Sterile Compounding PE Section 4
The USP Chapter 797 and 800 stated that hazardous drugs should be stored in a negative-pressure room with external ventilation and at least: a. 12 air changes per hour b. 5 air changes per hour c. 15 air changes per hour d. 2 air changes per hour
Answer: (a) 12 air changes per hour. According to both USP Chapter 797 and proposed Chapter 800, antineoplastic hazardous drugs requiring manipulation and hazardous drug active pharmaceutical ingredients must be stored separately from other inventory in a manner that prevents spillage or breakage if the container falls and contamination and health care worker exposure. In the past, USP Chapter 797 stated that hazardous drugs should be stored in a negative-pressure room with external ventilation (i.e., exhausting of air through a high efficiency particulate air filter to the exterior of the building where contaminants are diluted with fresh air) and at least 12 air changes per hour. These conditions are required in proposed Chapter 800, not merely strongly recommended as in the past in Chapter 797.
Which of the following is among the key elements of facility design in health care institutions where hazardous drugs are prepared? a. A certified Class II biological safety cabinet in a negative-pressure buffer room. b. A negative-pressure ISO Class 7 ante-room. c. A laminar airflow workbench in a negative pressure buffer room. d. A closed system drug-transfer device that meets NSA for Testing standards.
Answer: (a) A certified Class II biological safety cabinet in a negative-pressure buffer room. The key elements of facility design in health care organizations where sterile hazardous drugs are prepared include the use of a National Sanitation Foundation 49 certified Class II BSC or CACI that meets Controlled Environment Testing Association requirements and is located in a separate room under negative pressure, with external ventilation and the appropriate number of air changes per hour (12 for a C-SCA and 30 for an ISO Class 7 clean room or buffer room). Use of these elements with appropriate PPE and environmental monitoring can protect health care workers, the environment, and patients from hazardous drugs.
Only 10% of total products can be distributed out of state compounded by traditional compounding pharmacies. a. True b. False
Answer: (b) False. Section 503A - Defines Traditional Compounding Pharmacies Practice: 1. Applies to all pharmacies and compounding physicians 2. A licensed practitioner must complete the compounding. 3. Applies to sterile and nonsterile preparations. 4. Requires a prescription and an established physician-patient-pharmacist relationship. 5. No "office use" of compounded products is allowed. 6. Mandates compliance with USP standards. 7. Only limited anticipatory compounding can be completed. 8. Adequate labeling for use by patient must be provided. 9. Reporting of adverse events is voluntary. 10. Only 5% of total products can be distributed out of state (unless the state has a MOU-Memorandum of Understanding with FDA). 11. Regulated primarily by state boards of pharmacy, but also subject to direct regulation by FDA.
The Drug Quality and Security Act (DQSA) of 2013 Title 1 intent to: I. Distinguishes regulation of traditional pharmacies and outsourcing facilities. II. Provides more oversight of large-scale compounding facilities. III. Reduces exposure to counterfeit medicines. a. I only b. I and II only c. II and III only d. All
Answer: (b) I and II only. In 2012, a number of patients died or became ill from fungal meningitis. Investigation revealed they were caused by contaminated compounded products prepared by New England Compounding Center (NECC). The Drug Quality and Security Act (DQSA) of 2013 Title 1 intents to: a. Distinguishes regulation of traditional pharmacies and outsourcing facilities. b. Provides more oversight of large-scale compounding facilities. c. Coordinate regulation of compounding between FDA and state boards of pharmacy. The Drug Quality and Security Act (DQSA) of 2013 Title 2 intents to: a. Implements a system to track and trace prescription drugs as they are distributed. b. Reduces exposure to counterfeit medicines. c. Redefines the drug supply chain. d. Outlines new requirements for product verification, notification, tracing, record keeping and product identification.
Section 503B of the Federal Food, Drug, and Cosmetic Act addresses which of the following? a. Traditional Compounders b. Outsourcing Facilities c. Compounding pharmacies d. Compounding nuclear pharmacies
Answer: (b) Outsourcing Facilities. In the United States, the safety and efficacy of drugs are regulated at the federal level under the FDC Act. States have jurisdiction over the practices of medicine and pharmacy. The practice of compounding has traditionally been regulated by individual state pharmacy and other health professional practice laws, and enforced by state boards of pharmacy. In 2012, a multistate meningitis outbreak resulting from the contamination of methylprednisolone acetate, a steroid injection compounded by New England Compounding Center (NECC), caused the death of 64 people and illnesses in more than 800 people. Because of this large outbreak, and ongoing concern about large compounding operations that ship their products broadly to many facilities in anticipation of a need for a medication rather than as a result of an individual prescription, Congress enacted the Drug Quality and Security Act (DQSA). The DQSA has two key components, both of which amend the FDC Act: Title One, The Compounding Quality Act, and Title Two, The Drug Supply Chain Security Act (DQSA). The Compounding Quality Act of DQSA established two sections that established clearly differentiated types of compounding facilities: Section 503A set forth "Traditional Compounders" and Section 503B established "Outsourcing Facilities."
