{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3410.2.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3410.2.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3410.2.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3410.2.html"}],"law_id":84268,"edition_id":1,"section_id":84268,"structure_id":13871,"section_number":"54.1-3410.2","catch_line":"Compounding; pharmacists’ authority to compound under certain conditions; labeling and record maintenance requirements","history":"2003, c. 509; 2005, c. 200; 2012, c. 173; 2013, c. 765; 2014, c. 147; 2015, c. 300; 2016, c. 221; 2025, cc. 48, 71.","full_text":"A\n\nA pharmacist may engage in compounding of drug products when the dispensing of such compounded products is (i) pursuant to valid prescriptions for specific patients and (ii) consistent with the provisions of § 54.1-3303 relating to the issuance of prescriptions and the dispensing of drugs.\n\t\t\tPharmacists shall label all compounded drug products that are dispensed pursuant to a prescription in accordance with this chapter and the Board’s regulations, and shall include on the labeling an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding.B\n\nA pharmacist may also engage in compounding of drug products in anticipation of receipt of prescriptions based on a routine, regularly observed prescribing pattern.\n\t\t\tPharmacists shall label all products compounded prior to dispensing with (i) the name and strength of the compounded medication or a list of the active ingredients and strengths; (ii) the pharmacy’s assigned control number that corresponds with the compounding record; (iii) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding; and (iv) the quantity.C\n\nIn accordance with the conditions set forth in subsections A and B, pharmacists shall not distribute compounded drug products for subsequent distribution or sale to other persons or to commercial entities, including distribution to pharmacies or other entities under common ownership or control with the facility in which such compounding takes place, except for distribution within health systems under common ownership when the compounded drug products are administered only to patients within the hospital or health system; however, a pharmacist may distribute to a veterinarian in accordance with federal law.\n\t\t\tCompounded products for companion animals, as defined in regulations promulgated by the Board of Veterinary Medicine, and distributed by a pharmacy to a veterinarian for further distribution or sale to his own patients shall be limited to drugs necessary to treat an emergent condition when timely access to a compounding pharmacy is not available as determined by the prescribing veterinarian.\n\t\t\tA pharmacist may, however, deliver compounded products dispensed pursuant to valid prescriptions to alternate delivery locations pursuant to § 54.1-3420.2.\n\t\t\tA pharmacist may provide a reasonable amount of compounded products to practitioners of medicine, osteopathy, podiatry, or dentistry to administer to their patients, either personally or under their direct and immediate supervision, if there is a critical need to treat an emergency condition, or as allowed by federal law or regulations. A pharmacist may also provide compounded products to practitioners of veterinary medicine for office-based administration to their patients.\n\t\t\tPharmacists who provide compounded products for office-based administration for treatment of an emergency condition or as allowed by federal law or regulations shall label all compounded products distributed to practitioners other than veterinarians for administration to their patients with (i) the statement “For Administering in Prescriber Practice Location Only”; (ii) the name and strength of the compounded medication or list of the active ingredients and strengths; (iii) the facility’s control number; (iv) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding; (v) the name and address of the pharmacy; and (vi) the quantity.\n\t\t\tPharmacists shall label all compounded products for companion animals, as defined in regulations promulgated by the Board of Veterinary Medicine, and distributed to a veterinarian for either further distribution or sale to his own patient or administration to his own patient with (a) the name and strength of the compounded medication or list of the active ingredients and strengths; (b) the facility’s control number; (c) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding; (d) the name and address of the pharmacy; and (e) the quantity.D\n\nPharmacists shall personally perform or personally supervise the compounding process, which shall include a final check for accuracy and conformity to the formula of the product being prepared, correct ingredients and calculations, accurate and precise measurements, appropriate conditions and procedures, and appearance of the final product.E\n\nPharmacists shall ensure compliance with USP-NF standards for both sterile and non-sterile compounding.F\n\nPharmacists may use bulk drug substances in compounding when such bulk drug substances:1\n\nComply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if such monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding; or are drug substances that are components of drugs approved by the FDA for use in the United States; or are otherwise approved by the FDA; or are manufactured by an establishment that is registered by the FDA; and2\n\nAre distributed by a licensed wholesale distributor or registered nonresident wholesale distributor, or are distributed by a supplier otherwise approved by the Board and the FDA to distribute bulk drug substances if the pharmacist can establish purity and safety by reasonable means, such as lot analysis, manufacturer reputation, or reliability of the source.G\n\nPharmacists may compound using ingredients that are not considered drug products in accordance with the USP-NF standards and guidance on pharmacy compounding.H\n\nPharmacists shall not engage in the following:1\n\nThe