FOLLOWING IS THE AMENDED TEXT OF THE PENDING RULE FOR DOCKET NO. 27-0101-1301

004. INCORPORATION BY REFERENCE.

No documents have FDA's Compliance Policy Guidance for FDA Staff and Industry, Sec. 460.200, Pharmacy Compounding, Appendix A (Reissued May 29, 2002) has been incorporated by reference into these rules. (3-21-12)( )

(BREAK IN CONTINUITY OF SECTIONS)

010. DEFINITIONS AND ABBREVIATIONS (A -- I).

01. Accredited School or College of Pharmacy. A school or college that meets the minimum standards of the ACPE and appears on its list of accredited schools or colleges of pharmacy. (3-21-12)

02. ACPE. Accreditation Council for Pharmacy Education. (3-21-12)

03. Acute Care Hospital. A facility in which concentrated medical and nursing care is provided by, or under the supervision of, physicians on a twenty-four (24) hour basis to inpatients experiencing acute illnesses. (3-21-12)

04. ADS -- Automated Dispensing and Storage. A mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing, or distribution of drugs and that collects, controls, and maintains transaction information. (3-21-12)

05. CDC. United States Department of Health and Human Services, Centers for Disease Control and Prevention. (3-21-12)

06. Central Drug Outlet. A resident or nonresident pharmacy, drug outlet or business entity employing or contracting pharmacists to perform centralized pharmacy services. (7-1-13)

07. Central Pharmacist. A pharmacist performing centralized pharmacy services. (7-1-13)

08. Central Pharmacy. A pharmacy performing centralized pharmacy services. (7-1-13)

09. Centralized Pharmacy Services. The processing by a central drug outlet or central pharmacist of a request from another pharmacy to fill, refill, or dispense a prescription drug order, perform processing functions, or provide cognitive or pharmaceutical care services. Each function may be performed by the same or different persons and at the same or different locations. (7-1-13)

10. Change of Ownership. A change of majority ownership or controlling interest of a drug outlet licensed or registered by the Board. (3-21-12)

11. Charitable Clinic or Center -- Authorized Personnel. A person designated in writing and authorized by the qualifying charitable clinic or center's medical director or consultant pharmacist to perform specified duties within the charitable clinic or center under the supervision of a pharmacist, physician, dentist, optometrist, physician assistant, or an advanced practice professional nurse with prescriptive authority. (3-21-12)

12. Chart Order. A lawful drug order for a drug or device entered on the chart or a medical record of an inpatient or resident of an institutional facility. (3-21-12)

13. CME. Continuing medical education. (3-21-12)

14. COE -- Central Order Entry. A pharmacy that processes information related to the practice of pharmacy, engages solely in centralized prescription processing but from which drugs are not dispensed, is physically located outside the institutional pharmacy of a hospital, and is part of a hospital system. (3-21-12)

15. Collaborative Pharmacy Practice. A pharmacy practice whereby one (1) or more pharmacists jointly agree to work under a protocol authorized by one (1) or more prescribers to provide patient care and DTM services not otherwise permitted to be performed by a pharmacist under specified conditions or limitations. (3-21-12)

16. Collaborative Pharmacy Practice Agreement. A written agreement between one (1) or more pharmacists and one (1) or more prescribers that provides for collaborative pharmacy practice. (3-21-12)

17. Continuous Quality Improvement Program. A system of standards and procedures to identify and evaluate quality-related events and to constantly enhance the efficiency and effectiveness of the structures and processes of a pharmacy system. (3-21-12)

18. Correctional Facility. Any place used for the confinement of persons charged with or convicted of an offense or otherwise confined under a court order. (4-4-13)

19. CPE. Continuing pharmacy education. (3-21-12)

20. DEA. United States Drug Enforcement Administration. (3-21-12)

21. Distributor. A supplier of drugs manufactured, produced, or prepared by others to persons other than the ultimate consumer. (3-21-12)

22. DME. Durable medical equipment. (3-21-12)

23. Drug Order. A prescription drug order issued in the unique form and manner permitted for a patient or resident of an institutional facility or as permitted for other purposes by these rules. Unless specifically differentiated, rules applicable to a prescription drug order are also applicable to a drug order. (3-21-12)