Who maintains a list of antineoplastic and other hazardous drugs used in healthcare? a. OSHA b. NIOSH c. ACOEM d. ASHP
Answer: (b) The National Institute for Occupational Safety and Health (NIOSH) maintains a list of antineoplastic and other hazardous drugs (HDs) used in healthcare. An entity must maintain a list of HDs, which may include items on the current NIOSH list in addition to other agents not on the NIOSH list. The entity's list must be reviewed at least annually and whenever a new agent or dosage form is used. The NIOSH list of antineoplastic and other HDs provides the criteria used to identify HDs. These criteria must be used to identify HDs that enter the market after the most recent version of the NIOSH list, or that enter the entity as an investigational drug. If the information available on this drug is deemed insufficient to make an informed decision, consider the drug hazardous until more information is available.
For those new to compounding, how many successful gloved fingertip tests must be done and how many colony forming units (CFUs) are allowed? a. One set of tests with no growth b. One set of tests with no more than 3 CFUs c. Three sets of tests with no growth d. Three sets of tests with no more than 3 CFUs
Answer: (c) Three sets of tests with no growth. The 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. Retesting is required annually for those compounders mixing low- and medium-risk preparations and semiannually for high-risk preparations. For the retesting, the gloved fingertip test is performed following the media fill. Ideally, there will be no CFU growth for the fingertip sample test; it is failed if more than 3 CFUs are found.
Which of the following activities may increase the risk of exposing to hazardous drugs (HDs)? I. Crushing tablets or opening capsules II. Pouring oral or topical liquids drugs from one container to another III. Expelling air from syringes previously used for hazardous drugs a. I only b. I and II only c. II and III only d. All
Answer: (d) All. Routes of unintentional entry of HDs into the body include dermal and mucosal absorption, inhalation, injection, and ingestion (e.g., contaminated foodstuffs, spills, or mouth contact with contaminated hands). Both clinical and nonclinical personnel may be exposed to HDs when they handle HDs or touch contaminated surfaces. Examples of exposure to HDs while compounding: 1. Crushing tablets or opening capsules 2. Pouring oral or topical liquids from one container to another 3. Weighing or mixing components 4. Constituting or reconstituting powdered or lyophilized HDs 5. Withdrawing or diluting injectable HDs from parenteral containers 6. Expelling air or HDs from syringes 7. Contacting HD residue present on PPE or other garments 8. Deactivating, decontaminating, cleaning, and disinfecting areas contaminated with or suspected to be contaminated with HDs 9. Maintenance activities for potentially contaminated equipment and devices
Which of the following is/are TRUE about wearing disposable gowns while preparing hazardous drugs? I. Disposable gowns made of polyethylene-coated polypropylene or other laminate materials offer better protection than those made of uncoated materials. II. Gowns must close in the back be long sleeved, and have closed cuffs that are elastic or knit. III. If no permeation information is available from the manufacturer for the gowns used, change them every 2-3 hours or immediately after a spill or splash. a. I only b. I and II only c. II and III only d. All
Answer: (d) All. When required, disposable gowns must be tested and shown to resist permeability by HDs. Gowns must be selected based on the HDs handled. Disposable gowns made of polyethylene-coated polypropylene or other laminate materials offer better protection than those made of uncoated materials. Gowns must close in the back (i.e., no open front), be long sleeved, and have closed cuffs that are elastic or knit. Gowns must not have seams or closures that could allow HDs to pass through. Cloth laboratory coats, surgical scrubs, isolation gowns, or other absorbent materials are not appropriate outerwear when handling HDs because they permit the permeation of HDs and can hold spilled drugs against the skin, thereby increasing exposure. Clothing may also retain HD residue from contact, and may transfer to other healthcare workers or various surfaces. Washing of non-disposable clothing contaminated with HD residue may transfer drug residue to other clothing. Gowns must be changed per the manufacturer's information for permeation of the gown. If no permeation information is available for the gowns used, change them every 2-3 hours or immediately after a spill or splash. Gowns worn in HD handling areas must not be worn to other areas in order avoid spreading HD contamination and exposing other healthcare workers.