compounding for human use of a drug product that has been withdrawn or removed from the market by the FDA because such drug product or a component of such drug product has been found to be unsafe. However, this prohibition shall be limited to the scope of the FDA withdrawal;2\n\nThe regular compounding or the compounding of inordinate amounts of any drug products that are essentially copies of commercially available drug products. However, this prohibition shall not include (i) the compounding of any commercially available product when there is a change in the product ordered by the prescriber for an individual patient, (ii) the compounding of a commercially manufactured drug only during times when the product is not available from the manufacturer or supplier, (iii) the compounding of a commercially manufactured drug whose manufacturer has notified the FDA that the drug is unavailable due to a current drug shortage, (iv) the compounding of a commercially manufactured drug when the prescriber has indicated in the oral or written prescription for an individual patient that there is an emergent need for a drug that is not readily available within the time medically necessary, or (v) the mixing of two or more commercially available products regardless of whether the end product is a commercially available product; or3\n\nThe compounding of inordinate amounts of any preparation in cases in which there is no observed historical pattern of prescriptions and dispensing to support an expectation of receiving a valid prescription for the preparation. The compounding of an inordinate amount of a preparation in such cases shall constitute manufacturing of drugs.I\n\nPharmacists shall maintain records of all compounded drug products as part of the prescription, formula record, formula book, or other log or record. Records may be maintained electronically, manually, in a combination of both, or by any other readily retrievable method.1\n\nIn addition to other requirements for prescription records, records for products compounded pursuant to a prescription order for a single patient where only manufacturers’ finished products are used as components shall include the name and quantity of all components, the date of compounding and dispensing, the prescription number or other identifier of the prescription order, the total quantity of finished product, the signature or initials of the pharmacist or pharmacy technician performing the compounding, and the signature or initials of the pharmacist responsible for supervising the pharmacy technician and verifying the accuracy and integrity of compounded products.2\n\nIn addition to the requirements of subdivision I 1, records for products compounded in bulk or batch in advance of dispensing or when bulk drug substances are used shall include: the generic name and the name of the manufacturer of each component or the brand name of each component; the manufacturer’s lot number and expiration date for each component or when the original manufacturer’s lot number and expiration date are unknown, the source of acquisition of the component; the assigned lot number if subdivided, the unit or package size and the number of units or packages prepared; and the beyond-use date. The criteria for establishing the beyond-use date shall be available for inspection by the Board.3\n\nA complete compounding formula listing all procedures, necessary equipment, necessary environmental considerations, and other factors in detail shall be maintained where such instructions are necessary to replicate a compounded product or where the compounding is difficult or complex and must be done by a certain process in order to ensure the integrity of the finished product.4\n\nA formal written quality assurance plan shall be maintained that describes specific monitoring and evaluation of compounding activities in accordance with USP-NF standards. Records shall be maintained showing compliance with monitoring and evaluation requirements of the plan to include training and initial and periodic competence assessment of personnel involved in compounding, monitoring of environmental controls and equipment calibration, and any end-product testing, if applicable.J\n\nPractitioners who may lawfully compound drugs for administering or dispensing to their own patients pursuant to §§ 54.1-3301, 54.1-3304, and 54.1-3304.1 shall comply with all provisions of this section and the relevant Board regulations.K\n\nEvery pharmacist-in-charge or owner of a permitted pharmacy or a registered nonresident pharmacy engaging in sterile compounding shall notify the Board of its intention to dispense or otherwise deliver a sterile compounded drug product into the Commonwealth. Upon renewal of its permit or registration, a pharmacy or nonresident pharmacy shall notify the Board of its intention to continue dispensing or otherwise delivering sterile compounded drug products into the Commonwealth. Failure to provide notification to the Board shall constitute a violation of Chapter 33 (§ 54.1-3300 et seq.) or Chapter 34 (§ 54.1-3400 et seq.). The Board shall maintain this information in a manner that will allow the production of a list identifying all such sterile compounding pharmacies.","order_by":null,"text":{"0":{"id":302087,"text":"A pharmacist may engage in compounding of drug products when the dispensing of such compounded products is (i) pursuant to valid prescriptions for specific patients and (ii) consistent with the provisions of § 54.1-3303 relating to the issuance of prescriptions and the dispensing of drugs.\n\t\t\tPharmacists shall label all compounded drug products that are dispensed pursuant to a prescription in accordance with this chapter and the Board’s regulations, and shall include on the labeling an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":302088,"text":"A pharmacist may also engage in compounding of drug products in anticipation of receipt of prescriptions based on a routine, regularly observed prescribing pattern.