24. Drug Product Selection. The act of selecting either a brand name drug product or its therapeutically equivalent generic. (3-21-12)

25. Drug Product Substitution. Dispensing a drug product other than prescribed. (4-4-13)

26. DTM -- Drug Therapy Management. Selecting, initiating, or modifying drug treatment pursuant to a collaborative practice agreement. (3-21-12)

27. Emergency Drugs. Drugs required to meet the immediate therapeutic needs of one (1) or more patients that are not available from any other authorized source in sufficient time to avoid risk of harm due to the delay that would result from obtaining the drugs from another source. (3-21-12)

28. Executive Director. The Idaho State Board of Pharmacy executive director created by Sections 54-1713 and 54-1714, Idaho Code. (3-21-12)

29. FDA. United States Food and Drug Administration. (3-21-12)

30. Flavoring Agent. An additive used in food or drugs when the additive is used in accordance with the principles of good pharmacy practices and in the minimum quantity required to produce its intended effect. (3-21-12)

31. Floor Stock. Drugs or devices not labeled for a specific patient that are maintained at a nursing station or other department of an institutional facility, excluding the pharmacy, for the purpose of administering to patients of the facility. (3-21-12)

32. FPGEC. Foreign Pharmacy Graduate Examination Committee. (4-4-13)

33. Hazardous Drug. Any drug listed as such by the National Institute for Occupational Safety and Health or any drug identified by at least one of the following criteria: ( )

a. Carcinogenicity; ( )

b. Teratogenicity or developmental toxicity; ( )

c. Reproductive toxicity in humans; ( )

d. Organ toxicity at low doses in humans or animals; ( )

e. Genotoxicity; or ( )

f. New drugs that mimic existing hazardous drugs in structure or toxicity. ( )

34. High Risk Sterile Product Preparation. A sterile drug product that is compounded from nonsterile components, containers, or equipment and requires terminal sterilization. ( )

335. HIPAA. Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191). (3-21-12)

346. Hospital System. A hospital or hospitals and at least one (1) on-site institutional pharmacy under common ownership. A hospital system may also include one (1) or more COE pharmacies under common ownership. (3-21-12)

357. Idaho State Board of Pharmacy or Idaho Board of Pharmacy. The terms Idaho State Board of Pharmacy, Idaho Board of Pharmacy, State Board of Pharmacy, and Board of Pharmacy are deemed synonymous and are used interchangeably to describe the entity created under the authority of Title 54, Chapter 17, Idaho Code. Unless specifically differentiated, "the Board" or "Board" also means the Idaho State Board of Pharmacy. (3-21-12)

368. Individually Identifiable Health Information. Information that is a subset of health information, including demographic information, collected from an individual and that: (3-21-12)

a. Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and (3-21-12)

b. Relates to the past, present, or future physical or mental health or condition of an individual; or the past, present, or future payment for the provision of health care to an individual that: (3-21-12)

i. Identifies the individual; or (3-21-12)

ii. With respect to which there is a reasonable basis to believe the information can be used to identify the individual. (3-21-12)

379. Institutional Pharmacy. A pharmacy located in an institutional facility. (3-21-12)

011. DEFINITIONS AND ABBREVIATIONS (J -- R).

01. LTCF -- Long-Term Care Facility. An institutional facility that provides extended health care to resident patients. (3-21-12)

02. Mail Service Pharmacy. A nonresident pharmacy that ships, mails, or delivers by any lawful means a dispensed legend drug to residents in this state pursuant to a legally issued prescription drug order and ensures the provision of corresponding related pharmaceutical care services required by law. (7-1-13)

03. MPJE. Multistate Pharmacy Jurisprudence Exam. (3-21-12)

04. MTM -- Medication Therapy Management. A distinct service or group of services that optimize therapeutic outcomes for individual patients. MTM services are independent of, but can occur in conjunction with, the provision or administration of a drug or a device and encompass a broad range of activities and responsibilities. The MTM service model in pharmacy practice includes the following five core elements: (3-21-12)

a. Medication therapy review; (3-21-12)

b. Personal medication record; (3-21-12)

c. Medication-related action plan; (3-21-12)

d. Intervention or referral, or both; (3-21-12)

e. Documentation and follow-up. (3-21-12)

