ࡱ>  bjbj &|$222P| 2P) r5r5L558>R8f8 $x|;77"|;|;5544FAAA|;v55A|;AA^|-5 2;Lyhz<L0><J0--`,0Xr8v8TA<9D9r8r8r8>r8r8r8|;|;|;|;0r8r8r8r8r8r8r8r8r8 : COMPLEX NON-STERILE COMPOUNDING INSPECTION REPORT HYPERLINK "http://www.statesymbolsusa.org/Lists/state_seals.html" INCLUDEPICTURE "http://www.statesymbolsusa.org/IMAGES/Massachusetts/Seal_of_Massachusetts.jpg" \* MERGEFORMATINET  INCLUDEPICTURE "http://www.statesymbolsusa.org/IMAGES/Massachusetts/Seal_of_Massachusetts.jpg" \* MERGEFORMATINET  INCLUDEPICTURE "http://www.statesymbolsusa.org/IMAGES/Massachusetts/Seal_of_Massachusetts.jpg" \* MERGEFORMATINET  The Commonwealth of Massachusetts Executive Office of Health and Human Services Department of Public Health Bureau of Health Professions LicensureBoard of Registration in Pharmacy 239 Causeway Street, Suite 500, Boston, MA 02114 Tel: (617) 973-0800 TTY: (617) 973-0988 DATE(S) OF INSPECTION:ISP NUMBER:PHARMACY DBA NAME:STORE NUMBER:STREET ADDRESS:CITY / STATE / ZIP:TELEPHONE:FAX:EMAIL:PHARMACY LIC. NUMBERS:PHARMACY LIC. EXPIRATION:DEA REG. NUMBER:DEA REG. EXPIRATION:MANAGER OF RECORD (MOR):MOR REG. NUMBER:DAILY PHARMACY VOLUME (NON-STERILE COMPOUNDING):HOURS OF OPERATION:M-F: SAT: SUN: PHARMACY STAFFINGPHARMACY STAFF PRESENT AT TIME OF INSPECTION Supervisory ratios compliant with 247 CMR 8.06 (3): FORMCHECKBOX  Yes  FORMCHECKBOX  NoPHARMACISTSLICENSE# CURRENT?1  FORMCHECKBOX  Yes  FORMCHECKBOX  No2  FORMCHECKBOX  Yes  FORMCHECKBOX  No3  FORMCHECKBOX  Yes  FORMCHECKBOX  No4  FORMCHECKBOX  Yes  FORMCHECKBOX  No 5  FORMCHECKBOX  Yes  FORMCHECKBOX  No6  FORMCHECKBOX  Yes  FORMCHECKBOX  NoPHARMACY INTERNSLICENSE# CURRENT?1  FORMCHECKBOX  Yes  FORMCHECKBOX  No2  FORMCHECKBOX  Yes  FORMCHECKBOX  No3  FORMCHECKBOX  Yes  FORMCHECKBOX  NoPHARMACY TECHNICIANSCERTIFIED? LICENSE# CURRENT?1  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No2  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No3  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No4  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No5  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No6  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No7  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No8  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No9  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No10  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  NoOTHER PHARMACY STAFF including traineesPOSITION TRAINEE HOURS1234Item#RequirementsYes NoN/AAdditional InformationARegulatory Requirements1Are the following documents conspicuously displayed within the pharmacy or pharmacy department? (a) the pharmacy permit; (b) the pharmacys Massachusetts controlled substance registration; (c) the pharmacys U.S. Drug Enforcement Administration controlled substance registration; and (d) the pharmacys complex non-sterile compounding license 247 CMR 6.02(3) (a-c), M.G.L. c. 112, 39H  FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No2Is every prescription written in the Commonwealth in a prescription format that conforms to the requirements as set forth in 105 CMR 721.020? 247 CMR 9.01 (1); 105 CMR 721.0203Does the pharmacist conduct a prospective drug utilization review (DUR)? before each new prescription is dispensed or delivered to a patient or a person acting on behalf of the patient? which includes a review of the patient record and each new prescription presented for dispensing, for the purposes of promoting therapeutic appropriateness? 247 CMR 9.07 (1) (a) and (2) (a) FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No4Does the pharmacy keep a perpetual inventory of each controlled substance in Schedule II which the pharmacy has received, dispensed or disposed of in accordance with the law? Is this inventory reconciled at least once every ten days? 247 CMR 9.01(14)5Does the pharmacy maintain records associated with disposal or destruction of controlled substances pursuant to Sec.1304.03? 247 CMR 9.01 (1); 21 CFR 1304.21 (a)?6Does the pharmacy have a current copy or electronic version of the Board Regulations? (247 CMR 6.01 (5) (a) (3))7Does the pharmacy have a current copy or electronic version (with quarterly updates) of a compendium appropriate to the practice setting approved by the pharmacist manager of record? 247 CMR 6.01 (5) (a) (2)8Does the pharmacy maintain a written copy of its Continuous Quality Improvement (CQI) Program description on the pharmacy premises readily available to all pharmacy personnel? 