\n\t\t\tPharmacists shall label all products compounded prior to dispensing with (i) the name and strength of the compounded medication or a list of the active ingredients and strengths; (ii) the pharmacy’s assigned control number that corresponds with the compounding record; (iii) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding; and (iv) the quantity.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"C"},"2":{"id":302089,"text":"In accordance with the conditions set forth in subsections A and B, pharmacists shall not distribute compounded drug products for subsequent distribution or sale to other persons or to commercial entities, including distribution to pharmacies or other entities under common ownership or control with the facility in which such compounding takes place, except for distribution within health systems under common ownership when the compounded drug products are administered only to patients within the hospital or health system; however, a pharmacist may distribute to a veterinarian in accordance with federal law.\n\t\t\tCompounded products for companion animals, as defined in regulations promulgated by the Board of Veterinary Medicine, and distributed by a pharmacy to a veterinarian for further distribution or sale to his own patients shall be limited to drugs necessary to treat an emergent condition when timely access to a compounding pharmacy is not available as determined by the prescribing veterinarian.\n\t\t\tA pharmacist may, however, deliver compounded products dispensed pursuant to valid prescriptions to alternate delivery locations pursuant to § 54.1-3420.2.\n\t\t\tA pharmacist may provide a reasonable amount of compounded products to practitioners of medicine, osteopathy, podiatry, or dentistry to administer to their patients, either personally or under their direct and immediate supervision, if there is a critical need to treat an emergency condition, or as allowed by federal law or regulations. A pharmacist may also provide compounded products to practitioners of veterinary medicine for office-based administration to their patients.\n\t\t\tPharmacists who provide compounded products for office-based administration for treatment of an emergency condition or as allowed by federal law or regulations shall label all compounded products distributed to practitioners other than veterinarians for administration to their patients with (i) the statement “For Administering in Prescriber Practice Location Only”; (ii) the name and strength of the compounded medication or list of the active ingredients and strengths; (iii) the facility’s control number; (iv) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding; (v) the name and address of the pharmacy; and (vi) the quantity.\n\t\t\tPharmacists shall label all compounded products for companion animals, as defined in regulations promulgated by the Board of Veterinary Medicine, and distributed to a veterinarian for either further distribution or sale to his own patient or administration to his own patient with (a) the name and strength of the compounded medication or list of the active ingredients and strengths; (b) the facility’s control number; (c) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding; (d) the name and address of the pharmacy; and (e) the quantity.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B","next_prefix":"D"},"3":{"id":302090,"text":"Pharmacists shall personally perform or personally supervise the compounding process, which shall include a final check for accuracy and conformity to the formula of the product being prepared, correct ingredients and calculations, accurate and precise measurements, appropriate conditions and procedures, and appearance of the final product.","type":"section","prefixes":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C","next_prefix":"E"},"4":{"id":302091,"text":"Pharmacists shall ensure compliance with USP-NF standards for both sterile and non-sterile compounding.","type":"section","prefixes":["E"],"prefix":"E","entire_prefix":"E","prefix_anchor":"E","level":1,"prior_prefix":"D","next_prefix":"F"},"5":{"id":302092,"text":"Pharmacists may use bulk drug substances in compounding when such bulk drug substances:","type":"section","prefixes":["F"],"prefix":"F","entire_prefix":"F","prefix_anchor":"F","level":1,"prior_prefix":"E","next_prefix":"F1"},"6":{"id":302093,"text":"Comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if such monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding; or are drug substances that are components of drugs approved by the FDA for use in the United States; or are otherwise approved by the FDA; or are manufactured by an establishment that is registered by the FDA; and","type":"section","prefixes":["F","1"],"prefix":"1","entire_prefix":"F1","prefix_anchor":"F1","level":2,"prior_prefix":"F","next_prefix":"F2"},"7":{"id":302094,"text":"Are distributed by a licensed wholesale distributor or registered nonresident wholesale distributor, or are distributed by a supplier otherwise approved by the Board and the FDA to distribute bulk drug substances if the pharmacist can establish purity and safety by reasonable means, such as lot analysis, manufacturer reputation, or reliability of the source.","type":"section","prefixes":["F","2"],"prefix":"2","entire_prefix":"F2","prefix_anchor":"F2","level":2,"prior_prefix":"F1","next_prefix":"G"},"8":{"id":302095,"text":"Pharmacists may compound using ingredients that are not considered drug products in accordance with the USP-NF standards and guidance on pharmacy compounding.","type":"section","prefixes":["G"],"prefix":"G","entire_prefix":"G","prefix_anchor":"G","level":1,"prior_prefix":"F2","next_prefix":"H"},"9":{"id":302096,"text":"Pharmacists shall not engage in the following:","type":"section","prefixes":["H"],"prefix":"H","entire_prefix":"H","prefix_anchor":"H","level":1,"prior_prefix":"G","next_prefix":"H1"},"10":{"id":302097,"text":"The compounding for human use of a drug product that has been withdrawn or removed from the market by the FDA because such drug product