded under any of the following conditions are either contaminated or at a high risk to become contaminated. 1. Nonsterile ingredients, including manufactured products not intended for sterile routes of administration (e.g., oral), are incorporated or a nonsterile device is employed before terminal sterilization. 2. Any of the following are exposed to air quality worse than ISO Class 5 for more than 1 hour.a. sterile contents of commercially manufactured products,b. CSPs that lack effective antimicrobial preservatives, andc. sterile surfaces of devices and containers for the preparation, transfer, sterilization and packaging of CSPs. 3. Compounding personnel are improperly garbed and gloved. 4. Nonsterile water-containing preparations are stored for more than 6 hours before being sterilized. 5. It is assumed, and not verified by examination of labeling and documentation from suppliers or by direct determination, that the chemical purity and content strength of ingredients meet their original or compendia specifications in unopened or in opened packages of bulk ingredients.

Which of the following is/are examples of Medium Risk Compounding? I. Compounding of total parenteral nutrition fluids using manual or automated devices. II. Filling of reservoirs of injection and infusion devices with more than three sterile drug products and evacuation of air from those reservoirs before the filled device is dispensed. III. Transfer of volumes from multiple ampules or vials into one or more final sterile containers .A. I only B. I and II only C. II and III only D. All

Answer: (d) All. Examples of Medium Risk Compounding: 1. Compounding of total parenteral nutrition fluids using manual or automated devices during which there are multiple injections, detachments, and attachments of nutrient source products to the device or machine to deliver all nutritional components to a final sterile container. 2. Filling of reservoirs of injection and infusion devices with more than three sterile drug products and evacuation of air from those reservoirs before the filled device is dispensed. 3. Transfer of volumes from multiple ampules or vials into one or more final sterile containers.

Which of the following is/are TRUE ABOUT preparing allergen extracts as compounded sterile preparations? I. All allergen extracts as CSPs shall contain appropriate substances in effective concentrations to prevent the growth of microorganisms. II. Before beginning compounding activities, personnel perform a thorough hand-cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by vigorous hand and arm washing to the elbows for at least 30 seconds with either non-antimicrobial or antimicrobial soap and water. III. Compounding personnel don hair covers, facial hair covers, gowns, and face masks. A. I only B. I and II only C. II and III only D. All

Answer: (d) All. Allergen extracts as CSPs are single-dose and multiple-dose intradermal or subcutaneous injections that are prepared by specially trained physicians and personnel under their direct supervision. Allergen extracts as CSPs are not subject to the personnel, environmental, and storage requirements for all CSP Microbial Contamination Risk Levels only when all of the following criteria are met: 1. The compounding process involves simple transfer via sterile needles and syringes of commercial sterile allergen products and appropriate sterile added substances (e.g., glycerin, phenol in sodium chloride injection). 2. All allergen extracts as CSPs shall contain appropriate substances in effective concentrations to prevent the growth of microorganisms. Non-preserved allergen extracts shall comply with the appropriate CSP risk level requirements under the USP chapter 797. 3. Before beginning compounding activities, personnel perform a thorough hand-cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by vigorous hand and arm washing to the elbows for at least 30 seconds with either non-antimicrobial or antimicrobial soap and water. 4. Compounding personnel don hair covers, facial hair covers, gowns, and face masks. 5. Compounding personnel perform antiseptic hand cleansing with an alcohol-based surgical hand scrub with persistent activity. 6. Compounding personnel don powder-free sterile gloves that are compatible with sterile 70% isopropyl alcohol (IPA) before beginning compounding manipulations. 7. Compounding personnel disinfect their gloves intermittently with sterile 70% IPA when preparing multiple allergen extracts as CSPs. 8. Ampule necks and vial stoppers on packages of manufactured sterile ingredients are disinfected by careful wiping with sterile 70% IPA swabs to ensure that the critical sites are wet for at least 10 seconds and allowed to dry before they are used to compound allergen extracts as CSPs. 9. The aseptic compounding manipulations minimize direct contact contamination (e.g., from glove fingertips, blood, nasal and oral secretions, shed skin and cosmetics, other nonsterile materials) of critical sites (e.g., needles, opened ampules, vial stoppers). 10. The label of each multiple-dose vial (MDV) of allergen extracts as CSPs lists the name of one specific patient and a BUD and storage temperature range that is assigned based on manufacturers' recommendations or peer-reviewed publications. 11. Single-dose allergen extracts as CSPs shall not be stored for subsequent additional use