247 CMR 15.04(1)9Does the Pharmacy conducting complex non-sterile compounding have documentation certifying that their employees have been trained in lean concepts (at least annually), which are tools that assist in the identification and steady elimination of waste and promote continuous improvement in quality and efficiency? MGL 112 39H (a)(6).10Does the pharmacy maintain a written policy and procedure to effectuate a recall of non-sterile compounded preparations in accordance with M.G.L. c. 112, 39D(e)? 247 CMR 18.02(4)11Does the pharmacy keep a defective drug preparation log documenting all recalled drug preparations? M.G.L. c. 112, 39D(e)Item#RequirementsYes NoN/AAdditional InformationARegulatory Requirements (continued)12Does the Pharmacy only prepare compounded non-sterile preparations for a patient as a result of a practitioner's prescription order, based on the relationship between the practitioner, patient and pharmacist in the course of routine professional practice to meet the unique medical need of an individual patient by producing a significant difference between the compounded drug preparation and a comparable commercially available drug that is justified by a documented medical need as determined by the prescribing practitioner? M.G.L. c. 112, 39D(a)113Does the pharmacy ensure that compounding of FDA approved commercially available products (not on backorder) using non-sterile powders or other components does not occur?14If the pharmacy compounds FDA approved products using non-sterile powders or other components, can the pharmacy provided documentation confirming backorder?15Does the Pharmacy only prepare quantities of compounded non-sterile preparations in anticipation of prescription orders based on routine, regularly-observed prescribing patterns which can be verified by accountability documentation? M.G.L. c. 112, 39D(a)(2)16Does the pharmacy maintain a written continuity of care plan that describes the way patient needs will be met in the event the pharmacy is unexpectedly unable to provide pharmacy services? DRAFT 247 CMR 9.17 (15)BNon-Sterile Compounding ProcessPharmacy is engaged in the following levels of non-sterile compounding:YesNoN/AAdditional Comments17Non-sterile Compounding - simple preparations [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 beyond use dates (BUDs); or reconstituting or manipulating commercial products that may require the addition of one or more ingredients as directed by the manufacturer.] 247 CMR 9.01 (3) USP<795>18Non-sterile Compounding - moderate preparations [Making a preparation that requires special calculations or procedures 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.] 247 CMR 9.01 (3) USP<795>19Non-sterile Compounding - complex preparations [Making a preparation which requires special training, a special environment or special facilities or equipment or the use of compounding techniques and procedures that may present an elevated risk to the compounder or the patient.] M.G.L. c. 112, 39D(a)Item#RequirementsYes NoN/AAdditional InformationBNon-Sterile Compounding Process (continued)Pharmacy is engaged in the following levels of non-sterile compounding:20DOSAGE FORMS COMPOUNDED: (List is not all inclusive)  FORMCHECKBOX  Oral Solutions  FORMCHECKBOX  Oral Suspension  FORMCHECKBOX  Topical cream/ointment/gel   FORMCHECKBOX  Troches  FORMCHECKBOX  Suppositories  FORMCHECKBOX  Transdermals  FORMCHECKBOX  Modified Release Preparations  FORMCHECKBOX  Inserts  FORMCHECKBOX  Capsules/Tablets   FORMCHECKBOX  Investigational  FORMCHECKBOX  Dietary/Nutritional Supplements  FORMCHECKBOX  Hazardous Medications  FORMCHECKBOX  Other: __________________________ ___________________________________ 21Does the pharmacy maintain written policies and procedures specific to simple, moderate, and complex non-sterile compounding, as applicable? 247 CMR 18.02(3)22Does the pharmacist evaluate the dose, safety, and intended use of the non-sterile compounded preparation for suitability? Does the pharmacy maintain documentation of the evaluation? 247 CMR 18.02(6) (a-d)23Does the pharmacy maintain a written policy and procedure to confirm all compounding ingredients used in a formulation have the expected identity, quality, and purity? (This does not include commercially available products bearing a national drug code) 247 CMR 18.02(7)24Does the pharmacy only compound one preparation at a time in a specific workspace? 247 CMR 18.02(8)25Does the pharmacy utilize disposable or clean equipment dedicated for use for compounding with drugs (e.g., known allergens like penicillin, etc.) that require special precautions?. 247 CMR 9.01 (3) USP<795>26Does the pharmacy ensure that compounding personnel clean clothing, garb, and personal protective equipment appropriate to the type of compounding performed? 