or a component of such drug product has been found to be unsafe. However, this prohibition shall be limited to the scope of the FDA withdrawal;","type":"section","prefixes":["H","1"],"prefix":"1","entire_prefix":"H1","prefix_anchor":"H1","level":2,"prior_prefix":"H","next_prefix":"H2"},"11":{"id":302098,"text":"The regular compounding or the compounding of inordinate amounts of any drug products that are essentially copies of commercially available drug products. However, this prohibition shall not include (i) the compounding of any commercially available product when there is a change in the product ordered by the prescriber for an individual patient, (ii) the compounding of a commercially manufactured drug only during times when the product is not available from the manufacturer or supplier, (iii) the compounding of a commercially manufactured drug whose manufacturer has notified the FDA that the drug is unavailable due to a current drug shortage, (iv) the compounding of a commercially manufactured drug when the prescriber has indicated in the oral or written prescription for an individual patient that there is an emergent need for a drug that is not readily available within the time medically necessary, or (v) the mixing of two or more commercially available products regardless of whether the end product is a commercially available product; or","type":"section","prefixes":["H","2"],"prefix":"2","entire_prefix":"H2","prefix_anchor":"H2","level":2,"prior_prefix":"H1","next_prefix":"H3"},"12":{"id":302099,"text":"The compounding of inordinate amounts of any preparation in cases in which there is no observed historical pattern of prescriptions and dispensing to support an expectation of receiving a valid prescription for the preparation. The compounding of an inordinate amount of a preparation in such cases shall constitute manufacturing of drugs.","type":"section","prefixes":["H","3"],"prefix":"3","entire_prefix":"H3","prefix_anchor":"H3","level":2,"prior_prefix":"H2","next_prefix":"I"},"13":{"id":302100,"text":"Pharmacists shall maintain records of all compounded drug products as part of the prescription, formula record, formula book, or other log or record. Records may be maintained electronically, manually, in a combination of both, or by any other readily retrievable method.","type":"section","prefixes":["I"],"prefix":"I","entire_prefix":"I","prefix_anchor":"I","level":1,"prior_prefix":"H3","next_prefix":"I1"},"14":{"id":302101,"text":"In addition to other requirements for prescription records, records for products compounded pursuant to a prescription order for a single patient where only manufacturers’ finished products are used as components shall include the name and quantity of all components, the date of compounding and dispensing, the prescription number or other identifier of the prescription order, the total quantity of finished product, the signature or initials of the pharmacist or pharmacy technician performing the compounding, and the signature or initials of the pharmacist responsible for supervising the pharmacy technician and verifying the accuracy and integrity of compounded products.","type":"section","prefixes":["I","1"],"prefix":"1","entire_prefix":"I1","prefix_anchor":"I1","level":2,"prior_prefix":"I","next_prefix":"I2"},"15":{"id":302102,"text":"In addition to the requirements of subdivision I 1, records for products compounded in bulk or batch in advance of dispensing or when bulk drug substances are used shall include: the generic name and the name of the manufacturer of each component or the brand name of each component; the manufacturer’s lot number and expiration date for each component or when the original manufacturer’s lot number and expiration date are unknown, the source of acquisition of the component; the assigned lot number if subdivided, the unit or package size and the number of units or packages prepared; and the beyond-use date. The criteria for establishing the beyond-use date shall be available for inspection by the Board.","type":"section","prefixes":["I","2"],"prefix":"2","entire_prefix":"I2","prefix_anchor":"I2","level":2,"prior_prefix":"I1","next_prefix":"I3"},"16":{"id":302103,"text":"A complete compounding formula listing all procedures, necessary equipment, necessary environmental considerations, and other factors in detail shall be maintained where such instructions are necessary to replicate a compounded product or where the compounding is difficult or complex and must be done by a certain process in order to ensure the integrity of the finished product.","type":"section","prefixes":["I","3"],"prefix":"3","entire_prefix":"I3","prefix_anchor":"I3","level":2,"prior_prefix":"I2","next_prefix":"I4"},"17":{"id":302104,"text":"A formal written quality assurance plan shall be maintained that describes specific monitoring and evaluation of compounding activities in accordance with USP-NF standards. Records shall be maintained showing compliance with monitoring and evaluation requirements of the plan to include training and initial and periodic competence assessment of personnel involved in compounding, monitoring of environmental controls and equipment calibration, and any end-product testing, if applicable.","type":"section","prefixes":["I","4"],"prefix":"4","entire_prefix":"I4","prefix_anchor":"I4","level":2,"prior_prefix":"I3","next_prefix":"J"},"18":{"id":302105,"text":"Practitioners who may lawfully compound drugs for administering or dispensing to their own patients pursuant to §§ 54.1-3301, 54.1-3304, and 54.1-3304.1 shall comply with all provisions of this section and the relevant Board regulations.","type":"section","prefixes":["J"],"prefix":"J","entire_prefix":"J","prefix_anchor":"J","level":1,"prior_prefix":"I4","next_prefix":"K"},"19":{"id":302106,"text":"Every pharmacist-in-charge or owner of a permitted pharmacy or a registered nonresident pharmacy engaging in sterile compounding shall notify the Board of its intention to dispense or otherwise deliver a sterile compounded drug product into