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1 South Carolina General Assembly 2 120th Session, 2013-2014 3 4 S. 183 5 6 STATUS INFORMATION 7 8 General Bill 9 Sponsors: Senator Cromer 10 Document Path: l:\council\bills\nl\13056dg13.docx 11 Companion/Similar bill(s): 3161 12 13 Introduced in the Senate on January 8, 2013 14 Currently residing in the Senate Committee on Medical Affairs 15 16 Summary: Pharmacy Practice Act 17 18 19 HISTORY OF LEGISLATIVE ACTIONS 20 21 Date Body Action Description with journal page number 22 1/8/2013 Senate Introduced and read first time ( Senate Journalpage 114) 23 1/8/2013 Senate Referred to Committee on Medical Affairs ( Senate Journalpage 114) 24 25 26 VERSIONS OF THIS BILL 27 28 1/8/2013 29 1 2 3 4 5 6 7 8 9 A BILL 10 11 TO AMEND SECTION 404330, CODE OF LAWS OF SOUTH 12 CAROLINA, 1976, RELATING TO DEFINITIONS IN THE 13 SOUTH CAROLINA PHARMACY PRACTICE ACT, SO AS TO 14 DEFINE ADDITIONAL TERMS; TO AMEND SECTION 15 404386, RELATING TO COMPOUNDING PHARMACIES, SO 16 AS TO REVISE MINIMUM GOOD COMPOUNDING 17 PRACTICES, TO PROVIDE A PHARMACIST MUST 18 PERFORM A FINAL CHECK ON A PRODUCT 19 COMPOUNDED BY A PHARMACY TECHNICIAN, TO 20 MODIFY REQUIREMENTS FOR AN AREA USED FOR 21 COMPOUNDING IN A PHARMACY, TO PROVIDE 22 PHARMACISTS SHALL ENSURE CERTAIN EXPECTED 23 FEATURES OF INGREDIENTS USED IN A FORMULATION, 24 TO PROVIDE A MEANS FOR DETERMINING THE 25 MAXIMUM BEYONDUSE DATE OF AN EXCESS AMOUNT 26 OF A SPECIFIC COMPOUND IN CERTAIN 27 CIRCUMSTANCES, TO REQUIRE CERTAIN WRITTEN 28 POLICIES AND PROCEDURES APPLICABLE TO A 29 COMPOUNDING AREA, AND TO PROVIDE THAT 30 MATERIAL DATA SAFETY MUST BE READILY 31 ACCESSIBLE TO PHARMACY PERSONNEL WHO WORK 32 WITH DRUG SUBSTANCES OR BULK CHEMICALS, AND 33 TO DELETE OBSOLETE LANGUAGE; AND TO AMEND 34 SECTION 404388, RELATING TO THE HANDLING OF 35 STERILE PRODUCTS BY PHARMACIES, SO AS TO REVISE 36 ASSOCIATED STANDARDS AND TO BROADEN THE 37 APPLICATION OF THESE STANDARDS TO INCLUDE 38 OTHER FACILITIES PERMITTED BY THE BOARD, AMONG 39 OTHER THINGS. 40 41 Be it enacted by the General Assembly of the State of South 42 Carolina:

[183] 2 1 2 SECTION 1. Section 404330 of the 1976 Code is amended to 3 read: 4 5 “Section 404330. For purposes of this chapter: 6 (1) ‘Administer’ means the direct application of a drug or 7 device pursuant to a lawful order of a practitioner to the body of a 8 patient by injection, inhalation, ingestion, topical application, or 9 any other means. 10 (2) ‘Ante area’ means an ISO 8 or greater area where personnel 11 perform hand hygiene, garbing, and stage components. An ante 12 area precedes a buffer area, provided: 13 (a) a buffer area must be separated by a wall from an ante 14 area if highrisk preparations are compounded; and 15 (b) if only lowrisk and mediumrisk preparations are 16 compounded, separating an ante room from a buffer area is 17 recommended. 18 (3) ‘Aseptic preparation’ means the technique involving 19 procedures designed to preclude contamination of drugs, 20 packaging, equipment, or supplies by microorganisms during 21 processing. 22 (4) ‘Automated compounding device’ or ‘ACD’ means an 23 automated device that compounds, measures, counts, packages, or 24 labels a specified quantity of dosage units for a designated drug 25 preparation. 26 (5) ‘Beyonduse date’ or ‘BUD’ means the date or time after 27 which a compounded preparation is recommended not to be 28 dispensed or used. The date is determined from the date or time the 29 preparation is compounded. 30 (26) ‘Biological safety cabinet’ or ‘BSC’ means a containment 31 unit suitable for the preparation of lowtomoderate risk agents 32 where there is a need for protection of the product, personnel, and 33 environment, according to National Sanitation Foundation 34 Standard 49. 35 (37) ‘Board’ or ‘Board of Pharmacy’ means the State Board of 36 Pharmacy. 37 (48) ‘Brand name’ means the proprietary or trade name placed 38 upon a drug, its container, label, or wrapping at the time of 39 packaging. 40 (9) ‘Buffer area’ means an area where the primary engineering 41 control is physically located. Activities that occur in this area 42 include the preparation and staging of components and supplies 43 used when compounding sterile products.

[183] 3 1 (10) ‘Certified pharmacy technician’ means an individual who is 2 a registered pharmacy technician and who has completed the 3 requirements provided for in Section 404382(B). 4 (511) ‘Chart order’ means a lawful order from a practitioner 5 for a drug or device for patients of a hospital or extended care 6 facility, or such an order prepared by another person and signed by 7 a practitioner either immediately or at another time, issued for a 8 legitimate medical purpose within the practitioner’s course of 9 legitimate practice and including orders derived on behalf of a 10 practitioner from a practitioner approved drug therapy 11 management. 12 (612) ‘Class 100 environment’ or ‘ISO 5’ means an 13 atmospheric environment which contains less than one hundred 14 particles 0.5 microns in diameter per cubic foot of air. 15 (13) ‘Closedsystem transfer device’ or ‘CSTD’ means a 16 closedsystem hazardous drug handling device comprising a 17 number of interlocking parts for reconstituting, injecting, and 18 administering doses of hazardous drugs. 19 (14) ‘Colonyforming unit’ or ‘CFU’ means an estimate of cell 20 quantity. 21 (715) ‘Compounding’ means the preparation, propagation, 22 conversion, or processing of a drug or device, either directly or 23 indirectly, by extraction from substances of natural origin or 24 independently by means of chemical or biological synthesis, or the 25 preparation, mixing, assembling, packaging, or labeling of a drug 26 or device as the result of a practitioner’s prescription drug order or 27 initiative based on the practitioner/patient/pharmacist relationship 28 in the course of professional practice, or for the purpose of, or as 29 an incident to, research, teaching, or chemical analysis and not for 30 sale or dispensing. Compounding also includes the preparation of 31 drugs or devices in anticipation of prescription drug orders based 32 on routine, regularly observed prescribing patterns. The term 33 compounding does not include mixing, reconstituting, or other 34 such acts that are performed in accordance with directions 35 contained in approved labeling provided by the product’s 36 manufacturer and other manufacturer directions consistent with 37 that labeling. 38 (16) ‘Compounded sterile preparation’ or ‘CSP’ means a 39 compounded biologic, diagnostic, drug, nutrient, or 40 radiopharmaceutical that must be sterile when administered to a 41 patient. Among other things, CSPs include: 42 (a) aqueous bronchial and nasal inhalations; 43 (b) baths and soaks for live organs and tissues;

[183] 4 1 (c) injections, such as colloidal dispersions, emulsions, 2 solutions, suspensions, among others; 3 (d) irrigations for wounds and body cavities; 4 (e) ophthalmic drops and ointments; and 5 (f) tissue implants. 6 (17) ‘Compounding aseptic containment isolator’ or ‘CACI’ 7 means a completely enclosed isolating cabinet that makes use of 8 airtight glove ports designed to protect the user from exposure to 9 airborne drugs and other agents during the compounding and 10 material transfer processes. A CACI also provides an aseptic 11 environment for compounding sterile preparations. Air exchange 12 with the surrounding environment should not occur in a CACI 13 unless the air is first passed through a HEPA minimum, microbial 14 retentive filter system capable of containing airborne 15 concentrations of the physical size and state of the drug being 16 compounded. Where volatile hazardous drugs are prepared, the 17 exhaust air from the isolator should be appropriately removed by 18 properly designed building ventilation. 19 (18) ‘Compounding aseptic isolator’ or ‘CAI’ means a 20 completely enclosed isolating cabinet that makes use of airtight 21 glove ports designed to maintain an aseptic compounding 22 environment within the isolator throughout the compounding and 23 material transfer process. Air exchange into the isolator from the 24 surrounding environment should not occur unless the air has first 25 passed through a HEPA minimum, microbial retentive filter. A 26 CAI is primarily used for nonhazardous drug preparations. 27 (819) ‘Confidential information’ means information 28 maintained in a patient’s records or which is communicated to a 29 patient as part of patient counseling, which is privileged and may 30 be released only to the patient, to those practitioners and 31 pharmacists where, in the pharmacist’s professional judgment, 32 release is necessary to protect the patient’s health and well being, 33 and to other persons or governmental agencies authorized by law 34 to receive such confidential information. 35 (20) ‘Critical site’ means an opening that provides a direct 36 pathway between a CSP and the environment or any surface 37 coming in contact with the preparation or environment. 38 (9) ‘Cytotoxic agent’ means a drug that has the capability of 39 killing living cells. 40 (1021) ‘Deliver’ or ‘delivery’ means the actual, constructive, or 41 attempted transfer of a drug or device from one person to another, 42 whether or not for consideration.