Which of the following is/are TRUE ABOUT personnel cleansing and garbing in the compounding area? I. The wearing of artificial nails or extenders is prohibited while working in the sterile compounding environment. II. Before entering to compounding area, the compounding personnel shall remove all cosmetics from the face. III. Before entering to compounding area, the compounding personnel shall remove all hand, wrist, and other visible jewelry or piercings from the body. ` A. I only B. I and II only C. II and III only D. All

Answer: (d) All. The careful cleansing of hands and arms and the correct donning of PPE by compounding personnel constitute the first major step in preventing microbial contamination in CSPs. Squamous cells are normally shed from the human body at a rate of 10^6 or more per hour, and those skin particles are laden with microorganisms. When individuals are experiencing rashes, sun burn, weeping sores, conjunctivitis, active respiratory infection, as well as when they wear cosmetics, they shed these particles at even higher rates.Particles shed from compounding personnel pose an increased risk of microbial contamination of critical sites of CSPs.Before entering the buffer area or segregated compounding area, compounding personnel shall remove personal outer garments (e.g., bandannas, coats, hats, jackets, scarves, sweaters, vests); all cosmetics, because they shed flakes and particles; and all hand, wrist, and other visible jewelry or piercings (e.g., earrings, lip or eyebrow piercings) that can interfere with the effectiveness of PPE (e.g., fit of gloves and cuffs of sleeves).The wearing of artificial nails or extenders is prohibited while working in the sterile compounding environment. Natural nails shall be kept neat and trimmed.

Modified-release preparations should be classified as: A. Simple Compounding B. Simple-Moderate Compounding C. Moderate Compounding D. Complex Compounding

Answer: (d) Complex Compounding. Complex Compounding: Making a preparation that requires special training, environment, facilities, equipment, and procedures to ensure appropriate therapeutic outcomes. Examples of possible complex preparation types include transdermal dosage forms, modified-release preparations, and some inserts and suppositories for systemic effects.

The air exiting the HEPA filter in a unidirectional air stream that is essentially particle free is commonly known as: A. Purified Air B. Critical Air C. Microbes Free Air D. First Air

Answer: (d) First Air. The air exiting the HEPA filter in a unidirectional air stream that is essentially particle free is commonly known as First Air.A critical area within the ISO Class 5 primary engineering control (PEC) where critical sites are exposed to First Air is commonly defined as Direct Compounding Area (DCA).

What is the reason to avoid using ingredient certified by analytical reagents grade or American Chemical Society? a. Ingredients obtained from these sources are very expensive. b. Ingredients obtained from these sources are of poor quality. c. Ingredients obtained from these sources are hard to compound. d. Ingredients obtained from these sources do not consider whether any impurity present raises human or animal safety concerns. A. a and b B. a, b and d C. a only D. d only

Answer: (d) Ingredients obtained from these sources do not consider whether any impurity present raises human or animal safety concerns. When components of compendium quality are not obtainable, components of high quality such as those that are chemically pure, analytical reagent grade, or American Chemical Society-certified may be used. However, these components should be used cautiously because the standards for analytical reagents or American Chemical Society-grade materials do not consider whether any impurity present raises human or animal safety concerns.

Certification of the sterile compounding facility (hoods and rooms) by an independent certifier is required ________________. A. Every month B. Every two weeks C. Every three months D. Every six months E. yearly

Answer: (d). Certification of the sterile compounding facility (hoods and rooms) by an independent certifier is required every 6 months.

Which two solutions must be used at least daily to clean a primary engineering control (PEC) used for nonhazardous sterile preparations? A. Sterile alcohol and sterile water. B. Sporicidal and detergent. C. Sterile water and sterile alcohol. D. Detergent and sterile alcohol. E. Sporicidal and sterile alcohol.

Answer: (d). Each day, the primary engineering control must be cleaned with a detergent. Sterile alcohol is used after the detergent and throughout the compounding day.