the Commonwealth. Upon renewal of its permit or registration, a pharmacy or nonresident pharmacy shall notify the Board of its intention to continue dispensing or otherwise delivering sterile compounded drug products into the Commonwealth. Failure to provide notification to the Board shall constitute a violation of Chapter 33 (§ 54.1-3300 et seq.) or Chapter 34 (§ 54.1-3400 et seq.). The Board shall maintain this information in a manner that will allow the production of a list identifying all such sterile compounding pharmacies.","type":"section","prefixes":["K"],"prefix":"K","entire_prefix":"K","prefix_anchor":"K","level":1,"prior_prefix":"J"}},"ancestry":[{"id":13871,"edition_id":1,"name":"General Provisions","identifier":"1","label":"article","depth":4,"order_by":1,"parent_id":13240,"metadata":{},"date_created":"2026-06-26 03:46:08","date_modified":"2026-06-26 03:46:08","permalink":{"id":243225,"object_type":"structure","relational_id":13871,"identifier":"1","token":"54.1\/III\/34\/1","url":"\/54.1\/III\/34\/1\/","edition_id":1,"permalink":0,"preferred":1}},{"id":13240,"edition_id":1,"name":"Drug Control Act","identifier":"34","label":"chapter","depth":3,"order_by":1,"parent_id":12758,"metadata":{},"date_created":"2026-06-26 03:44:30","date_modified":"2026-06-26 03:44:30","permalink":{"id":243223,"object_type":"structure","relational_id":13240,"identifier":"34","token":"54.1\/III\/34","url":"\/54.1\/III\/34\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12758,"edition_id":1,"name":"Professions and Occupations Regulated by Boards Within the Department of Health Professions","identifier":"III","label":"subtitle","depth":2,"order_by":1,"parent_id":12754,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":241105,"object_type":"structure","relational_id":12758,"identifier":"III","token":"54.1\/III","url":"\/54.1\/III\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12754,"edition_id":1,"name":"Professions and Occupations","identifier":"54.1","label":"title","depth":1,"order_by":1,"parent_id":null,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":239313,"object_type":"structure","relational_id":12754,"identifier":"54.1","token":"54.1","url":"\/54.1\/","edition_id":1,"permalink":0,"preferred":1}}],"structure_contents":[{"id":77846,"structure_id":13871,"section_number":"54.1-3400","catch_line":"Citation","url":"\/54.1-3400\/","token":"54.1\/III\/34\/1\/54.1-3400","metadata":false},{"id":59669,"structure_id":13871,"section_number":"54.1-3401","catch_line":"Definitions","url":"\/54.1-3401\/","token":"54.1\/III\/34\/1\/54.1-3401","metadata":false},{"id":73061,"structure_id":13871,"section_number":"54.1-3401.1","catch_line":"Repealed","url":"\/54.1-3401.1\/","token":"54.1\/III\/34\/1\/54.1-3401.1","metadata":false},{"id":67762,"structure_id":13871,"section_number":"54.1-3402","catch_line":"Repealed","url":"\/54.1-3402\/","token":"54.1\/III\/34\/1\/54.1-3402","metadata":false},{"id":66637,"structure_id":13871,"section_number":"54.1-3403","catch_line":"Chapter not applicable to economic poisons","url":"\/54.1-3403\/","token":"54.1\/III\/34\/1\/54.1-3403","metadata":false},{"id":64371,"structure_id":13871,"section_number":"54.1-3404","catch_line":"Inventories of controlled substances required of certain persons; contents and form of record","url":"\/54.1-3404\/","token":"54.1\/III\/34\/1\/54.1-3404","metadata":false},{"id":55711,"structure_id":13871,"section_number":"54.1-3405","catch_line":"Access to and copies of records; inspections","url":"\/54.1-3405\/","token":"54.1\/III\/34\/1\/54.1-3405","metadata":false},{"id":69269,"structure_id":13871,"section_number":"54.1-3406","catch_line":"Records confidential; disclosure of information about violations of federal law","url":"\/54.1-3406\/","token":"54.1\/III\/34\/1\/54.1-3406","metadata":false},{"id":62600,"structure_id":13871,"section_number":"54.1-3407","catch_line":"Analysis of controlled substances","url":"\/54.1-3407\/","token":"54.1\/III\/34\/1\/54.1-3407","metadata":false},{"id":77665,"structure_id":13871,"section_number":"54.1-3408","catch_line":"Professional use by practitioners","url":"\/54.1-3408\/","token":"54.1\/III\/34\/1\/54.1-3408","metadata":false},{"id":68723,"structure_id":13871,"section_number":"54.1-3408.01","catch_line":"Requirements for prescriptions","url":"\/54.1-3408.01\/","token":"54.1\/III\/34\/1\/54.1-3408.01","metadata":false},{"id":69355,"structure_id":13871,"section_number":"54.1-3408.02","catch_line":"Transmission of prescriptions","url":"\/54.1-3408.02\/","token":"54.1\/III\/34\/1\/54.1-3408.02","metadata":false},{"id":81842,"structure_id":13871,"section_number":"54.1-3408.03","catch_line":"Dispensing of therapeutically equivalent drug product permitted","url":"\/54.1-3408.03\/","token":"54.1\/III\/34\/1\/54.1-3408.03","metadata":false},{"id":61115,"structure_id":13871,"section_number":"54.1-3408.04","catch_line":"Dispensing of interchangeable biosimilars permitted","url":"\/54.1-3408.04\/","token":"54.1\/III\/34\/1\/54.1-3408.04","metadata":false},{"id":58824,"structure_id":13871,"section_number":"54.1-3408.05","catch_line":"Use of FDA-approved substance upon publication of final rule","url":"\/54.1-3408.05\/","token":"54.1\/III\/34\/1\/54.1-3408.05","metadata":false},{"id":82403,"structure_id":13871,"section_number":"54.1-3408.1","catch_line":"Prescription in excess of recommended dosage in certain cases","url":"\/54.1-3408.1\/","token":"54.1\/III\/34\/1\/54.1-3408.1","metadata":false},{"id":54900,"structure_id":13871,"section_number":"54.1-3408.2","catch_line":"Failure to report administration or dispensing of or prescription for controlled substances; report required; penalty","url":"\/54.1-3408.2\/","token":"54.1\/III\/34\/1\/54.1-3408.2","metadata":false},{"id":66341,"structure_id":13871,"section_number":"54.1-3408.3","catch_line":"Certification for use of cannabis for treatment","url":"\/54.1-3408.3\/","token":"54.1\/III\/34\/1\/54.1-3408.3","metadata":false},{"id":84329,"structure_id":13871,"section_number":"54.1-3408.4","catch_line":"Expired","url":"\/54.1-3408.4\/","token":"54.1\/III\/34\/1\/54.1-3408.4","metadata":false},{"id":64050,"structure_id":13871,"section_number":"54.1-3408.5","catch_line":"Epinephrine