247 CMR 18.02(9)27Does the pharmacy ensure that compounding staff perform hand hygiene activities prior to compounding? 28Does the pharmacy and pharmacist utilizing pre-measured compounding kits adhere to all USP <795> standards and 247 CMR 18.00? 247 CMR 18.02(11)Item#RequirementsYes NoN/AAdditional InformationCNon-Sterile Compounding Facility29Are the areas used for compounding maintained in a clean, orderly, and sanitary condition and maintained in a good state of repair? 247 CMR 6.02(1); 9.01 (3); USP Chapter <795>30Does the complex non-sterile compounding pharmacy have a dedicated compounding room that is at least 100 square feet? 247 CMR 18.03(1)31Does the complex non-sterile compounding pharmacy have a containment hood? 247 CMR 18.03(2)32Does the pharmacy maintain the containment hood in accordance with manufacturer specifications and ensure the containment hood is certified at least one time per year? 247 CMR 18.03(3)33Does the pharmacy performing simple or moderate level non-sterile compounding have a designated compounding area that is at least 10 square feet of counter space and suitable for its intended purpose? 247 CMR 18.03(4)34Is the designated compounding area located in an area that minimizes contact with water from a sink? 247 CMR 18.03(4)35Does the pharmacy ensure non-sterile compounding rooms and areas are suitable for their intended purpose, allow for the orderly placement of equipment and materials to prevent confusion among ingredients, containers, labels, in-process materials, and finished preparations and designed, arranged, and used to prevent cross-contamination? 247 CMR 18.03(5) (a-c)36Are the prescription and compounding areas arranged appropriately for the storage of drugs, ingredients, supplies, and equipment? DRAFT 247 CMR 9.17 (4) (f).37Does the pharmacy have a potable water supply in the non-sterile compounding area or room to wash hands and equipment? 247 CMR 18.03(8)38Does the sink have hot and cold water, soap or detergent, and single-use towels? 247 CMR 18.03(8)39Does the pharmacy maintain a plumbing system that is free of defects that could contribute to contamination of any non-sterile compounded preparation? 247 CMR 18.03(9)40Does the pharmacy ensure that refrigerators and freezers are maintained within proper range (Refrigeration at 36 to 46F/2 to 8C; Freezer at-13 to 14F/-25 to -10C USP recommended range) in accordance with manufacturer recommended medication storage requirements? 247 CMR 9.01(1) and (5); Board Policy No. 2011-0141Does the pharmacy ensure refrigerators and freezers are kept clean, organized, and defrosted? 247 CMR 9.01(1) and (5); Board Policy No. 2011-0142Does the complex non-sterile compounding pharmacy maintain a temperature of not more than 77F (25C) in the compounding room? 247 CMR 18.03(10)43Does the complex non-sterile compounding pharmacy maintain a humidity of not more than 65% in the compounding room? 247 CMR 18.03(10)44Does the pharmacy store all non-sterile compounding ingredients, equipment, utensils, glassware, and containers off the floor, in a manner to prevent contamination, and in a manner to permit inspection and cleaning? 247 CMR 18.03(11)Item#RequirementsYesNoN/AAdditional InformationENon-Sterile Compounding Equipment45Are all non-sterile compounding equipment, utensils, and glassware clean, properly maintained, and appropriate for compounding non-sterile preparations? 247 CMR 18.04(1)46Do compounding personnel inspect equipment, utensils, and glassware for suitability prior to use? 247 CMR 18.04(1) 47Does the pharmacy use equipment for non-sterile compounding that is commercial or pharmaceutical grade or comparable quality? 247 CMR 18.04(2)48Is the non-sterile compounding equipment of suitable composition so that the surfaces that contact ingredients do not adversely affect the ingredients or final product? 247 CMR 18.04(3)49Does the pharmacy have a balance capable of accurately weighing quantities as small as 13 milligrams and has the balance been tested and sealed by the state or local sealer of weights and measures within the current or previous calendar year? 247 CMR 6.01(5)(a)(4); 247 CMR 9.01(1).50Does the pharmacy maintain a written policy and procedure regarding non-sterile compounding equipment that requires? routine inspection and calibration of non-sterile compounding equipment; and inspection by compounding personnel immediately prior to each use (to ensure proper performance)? 247 CMR 18.04(4) (a-b)  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  NoFNon-Sterile Compounding Ingredient Selection, Handling, and Storage51Does the pharmacy store all non-sterile compounding ingredients in accordance with manufacturer specifications or per USP monograph requirements if manufacturer specifications are not available? 