05. NABP. National Association of Boards of Pharmacy. (3-21-12)

06. NAPLEX. North American Pharmacists Licensure Examination. (3-21-12)

07. NDC. National Drug Code. (3-21-12)

08. Non-Institutional Pharmacy. A pharmacy located in a drug outlet that is not an institutional facility. (3-21-12)

09. Parenteral Admixture. The preparation and labeling of sterile products intended for administration by injection. (3-21-12)

10. Pharmaceutical Care Services. A broad range of pharmacist-provided cognitive services, activities and responsibilities intended to optimize drug-related therapeutic outcomes for patients. Pharmaceutical care services may be performed independent of, or concurrently with, the dispensing or administration of a drug or device and encompasses services provided by way of DTM under a collaborative practice agreement, pharmacotherapy, clinical pharmacy practice, pharmacist independent practice, and MTM. Except as permitted pursuant to a collaborative practice agreement, nothing in these rules allows a pharmacist, beyond what is statutorily allowed, to engage in the unlicensed practice of medicine or to diagnose, prescribe, or conduct physical examinations. Pharmaceutical care services are not limited to, but may include one (1) or more of the following, according to the individual needs of the patient: (4-4-13)

a. Performing or obtaining necessary assessments of the patient's health status, including the performance of health screening activities that may include, but are not limited to, obtaining finger-stick blood samples; (3-21-12)

b. Reviewing, analyzing, evaluating, formulating or providing a drug utilization plan; (3-21-12)

c. Monitoring and evaluating the patient's response to drug therapy, including safety and effectiveness; (3-21-12)

d. Performing a comprehensive drug review to identify, resolve, and prevent drug-related problems, including adverse drug events; (3-21-12)

e. Documenting the care delivered; (3-21-12)

f. Communicating essential information or referring the patient when necessary or appropriate; (3-21-12)

g. Providing counseling education, information, support services, and resources applicable to a drug, disease state, or a related condition or designed to enhance patient compliance with therapeutic regimens; (3-21-12)

h. Conducting a drug therapy review consultation with the patient or caregiver; (3-21-12)

i. Preparing or providing information as part of a personal health record; (3-21-12)

j. Identifying processes to improve continuity of care and patient outcomes; (3-21-12)

k. Providing consultative drug-related intervention and referral services; (3-21-12)

l. Coordinating and integrating pharmaceutical care services within the broader health care management services being provided to the patient; and (3-21-12)

m. Other services as allowed by law. (3-21-12)

11. Pharmacist Extern. A person enrolled in an accredited school or college of pharmacy who is pursuing a professional degree in pharmacy. (4-4-13)

12. Pharmacist Intern. A person who has successfully completed a course of study at an accredited school or college of pharmacy, has received a professional degree in pharmacy, and is obtaining practical experience under the supervision of a pharmacist. (3-21-12)

13. Pharmacy Operations. Activities related to and including the preparation, compounding, distributing, or dispensing of drugs or devices from a pharmacy. (3-21-12)

14. PHI -- Protected Health Information. Individually identifiable health information that is: (3-21-12)

a. Transmitted by electronic media (as defined by the HIPAA Privacy Rule at 45 CFR 160.103); (3-21-12)

b. Maintained in electronic media; and (3-21-12)

c. Transmitted or maintained in any other form or medium. (3-21-12)

d. PHI excludes individually identifiable health information in: (3-21-12)

i. Education records covered by the Family Education Right and Privacy Act, as amended (20 U.S.C. Section 1232g); (3-21-12)

ii. Records described at 20 U.S.C. Section 1232g(a)(4)(B)(iv); and (3-21-12)

iii. Employment records held by a covered entity (as defined by the HIPAA Privacy Rule at 45 CFR 160.103) in its role as an employer. (3-21-12)

15. PIC. Pharmacist-in-charge. (3-21-12)

16. PMP. Prescription Monitoring Program. (3-21-12)

17. Prepackaging. The act of transferring a drug, manually or using an automated system, from a manufacturer's original container to another container prior to receiving a prescription drug order or prior to distributing a sterile product as allowed by these rules. (3-21-12)( )