required in certain places of public accommodation","url":"\/54.1-3408.5\/","token":"54.1\/III\/34\/1\/54.1-3408.5","metadata":false},{"id":86191,"structure_id":13871,"section_number":"54.1-3409","catch_line":"Professional use by veterinarians","url":"\/54.1-3409\/","token":"54.1\/III\/34\/1\/54.1-3409","metadata":false},{"id":83740,"structure_id":13871,"section_number":"54.1-3410","catch_line":"When pharmacist may sell and dispense drugs","url":"\/54.1-3410\/","token":"54.1\/III\/34\/1\/54.1-3410","metadata":false},{"id":56420,"structure_id":13871,"section_number":"54.1-3410.1","catch_line":"Requirements for radiopharmaceuticals","url":"\/54.1-3410.1\/","token":"54.1\/III\/34\/1\/54.1-3410.1","metadata":false},{"id":84268,"structure_id":13871,"section_number":"54.1-3410.2","catch_line":"Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements","url":"\/54.1-3410.2\/","token":"54.1\/III\/34\/1\/54.1-3410.2","metadata":false},{"id":70552,"structure_id":13871,"section_number":"54.1-3410.3","catch_line":"Accessible prescription labels","url":"\/54.1-3410.3\/","token":"54.1\/III\/34\/1\/54.1-3410.3","metadata":false},{"id":77643,"structure_id":13871,"section_number":"54.1-3411","catch_line":"When prescriptions may be refilled","url":"\/54.1-3411\/","token":"54.1\/III\/34\/1\/54.1-3411","metadata":false},{"id":61132,"structure_id":13871,"section_number":"54.1-3411.1","catch_line":"Prohibition on returns, exchanges, or re-dispensing of drugs; exceptions","url":"\/54.1-3411.1\/","token":"54.1\/III\/34\/1\/54.1-3411.1","metadata":false},{"id":65473,"structure_id":13871,"section_number":"54.1-3411.2","catch_line":"Prescription drug disposal programs","url":"\/54.1-3411.2\/","token":"54.1\/III\/34\/1\/54.1-3411.2","metadata":false},{"id":86720,"structure_id":13871,"section_number":"54.1-3411.2:1","catch_line":"Guidelines for disposal of unused drugs","url":"\/54.1-3411.2_1\/","token":"54.1\/III\/34\/1\/54.1-3411.2_1","metadata":false},{"id":79333,"structure_id":13871,"section_number":"54.1-3412","catch_line":"Date of dispensing; initials of pharmacist; automated data processing system","url":"\/54.1-3412\/","token":"54.1\/III\/34\/1\/54.1-3412","metadata":false},{"id":84967,"structure_id":13871,"section_number":"54.1-3413","catch_line":"Manufacturing and administering Schedule I drugs","url":"\/54.1-3413\/","token":"54.1\/III\/34\/1\/54.1-3413","metadata":false},{"id":72920,"structure_id":13871,"section_number":"54.1-3414","catch_line":"Official orders for Schedule II drugs","url":"\/54.1-3414\/","token":"54.1\/III\/34\/1\/54.1-3414","metadata":false},{"id":75448,"structure_id":13871,"section_number":"54.1-3415","catch_line":"Distribution of drugs in Schedules II through VI by manufacturers and wholesalers","url":"\/54.1-3415\/","token":"54.1\/III\/34\/1\/54.1-3415","metadata":false},{"id":65722,"structure_id":13871,"section_number":"54.1-3415.1","catch_line":"Delivery of medical devices on behalf of a medical equipment supplier","url":"\/54.1-3415.1\/","token":"54.1\/III\/34\/1\/54.1-3415.1","metadata":false},{"id":81317,"structure_id":13871,"section_number":"54.1-3416","catch_line":"No prescription for preparations listed pursuant to Schedule V","url":"\/54.1-3416\/","token":"54.1\/III\/34\/1\/54.1-3416","metadata":false},{"id":85551,"structure_id":13871,"section_number":"54.1-3417","catch_line":"Disposing of stocks of Schedules II through V drugs","url":"\/54.1-3417\/","token":"54.1\/III\/34\/1\/54.1-3417","metadata":false},{"id":57515,"structure_id":13871,"section_number":"54.1-3418","catch_line":"Sale of aqueous or oleaginous solutions","url":"\/54.1-3418\/","token":"54.1\/III\/34\/1\/54.1-3418","metadata":false},{"id":72600,"structure_id":13871,"section_number":"54.1-3419","catch_line":"Dispensing of insulin preparations","url":"\/54.1-3419\/","token":"54.1\/III\/34\/1\/54.1-3419","metadata":false},{"id":83366,"structure_id":13871,"section_number":"54.1-3420","catch_line":"Distribution of certain drugs; written request or confirmation of receipt","url":"\/54.1-3420\/","token":"54.1\/III\/34\/1\/54.1-3420","metadata":false},{"id":79253,"structure_id":13871,"section_number":"54.1-3420.1","catch_line":"Identification required for filling prescriptions","url":"\/54.1-3420.1\/","token":"54.1\/III\/34\/1\/54.1-3420.1","metadata":false},{"id":56483,"structure_id":13871,"section_number":"54.1-3420.2","catch_line":"Delivery of prescription drug order","url":"\/54.1-3420.2\/","token":"54.1\/III\/34\/1\/54.1-3420.2","metadata":false},{"id":55265,"structure_id":13871,"section_number":"54.1-3420.3","catch_line":"Prohibition on refusing to fill prescription from telemedicine provider","url":"\/54.1-3420.3\/","token":"54.1\/III\/34\/1\/54.1-3420.3","metadata":false},{"id":55995,"structure_id":13871,"section_number":"54.1-3421","catch_line":"New drugs","url":"\/54.1-3421\/","token":"54.1\/III\/34\/1\/54.1-3421","metadata":false},{"id":73818,"structure_id":13871,"section_number":"54.1-3422","catch_line":"Controlled substances registration certificate required in addition to other requirements; exemptions","url":"\/54.1-3422\/","token":"54.1\/III\/34\/1\/54.1-3422","metadata":false},{"id":87135,"structure_id":13871,"section_number":"54.1-3423","catch_line":"Board to issue registration unless inconsistent with public interest; authorization to conduct research; application and fees","url":"\/54.1-3423\/","token":"54.1\/III\/34\/1\/54.1-3423","metadata":false},{"id":59124,"structure_id":13871,"section_number":"54.1-3424","catch_line":"Suspension or revocation of registration, license or permit; limitation to particular controlled substance; controlled substances placed under seal; sale of perishables and forfeiture; notification to DEA","url":"\/54.1-3424\/","token":"54.1\/III\/34\/1\/54.1-3424","metadata":false},{"id":83858,"structure_id":13871,"section_number":"54.1-3425","catch_line":"Repealed","url":"\/54.1-3425\/","token":"54.1\/III\/34\/1\/54.1-3425","metadata":false},{"id":86762,"structure_id":13871,"section_number":"54.1-3426","catch_line":"Regulations