[183] 5 1 (1122) ‘Designated agent’ means a person employed by an 2 authorized practitioner to transmit, either orally or electronically, a 3 prescription drug order on behalf of the authorized practitioner to 4 the pharmacist. The authorized practitioner accepts the 5 responsibility for the correct transmission of the prescription drug 6 order. 7 (1223) ‘Designated pharmacist’ means an individual currently 8 licensed by the Board of Pharmacy in this State who certifies 9 internship training. 10 (1324) ‘Device’ means an instrument, apparatus, implement, 11 machine, contrivance, implant, or other similar or related article, 12 including any component part or accessory, which is required 13 under federal law to bear the label: ‘Caution: Federal law restricts 14 this device for sale by or on the order of a ______’, the 15 blank to be filled with the word physician, dentist, veterinarian, or 16 with the descriptive designation of any other practitioner licensed 17 by the law of the State in which he practices to use or order the use 18 of the device; or ‘Federal law prohibits dispensing without 19 prescription’; or any products deemed to be a public health threat 20 after notice and public hearing as designated by the board. 21 (25) ‘Direct compounding area’ or ‘DCA’ means the area within 22 the primary engineering controls where critical sites are exposed to 23 unidirectional HEPAfiltered air, also known as first air. 24 (26) ‘Disinfectant’ means an agent that frees from infection, 25 usually a chemical agent but sometimes a physical one, and that 26 destroys diseasecausing pathogens or other harmful 27 microorganisms but may not kill bacterial and fungal spores. It 28 refers to substances applied to inanimate objects. 29 (1427) ‘Dispense’ means the transfer of possession of one or 30 more doses of a drug or device by a licensed pharmacist or person 31 permitted by law, to the ultimate consumer or his agent pursuant to 32 a lawful order of a practitioner in a suitable container appropriately 33 labeled for subsequent administration to, or use by, a patient. As 34 an element of dispensing, the dispenser shall, before the actual 35 physical transfer, interpret and assess the prescription order for 36 potential adverse reactions or side effects, interactions, allergies, 37 dosage, and regimen the dispenser considers appropriate in the 38 exercise of his professional judgment, and the dispenser shall 39 determine that the drug or device called for by the prescription is 40 ready for dispensing. The dispenser shall also provide counseling 41 on proper drug usage, either orally or in writing, as provided in this 42 chapter. The actual sales transaction and delivery of a drug or

[183] 6 1 device is not considered dispensing and the administration is not 2 considered dispensing. 3 (1528) ‘Distribute’ means the delivery of a drug or device other 4 than by administering or dispensing. 5 (1629) ‘Drug’ or ‘medicine’ means: 6 (a) articles recognized as drugs in an official compendium, 7 or supplement to a compendium, including, but not limited to, 8 USP/NF designated from time to time by the board for use in the 9 diagnosis, cure, mitigation, treatment, or prevention of disease in 10 humans or other animals; 11 (b) articles intended for use in the diagnosis, cure, 12 mitigation, treatment, or prevention of disease in humans or other 13 animals; 14 (c) articles, other than food, or nonprescription vitamins 15 intended to affect the structure or a function of the human body or 16 other animals; and 17 (d) articles intended for use as a component of any articles 18 specified in item (a), (b), or (c) of this subsection. 19 (1730) ‘Drug regimen review’ includes, but is not limited to, the 20 following activities: 21 (a) evaluation of prescription drug orders and pharmacy 22 patient records for: 23 (i) known allergies; 24 (ii) rational therapycontraindications; 25 (iii) reasonable dose and route of administration; and 26 (iv) reasonable directions for use. 27 (b) evaluation of prescription drug orders and pharmacy 28 patient records for duplication of therapy. 29 (c) evaluation of prescription drug orders and pharmacy 30 patient records for interactions: 31 (i) drugdrug; 32 (ii) drugfood; 33 (iii) drugdisease, if available; and 34 (iv) adverse drug reactions. 35 (d) evaluation of prescription drug orders and pharmacy 36 patient records for proper utilization, including overutilization or 37 underutilization, and optimum therapeutic outcomes. 38 (1831) ‘Drug therapy management’ is that practice of pharmacy 39 which involves the expertise of the pharmacist in a collaborative 40 effort with the practitioner and other health care providers to 41 ensure the highest quality health care services for patients.

[183] 7 1 (32) ‘Endotoxin’ means a toxin in the cell walls of all 2 gramnegative bacteria that is the most common type of pyrogenic 3 substance. 4 (1933) ‘Enteral’ means within or by way of the intestine. 5 (2034) ‘Equivalent drug product’ means a drug product which 6 has the same established name and active ingredients to meet the 7 same compendia or other applicable standards, but which may 8 differ in characteristics such as shape, scoring configuration, 9 packaging, excipient (including colors, flavors, preservatives), and 10 expiration time. Pharmacists may utilize as a basis for the 11 determination of generic equivalency Approved Drug Products 12 with Therapeutic Equivalence Evaluations and current 13 supplements published by the Federal Food and Drug 14 Administration, within the limitations stipulated in that 15 publication. 16 (35) ‘Expiration date’ means the maximum time period that a 17 manufactured, compounded, or repackaged product may be used 18 based on specified storage requirements. 19 (2136) ‘Extern’ means an individual currently enrolled in an 20 approved college or school of pharmacy who is on required 21 rotations for obtaining a degree in pharmacy. 22 (37) ‘First air’ means the air exiting the HEPA filter in a 23 unidirectional airstream that is essentially particulatefree. 24 (2238) ‘Generic names’ mean the official compendia names or 25 United States Adopted Names (USAN). 26 (39) ‘Glove fingertip test’ means a test where the gloved 27 fingertips and thumb are lightly pressed into appropriate agar 28 plates. The plates are incubated for an appropriate time period and 29 at an appropriate temperature. 30 (40) ‘Hazardous drug’ means a drug that has at least one of the 31 following properties: carcinogenicity; teratogenicity or 32 developmental toxicity; reproductive toxicity in humans; organ 33 toxicity at low doses in humans or animals; genotoxicity; or new 34 drugs that mimic existing hazardous drugs in structure or toxicity. 35 (2341) ‘Health care provider’ includes a pharmacist who 36 provides health care services within the pharmacist’s scope of 37 practice pursuant to state law and regulation. 38 (42) ‘Highefficiency particulate arrestor’ or ‘HEPA’ means a 39 type of air filter that must satisfy certain efficiency standards set 40 by the United States Department of Energy. A filter that qualifies 41 as a HEPA is subject to interior classifications. 42 (2443) ‘Institutional facility’ means an organization whose 43 primary purpose is to provide a physical environment for patients