18. Prescriber. An individual currently licensed, registered, or otherwise authorized to prescribe and administer drugs in the course of professional practice. (3-21-12)

19. Prescriber Drug Outlet. A drug outlet in which prescription drugs or devices are dispensed

directly to patients under the supervision of a prescriber, except where delivery is accomplished only through on-site administration or the provision of drug samples. (3-21-12)

20. Readily Retrievable. Records are considered readily retrievable if they are able to be completely and legibly produced upon request within seventy-two (72) hours. (3-21-12)

21. Reconstitution. The process of adding a dilute to a powdered medication to prepare a solution or suspension, according to the product's labeling or the manufacturer's instructions. ( )

212. Relative Contraindication. A condition that renders a particular treatment or procedure inadvisable, but not prohibitive. (3-21-12)

223. Remote Dispensing Site. A licensed pharmacy staffed by one or more certified technicians at which telepharmacy services are provided through a supervising pharmacy. (3-21-12)

234. Remote Office Location. A secured area that is restricted to authorized personnel, adequately protects private health information, and shares a secure common electronic file or a private, encrypted connection with a pharmacy, from which a pharmacist who is contracted or employed by a central drug outlet performs centralized pharmacy services. (7-1-13)

245. Retail Non-Pharmacy Drug Outlet. A retail outlet that sells non-prescription drugs or devices that is not a pharmacy. (3-21-12)

256. Retail Pharmacy. A community or other pharmacy that sells prescription drugs at retail and is open to the public for business. (3-21-12)

267. R.N. Registered nurse. (3-21-12)

28. USP 795. The current edition of the United States Pharmacopeia-National Formulary, Chapter 795. ( )

29. USP 797. The current edition of the United States Pharmacopeia-National Formulary, Chapter 797. ( )

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231. -- 2398. (RESERVED)

239. COMPOUNDING DRUG PRODUCTS.

01. Application. These rules apply to any person, including any business entity, authorized to engage in the practice of non-sterile compounding, sterile compounding and sterile prepackaging of drug products in or into Idaho. ( )

a. USP. Strict application of or adherence to the guidelines of USP 795 and USP 797 is not mandated; however, it is expected that all persons and business entities will strive to practice in accordance with those guidelines that apply to their practice settings and in all situations comply with the spirit of USP 797 and USP 795. ( )

b. Manufacturing. Any compounding that is not permitted herein is considered manufacturing. ( )

02. General Compounding Standards. ( )

a. Certificate of Analysis. A COA issued by a firm located in the United States must be obtained for all active ingredients procured for compounding and retained for a period of not less than three (3) years from the date the container is emptied. If a COA is not available from the vendor, one must be procured from a laboratory located in the United States. COAs are not required if the active ingredient utilized is designated USP-NF. If the product is not designated as USP-NF, then the following minimum information is required on the COA: ( )

i. Product name; ( )

ii. Lot number; ( )

iii. Expiration date; and ( )

iv. Assay. ( )

b. Prohibited Compounding. Compounding any drug for human use that the FDA, in its Compliance Policy Guidance for FDA Staff and Industry, Sec. 460.200 Pharmacy Compounding, Appendix A (Reissued May 29, 2002), has identified as prohibited for compounding or withdrawn or removed from the market for safety reasons is prohibited. ( )

c. Equipment. Equipment and utensils must be of suitable design and composition and cleaned, sanitized, or sterilized as appropriate prior to use. ( )

d. Disposing Compromised Drugs. When the correct identity, purity, strength, and sterility of ingredients and components cannot be confirmed (in cases of, for example, unlabeled syringes, opened ampules, punctured stoppers of vials and bags, and containers of ingredients with incomplete labeling) or when the ingredients and components do not possess the expected appearance, aroma, and texture, they must be disposed of immediately. ( )

e. Hazardous Drugs. Drug outlets must ensure the storage area has sufficient general exhaust ventilation to dilute and remove any airborne contaminants and use a ventilated cabinet designed to reduce worker exposures while preparing hazardous drugs. When asepsis is not required, a Class I BSC, powder containment hood or an isolator intended for containment applications may be sufficient. A ventilated cabinet that re-circulates air inside the cabinet or exhausts air back into the room environment is prohibited, unless the hazardous drugs in use will not volatilize while they are being handled. Additionally, a drug outlet that prepares hazardous drugs must: ( )