247 CMR 18.05(1)52When no commercial source exists to prepare compounded products, does the compounder use USP grade bulk ingredients obtained from a GMP compliant supplier? 53Does the pharmacy maintain a certificate of analysis for each active pharmaceutical ingredient (API)? The certificates of analysis shall be readily retrievable. 247 CMR 18.05(3)54In the event a pharmacy cannot obtain non-sterile compounding ingredients from an FDA-registered facility, does the pharmacist verify the purity and safety of ingredients by reasonable means including review of the Certificate of Analysis, when available? 247 CMR 18.05(2)55In the event a manufacturer or supplier of a stock container of a non-sterile compounding ingredient does not assign an expiration date to the ingredient, does the pharmacy assign an expiration date to the stock container based on the nature of the ingredient, the packaging, and the storage considerations? 247 CMR 18.05(4)Item#RequirementsYesNoN/AAdditional InformationFNon-Sterile Compounding Ingredient Selection, Handling, and Storage (continued)56If the pharmacy receives a non-sterile compounding ingredient without a manufacturer or supplier assigned expiration date on the stock container, does the pharmacy ensure that; the assigned expiration dates do not exceed 3 years from the date the pharmacy received the stock container or one year from the date the container was opened (whichever period is shorter)? the stock container is labeled with the date the pharmacy received the stock container, the date opened and the assigned expiration date? 247 CMR 18.05(4)  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No57Does the pharmacy utilize purified water for non-sterile compounding when a formulation requires the inclusion of water? 247 CMR 18.03(7)58Does the pharmacy maintain written documentation demonstrating that any compounding ingredient derived from ruminant animals complies with federal laws and regulations governing the processing, use, and importation requirements for these materials? 247 CMR 18.05(5)59Does the pharmacy ensure each non-sterile compounding ingredient is clearly labeled with the product name, original supplier, lot number, strength or concentration, expiration date, and transfer date if the ingredient was transferred out of its original container? 247 CMR 18.05(6)60Does the pharmacy ensure all components are stored off the floor, handled and stored to prevent contamination, and rotated so that the oldest stock is used first (i.e. first in first out)? 247 CMR 9.01 (3) USP<795>61Does the pharmacy have a mechanism to ensure expired, outdated or otherwise substandard drugs or devices or counterfeit drugs or devices are not dispensed to any person or entity who is not licensed or legally authorized to receive such drugs or devices? Is a segregated area available for storage of these products? 247 CMR 9.01(10)Packaging and Preparation Containers62Does the pharmacy utilize containers and closures made of suitable and clean material that does not alter the quality, strength, or purity of the non-sterile compounded preparation? 247 CMR 18.06(1)63Does the pharmacy verify packing, shipping, and transportation processes to ensure they do not adversely affect the integrity and stability of non-sterile compounded preparations? 247 CMR 18.06(2)64Does the pharmacy maintain written policies and procedures regarding packing, shipping, and transportation processes?65In addition to standard prescription labeling requirements, does the pharmacy include the following information on the label or container for each non-sterile compounded preparation: (a) the Beyond Use Date (BUD); (b) storage information; and (c) the statement, This is a non-sterile compounded drug preparation? 247 CMR 18.06(3) (a-c)  FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  NoItem#RequirementsYesNoN/AAdditional Information Stability and Beyond Use Dating (BUD)66Does the pharmacy assign a BUD to a water-containing oral formulation that does not exceed 14 days when stored at 36-46F (2-8C)? 247 CMR 18.07(2)67Does the pharmacy assign a BUD to a water-containing topical/dermal, mucosal liquid or semisolid formulation that does not exceed 30 days? 247 CMR 18.07(3)68Does the pharmacy assign a BUD to a solid or non-aqueous (non-water containing) liquid preparation that does not exceed the earliest expiration date of any ingredient or six months, whichever is earlier? 247 CMR 18.07(1)69Does the pharmacy assign extended BUDs to non-sterile compounded preparations that exceed the BUDs described in 247 CMR 18.07(1-3)? 