[183] 8 1 to obtain health care services and shall not include those places 2 where physicians, dentists, veterinarians, or other practitioners, 3 who are duly licensed, engage in private practice. 4 (2544) ‘Institutional pharmacy’ means the physical portion of an 5 institutional facility that is engaged in the compounding, 6 dispensing, and distribution of drugs, devices, and other materials, 7 hereinafter referred to as ‘drugs’, used in the diagnosis and 8 treatment of injury, illness, and disease and which is permitted by 9 the State Board of Pharmacy. 10 (2645) ‘Institutional consultant pharmacist’ means a pharmacist 11 licensed in this State who acts as a consultant for institutional 12 facilities. 13 (2746) ‘Intern’ means an individual who is currently registered 14 by certificate in this State to engage in the practice of pharmacy 15 while under the personal supervision of a pharmacist and is 16 satisfactorily progressing toward meeting the requirements for 17 licensure as a pharmacist. 18 (47) ‘ISO’ means the International Organization for 19 Standardization. 20 (48) ‘ISO 5 environment’ means an atmospheric environment 21 that contains fewer than 3,520 particles no greater than 0.5 22 millimeters in diameter per cubic meter of air. The previous 23 designation of this environment was known as Class 100. 24 (49) ‘ISO 7 environment’ means an atmospheric environment 25 that contains fewer than 352,000 particles no greater than 0.5 26 millimeters in diameter per cubic meter of air. The previous 27 designation of this environment was known as Class 10,000. 28 (50) ‘ISO 8 environment’ means an atmospheric environment 29 that contains fewer than 3,520,000 particles no greater than 0.5 30 millimeters in diameter per cubic meter of air. The previous 31 designation of this environment was known as Class 100,000. 32 (51) ‘Isolator’ means a selfcontained primary engineering 33 control defined by having fixed walls, a floor, and a ceiling, and 34 includes barriers such as gloves, sleeves, and air locks that separate 35 transfers of materials into and out of the environment. The use of 36 an isolator can be an alternative to a buffer area for sterile 37 preparations. 38 (2852) ‘Labeling’ means the process of preparing and affixing a 39 label which includes all information required by federal and state 40 law to a drug container exclusive of the labeling by a 41 manufacturer, packer, or distributor of a nonprescription drug or 42 commercially packaged legend drug or device.

[183] 9 1 (53) ‘Laminar air flow workbench’ or ‘LAFW’ means a primary 2 engineering control that uses an ISO 5 controlled environment 3 created by a HEPA filter to retain airborne particles and 4 microorganisms, and has horizontal air flow or vertical air flow. 5 (2954) ‘Manufacturing’ of products means the production, 6 preparation, propagation, conversion, or processing of a drug or 7 device, either directly or indirectly, by extraction from substances 8 of natural origin or independently by means of chemical or 9 biological synthesis, or from bulk chemicals, and includes any 10 packaging or repackaging of the substances or labeling or 11 relabeling of its container, if these actions are followed by the 12 promotion and marketing of the drugs or devices for resale to 13 pharmacies, practitioners, or other persons. 14 (3055) ‘Manufacturer’ means a person engaged in the 15 manufacture of prescription drugs or devices. 16 (56) ‘Mediafill test’ means a test to evaluate the aseptic 17 technique of: 18 (a) compounding personnel; 19 (b) a process to ensure that the process used can produce 20 sterile product that has no microbial contamination. 21 (57) ‘Material safety data sheet’ or ‘MSDS’ means a resource 22 that provides information concerning a chemical, including: 23 (a) the identity, physical and chemical characteristics, 24 physical and health hazards, primary routes of entry, exposure 25 limits of the chemical; 26 (b) whether the chemical is a carcinogen; 27 (c) precautions for safe handling and use of the chemical; 28 (d) control measures; 29 (e) emergency and first aid procedures; 30 (f) the latter of the date the MSDS was prepared or last 31 modified; and 32 (g) the name, address, and telephone number of the 33 manufacturer, importer, or employer who distributes the MSDS. 34 (3158) ‘Medical order’ means a lawful order of a practitioner 35 which may or may not include a prescription drug order. 36 (59) ‘Negative pressure’ means a room or device that is at a 37 lower pressure than adjacent space; the air flow moves into the 38 room or device. 39 (3260) ‘Nonprescription drug’ means a drug which may be sold 40 without a prescription and which is labeled for use by the 41 consumer in accordance with the requirements of the laws of this 42 State and the federal government.

[183] 10 1 (3361) ‘Nonresident pharmacy’ means a pharmacy located 2 outside this State. 3 (3462) ‘Parenteral’ means a sterile preparation of drugs for 4 injection through one or more layers of the skin. 5 (3563) ‘Patient counseling’ means the oral or written 6 communication by the pharmacist to a patient or caregiver 7 providing information on the proper use of drugs and devices. 8 (3664) ‘Permit consultant pharmacist’ means a pharmacist 9 licensed in this State who acts as a consultant for a permit holder 10 other than a pharmacy or institution. 11 (3765) ‘Person’ means an individual, soleproprietorship, 12 corporation, partnership, association, or any other legal entity 13 including government. 14 (66) ‘Personal protective equipment’ or ‘PPE’ means a gown, 15 glove, mask, hair cover, shoe cover, eye shield, and similar items 16 intended to protect the compounder from hazards and minimize 17 particle shedding. 18 (3867) ‘Pharmacy care’ is the direct provision of drug therapy 19 and other pharmacy patient care services through which 20 pharmacists, in cooperation with the patient and other health care 21 providers, design, implement, monitor, and manage therapeutic 22 plans for the purpose of improving a patient’s quality of life. 23 Objectives include cure of disease, elimination or reduction of a 24 patient’s symptomatology, arresting or slowing a disease process, 25 or prevention of a disease or symptomatology. The process 26 includes three primary functions: 27 (a) identifying potential and actual drugrelated problems; 28 (b) resolving actual drugrelated problems; and 29 (c) preventing potential drugrelated problems. 30 (3968) ‘Pharmacist’ means an individual health care provider 31 licensed by this State to engage in the practice of pharmacy. A 32 pharmacist is a learned professional authorized to provide patient 33 care services within the scope of his knowledge and skills. 34 (4069) ‘Pharmacistincharge’ means a pharmacist currently 35 licensed in this State who accepts responsibility for the operation 36 of a pharmacy in conformance with all laws pertinent to the 37 practice of pharmacy and the distribution of drugs and who is in 38 full and actual charge of the pharmacy and personnel. 39 (4170) ‘Pharmacy’ means a location for which a pharmacy 40 permit is required and in which prescription drugs and devices are 41 maintained, compounded, and dispensed for patients by a 42 pharmacist. This definition includes a location where 43 pharmacyrelated services are provided by a pharmacist.

[183] 11 1 (4271) ‘Pharmacy technician’ means an individual other than an 2 intern or extern, who assists in preparing, compounding, and 3 dispensing medicines under the personal supervision of a licensed 4 pharmacist and who is required to register as a pharmacy 5 technician. 6 (72) ‘Pointofcare activated delivery system’ means a vial or bag 7 system where a medication and an intravenous solution is attached, 8 but not activated or otherwise mixed until immediately before 9 administration to a patient. 10 (4373) ‘Poison’ means: 11 (a) a drug, chemical, substance, or preparation which, 12 according to standard works on medicine, materia medica, or 13 toxicology, is liable to be destructive to adult human life in doses 14 of sixty grains or less; or 15 (b) a substance recognized by standard authorities on 16 medicine, materia medica, or toxicology as poisonous; or 17 (c) any other item enumerated in this chapter; or 18 (d) a drug, chemical, substance, or preparation which is 19 labeled ‘Poison’. 20 (74) ‘Positive pressure’ means a room or device with higher 21 pressure than adjacent space so that air flow moves out of, rather 22 than into, the room or device. 23 (4475) ‘Practice of pharmacy’ means the interpretation, 24 evaluation, and dispensing of prescription drug orders in the 25 patient’s best interest; participation in drug and device selection, 26 drug administration, prospective drug reviews, and drug or 27 drugrelated research; provision of patient counseling and the 28 provision of those acts or services necessary to provide pharmacy 29 care and drug therapy management; and responsibility for 30 compounding and labeling of drugs and devices, (except labeling 31 by a manufacturer, repackager, or distributor or nonprescription 32 drugs and commercially packaged legend drugs and devices) 33 proper and safe storage of drugs and devices and maintenance of 34 proper records for them; or the offering or performing of those 35 acts, services, operations, or transactions necessary in the conduct, 36 operation, education, management, and control of pharmacy. 37 (4576) ‘Practitioner’ means a physician, dentist, optometrist, 38 podiatrist, veterinarian, or other health care provider authorized by 39 law to diagnose and prescribe drugs and devices. 40 (4677) ‘Prescription drug’ or ‘legend drug’ means: 41 (a) a drug which, under federal law, is required, prior to 42 being dispensed or delivered, to be labeled with any of the 43 following statements:

[183] 12 1 (i) ‘Caution: Federal law prohibits dispensing without 2 prescription’; 3 (ii) ‘Caution: Federal law restricts this drug to use by, or 4 on the order of, a licensed veterinarian’; 5 (iii) ‘Rx only’; or 6 (b) a drug which is required by any applicable federal or 7 state law to be dispensed pursuant only to a prescription drug order 8 or is restricted to use by practitioners only; 9 (c) any drug products considered to be a public health threat, 10 after notice and public hearing as designated by the board; or 11 (d) any prescribed compounded prescription is a prescription 12 drug within the meaning of this act. 13 (4778) ‘Prescription drug order’ means a lawful order from a 14 practitioner for a drug or device for a specific patient, issued for a 15 legitimate medical purpose within the prescriber’s course of 16 legitimate practice and including orders derived from collaborative 17 pharmacy practice. 18 (79) ‘Primary engineering control’ or ‘PEC’ means a device, 19 such as a laminar airflow workbench or an isolator, or a room that 20 provides an ISO 5 environment. 21 (80) ‘Process verification and validation’ means the process: 22 (a) used to evaluate whether a product, service, or system 23 meets specifications and fulfills its intended purpose; and 24 (b) of establishing evidence that provides a high degree of 25 assurance that a product, service, or system accomplishes its 26 intended requirements. 27 (4881) ‘Prospective drug use review’ means a review of the 28 patient’s drug therapy and prescription drug order before 29 dispensing the drug as part of a drug regimen review. 30 (82) ‘Pyrogen’ means a substance or agent that tends to cause a 31 rise in body temperature or fever. 32 (83) ‘Revocation’ means the cancellation or withdrawal of a 33 license, permit, or other authorization issued by the board either 34 permanently or for a period specified by the board before the 35 person shall be eligible to apply anew. A person whose license, 36 permit, or other authorization has been permanently revoked by the 37 board shall never again be eligible for a license or permit of any 38 kind from the board. 39 (84) ‘Secondary engineering control’ means a buffer area and an 40 ante area that meet the designated ISO classification. 41 (85) ‘Segregated compounding area for compounding sterile 42 products’ means a designated space: 43 (a) confined to a room or a demarcated area;

[183] 13 1 (b) restricted to preparing lowrisk CSPs with a twelve hour 2 or less beyonduse time; 3 (c) containing a device that provides unidirectional air flow 4 of ISO 5 air quality; 5 (d) free of materials extraneous to sterile compounding; and 6 (e) not used for other activities or purposes. 7 (4986) ‘Significant adverse drug reaction’ means a drugrelated 8 incident that may result in serious harm, injury, or death to the 9 patient. 10 (5087) ‘Sterile pharmaceutical’ means a dosage form devoid of 11 viable microorganisms. 12 (88) ‘Sterility test’ means a process designed to determine the 13 presence of bacteria or fungi in or on a test device or solution. 14 (5189) ‘Therapeutically equivalent’ means a drug product with 15 the same efficacy and toxicity when administered to an individual 16 as the originally prescribed drug as provided for in Section 17 392440. 18 (90) ‘Velocity’ means the displacement air flow across the line 19 of demarcation between a buffer area into the ante area in a single 20 room. 21 (5291) ‘Wholesale distributor’ means a person engaged in 22 wholesale distribution of prescription drugs or devices including, 23 but not limited to, manufacturers; repackagers; ownlabel 24 distributors; privatelabel distributors; jobbers; brokers; 25 warehouses including manufacturers’ and distributors’ 26 warehouses, chain drug warehouses, and wholesale drug 27 warehouses; independent wholesale drug traders; and retail 28 pharmacies that conduct wholesale distributions. "Wholesale 29 distributor" does not include: 30 (a) intracompany sales, being defined as a transaction or 31 transfer between a division, subsidiary, parent, or affiliated or 32 related company under the common ownership and control of a 33 corporate entity; 34 (b) the purchase or other acquisition by a hospital or other 35 health care entity that is a member of a grouppurchasing 36 organization of a drug for its own use from the grouppurchasing 37 organization or from other hospitals or health care entities that are 38 members of such organizations; 39 (c) the sale, purchase, or trade of a drug or an offer to sell, 40 purchase, or trade a drug by a charitable organization described in 41 section 501(c)(3) of the Internal Revenue Code of 1986 to a 42 nonprofit affiliate of the organization to the extent otherwise 43 permitted by law;

[183] 14 1 (d) the sale, purchase, or trade of a drug or an offer to sell, 2 purchase, or trade a drug among hospitals or other health care 3 entities that are under common control. For purposes of this 4 section, ‘common control’ means the power to direct or cause the 5 direction of the management and policies of a person or an 6 organization, whether by ownership of stock, voting rights, by 7 contract, or otherwise; 8 (e) the sale, purchase, or trade of a drug or an offer to sell, 9 purchase, or trade a drug for emergency medical reasons. For 10 purposes of this section, "emergency medical reasons" includes the 11 transfer of legend drugs by a licensed pharmacy to another 12 licensed pharmacy or a practitioner licensed to possess prescription 13 drugs to alleviate a temporary shortage, except that the gross dollar 14 value of the transfers may not exceed five percent of the total 15 legend drug sales revenue of either the transferor or the transferee 16 pharmacy during a consecutive twelvemonth period; 17 (f) the sale, purchase, or trade of a drug, an offer to sell, 18 purchase, or trade a drug, or the dispensing of a drug pursuant to a 19 prescription; or 20 (g) the sale, purchase, or trade of blood and blood 21 components intended for transfusion. 22 (92) ‘Zone of turbulence’ means the pattern of flow of air from 23 the HEPA filter created behind an object placed within the LAFW 24 pulling or allowing contaminated room air into the aseptic 25 environment. 26 (53) ‘Revocation’ means the cancellation or withdrawal of a 27 license, permit, or other authorization issued by the board either 28 permanently or for a period specified by the board before the 29 person shall be eligible to apply anew. A person whose license, 30 permit, or other authorization has been permanently revoked by the 31 board shall never again be eligible for a license or permit of any 32 kind from the board. 33 (54) ‘Certified pharmacy technician’ means an individual who is 34 a registered pharmacy technician and who has completed the 35 requirements provided for in Section 404382(B).” 36 37 SECTION 2. Section 404386(CC) of the 1976 Code is amended 38 to read: 39 40 “(CC)(1) The provisions of this subsection only apply to the 41 compounding of medication by pharmacies permitted in the State 42 of South Carolina.

[183] 15 1 (2) The following are the minimum current good 2 compounding practices for the preparation of medications by 3 pharmacists licensed in the State for dispensing or administering, 4 or both, to humans or animals: 5 (a) Pharmacists engaged in the compounding of drugs 6 shall operate in conformance with applicable laws regulating the 7 practice of pharmacy; 8 (b) Based on the existence of a 9 pharmacist/patient/practitioner relationship and the presentation of 10 a valid prescription, or in anticipation of prescription medication 11 orders based on routine, regularly observed prescribing patterns, 12 pharmacists may compound, for an individual patient medications 13 that are commercially available in the market place for which the 14 components are commercially available; 15 (c) Pharmacists shall receive, store, or use drug 16 substances for compounding that meet official compendia 17 requirements, or of a chemical grade in one of the following 18 categories: chemically pure (CP), analytical reagent (AR), 19 American Chemical Society (ACS), or, if other than this, drug 20 substances that meet the accepted standard of the practice of 21 pharmacy; 22 (d) Pharmacists may compound drugs before receiving a 23 valid prescription based on a history of receiving valid 24 prescriptions that have been generated solely within an established 25 pharmacist/patient/practitioner relationship, for all such products 26 compounded at the pharmacy as required by the Board of 27 Pharmacy A compounder shall first attempt to use components 28 manufactured in an FDAregistered facility. When components 29 cannot be obtained from an FDAregistered facility, a compounder 30 shall use his professional judgment in selecting an acceptable and 31 reliable source and shall establish purity and safety by reasonable 32 means, to include Certificate of Analysis, manufacturer reputation, 33 and reliability of source. 34 (e) For components that do not have expiration dates 35 assigned by the manufacturer or supplier, a compounder shall label 36 the container with the date of receipt and assign a conservative 37 expiration date, not to exceed three years after receipt of the 38 component based on the nature of the component and its 39 degradation mechanism, the container in which it is packaged, and 40 the storage conditions; 41 (ef) Pharmacists may not offer compounded medications to 42 other pharmacies for resale; however, pharmacists may compound 43 products based on an order from a practitioner for use by