Section 503A of DQSA requires: I. A pharmacy may compound a prescription drug product only upon receipt of a valid prescription for an individual patient. II. Drugs that have been withdrawn from the market due to concerns about safety or a lack of efficacy may not be compounded. III. A pharmacy may not compound products that are essentially copies of commercially available drug products. a. I only b. I and II only c. II and III only d. All
Answer: (d) All. Section 503A defines when a pharmacy is engaged in traditional compounding rather than manufacturing. Any pharmacy engaged in traditional compounding must observe the requirements of Section 503A, and is exempt from 3 FDCA requirements that would otherwise apply to a prescription drug product: 1. Compliance with current Good Manufacturing Practices (cGMP) (Section 501(a)(2)); 2. Compliance with extensive manufacturer product labeling requirements, which are discussed below (Section 502(f)(1)); and 3. Establishing the product is safe and effective for its intended use via new drug applications (NDAs) or abbreviated new drug applications (ANDAs) filed with FDA (Section 505). To qualify for exemptions from these requirements, a pharmacy must satisfy Section 503A's numerous restrictions, which are detailed in the following paragraphs. 1. Compounding must be performed by a licensed pharmacist or any member of the pharmacy staff working under a pharmacist's supervision in a licensed pharmacy or federal facility or by a licensed physician. 2. Compounding must be conducted in compliance with the standards outlined in USP Chapter 795 for nonsterile preparations and USP Chapter 797 for sterile preparations. 3. Compounded products must be packaged in a manner to promote safety and stability as outlined in USP or other official compendium. 4. A pharmacy may compound a prescription drug product only upon receipt of a valid prescription for an individual patient. A pharmacy may engage in the practice of anticipatory compounding for prescription drug products in limited quantities based on historical prescribing or a relationship between the compounder, the prescriber, and the patient. But, even then, the pharmacy may not dispense the product unless and until it receives a valid prescription for an individual patient. 5. A pharmacy may not compound products for physician's office use. 6. Products that appear on the FDA list of drug substances having "Demonstrable Difficulties for Compounding" that could adversely affect the safety or efficacy of the compounded product cannot be compounded. 7. Drugs that have been withdrawn from the market due to concerns about safety or a lack of efficacy may not be compounded. 8. A pharmacy may not compound products that are essentially copies of commercially available drug products.
Outsourcing facilities, as defined under the section 503B of DQSA, must: I. comply with CGMP requirements. II. be inspected by FDA according to a risk-based schedule. III. provide FDA with certain information about the products they compound. a. I only b. I and II only c. II and III only d. All
Answer: (d) All. The Drug Quality and Security Act, signed into law on November 27, 2013, creates a new section 503B in the FDCA. Under section 503B, a compounder can become an "outsourcing facility." The law defines an "outsourcing facility" as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B. An outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from current good manufacturing practice (CGMP) requirements. Outsourcing facilities: a. must comply with CGMP requirements; b. will be inspected by FDA according to a risk-based schedule; and c. must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
For which of the following activities should a facility register with the FDA as an outsourcing facility? I. The facility regularly repackages tablets into unit dose packs. II. A pharmacy reconstituting the powdered Augmentin by adding distilled water. III. Compounding only non-sterile drugs by a pharmacist for hospital. a. I only b. I and II only c. All d. None of the above
Answer: (d) None of the above. The draft guidance states that a facility that engages in only following activities, or engages only in a combination of following activities, should not register as an outsourcing facility because the drugs it produces will not be eligible for the statutory exemptions described in section 503B of the FDC Act. a. Repackaging human drugs b. Mixing, diluting, or repackaging biological products c. Compounding non-sterile drugs d. Compounding animal drugs
Which of the following is an example of supplemental engineering controls for containment? a. A-PEC b. C-PEC c. C-SEC d. CSTD
Answer: (d) closed-system drug-transfer device (CSTD). Engineering controls are required to protect the preparation from cross-contamination and microbial contamination (if preparation is intended to be sterile) during all phases of the compounding process. Engineering controls for containment are divided into three categories representing primary, secondary, and supplementary levels of control. A containment primary engineering control (C-PEC) is a ventilated device designed to minimize worker and environmental HD exposure when directly handling HDs. Containment secondary engineering controls (C-SEC) is the room in which the C-PEC is placed. Supplemental engineering controls [e.g., closed-system drug-transfer device (CSTD)] are adjunct controls to offer additional levels of protection. Sterile and nonsterile HDs must be compounded within a C-PEC located in a C-SEC. The C-SEC used for sterile and nonsterile compounding must: a. Be externally vented through high-efficiency particulate air (HEPA) filtration b. Be physically separated (i.e., a different room from other preparation areas) c. Have a negative pressure between 0.01 and 0.03 inches of water column