i. Clearly identify prepared doses of hazardous drugs, label them with proper precautions, and dispense them in a manner to minimize risk of hazardous spills; ( )

ii. Comply with applicable local, state, and federal laws in the disposal of hazardous waste; and ( )

iii. Include procedures for handling hazardous spills in the policies and procedures manual. ( )

iv. Supplies necessary for handling hazardous spills and disposal of wastes must be available and maintained in the area at all times. ( )

03. Scope of Practice. A pharmacist may compound a drug product in the usual course of professional practice for an individual patient pursuant to an established prescriber/patient/pharmacist relationship and a valid prescription drug order. ( )

a. Commercially Available Products. Compounding a drug product that is commercially available is prohibited, provided however, that a pharmacist may compound a drug product that is essentially a copy of an available FDA-approved drug product if: ( )

i. Pursuant to a valid pharmacist/patient/prescriber relationship and valid prescription drug order, it is medically warranted to provide an alternate ingredient, dosage form, or strength of significance; or ( )

ii. Commercial product is not reasonably available in the market in time to meet the patient's needs. ( )

b. Anticipatory Compounding. A pharmacist may compound limited quantities of a drug product prior to receiving a valid prescription drug order based on a history of receiving valid prescription drug orders generated solely within an established pharmacist/patient/prescriber relationship. ( )

c. Office Use. A pharmacist may distribute non-patient specific drug products in the absence of a valid prescription drug order to licensed practitioners to administer (and not for resale) to their patients in the course of their professional practice. The quantity shall be limited to five percent (5%) of the total number of compounded or sterile prepackaged drug products dispensed and distributed on an annual basis by the pharmacy, except that this limit shall not apply to nuclear pharmacies. ( )

d. Research. A drug may be compounded for the purpose of, or incident to, research, teaching, or chemical analysis and not for resale or dispensing. ( )

e. Exceptions. Compounding does not include reconstituting of a nonsterile drug or a sterile drug for immediate administration or the addition of a flavoring agent to a drug product. ( )

04. Drug Compounding Controls. ( )

a. Policies and Procedures. In consideration of the applicable provisions of USP 795 concerning pharmacy compounding of non-sterile preparations, USP 797 concerning sterile preparations, Chapter 1075 of the USP-NF concerning good compounding practices, and Chapter 1160 of the USP-NF concerning pharmaceutical calculations, policies and procedures for the compounding or sterile prepackaging of drug products must ensure the safety, identity, strength, quality, and purity of the finished product, and must include any of the following that are applicable to the scope of compounding being performed: ( )

i. Appropriate packaging, handling, transport, and storage requirements; ( )

ii. Accuracy and precision of calculations, measurements, and weighing; ( )

iii. Determining ingredient identity, quality, and purity; ( )

iv. Labeling accuracy and completeness; ( )

v. Beyond use date assignment; ( )

vi. Auditing for deficiencies, including routine environmental sampling, quality and accuracy testing, and maintaining inspection and testing records; ( )

vii. Maintaining environmental quality control; ( )

viii. Safe limits and ranges for strength of ingredients, pH, bacterial endotoxins, and particulate matter; and ( )

b. Accuracy. Components, including but not limited to, bulk drug substances, used in the compounding or sterile prepackaging of drug products must be accurately weighed, measured, or subdivided, as appropriate. The amount of each active ingredient contained within a compounded drug product must not vary from the labeled potency by more than the drug product's acceptable potency range listed in the USP-NF monograph for that product. If USP-NF does not publish a range for a particular drug product, the active ingredients must not contain less than ninety percent (90%) and not more than one hundred ten percent (110%) of the potency stated on the label. If any drug potency analysis is conducted, records must be maintained in a readily retrievable manner. ( )

c. Non-Patient Specific Records. Except for drug products that are being compounded for direct administration, a production record of drug products compounded or sterile prepackaged for office use or prepared in anticipation of receiving prescription drug orders, solely as permitted herein, must be prepared and kept for each drug product prepared, including: ( )

i. Production date; ( )

ii. Beyond use date; ( )

iii. List and quantity of each ingredient; ( )

iv. Internal control or serial number; and ( )

v. Initials or unique identifier of all persons involved in the process or the compounder responsible for the accuracy of these processes. ( )

d. Labeling. The label affixed to the container of a compounded or sterile prepackaged drug product that is: ( )

i. Dispensed must comply with the standard prescription drug labeling requirements. ( )

ii. Distributed in the absence of a patient specific prescription drug order, solely as permitted herein, must contain the following information: ( )