How often shall viable air testing be performed? A. Every month. B. Every two weeks. C. Every three months. D. Every six months. E. yearly.

Answer: (d). Many industries such as biotechnology, medical device manufacturing, pharmaceutical, medical disposables, and hospital pharmacies carry out air sampling in their rooms and production areas. Air sampling refers to collecting a volume of air to inspect it for undesirable particles and contaminants.Viable testing includes sampling of surfaces and other areas that might be contaminated through touching in the primary and secondary engineering control areas, as well as electronic air sampling.Viable air testing must be performed at least every 6 months using an impaction device that captures a measured volume of air within the ISO classified areas. The device includes an agar plate.If microbial contamination is present, it will be captured on the plate, which is then incubated by a laboratory that performs environmental testing.If any growth is found, it must be addressed and corrected. The area is then retested to ensure the correction.Surface sampling must be performed monthly in all PECs, ISO classified areas, and pass-throughs that open into ISO classified rooms.

Which of the following USP chapters defines the standards and requirements for sterile compounding? A. Chapter 794 B. Chapter 795 C. Chapter 796 D. Chapter 797 E. Chapter 800

Answer: (d). 1. The USP General Chapter 795 defines the standards and requirements for non-sterile compounding. 2. The USP General Chapter 797 defines the standards and requirements for sterile compounding. 3. The USP General Chapter 800 defines the standards and requirements for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.

Which of the following information is/are TRUE ABOUT a "Media fill testing"? I. It proves that a compounder can aseptically mix a CSP at the facility using sterile fluid culture media. II. It should be completed before personnel are allowed to compound independently. III. It must be conducted at least every 6 months. A. I only B. III only C. I and II only D. II and III only E. All

Answer: (e). A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.Media-fill testing is used to measure the aseptic skill of compounding personnel. In order to be effective, the media-fill testing procedure must represent the most complex and challenging procedures performed in a pharmacy during the most stressful conditions possible.A sterile fluid culture media such as soybean casein digest medium (SCDM) or tryptic soy broth is used in place of the steps one would take to make the most complicated compounded sterile preparation (CSP) which is then incubated to test for growth that was introduced during the process.Media fill testing shows that a compounder can aseptically mix a CSP (Compounded sterile preparation) at the facility using sterile fluid culture media. The media fill test is completed before personnel are allowed to compound independently. It must then be conducted at least every 6 months.Media-Fill Testing Procedure: 1. If all of the starting components are sterile to begin with, manipulate them in a manner that simulates sterile-to-sterile compounding activities, and transfer the sterile soybean-casein. Digest media into the same types of container-closure systems commonly used at the facility. Do not further dilute the media unless specified by the manufacturer. 2. If some of the starting components are nonsterile to begin with, use a nonsterile soybean-casein digest powder to make a solution. Dissolve nonsterile commercially available soybean-casein medium in non-bacteriostatic water to make a 3% nonsterile solution.Manipulate it in a manner that simulates nonsterile-to-sterile compounding activities. Prepare at least 1 container as the positive control to demonstrate growth promotion, which is indicated by visible turbidity upon incubation. 3. Once the compounding simulation is completed and the final containers are filled with the test media, incubate them in an incubator for 7 days at 20°-25° followed by 7 days at 30°-35° to detect a broad spectrum of microorganisms. 4. Failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container-closure units(s) on or before 14 days.

Which of the following information is/are TRUE ABOUT a closed-system drug-transfer device (CSTD)? I. It protects personnel when they are compounding hazardous drugs (HDs) and administering them to the patient. II. The CSTD enables much easier and safer sterile HD compounding and delivery. III. The physical barrier systems is one of examples of the closed-system drug-transfer device (CSTD). A. I only B. III only C. I and II only D. II and III only E. All

Answer: (e).A closed-system drug-transfer device (CSTD) protects personnel when they are compounding HDs and administering them to the patient. The CSTD enables much easier and safer sterile HD compounding and delivery.Currently, two types of CSTDs are on the market:1. physical barrier systems and2. air-cleaning systems.General Chapter 800 recommends use of a CSTD when compounding HDs and requires the use of a CSTD during their administration when dosage forms allow for it.