[183] 16 1 practitioners for patient use administration to a patient in 2 institutional or office settings. Compounding 3 pharmacies/pharmacists may advertise or otherwise promote the 4 fact that they provide prescription compounding services, e.g., 5 chemicals, devices, and information, when requested; however, 6 they may not solicit business by promoting to compound specific 7 drug products, e.g., like a manufacturer; 8 (fg) The compounding of legend drugs in anticipation of 9 receiving prescriptions without a historical basis or the distribution 10 of compounded products without a patient/practitioner/pharmacist 11 relationship is considered manufacturing. 12 (3)(a) Pharmacists engaging in compounding shall maintain 13 proficiency through current awareness and training. Continuing 14 education shall include training in the art and science of 15 compounding and the rules and regulations of compounding. 16 (b) Pharmacy technicians may assist the pharmacist in 17 compounding. The pharmacist is responsible for training and 18 monitoring the pharmacy technician. The pharmacy technician’s 19 duties must be consistent with the training received. The 20 pharmacist must perform the final check of the compound product 21 to determine if the product is ready to dispense. 22 (c) Personnel engaged in the compounding of medications 23 shall wear clean clothing appropriate to the operation being 24 performed. Protective apparel, such as coats, jackets, aprons, 25 gowns, hand or arm coverings, or masks must be worn as 26 necessary to protect personnel from chemical exposure and 27 medication or chemical contamination. 28 (d) Only personnel authorized by the responsible 29 pharmacist may be in the immediate vicinity of the drug 30 compounding operation. A person shown at any time, either by 31 medical examination or pharmacist determination, to have an 32 apparent illness or open lesions that may adversely affect the 33 safety or quality of a drug product being compounded must be 34 excluded from direct contact with components, medication 35 containers, closures, inprocess materials, and medication products 36 until the condition is corrected or determined by competent 37 medical personnel not to jeopardize the safety or quality of the 38 products being compounded. All personnel who assist the 39 pharmacists in compounding procedures must be instructed to 40 report to the pharmacist any health conditions that may have an 41 adverse effect on drug products. 42 (4)(a) Pharmacists engaging in compounding shall have a 43 specifically designated and an adequate area (space) for the orderly

[183] 17 1 complexity level of compounding of prescriptions that is 2 maintained in a good state of repair for the placement of material 3 and equipment. Sterile compounding must be performed in a 4 separate area in compliance with Section 404388. 5 (b) Bulk medications and other chemicals or materials 6 used in the compounding of medication must be stored in 7 adequately labeled containers in a clean, dry, and 8 temperaturecontrolled area or, if required, under proper 9 refrigeration. 10 (c) Pharmacists must ensure ingredients used in 11 formulations have their expected identity, quality, and purity. 12 (d) Adequate lighting and ventilation must be provided in 13 all drug compounding areas. Potable water must be supplied under 14 continuous positive pressure in a plumbing system free of defects 15 that could contribute contamination to a compounded drug 16 product. Adequate washing facilities, easily accessible to the 17 compounding areas of the pharmacy, must be provided. These 18 facilities shall include, but are not limited to, hot and cold water, 19 soap or detergent, and airdryers or singleuse towels. 20 (e) The area used for the compounding of drugs must be 21 maintained in a clean and sanitary condition. It must be free of 22 infestation by insects, rodents, and other vermin. Trash must be 23 held and disposed of in a timely and sanitary manner. Sewage and 24 other refuse in and from the pharmacy and immediate medication 25 compounding areas must be disposed of in a safe and sanitary 26 manner. 27 (f) If sterile products are being compounded, the 28 pharmacist shall comply with Section 404388 as applicable to the 29 procedure. 30 (g) If radiopharmaceuticals are being compounded, the 31 pharmacist shall comply with Section 404387 as applicable to the 32 procedure. 33 (h) If drug products with special precautions for 34 contamination, such as penicillin or hazardous drugs, are involved 35 in a compounding procedure, appropriate measures, including 36 either the dedication of equipment or meticulous cleaning of 37 contaminated equipment before its use for the preparation of other 38 drugs, must be utilized in order to prevent crosscontamination. 39 (5)(a) Equipment and utensils used for compounding must be 40 of appropriate design and capacity and stored in a manner to 41 protect from contamination. In addition, all equipment and 42 utensils must be cleaned and sanitized before use to prevent 43 contamination that would alter the safety or quality of the drug

[183] 18 1 product beyond that desired. The pharmacist is responsible for 2 determining suitability for use. In the case of sterile compounding, 3 the pharmacist shall comply with Section 404388 as applicable to 4 equipment and utensils. 5 (b) Automatic, mechanical, electronic, or other equipment 6 used in compounding must be routinely inspected, calibrated, if 7 necessary, or checked to ensure proper performance. 8 (c) The pharmacist shall ensure that the proper container 9 is selected to dispense the finished compounded prescription, 10 whether sterile or nonsterile. 11 (6)(a) The pharmacist shall ensure that there are formulas 12 and logs maintained either electronically or manually. Formulas 13 must be comprehensive and include ingredients, amounts, 14 methodology, and equipment, if needed, and special information 15 regarding sterile compounding. 16 (b) The pharmacist shall ensure that components used in 17 compounding are accurately weighed, measured, or subdivided as 18 appropriate at each stage of the compounding procedure to 19 conform to the formula being prepared. Any chemical transferred 20 to a container from the original container must be labeled with the 21 same information as on the original container and the date of 22 transfer placed on the label. 23 (c) The pharmacist shall establish and conduct procedures 24 so as to monitor the output of compounded prescriptions, i.e., 25 capsule weight variation, adequacy of mixing, clarity, pH of 26 solutions, and, where appropriate, procedures to prevent microbial 27 contamination of medications purported to be sterile. 28 (7)(a) The pharmacist shall label any excess compounded 29 product so as to reference it to the formula used and the assigned 30 control number and the estimated beyonduse date based on the 31 pharmacist’s professional judgment, appropriate testing, or 32 published data. In the absence of stability information applicable 33 to the specific compound, the maximum BUD must be determined 34 by: 35 (i) the type of formulation, such as nonaqueous, water 36 containing, or topical; and 37 (ii) professional judgment. 38 (b) The product must be stored appropriately. 39 (c) At the completion of compounding the prescription, 40 the pharmacist shall examine the prescription for correct labeling. 41 (8) The pharmacist shall keep records of all compounded 42 products for a period of time as other prescriptions as required by 43 the Board of Pharmacy. These records must be readily available

[183] 19 1 for authorized inspection during the retention period at the 2 establishment. These records are subject to duplication by 3 photocopying or other means of reproduction as part of the 4 inspection. 5 (9) All significant procedures performed in the compounding 6 area must be covered in written policies and procedures. These 7 procedures must be developed for the facility, equipment, 8 personnel, preparation, packaging, and storage of compounded 9 preparations and ingredients to ensure accountability, accuracy, 10 quality safety, and uniformity in compounding as appropriate for 11 the level of compounding performed at the facility. 12 (10) Material Data Safety should be readily accessible from an 13 internet website or otherwise to all personnel working with drug 14 substances or bulk chemicals located on the compounding facility 15 premises, and personnel should be instructed on how to retrieve 16 needed information.” 17 18 SECTION 3. Section 404388 of the 1976 Code is amended to 19 read: 20 21 “Section 404388. (A) The purpose of this section is to provide 22 standards for the preparation, labeling, and distribution of sterile 23 products by pharmacies, pursuant to or in anticipation of a 24 prescription drug order for a patient in home health care. 25 (B) The pharmacy shall have a separate area designated for 26 placement of the Class 100 laminar airflow hood, which must: 27 (1) be constructed so as to allow visual observation; 28 (2) not be a thruway for traffic; 29 (3) have walls, floor, ceiling, and work surfaces constructed 30 of materials that are nonporous and do not produce particulate 31 matter; 32 (4) be ventilated in a manner that will not interfere with the 33 outward flow of air from the hood; 34 (5) not be used for unpacking bulk supplies; 35 (6) not be used for storage of bulk supplies and materials; 36 and 37 (7) have an eye wash station and sink readily accessible to 38 the area. 39 (C)(1) All sterile pharmaceuticals must be prepared within the 40 airflow hood work surface. 41 (2) Work surfaces of the airflow hood must be cleaned with 42 seventy percent isopropyl alcohol or an equivalent disinfectant 43 every eighthour work shift and as needed for microbial, drug, and