(1) The name of each drug included; ( )

(2) The strength or concentration of each drug included; ( )

(3) If applicable, the name and concentration of the base or diluents; ( )

(4) If applicable, the dosage form or route of administration; ( )

(5) The total quantity of the drug product; ( )

(6) The expiration or beyond use date; ( )

(7) The initials or unique identifier of the compounder responsible for the accuracy of the drug product; ( )

(8) The statement "not for resale;" and ( )

(9) Handling, storage or drug specific instructions, cautionary information, and warnings as required or deemed appropriate for proper use and patient safety. ( )

240. STERILE PRODUCT PREPARATION.

01. Application. In addition to all other applicable rules in this chapter, including the rules governing Compounding Drug Products, these rules apply to all persons, including any business entity, engaged in the practice of sterile compounding and sterile prepackaging. ( )

02. Dosage Forms Requiring Sterility. The sterility of compounded biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals must be maintained or the compounded drug product must be sterilized when prepared in the following dosage forms: ( )

a. Aqueous bronchial and nasal inhalations, except sprays intended to treat bronchial mucosa only; ( )

b. Baths and soaks for live organs and tissues; ( )

c. Injections (for example, colloidal dispersions, emulsions, solutions, suspensions); ( )

d. Irrigations for wounds and body cavities; ( )

e. Ophthalmic drops and ointments; and ( )

f. Tissue implants. ( )

03. Compounder Responsibilities. Compounders and sterile prepackagers are responsible for ensuring that sterile products are accurately identified, measured, diluted, and mixed and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed, as well as prepared in a manner that maintains sterility and minimizes the introduction of particulate matter; ( )

a. Unless following manufacturer's guidelines or another reliable literature source, opened or partially used packages of ingredients for subsequent use must be properly stored as follows; ( )

i. Opened or entered (such as needle-punctured) single-dose containers, such as bags, bottles, syringes, and vials of sterile products and compounded sterile products shall be used within one (1) hour if opened in non-sterile conditions, and any remaining contents must be discarded; ( )

ii. Single-dose vials needle-punctured in a sterile environment may be used up to six (6) hours after initial needle puncture; ( )

iii. Opened single-dose ampules shall not be stored for any time period; and ( )

iv. Multiple-dose containers (for example, vials) that are formulated for removal of portions on multiple occasions because they contain antimicrobial preservatives, may be used for up to twenty-eight (28) days after initial opening or entering, unless otherwise specified by the manufacturer; ( )

b. Water-containing compounded sterile products that are non-sterile during any phase of the compounding procedure must be sterilized within six (6) hours after completing the preparation in order to minimize the generation of bacterial endotoxins; ( )

c. Food, drinks, and materials exposed in patient care and treatment areas shall not enter ante-areas, buffer areas, or segregated areas where components and ingredients of sterile products are prepared. ( )

014. Environmental Controls. Except when prepared for immediate administration, the environment for the preparation of sterile products in a drug outlet must be in an isolated area, designed to avoid unnecessary traffic and airflow disturbances, and equipped to accommodate aseptic techniques and conditions. (3-21-12)

a. Hoods and aseptic environmental control devices must be certified for operational efficiency as often as recommended by the manufacturer or at least every twelve six (126) months or if relocated. (3-21-12)( )

b. PrefFilters must be inspected and replaced in accordance with the manufacturer's recommendations. (3-21-12)( )