70If the pharmacy assigns extended BUDs to non-sterile compounded preparations, does the pharmacy maintain scientific evidence from relevant and reliable sources or validation studies by direct testing that demonstrate the specific preparation remains stable until the extended BUD expires? 247 CMR 18.07(4)Cleaning and Disinfection71Are all work surfaces are cleaned of loose materials and residue from spills before compounding? 247 CMR 9.01(3), USP40/NF3572Documentation is available that cleaning methods and agents are effective in preventing contamination and cross-contamination of non-sterile materials and drugs within the compounding preparations areas. 247 CMR 9.01(3); USP <795>; USP <1072>   Item#RequirementsYesNoN/AAdditional Information Non-Sterile Compounding Documentation73Does the pharmacy follow a master formulation record each time it prepares a non-sterile compounded preparation? 247 CMR 18.08(1) (a-l) 74Does the master formulation record contain? (a) official or assigned name, strength, and dosage form of the preparation; (b) calculations to determine and verify quantities of compounding ingredients and doses of active pharmaceutical ingredients; (c) list of all ingredients and their quantities; (d) compatibility and stability information, including references when applicable; (e) equipment necessary to prepare the preparation; (f) instructions for mixing; (g) labeling information; (h) container to be used for dispensing; (i) packaging and storage requirements; (j) physical description of final preparation; (k) quality control procedures and expected results; (l) appropriate safety precautions  FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No75Does the pharmacy complete a compounding record each time a non-sterile compounded medication is prepared? 247 CMR 18.08(2) (a-o)76Does the compounding record contain? (a) official or assigned name, strength, and dosage of the preparation; (b) reference to the master formulation record; (c) names and quantities of all ingredients; (d) all manually computed calculations; (e) sources of ingredients, lot numbers, and expiration dates of all ingredients; (f) total quantity compounded; (g) name of person who prepared the preparation, performed the quality control procedures, and verified the preparation; (h) identity of any automated compounding device; (i) date of preparation; (j) prescription number or lot number if prepared in a batch; (k) BUD; (l) duplicate label or label elements as described in the master formulation record; (m) physical description of final preparation; (n) results of quality control procedures; (o) documentation of quality control issues and any adverse reactions or preparation problems reported   FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  NoItem#RequirementsYesNoN/AAdditional InformationQuality Control77Does the pharmacy maintain a Safety Data Sheet (SDS) for each drug substance and bulk chemical? Are the SDSs readily retrievable? 247 CMR 18.08(4)78Does the pharmacist verify the compounding record followed the master formulation record to ensure that errors did not occur in the compounding process and that the preparation is suitable for use? 247 CMR 18.08(5)79Does the pharmacist verify the accuracy of each procedure in the non-sterile compounding process, including all pharmaceutical calculations? 247 CMR 18.09(1) 80Does the pharmacy maintain written policies and procedures to ensure that the pharmacist investigates, documents, and corrects any reported problem with a non-sterile compounded preparation? 247 CMR 18.09(3)81Does the pharmacy maintain written policies and procedures that describe the way any quality control procedure is conducted on the non-sterile compounded preparation to ensure uniformity and integrity? 247 CMR 18.09(5)82Does the complex non-sterile compounding pharmacy maintain written policies and procedures for change control, including planning, implementation, and validation of new or changed facilities, equipment, or processes? 247 CMR 18.09(6)Patient Counseling83Does the pharmacist or pharmacy intern counsel each patient or patients agent that receives a new non-sterile compounded preparation? In addition to the counseling described in M.G.L. c. 94C, 21A, counseling on a non-sterile compounded preparation may include the use, storage, handling, and disposal of the medication. 247 CMR 18.10(2)84Does the pharmacist or pharmacy intern instruct the patient or the patients agent to report any adverse event related to the preparation to the compounding pharmacy and to observe and report any changes in the physical characteristics of the non-sterile compounded preparation to the compounding pharmacy? 