Mass MPJE()Questions & Answers 100% Correct!!

Notify BORP within _______ of receipt of an Above Action Level EM result. - ANSWER7 days What are the non-viable air sample action levels per USP 797 for ISO Classes 5, 7, and 8? - ANSWERAnswers are in particles 0.5 um or greater per cubic meter of air Class 5: 3,520 Class 7: 352,000 Class 8: 3,520,000 What are the viable air sample action levels per USP 797 for ISO Classes 5, 7, and 8? - ANSWERFor highly pathogenic organisms (fungi, GN rods, and coag pos Staph): 1 or more CFU Class 5: 1 CFU Class 7: 10 CFU Class 8: 100 CFU What are the viable surface sample action levels per USP 797? - ANSWERFor highly pathogenic organisms (fungi, GN rods, coag neg Staph): 1 or more CFU Class 5: 3 CFU Class 7: 5 CFU Class 8: 100 CFU Within _____ after submission of Form 1 for Above Action Level EM results, the final report (Form 2) must be submitted to the BORP. - ANSWER21 days Report failed certification of PEC and/or SEC to BORP along with a copy of a CAP within _______. - ANSWER7 business days Pharmacies are required to report any defective drug preparation that is a CSP or a complex non-sterile product (CNP) dispensed or distributed into or from Mass to the BORP within ________. - ANSWER7 days Pharmacies that compound CSPs are required to send a Sterile Compounding Reporting Form to the BORP how often? - ANSWEREvery six months (on or before August 15th for the first half of the year and on or before February 15 for the second half of the year). Single volume transfers of not more than 3 sterile dosage forms and not more than 2 entries into a sterile container - ANSWERLow Risk Compounding Complex aseptic manipulations other than single volume transfer - ANSWERMedium Risk Compounding Non-sterile ingredients, including manufactured products not intended for sterile routes of administration, are incorporated or a non-sterile device is employed before terminal sterilization - ANSWERHigh Risk Compounding The Sterile Compounding Reporting Form (along with the Excel Spreadsheet for CSP Prescriptions) submitted to BORP contains what type of data? - ANSWERProduct, volume, and distribution data The BORP is located within - ANSWERThe Department of Public Health, Bureau of Health Professions Licensure If deficiencies are noted on a BORP inspection, the pharmacy has ______ days to submit a typed plan of correction. - ANSWER15 business days Temperature and humidity must be monitored in each room of the cleanroom suite daily, and acceptable levels are: - ANSWER20C (68 F) or cooler 60% relative humidity or less Controlled room temperature, per USP - ANSWER20 to 25 C (68 to 77 F) USP-800 C-PEC requirements: - ANSWERPlaced in ISO-7 buffer room that has 1) fixed walls 2) HEPA-filtered supply air 3) negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas 4) minimum of 30 ACPH In a cleanroom suite, a minimum differential positive pressure of 0.020-inch water column is required between each ISO-classified area. The pressure differential between the ante-room and the unclassified area must be not less than _______ water column. - ANSWER0.020-inch All containment strategies of USP 800 must be followed in which three scenarios? - ANSWER1) when manipulating antineoplastic drugs 2) when compounding with any NIOSH HD active pharmaceutical ingredient (API), includi