025. Sterile Product Preparation Equipment. A drug outlet in which sterile products are prepared must be equipped with at least the following: (3-21-12)

a. Protective apparel including non-vinyl gloves, gowns, and masks unless the PIC or director can provide aseptic isolator manufacturer's written documentation that any component of garbing is not required; (3-21-12)( )

b. A sink with hot and cold water in close proximity to the hood; (3-21-12)

c. A refrigerator for proper storage of additives and finished sterile products prior to delivery when necessary; (3-21-12)

d. An appropriate laminar airflow hood or other aseptic environmental control device such as a laminar flow biological safety cabinet;. (3-21-12)( )

e. A separate vertical flow biohazard safety hood, if hazardous materials are prepared; and (3-21-12)

f. Supplies necessary for handling both hazardous and biohazardous spills and disposal of wastes must be available and maintained in the area at all times. (3-21-12)

036. Cytotoxic Sterile Hazardous Drugs Preparation Equipment. A drug outlet in which cytotoxic Sterile hazardous drugs are prepared must also: (3-21-12)

a. Bbe equipped with and prepared the drugs in a vented dedicated class II biological safety cabinet or a barrier isolator of appropriate design to meet the personnel exposure limits described in product material safety data sheets;. (3-21-12)( )

b. Require appropriate containment techniques; (3-21-12)

c. Clearly identify prepared doses of cytotoxic drugs, label them with proper precautions, and dispense them in a manner to minimize risk of cytotoxic spills; (3-21-12)

d. Comply with applicable local, state, and federal laws in the disposal of cytotoxic waste; and (3-21-12)

e. Include procedures for handling cytotoxic spills in the policies and procedures manual. (3-21-12)

047. Documentation Requirements. The following documentation must also be maintained by a drug outlet in which sterile products are prepared: (3-21-12)

a. Justification of expiration beyond use dates chosen assigned, pursuant to direct testing or extrapolation from reliable literature sources; (3-21-12)( )

b. Employee tTraining records, ensuring that personnel are adequately skilled, educated, and instructed; (3-21-12)( )

c. Technique aAudits; and appropriate for the risk of contamination for the particular sterile product including: (3-21-12)( )

i. Visual inspection to ensure the absence of particulate matter in solutions, the absence of leakage from bags and vials, and the accuracy of labeling with each dispensing; ( )

ii. Initial hand hygiene and garbing competency; ( )

iii. Media-fill test procedures (or equivalent), aseptic technique, and practice related competency evaluation at least annually by each compounder or sterile prepackager; ( )

iv. Environmental sampling testing at least upon registration of a new drug outlet, following the servicing or re-certification of facilities and equipment, or in response to identified problems with end products, staff techniques or patient-related infections, or every six (6) months, including: ( )

(1) Total particle counts; ( )

(2) Viable air sampling; ( )

(3) Gloved fingertip sampling; ( )

(4) Surface sampling; ( )

v. Sterility testing of high risk batches of more than twenty-five (25) identical packages (ampules, bags, vials, etc.) before dispensing or distributing; ( )

d. Temperature, logged daily; ( )

e. Beyond use date and accuracy testing, when appropriate; and ( )

df. Measuring, mixing, sterilizing and purification Eequipment inspection, monitoring, cleaning, and maintenance to ensure accuracy and effectiveness for their intended use. (3-21-12)( )

058. Policies and Procedures. Policies and procedures appropriate to the practice setting must be adopted by a drug outlet compounding preparing sterile pharmaceutical products and must: (3-21-12)

a. Be designed and sufficiently detailed to protect the health and safety of persons preparing or receiving sterile products; and (3-21-12)

b. Iinclude a continuous quality improvement program for monitoring personnel qualifications and training in sterile technique, product storage, stability standards, and infection control. including: (3-21-12)( )

a. Antiseptic hand cleansing; ( )

b. Disinfection of non-sterile compounding surfaces; ( )

c. Appropriately selecting and donning protective garb; ( )

d. Maintaining or achieving sterility of sterile products while maintaining the labeled strength of active ingredients; ( )

e. Manipulating sterile products aseptically, including mixing, diluting, purifying, and sterilizing in the proper sequence; ( )

f. Choosing the sterilization method, pursuant to the risk of a contamination of particular compounded sterile product; and ( )

g. Inspecting for quality standards before dispensing or distributing. ( )