247 CMR 18.10(3)Training85Does the pharmacy ensure all personnel that engage in or oversee non-sterile compounding or that engage in or oversee the evaluation, packaging, and dispensing of non-sterile compounded preparations are properly trained for the type of compounding conducted? 247 CMR 18.11(1)86Does the pharmacy evaluate and document the competency of all personnel who engage in or oversee non-sterile compounding at least one time per year? 247 CMR 18.11(2)Item#RequirementsYesNoN/AAdditional InformationTraining (continued)87Does the pharmacy maintain documentation of all training activities and competency assessments? The documentation shall be readily retrievable and retained for at least two years. 247 CMR 18.11(3)Compounding for Veterinary Patients88Do non-sterile compounded preparations for veterinary patients comply with USP <795> and 247 CMR 18.00? 247 CMR 18.12(1)89Does the pharmacist demonstrate competency in veterinary compounding if he or she engages in veterinary compounding? 247 CMR 18.12(2)90If the pharmacy performs compounding for food producing animals, do they consult  HYPERLINK "http://www.FDA.gov" www.FDA.gov for the list of prohibited chemicals?91Does the pharmacy maintain an appropriate reference source specific to veterinary pharmacy?Hazardous Medication Handling92Does the pharmacy have a method to identify hazardous drugs utilized within the pharmacy, ? 247 CMR 9.01 (3); USP<795>93Does the pharmacy maintain written policies and procedures detailing the storing, handling (including appropriate personal protective equipment), labeling and disposing requirements for hazardous drugs? 247 CMR 9.01 (3); USP<795>94Does the pharmacy maintain written confirmation that all compounding personnel of reproductive age (male and female) understand the risks of handling hazardous drugs? 247 CMR 9.01 (3); USP40/NF35 95Does the pharmacy ensure that all compounding personnel who handle hazardous drugs are fully trained in all the following areas prior to handling hazardous drugs? storage, handling, and disposal of hazardous drugs; containment, cleanup, and disposal procedures for spills; procedures for managing inadvertent exposure of personnel. 247 CMR 9.01 (3); USP<795>  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No 96Are hazardous drugs stored separately from other inventory in a manner to prevent contamination and personnel exposure? 247 CMR 9.01 (3); USP40/NF3597Does the pharmacy ensure that all personnel who perform routine custodial waste removal and cleaning activities in storage and preparation areas for hazardous drugs are trained in appropriate procedures to protect themselves and prevent contamination? 247 CMR 9.01 (3); USP<795>Item#RequirementsYesNoN/AAdditional InformationHazardous Medication Handling (continued)98Does the pharmacy ensure that prior to disposal, hazardous drug waste, including expired hazardous drugs, are stored in a marked segregated area within a designated hazardous drug storage area? 247 CMR 9.01 (3); USP<795>99Does the pharmacy ensure that hazardous drug waste is disposed of in a manner that complies with local, state, and federal regulations? 247 CMR 9.01 (3); USP<795>100Does the pharmacy label bulk ingredient containers with the appropriate Occupational Safety and Health Administration (OSHA)  hazard communication labels, and Safety Data Sheets (SDS) are available to personnel for drugs and chemicals within the pharmacy? 247 CMR 9.01 (3); USP<795> Investigator Notes:             Inspection CompletionExit InterviewI have participated in a pharmacy Complex Non-Sterile Compounding Inspection and have reviewed the Complex Non-Sterile Compounding Inspection Report with the Investigator(s). Plan of Correction (POC) Issued?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If yes, the pharmacist Manager of Record (MOR) will provide a plan of correction for all observed deficiencies within 15 business days. __________________________(MM/DD/YYYY)Print Name:Signature:Title:License Number: Investigator SignaturesInvestigator:Date:Investigator:Date:Investigator:Date: The deficiencies cited in this Compliance Inspection Report are not intended to be an all-inclusive list of deficiencies that exist at this licensed facility. The pharmacy and the pharmacist Manager of Record are responsible for investigating and determining the causes of the deficiencies identified and for preventing their recurrence and the occurrence of other deficiencies. All licensees are responsible for complying with state and federal laws and regulations governing the practice of pharmacy.  