[183] 20 1 particulate matter removal. This cleaning must be documented by 2 date, time, and initials. Documentation must be retained for two 3 years. 4 (3) The airflow hood must be certified by a qualified 5 technician every twelve months and must be recertified each time 6 the hood is moved for operational efficiency in accordance with 7 federal standards. The certification must be attached to the front of 8 the hood and shall state the date the certification was performed. 9 Certification documents must be retained for two years. 10 (4) The sterile product preparation area must be cleaned and 11 disinfected weekly with appropriate agents according to written 12 policy and procedures. This must be documented by date and 13 initials and retained for two years. 14 (5) Prefilters must be changed in accordance with 15 manufacturer’s specifications. Changes must be documented by 16 date and initials and documentation must be retained for two years. 17 (6) Work surfaces inside the airflow hood must be clear of 18 drugs, records, labels, and equipment unrelated to work in process. 19 (7) All solutions, additive and nonadditive, must be checked 20 by a pharmacist before dispensing. The checking pharmacist’s 21 initials must appear on either the prescription or medical order, the 22 patient’s profile, a compounding record, or label. Only one system 23 must be used. Initials may be computer produced or stamped for 24 solutions containing noncontrolled additives. 25 (8) Sterile pharmaceuticals returned by an outpatient or the 26 outpatient’s agent must be destroyed. Supplies and equipment 27 designed by the manufacturer for one time use may not be reused. 28 Returned sterile pharmaceuticals containing controlled substances 29 must be destroyed in accordance with federal and state 30 requirements. 31 (9) A sink with hot and cold running water readily accessible 32 to the sterile products preparation area with immediate availability 33 of germicidal skin cleanser and either a warm air blower or 34 nonshedding singleuse towels for hand drying must be available to 35 all personnel preparing sterile pharmaceuticals. 36 (10) Adverse drug reactions sustained by patients must be 37 documented in the patient’s profile. Significant untoward 38 reactions must be reported to the Food and Drug Administration 39 and the manufacturer. 40 (D)(1) Compounding shall involve aseptic manipulations that 41 are properly and promptly executed.

[183] 21 1 (2) Closed system transfers must be used in compounding 2 sterile pharmaceuticals, except for initial withdrawals from 3 ampules. 4 (a) All container closures shall remain intact throughout 5 the aseptic process, except for the penetration of sterile, 6 pyrogenfree, and particulate matterfree needles or cannulas 7 through the designated stopper or port. 8 (b) Ancillary devices used to facilitate the transfer, 9 withdrawal, or delivery of sterile solutions must be sterile, free of 10 pyrogen and particulate matter, and used in accordance with the 11 manufacturer’s labeled instructions. 12 (3) Compounded sterile pharmaceuticals must be stored 13 immediately according to published and professional guidelines. 14 (4) Administration must be initiated in accordance with 15 stability standards. 16 (5) If products are prepared from nonsterile ingredients, 17 these products must be appropriately sterilized before dispensing. 18 (E) In addition to reference books currently required in a 19 pharmacy, at least one current reference on compatibility and 20 stability of sterile pharmaceuticals must be available. 21 (F) All sterile pharmaceuticals prepared for dispensing shall 22 have an adhesive label affixed which shall contain the following: 23 (1) name, address, and telephone number of pharmacy for 24 outpatients and name of facility for inpatients; 25 (2) if additive, the date solution was prepared. Nonadditive 26 solutions must be dated if the manufacturer’s protective cover is 27 removed before dispensing; 28 (3) name of physician; 29 (4) name of patient; 30 (5) room number and bed of patient, if applicable; 31 (6) serial number of prescription or other identifying 32 number; 33 (7) if additive solution, the name and amount of additive. If 34 additives are identified by their generic name, the manufacturer 35 must be identified on either the prescription, the patient’s profile, 36 or compounding record; 37 (8) name of basic solution; 38 (9) name or initials of individual preparing sterile 39 pharmaceutical on either the prescription or medical order, the 40 patient’s profile, compounding record, or label. For solutions 41 containing noncontrolled additives, the initials may be imprinted;

[183] 22 1 (10) expiration date and, if applicable, the expiration time of 2 the solution in accordance with the manufacturer’s specifications 3 or researchsupported standard of practice; 4 (11) frequency and rate of administration; 5 (12) precautionary statements, auxiliary labels, or warning 6 labels in keeping with current standards or practice; 7 (13) special handling or storage requirements, or both; 8 (G) There must be a system for a pharmacist to be available 9 twentyfour hours a day for a patient, nursing agency, or physician 10 to which the pharmacy is providing services. 11 (H) A profile or medical record must be maintained for each 12 patient. This profile must be maintained for two years after the 13 last dispensing activity. It shall contain at a minimum: 14 (1) patient’s name, address, telephone number and, if 15 applicable, the patient’s bed or room number; 16 (2) age or date of birth, weight, height, and sex of patient; 17 (3) identity of the health care agency, if applicable; 18 (4) itemization of sterile pharmaceuticals dispensed with 19 prescription number or other identifying number, including date 20 dispensed and the name and amount of additives; 21 (5) drug and food allergies; 22 (6) primary diagnosis; 23 (7) prescription and nonprescription drugs and home 24 remedies the patient is receiving; and 25 (8) documentation by a pharmacist of the resolution of other 26 potential drug related problems. 27 (I)(1) All cytotoxic solutions must be compounded in a Class 28 II, biological safety cabinet. No other products may be 29 compounded in this cabinet. 30 (2) Protective apparel must be worn by personnel 31 compounding cytotoxic agents including gloves, closed front 32 gowns with tight cuffs, and masks. Written procedures for 33 handling spills of cytotoxic agents must be developed. 34 (3) There must be immediate access to emergency spill 35 supplies wherever cytotoxic drugs are prepared. 36 (4) Prepared solutions must be identified with warning labels 37 in accordance with state and federal requirements. 38 (5) Prepared solutions must be packaged for handling and 39 delivery in a manner that minimizes the risk of rupture of the 40 primary container and ensures the stability and potency of the 41 solution.

[183] 23 1 (6) Documentation that personnel have been trained in the 2 compounding, handling, and destruction of cytotoxic agents must 3 be available. This documentation must be obtained annually. 4 (7) Documentation that personnel have been informed of the 5 carcinogenic, mutagenic, and teratogenic nature of the cytotoxic 6 agents handled must be available. This documentation must be 7 updated annually by all personnel. 8 (8) Class II safety cabinets must be certified by a qualified 9 technician every twelve months and must be recertified each time 10 the hood is moved for operational efficiency. Earlier 11 recertification may be required if dictated by federal or state 12 requirements or manufacturer’s specifications due to workload. 13 (J) All waste materials must be disposed of in accordance with 14 federal, state, and local requirements. 15 (K) A policy and procedure manual must be available in the 16 pharmacy. The manual shall include policies and procedures as 17 applicable for the following: 18 (1) quality control; 19 (2) sterile technique; 20 (3) destruction of returned solutions; 21 (4) labeling of injectable solutions; 22 (5) drug recall procedures; 23 (6) investigational drugs; 24 (7) handling and disposal of hazardous waste; 25 (8) cytotoxic agents; 26 (9) maintenance of patient profiles; and 27 (10) material safety data sheets. 28 (L) When sterile pharmaceuticals are provided to home care 29 patients, the dispensing pharmacy may supply a nurse with 30 emergency drugs if a physician has authorized the use of these 31 drugs by a protocol or prescription drug order for use in an 32 emergency situation, e.g., anaphylactic shock. 33 (M) A licensed health care professional may possess 34 noncontrolled prescribed legend drugs or devices such as water for 35 injection, normal saline for IV, and heparin flush used in the 36 administration of sterile pharmaceuticals. 37 (N) If appropriate, the pharmacist shall demonstrate or 38 document the patient’s training and competency in managing 39 therapy provided by the pharmacist to the patient in the home 40 environment. A pharmacist must be involved in the patient 41 training process in any area that relates to drug compounding, 42 labeling, administration, storage, stability, compatibility, or 43 disposal. The pharmacist is responsible for seeing that the

[183] 24 1 patient’s competency in the above areas is reassessed on an 2 ongoing basis. 3 (O) There must be a documented, ongoing, quality assurance 4 control program that monitors patient care and pharmacy care 5 outcomes, including but not limited to: 6 (1) routine performance of prospective drug use review and 7 patient monitoring functions by a pharmacist; 8 (2) patientmonitoring plans that include written outcome 9 measures and systems for routine patient assessment including, but 10 not limited to, infection rates, rehospitalization rates, and the 11 incidence of adverse drug reactions; 12 (3) documentation of patient training as specified in 13 subsection (N); 14 (4) appropriate collaboration with other health care 15 professionals. (A) The purpose of this section is to provide 16 standards for the preparation, labeling, storing, dispensing and 17 distribution of sterile products by pharmacies and other facilities 18 permitted by the board. 19 (B) Compounded sterile product (CSP) microbial 20 contamination risk level is assigned according to the corresponding 21 probability of contamination. 22 (1) A lowrisk level CSP is compounded under the following 23 conditions: 24 (a) The CSP must be compounded with aseptic 25 manipulations entirely within ISO Class 5 or better air quality 26 using only sterile ingredients, products, components, and devices 27 with the exception of radiopharmaceuticals as stated in Section 28 404387. 29 (b) The compounding only may involve transfer, 30 measuring, and mixing manipulations using not more than three 31 commercially manufactured packages of sterile products and not 32 more than two entries into one sterile container or package of 33 sterile product or administration container or device to prepare the 34 CSP. 35 (c) For a lowrisk level preparation, in the absence of 36 passing a sterility test or process validation, the storage periods 37 should not exceed the following time periods before administration 38 and with proper storage: 39 (i) not more than fortyeight hours at controlled room 40 temperature; 41 (ii) not more than fourteen days at a cold temperature; 42 and 43 (iii) not more than fortyfive days in solid frozen state.

