compounding exam 1 chapter Q's

1 Which are the two primary regulators in compounding? a. USP-NF and individual state boards of pharmacy. b. USP-NF and FDA. c. Individual state boards of pharmacy and FDA. d. Individual state boards of pharmacy and NABP. - ANS b. USP-NF and FDA. 2 Several court decisions have upheld that individual state boards of pharmacy have jurisdiction when dealing with compounding pharmacies. a. True b. False - ANS a. True 3 Which is incorrect about official USP-NF compounded preparation monographs? a. When a preparation is compounded as described in a monograph, the stability is lower than that stated in the monograph. b. Official monographs are created using validated USP-NF methods. c. Official monographs have the advantage of USP-NF testing, quality assurance, and beyond-use-date assignment. d. Official monographs of the USP-NF are one way to ensure the quality and benefit of a compounded preparation. - ANS a. When a preparation is compounded as described in a monograph, the stability is lower than that stated in the monograph. 4 Complete the following table. Compounding ManufacturingDosage form is called a "______A______" Dosage form is called a "______B______"Prepared in limited quantities as a result of a physician's drug prescription order based on the prescriber-patient-pharmacist-compounder relationshipMass produced from natural or synthetic bulk chemicals and marketed for resale by pharmacist, practitioners, and others.Regulated by "______C______" Regulated by "______D______" a. A- product, B- preparation, C- USP-NP, D- FDA b. A- prescription, B- preparation, C- State boards of pharmacy, D- FDA c. A- preparation, B- product, C- State boards of pharmacy, D- FDA d. A- preparation, B- compounding, C- FDA, D- State boards of pharmacy - ANS c. A- preparation, B- product, C- State boards of pharmacy, D- FDA 5 The USP and NF were both established as the official compendia of the United States in the _____________. a. U.S. Compendial Act of 1820 b. Drug Import Act of 1948 c. Food, Drug, and Cosmetic Act of 1906 d. National Boards of Pharmacy Model Pharmacy Act of 1962 e. FDA Modernization Act of 1997 - ANS c. Food, Drug, and Cosmetic Act of 1906 6 Three well-known General Chapters related to compounding in the current USP are 795, 797, and 800. These chapters are _________________________. a. requirements and potentially enforceable by the FDA and state boards of pharmacy b. informational and potentially enforceable by only the state boards of pharmacy c. requirements and potentially enforceable by only the state boards of pharmacy d. informational and potentially enforceable by the USP and state boards of pharmacy e. requirements and informational and potentially enforceable by USP, FDA, and state boards of pharmacy - ANS e. requirements and informational and potentially enforceable by USP, FDA, and state boards of pharmacy 7 The Drug Quality and Security Act (DQSA) of 2013 established types of compounding operations. Traditional compounders were given a section of the FD&C Act, section 503A, which allowed them to ___________. a. compound without holding a state board of pharmacy license b. compound without having a prescription from a practitioner c. compound for multiple patients if they use good manufacturing practices (GMPs) d. compound for an individual patient on issuance of a prescription by a valid provider - ANS d. compound for an individual patient on issuance of a prescription by a valid provider 8 The FDA regularly issues guidance documents containing policies, rules, and guidances pertaining to compounding. These guidance documents are _______________. a. legally enforceable by the FDA b. explain the enforceable actions the FDA will execute on the date specified in the document c. nonbinding, and explain the current FDA "thinking" d. only available from the FDA upon request in writing - ANS c. nonbinding, and explain the current FDA "thinking" 9 State boards of pharmacy must require all pharmacies in their state to comply with USP General Chapters 795, 797, and 800. a. True b. False - ANS b. False 10 Which organization does not accredit a compounding practice? a. Joint Commission. b. National Infusion Council. c. Community Health Accreditation Program. d. Accreditation Commission for Health Care. - ANS b. National Infusion Council. 1 The primary goal of a quality assurance program with respect to a compounding facility is to _____________________. a. provide proper customer care for the compounders b. make sure preparations meet the same standards of safety, stability, proper identity, strength, purity, and quality when repeatedly compounded, even by different compounders c. be accredited by The Joint Commission d. maintain the cleanliness of the facilities and equipment - ANS b. make sure preparations meet the same standards of safety, stability, proper identity, strength, purity, and quality when repeatedly compounded, even by different compounders 2 The QA program should fulfill the following functions _______. a. provide a mechanism for monitoring, evaluating, correcting, and improving activities and processes for preparing compounded preparations b. maintain and improve the quality of systems and the provision of patient care c. provide appropriate follow-up for identified problems d. all of the above are correct - ANS d. all of the above are correct 3 Before beginning any outsourcing agreement, it is prudent to conduct a site visit and to ascertain the following qualifications: _______________________. a. licenses and permits b. compounding services provided c. internet controls and quality assurance