105 CMR 721.020 -  HYPERLINK "http://www.mass.gov/courts/docs/lawlib/104-105cmr/105cmr721.pdf" http://www.mass.gov/courts/docs/lawlib/104-105cmr/105cmr721.pdf  Including, but not limited to, the removal of a dye for medical reasons, a change in strength, a change in dosage, form or delivery mechanism; provided, that a price difference shall not be a significant difference to justify compounding.  M.G.L. c.112 39D(a)(1); for use on or for a patient as a result of a practitioner's prescription order, based on the relationship between the practitioner, patient and pharmacist in the course of routine professional practice to meet the unique medical need of an individual patient by producing a significant difference between the compounded drug preparation and a comparable commercially available drug that is justified by a documented medical need as determined by the prescribing practitioner including, but not limited to, the removal of a dye for medical reasons, a change in strength, a change in dosage, form or delivery mechanism; provided, that a price difference shall not be a significant difference to justify compounding.  See Board of Registration in Pharmacy guidance document on compounding. Per M.G.L. c.112 39D(a)(1); "compounding'' shall not include the preparation of commercially available, federal Food and Drug Administration approved drugs or drug preparations.  M.G.L. c.112 39D(a);Complex non-sterile drug preparation''  See Board of Registration in Pharmacy guidance document on compounding  Participation in investigational studies require the approval of the Board of Registration in Pharmacy.  The evaluation shall include: (a) the chemical and physical properties of the components; (b) dosage form; (c) therapeutic appropriateness and route of administration; and (d) legal limitations, if any.  Extra care should be used when cleaning equipment used in compounding preparations that require special precaution (e.g., antibiotics and cytotoxic and other hazardous materials). When possible, special equipment should be dedicated for such use, or when the same equipment is being used for all drug products, appropriate procedures shall be in place to allow meticulous cleaning of equipment before use with other drugs. If possible, disposable equipment should be used to reduce chances of bioburden and cross-contamination. USP <795>.  Hand hygiene includes nail, hands, wrists, and forearms. They should be washed thoroughly for at least 30 seconds with warm water and antimicrobial skin cleanser.  Smooth, seamless, non-shedding, impervious surfaces to facilitate cleaning and minimize cross contamination.  Appropriate arrangement is required to help prevent accidental misuse and ensure separation of internal and external use only medications (Note: Storage areas shall be clearly labeled). Utilize special storage equipment or storage instructions for combustible or volatile substances as directed by the Safety Data Sheet or other reference source for the specific substance.  Includes documenting filter changes and maintenance for purified water systems (sinks, dishwashers, purified water dispensers).  Cleaning compounding equipment and utensils either by manual or automated processes should conduct a final rinse with at least purified water. Facilities that utilize automated processes, such as dishwashers, should validate water temperature, utilize appropriate cleansing agents, and develop policies and procedures that at a minimum dictate length of cycle, method of loading, and manufacturer specific cleaning requirements. Use of the dishwasher must be documented with other cleaning activities. Dishwasher is to be included in the pharmacy equipment preventative maintenance program.  All new equipment must meet the requirements in M.G.L. c. 98 29 (all new balances shall have legal for trade designation). Refer to the National Institute of Standards and Technologys (NIST) Handbook 44.  247 CMR 9.01(3), USP <795> General Guidelines for Assigning Beyond-Use Dates maximum BUDs recommended for nonsterile compounded drug preparations that are packaged in tight, light-resistant containers.  A retail complex non-sterile compounding pharmacy licensed by the Commonwealth shall adhere to the most current standards established by USP, all chapters, when engaging in any form of complex non-sterile compounding. Such pharmacy shall also adhere to the additional regulations promulgated by the board pursuant to subsection (c). M.G.L. c. 112 39H (4), (247 CMR 9.01(3))  Minimum documentation includes, but is not limited to, a cleaning and disinfection log describing the cleaning activities conducted, daily, weekly, monthly, as needed, etc., and specifications for each cleaning agent used to ensure appropriate microbial coverage. Cleaning log must provide space for employee to enter initials to notate task as completed.  