[183] 25 1 (2) A lowrisk level CSP prepared in a PEC and that cannot 2 be located within an ISO Class 7 or better buffer area requires a 3 twelve hour or less BUD. A lowrisk level CSP with a BUD of 4 twelve hours or less must meet the following criteria: 5 (a) PECs must be certified and maintain ISO Class 5 for 6 exposure to critical sites and must be in a segregated compounding 7 area restricted to sterile compounding activities that minimize the 8 risk of CSP contamination. 9 (b) The segregated compounding area must not be in a 10 location that has unsealed windows or doors that connect to the 11 outdoors or high traffic flow, or that is adjacent to construction 12 sites, warehouses, or food preparation. 13 (c) Personnel shall follow all procedures outlined in 14 subsection (F) prior to compounding. A sink may not be located 15 adjacent to the ISO Class 5 PEC and must be separated from the 16 immediate area of the ISO Class 5 PEC device. 17 (d) The specifications for cleaning and disinfecting the 18 sterile compounding area, personnel training and responsibilities, 19 aseptic procedures, and air sampling must be followed as described 20 in subsection (F). 21 (3) A mediumrisk level CSP occurs under lowrisk conditions 22 when one or more of the following conditions exist: 23 (a) Multiple individual or small doses of sterile products 24 are combined or pooled to prepare CSPs that will be administered 25 either to multiple patients or to one patient on multiple occasions. 26 (b) The compounding process includes complex aseptic 27 manipulations other than the singlevolume transfer. 28 (c) The compounding process requires unusually long 29 duration, such as that required to complete dissolution or 30 homogeneous mixing. 31 (d) In the absence of passing a sterility test or process 32 validation, the storage periods should not exceed the following 33 time periods before administration and with proper storage: 34 (i) not more than thirty hours at controlled room 35 temperature; 36 (ii) not more than nine days at a cold temperature; and 37 (iii) not more than fortyfive days in solid frozen state. 38 (4) A CSP is considered high-risk if it is compounded under 39 the following conditions due to contamination or high risk of 40 becoming contaminated: 41 (a) Nonsterile ingredients and products are incorporated 42 or a nonsterile device is employed before terminal sterilization.

[183] 26 1 (b) Any of the following are exposed to air quality worse 2 than ISO Class 5 for more than one hour: 3 (i) sterile contents of commercially manufactured 4 products; 5 (ii) CSPs that lack effective antimicrobial preservatives; 6 and 7 (iii) sterile surfaces of devices and containers for the 8 preparation, transfer, sterilization, and packaging of CSPs. 9 (c) Presterilization procedures for highrisk level CSP, 10 such as weighing and mixing, are completed in an ISO Class 8 or 11 better environment. 12 (d) Products are appropriately sterilized before dispensing. 13 (e) For a highrisk level preparation, in the absence of 14 passing a sterility test or process validation, the storage periods 15 should not exceed the following time periods before administration 16 and with proper storage: 17 (i) not more than twenty four hours at controlled room 18 temperature; 19 (ii) not more than three days at a cold temperature; and 20 (iii) not more than forty five days in solid frozen state. 21 (5) The immediateuse CSP provision stated here only may 22 be used for situations where a need for emergency or immediate 23 patient administration of a CSP exists. An immediateuse 24 preparation may not include a mediumrisk level or a highrisk level 25 CSP. An immediateuse CSP is exempt from the requirements 26 described in subection (B)(1) if: 27 (a) The compounding process involves simple transfer of 28 commercially manufactured packages of sterile nonhazardous 29 products or diagnostic radiopharmaceutical products from the 30 manufacturers’ original containers into any one container or 31 package of sterile infusion solution or administration container or 32 device. 33 (b) The compounding procedure is a continuous process 34 not to exceed one hour unless otherwise required for preparation. 35 (c) During preparation, aseptic technique is followed and, 36 if not immediately administered, the finished CSP is under 37 continuous supervision to minimize the potential for contact with 38 nonsterile surfaces, introduction of particulate matter or biological 39 fluids, mixups with other CSPs, and direct contact of outside 40 surfaces. 41 (d) Administration begins not later than one hour 42 following the start of the preparation of the CSP.

[183] 27 1 (e) Unless immediately and completely administered by 2 the person who prepared it or immediate and complete 3 administration is witnessed by the preparer, the CSP must bear a 4 label listing the patient identification information, the names and 5 amounts of all ingredients, the name or initials of the person who 6 prepared the CSP, and the exact one hour BUD and time. 7 (f) If administration has not begun within one hour 8 following the start of preparing the CSP, the CSP must be 9 discarded. 10 (C) The compounding area of the facility must meet the facility 11 requirements relative to the risk level of products they prepare. 12 (1) Facility design and environmental control must be 13 designed to minimize airborne contamination from contacting 14 critical sites. 15 (a) A PEC must maintain ISO Class 5 or better conditions 16 while compounding. 17 (b) The PEC HEPAfiltered air must be supplied in critical 18 areas at a velocity sufficient to sweep particles away from the 19 compounding area. 20 (2) The buffer area must maintain at least ISO Class 7 21 conditions under dynamic operating conditions. 22 (a) The room must be segregated from surrounding, 23 unclassified spaces to reduce the risk of contaminants being blown, 24 dragged, or otherwise introduced into the HEPAfiltered airflow 25 environment. 26 (b) For buffer areas not physically separated from the ante 27 areas, the principle of displacement airflow must be employed. 28 The displacement concept shall not be used for high–risk 29 compounding. 30 (c) The PEC must be placed out of the traffic flow in a 31 manner to avoid conditions that could adversely affect their 32 operation. 33 (d) Cleaning materials must be nonshedding and dedicated 34 for use only in the sterile compounding area. 35 (e) Only the furniture, equipment, supplies, and other 36 material required for the compounding activities to be performed 37 may be brought into the buffer area, and they must be 38 nonpermeable, nonshedding, cleanable, and resistant to 39 disinfectants. They must be cleaned, then disinfected before 40 brought into the area. 41 (f) The surfaces of ceilings, walls, floors, fixtures, 42 shelving, counters, and cabinets in the buffer area must be smooth, 43 impervious, and nonshedding in order to promote cleanliness.

[183] 28 1 (g) The buffer area shall not contain sources of water or 2 floor drains with the exception of emergency safety devices. 3 (3) An ISO Class 7 buffer area and ante area supplied with 4 HEPAfiltered air must have air changes per hour (ACPH) of not 5 less than thirty. 6 (4) HEPAfiltered supply air should be introduced at the 7 ceiling and returns must be mounted low on the wall, creating a 8 general topdown dilution of area air. 9 (5) The floors in the clean and ante areas are cleaned by 10 sweeping and mopping on each day of operation when no aseptic 11 operations are in progress. 12 (6) The environment for compounding must contain an ante 13 area that is ISO Class 8 quality air or better. Areas participating in 14 high risk compounding must have a separate ante area. Supplies 15 and equipment must be removed from shipping cartons outside of 16 the ante area, and must be wiped with a sanitizing agent before 17 being transported to the clean room. 18 (7) Placement of a PEC must be based on the following: 19 (a) a LAFW, BSC, CAI, and CACI only may be located 20 within a restricted access ISO Class 7 buffer area; and 21 (b) a CAI and CACI only may be placed in an ISO Class 7 22 buffer area unless the isolator maintains ISO Class 5 during 23 dynamic operating conditions. 24 (8) The buffer area designated for placement of the ISO 25 Class 5 PEC must be constructed to allow visual observation. 26 (9) The buffer area may not be used for storage of bulk 27 supplies and materials. 28 (10) Maintain areas at temperatures and humidity levels to 29 ensure the integrity of the drugs prior to their dispensing as 30 stipulated by the USP/NF or the labeling of the manufacturer or 31 distributor, or both. 32 (11) A sink with hot and cold running water readily accessible 33 to the sterile products preparation area with immediate availability 34 of germicidal skin cleanser and either an air blower or 35 nonshedding singleuse towels for hand drying must be available to 36 all personnel preparing sterile pharmaceuticals. 37 (D) Environmental quality and control practices include: 38 (1) Giving the highest priority in a sterile compounding 39 practice to the protection of critical sites by precluding physical 40 contact and airborne contamination. 41 (2) Performing viable and nonviable environmental air 42 sampling testing every six months as part of a comprehensive 43 quality management program and:

[183] 29 1 (a) as part of the commissioning and certification of new 2 facilities and equipment; 3 (b) as part of the recertification of facilities and 4 equipment; or 5 (c) in response to identified problems with the sterility of 6 end products. 7 (3) Engineering control performance verification procedures 8 must be performed by a qualified individual no less than every six 9 months and when the device or room is relocated or altered. 10 Certification documents must be retained for two years. 11 (4) Certification that each ISO classified area is within 12 established guidelines for total particle counts must be performed 13 no less than every six months and whenever the LAFW, BSC, 14 CAI, or CACI is relocated or the physical structure of the buffer 15 area or ante area has been altered. Testing must be performed by 16 qualified operators. 17 (5) All certification records must be maintained and 18 reviewed by pharmacy personnel to ensure that the controlled 19 environments are in compliance. 20 (6) A pressure gauge or velocity meter must be installed to 21 monitor the pressure differential or airflow between the buffer area 22 and the ante area and between the ante area and the general 23 environment outside the compounding area. 24 (a) The pressure between the positive ISO Class 7 or 25 better buffer area, the ante area, and the general pharmacy area 26 may not be less than a 0.02 inch water column. 27 (b) The pressure between the negative ISO Class 7 or 28 better buffer area, the ante area, and the general pharmacy area 29 may not be less than a –0.01inch water column. For negative 30 pressure buffer areas, the ante area must be ISO Class 7 or better. 31 (c) The results must be reviewed and documented on a log 32 maintained either electronically or manually at least every work 33 shift or by a continuous recording device. 34 (7) An appropriate facility specific environmental sampling 35 procedure must be followed for airborne viable particles based on 36 a risk assessment of compounding activities performed. 37 (a) The documentation must include sample location, 38 method of collection, volume of air sampled, time of day and 39 action levels. 40 (b) Evaluation of airborne microorganisms using 41 volumetric collection methods in the controlled air environments, 42 including LAFWs, CAIs, clean room or buffer areas, and ante 43 areas, must be performed by properly trained individuals for all

[183] 30 1 compounding risk levels. Impaction is the preferred method of 2 volumetric air sampling. 3 (c) For all compounding risk levels, air sampling must be 4 performed at locations prone to contamination during 5 compounding activities and during other activities such as staging, 6 labeling, gowning, and cleaning. Locations must include zones of 7 air backwash turbulence within LAFW and other areas where air 8 backwash turbulence may enter the compounding area. 9 (d) Corrective actions must be taken when CFU counts for 10 each ISO classification are exceeded, or when microorganisms are 11 identified that are potentially harmful to patients receiving CSPs. 12 (E)(1) All hazardous CSPs must be compounded and prepared 13 in an ISO Class 5 environment in a BSC or CACI with the 14 exception of radiopharmaceuticals as stated in Section 404387. 15 Hazardous drugs may not be prepared in a laminar airflow 16 workbench or a compounding aseptic isolator. 17 (2) Appropriate personal protective equipment must be worn 18 by personnel compounding hazardous agents. 19 (3) Written procedures for disposal and handling spills of 20 hazardous agents must be developed. 21 (4) There must be immediate access to emergency spill 22 supplies wherever hazardous drugs are prepared. 23 (5) A hazardous CSP must be identified with warning labels 24 in accordance with state and federal requirements. 25 (6) A hazardous CSP must be packaged for handling and 26 delivery in a manner that minimizes the risk of rupture of the 27 primary container and ensures the stability, sterility, and potency 28 of the solution. 29 (7) A hazardous drug must be handled with caution at all 30 times during receiving, distribution, stocking, inventorying, 31 preparation for administration, and disposal. 32 (8) Documentation that personnel have been trained in the 33 compounding, handling, and disposal of hazardous agents must be 34 available. This documentation must be updated annually. The 35 training must include the following if applicable: 36 (a) safe aseptic manipulation practices; 37 (b) negative pressure techniques when utilizing a BSC or 38 CACI; 39 (c) correct use of CSTD devices; 40 (d) containment, cleanup and disposal procedures for 41 breakages and spills; and 42 (e) treatment of personnel contact and inhalation 43 exposure.

[183] 31 1 (F) Policies and procedures must be developed and 2 implemented for the pharmacy. These policies and procedures 3 must include the following as applicable: 4 (1) annual training and evaluation of sterile compounding 5 personnel to include skills observation of antiseptic hand 6 cleansing, other personnel cleansing, mediafill challenge, glove 7 fingertip testing, cleaning of compounding environment, donning 8 protective garb, maintaining or achieving sterility of CSPs; 9 (2) semiannual mediafill test representative of high risk 10 compounding must be performed by all personnel authorized to 11 prepare high risk CSPs; 12 (3) cleaning and disinfecting of the sterile compounding 13 areas and devices with supporting documentation; 14 (4) ensuring identity, quality, and purity of ingredients; 15 (5) sterilization methods for High Risk CSPs; 16 (6) establishment of appropriate storage requirements and 17 BUDs; 18 (7) measuring, mixing, dilution, purification, packaging, and 19 labeling; 20 (8) unpackaging and introducing supplies into the sterile 21 compounding environment; 22 (9) compounding activities that require the manipulation and 23 disposal of a hazardous material; 24 (10) expiration dating of single dose and multiple dose 25 containers; 26 (11) quality control and quality assurance of CSP processes; 27 (12) material safety data sheets; 28 (13) use of investigational drugs; 29 (14) written procedures outlining required equipment 30 calibration, maintenance, monitoring for proper function, and 31 controlled procedures for use of the equipment and specified time 32 frames for these activities must be established and followed. 33 Results from the equipment calibration, semiannual certification 34 reports, and routine maintenance must be kept on file for two 35 years; 36 (15) patient training and competency in managing therapy in 37 the home environment; 38 (16) safety measures to ensure accuracy of CSPs; and 39 (17) compounding logs for nonpatient specific CSPs. 40 (G) Compounding personnel: 41 (1) may not introduce food or drinks, into the ante areas, 42 buffer areas, or segregated compounding areas; and

[183] 32 1 (2) shall ensure that all CSPs are checked by a pharmacist 2 before dispensing. 3 (H) In addition to references currently required in a pharmacy, 4 at least one current reference on compatibility and stability of 5 sterile pharmaceuticals must be available. 6 (I) All sterile pharmaceuticals prepared for dispensing must be 7 labeled in accordance with Section 404386 and include: 8 (1) name, address, and telephone number of pharmacy for 9 outpatients and name of facility for inpatients; 10 (2) dating of a nonadditive solution if the manufacturer’s 11 protective cover, if applicable, is removed before dispensing; 12 (3) name of prescribing physician; 13 (4) room number and bed of patient, if applicable; and 14 (5) special handling, storage requirements, or both. 15 (J) Bulk or unformulated drug substances and added 16 substances or excipients must be stored in tightly closed containers 17 under temperature, humidity, and lighting conditions that are either 18 indicated in official monographs or approved by suppliers. The 19 date of receipt by the compounding facility must be clearly and 20 indelibly marked on each package of ingredient. After receipt by 21 the compounding facility, packages of ingredients that lack a 22 supplier’s expiration date cannot be used after one year unless 23 either appropriate inspection or testing indicates that the ingredient 24 has retained its purity and quality for use in CSPs. 25 (K) When sterile pharmaceuticals are provided to home care 26 patients, the dispensing pharmacy may supply a nurse with 27 emergency drugs if a physician has authorized the use of these 28 drugs by a protocol or prescription drug order for use in an 29 emergency situation, such as anaphylactic shock. 30 (L) A licensed health care professional may possess 31 noncontrolled legend drugs or devices such as water for injection, 32 normal saline for an IV, and heparin flushes to facilitate in the 33 administration of prescribed CSPs. 34 (M) There must be a system that requires an institutional or 35 home infusion pharmacist to be available twentyfour hours a 36 day for a patient, nursing agency, or physician to which the 37 pharmacy is providing services.” 38 39 SECTION 4. This act takes effect upon approval by the 40 Governor. 41 XX 42

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