Including order of mixing, mixing temperatures or other environmental controls (when applicable), during of mixing, and other necessary information.  Generic name and quantity or concentration of each active ingredient, BUD, storage conditions, and prescription, lot, or control number (whichever is applicable).  The compounding record shall serve as the accountability documentation pursuant to M.G.L. c. 112, 39D & 39F. (247 CMR 18.08 (3))  1163 QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING: The authority and responsibility for the Quality Assurance program should be clearly defined and implemented and should include at least the following nine separate but integrated components: (1) training; (2) standard operating procedures (SOPs); (3) documentation; (4) verification; (5) testing; (6) cleaning, disinfecting, and safety; (7) containers, packaging, repackaging, labeling, and storage; (8) outsourcing, if used; and (9) responsible personnel.  The provisions of 247 CMR 18.10 shall not apply to any non-sterile compounded preparation dispensed to an inpatient at a hospital or nursing home or to non-sterile compounded preparations dispensed by a nuclear pharmacy.247 CMR 18.10 (3)  NIOSH List of Antineoplastic and other Hazardous Drugs in Healthcare Settings. Available at  HYPERLINK "https://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf" https://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. This includes medications new to the pharmacy, the pharmacy determines whether the medication is hazardous and the appropriate storing, handling (including appropriate personal protective equipment), labeling and disposing requirements  Hazardous drugs include hazardous ingredients, hazardous preparations, and hazardous waste  Work Precautions for Handling Hazardous Drugs Highlighted by NIOSH, OSHA and Joint Commission. Available at HYPERLINK "http://www.cdc.gov/niosh/nppm/upd-04-08-11.html"http://www.cdc.gov/niosh/nppm/upd-04-08-11.html  Per USP <800>: Antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage forms and any HD API must be stored separately from non-HDs in a manner that prevents contamination and personnel exposure. These HDs must be stored in an externally ventilated, negative-pressure room with at least 12 air changes per hour (ACPH). Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy.  Includes pre-filters and filters removed from C-PECs and C-SECs during maintenance.  OSHA Technical Manual Section VI: Chapter 2, Controlling Occupational Exposure to Hazardous Drugs -  HYPERLINK "https://www.osha.gov/SLTC/hazardousdrugs/controlling_occex_hazardousdrugs.html" https://www.osha.gov/SLTC/hazardousdrugs/controlling_occex_hazardousdrugs.html     FINAL DRAFT 5.16.17 12345vwxyc e M ƲymymymyYyK;h96hx5OJQJ\^Jh96hx5OJQJ\&jh_"hHkB*OJQJUphhxB*OJQJph jhxB*OJQJUphjhHkUjhxUhx h96hd~CJOJQJ^JaJ'hr#hx5B*OJQJ\^Jph8hr#hx5B*OJQJ\^JfH@phq 8hr#hMe5B*OJQJ\^JfH@phq 234 dH$$&P#$/If[$\$a$gd2~kd$$IflJ+&, @ 6P 0,44 lap ytk_$$&P#$/If[$\$a$gdk_ t u Ekd$$IflJ0R+'F 6P0,44 laytE$$&P#$/If[$\$a$gd;/5$$&P#$/If[$\$a$gd?M S T s t u     . 0 1 ? A B R T U i k l w y z  ¾ӱӱ¾¾¾¾¾¾¾¾¾¾ h96hxCJOJQJ^JaJh9=hx5OJQJ\h96hx5OJQJ\hx5OJQJ\^Jhx h96hxCJOJQJ^JaJh96hx5OJQJ\^Jh96h;/55OJQJ\^Jh;/55OJQJ\^J2 w[$$&P#$/If[$\$a$gd?$&P#$/If[$\$gd?okd7$$IflJ+', 6P0,44 laytE   }dH$$&P#$/If[$\$a$gd?$&P#$/If[$\$gd?kd$$IflJ0R+'F 6P0,44 laytE  . 0 }dH$$&P#$/If[$\$a$gd?$&P#$/If[$\$gd?kdc$$IflJ0R+'F 6P0,44 laytE0 1 ? 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t096,,5~5'55559ap<ytS$$If!vh#v~#v'#v#v#v#v:V l t096,5~5'55559ap<ytStDeCheck1tDeCheck1tDeCheck1tDeCheck1tDeCheck1tDeCheck10$$If!vh#v~#v"#v#v#v#v#v:V l t096,,5~5"555559apFytSkd$$Ifl֞y"')+.$6~"&&& t09644 lapFytS`$$If!vh#v~#v'#v#v#v#v:V l @@@@@@ t<096,5~5'55559ap<yt6!kd$$Iflֈy')+.$6~'&&& @@@@@@ t<09644 lap<yt6`$$If!vh#v~#v'#v#v#v#v:V lP t<096,5~5'55559ap<yt6!kd=$$IflPֈy')+.$6~'&&& t<09644 lap<yt6$$If!vh#v~#v'#v#v#v#v:V l t096,,5~5'55559ap<ytS$$If!vh#v~#v'#v#v#v#v:V l t096,,5~5'55559ap<ytS$$If!vh#v~#v'#v#v#v#v:V l t096,,5~5'55559ap<ytS$$If!vh#v~#v'#v#v#v#v:V l t096,,5~5'55559ap<ytS$$If!vh#v~#v'#v#v#v#v:V l t096,,5~5'55559ap<ytS`$$If!vh#v~#v'#v#v#v#v:V l t<096,5~5'55559ap<yt6!kdD$$Iflֈy')+.$6~'&&& t<09644 lap<yt6&$$If!vh#v~#v'#v#v#v#v:V l t096,,5~5'55559/ ap<ytS $$If!vh#v~#v'#v#v#v#v:V l t096,5~5'55559/ ap<ytS.$$If!vh#v~#v'#v#v#v#v:V l t096,5~5'55559/ / ap<ytSn$$If!vh#v~#v'#v#v#v#v:V l @@@@@@ t<096,5~5'55559/ ap<yt6!kdC$$Iflֈy')+.$6~'&&& @@@@@@ t<09644 lap<yt6n$$If!vh#v~#v'#v#v#v#v:V l 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