for special packaging","url":"\/54.1-3426\/","token":"54.1\/III\/34\/1\/54.1-3426","metadata":false},{"id":85278,"structure_id":13871,"section_number":"54.1-3427","catch_line":"Dispensing drugs without safety closure container","url":"\/54.1-3427\/","token":"54.1\/III\/34\/1\/54.1-3427","metadata":false},{"id":68396,"structure_id":13871,"section_number":"54.1-3428","catch_line":"Dissemination of information","url":"\/54.1-3428\/","token":"54.1\/III\/34\/1\/54.1-3428","metadata":false},{"id":74207,"structure_id":13871,"section_number":"54.1-3429","catch_line":"Revocation of permit issued to manufacturer, wholesaler or distributor","url":"\/54.1-3429\/","token":"54.1\/III\/34\/1\/54.1-3429","metadata":false},{"id":73141,"structure_id":13871,"section_number":"54.1-3430","catch_line":"Display of permit; permits nontransferable; renewal","url":"\/54.1-3430\/","token":"54.1\/III\/34\/1\/54.1-3430","metadata":false},{"id":76001,"structure_id":13871,"section_number":"54.1-3431","catch_line":"Admission into evidence of certain certificates of analysis","url":"\/54.1-3431\/","token":"54.1\/III\/34\/1\/54.1-3431","metadata":false}],"previous_section":{"id":56420,"structure_id":13871,"section_number":"54.1-3410.1","catch_line":"Requirements for radiopharmaceuticals","url":"\/54.1-3410.1\/","token":"54.1\/III\/34\/1\/54.1-3410.1","metadata":false},"next_section":{"id":70552,"structure_id":13871,"section_number":"54.1-3410.3","catch_line":"Accessible prescription labels","url":"\/54.1-3410.3\/","token":"54.1\/III\/34\/1\/54.1-3410.3","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3410.2\/","history_text":"

This law was first created in 2003. The record of its establishment is cataloged in chapter 509<\/a> of that year\u2019s edition of \u201cActs of Assembly,\u201d the annual state publication listing all changes made to the Code of Virginia in that year. It has been modified 7 times. Those modifications are cataloged by \u201cThe Acts of Assembly,\u201d a state publication, by year and chapter. Those modifications that can be read on the General Assembly\u2019s website will be linked accordingly. Those modifications are as follows: in 2005, chapter 200<\/a>; in 2012, chapter 173<\/a>; in 2013, chapter 765<\/a>; in 2014, chapter 147<\/a>; in 2015, chapter 300<\/a>; in 2016, chapter 221<\/a>; in 2025, chapters 48<\/a> and 71<\/a>.<\/p>","references":[{"id":69269,"section_number":"54.1-3406","catch_line":"Records confidential; disclosure of information about violations of federal law","order_by":null,"url":"\/54.1-3406\/"},{"id":80945,"section_number":"54.1-3434.05","catch_line":"Permit to act as an outsourcing facility","order_by":null,"url":"\/54.1-3434.05\/"},{"id":85801,"section_number":"54.1-3434.5","catch_line":"Nonresident outsourcing facilities to register with the Board","order_by":null,"url":"\/54.1-3434.5\/"}],"refers_to":[{"id":72064,"section_number":"54.1-3300","catch_line":"Definitions","order_by":null,"url":"\/54.1-3300\/"},{"id":55719,"section_number":"54.1-3301","catch_line":"Exceptions","order_by":null,"url":"\/54.1-3301\/"},{"id":85347,"section_number":"54.1-3303","catch_line":"Prescriptions to be issued and drugs to be dispensed for medical or therapeutic purposes only","order_by":null,"url":"\/54.1-3303\/"},{"id":58623,"section_number":"54.1-3304","catch_line":"Licensing of physicians to dispense drugs; renewals","order_by":null,"url":"\/54.1-3304\/"},{"id":68921,"section_number":"54.1-3304.1","catch_line":"Authority to license and regulate practitioners; permits","order_by":null,"url":"\/54.1-3304.1\/"},{"id":77846,"section_number":"54.1-3400","catch_line":"Citation","order_by":null,"url":"\/54.1-3400\/"},{"id":56483,"section_number":"54.1-3420.2","catch_line":"Delivery of prescription drug order","order_by":null,"url":"\/54.1-3420.2\/"}],"permalink":{"id":243319,"object_type":"law","relational_id":84268,"identifier":"54.1-3410.2","token":"54.1\/III\/34\/1\/54.1-3410.2","url":"\/54.1-3410.2\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3410.2\/","token":"54.1\/III\/34\/1\/54.1-3410.2","dublin_core":{"Title":"Compounding; pharmacists’ authority to compound under certain conditions; labeling and record maintenance requirements","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3410.2","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> A pharmacist may engage in compounding<\/span> of drug products<\/span> when the dispensing<\/span> of such compounded products is (i) pursuant to valid prescriptions<\/span> for specific patients and (ii) consistent with the provisions of § 54.1-3303<\/a> relating to the issuance of prescriptions<\/span> and the dispensing<\/span> of drugs<\/span>.\n\t\t\tPharmacists shall label<\/span> all compounded drug products<\/span> that are dispensed pursuant to a prescription<\/span> in accordance with this chapter and the Board<\/span>’s regulations, and shall include on the labeling<\/span> an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF<\/span> standards for pharmacy compounding<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> A pharmacist may also engage in compounding<\/span> of drug products<\/span> in anticipation of receipt of prescriptions<\/span> based on a routine, regularly observed prescribing pattern.\n\t\t\tPharmacists shall label<\/span> all products compounded prior to dispensing<\/span> with (i) the name and strength of the compounded medication or a list of the active ingredients and strengths; (ii) the pharmacy’s assigned control number that corresponds with the compounding<\/span> record; (iii) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF<\/span> standards for pharmacy compounding<\/span>; and (iv) the quantity. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> In accordance with the conditions set forth in subsections A and B, pharmacists shall not distribute<\/span> compounded drug products<\/span> for subsequent distribution or sale<\/span> to other persons<\/span> or to commercial entities, including distribution to pharmacies or other entities under common ownership or control with the facility in which such compounding<\/span> takes place, except for distribution within health systems under common ownership when the compounded drug products<\/span> are administered only to patients within the hospital or health system; however, a pharmacist may distribute<\/span> to a veterinarian in accordance with federal law<\/span>.\n\t\t\tCompounded products for companion animals<\/span>, as defined in regulations promulgated by the Board<\/span> of Veterinary Medicine, and distributed by a pharmacy to a veterinarian for further distribution or sale<\/span> to his own patients shall be limited to drugs<\/span> necessary to treat an emergent condition when timely access to a compounding<\/span> pharmacy is not available as determined by the prescribing veterinarian.\n\t\t\tA pharmacist may, however, deliver<\/span> compounded products dispensed pursuant to valid prescriptions<\/span> to alternate delivery<\/span> locations pursuant to § 54.1-3420.2<\/a>.\n\t\t\tA pharmacist may provide a reasonable amount of compounded products to practitioners<\/span> of medicine, osteopathy, podiatry, or dentistry to administer<\/span> to their patients, either personally or under their direct and immediate supervision, if there is a critical need to treat an emergency condition, or as allowed by federal law<\/span> or regulations. A pharmacist may also provide compounded products to practitioners<\/span> of veterinary medicine for office-based administration to their patients.\n\t\t\tPharmacists who provide compounded products for office-based administration for treatment of an emergency condition or as allowed by federal law<\/span> or regulations shall label<\/span> all compounded products distributed to practitioners<\/span> other than veterinarians for administration to their patients with (i) the statement “For Administering in Prescriber<\/span> Practice Location Only”; (ii) the name and strength of the compounded medication or list of the active ingredients and strengths; (iii) the facility’s control number; (iv) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF<\/span> standards for pharmacy compounding<\/span>; (v) the name and address of the pharmacy; and (vi) the quantity.\n\t\t\tPharmacists shall label<\/span> all compounded products for companion animals<\/span>, as defined in regulations promulgated by the Board<\/span> of Veterinary Medicine, and distributed to a veterinarian for either further distribution or sale<\/span> to his own patient or administration to his own patient with (a) the name and strength of the compounded medication or list of the active ingredients and strengths; (b) the facility’s control number; (c) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF<\/span> standards for pharmacy compounding<\/span>; (d) the name and address of the pharmacy; and (e) the quantity. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

D.<\/span> Pharmacists shall personally perform or personally supervise the compounding<\/span> process, which shall include a final check for accuracy and conformity to the formula of the product being prepared, correct ingredients and calculations, accurate and precise measurements, appropriate conditions and procedures, and appearance<\/span> of the final product. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

E.<\/span> Pharmacists shall ensure compliance with USP-NF<\/span> standards for both sterile and non-sterile compounding<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

F.<\/span> Pharmacists may use bulk drug substances<\/span> in compounding<\/span> when such bulk drug substances<\/span>: <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

1.<\/span> Comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if such monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding<\/span>; or are drug substances that are components of drugs<\/span> approved by the FDA<\/span> for use in the United States; or are otherwise approved by the FDA<\/span>; or are manufactured by an establishment that is registered by the FDA<\/span>; and <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

2.<\/span> Are distributed by a licensed wholesale distributor<\/span> or registered nonresident wholesale distributor<\/span>, or are distributed by a supplier otherwise approved by the Board<\/span> and the FDA<\/span> to distribute<\/span> bulk drug substances<\/span> if the pharmacist can establish purity and safety by reasonable means, such as lot analysis, manufacturer<\/span> reputation, or reliability of the source. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

G.<\/span> Pharmacists may compound using ingredients that are not considered drug products<\/span> in accordance with the USP-NF<\/span> standards and guidance on pharmacy compounding<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

H.<\/span> Pharmacists shall not engage in the following: <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

1.<\/span> The compounding<\/span> for human use of a drug product<\/span> that has been withdrawn or removed from the market by the FDA<\/span> because such drug product<\/span> or a component of such drug product<\/span> has been found to be unsafe. However, this prohibition shall be limited to the scope of the FDA<\/span> withdrawal; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

2.<\/span> The regular compounding<\/span> or the compounding<\/span> of inordinate amounts of any drug products<\/span> that are essentially copies of commercially available drug products<\/span>. However, this prohibition shall not include (i) the compounding<\/span> of any commercially available product when there is a change in the product ordered by the prescriber<\/span> for an individual patient, (ii) the compounding<\/span> of a commercially manufactured drug only during times when the product is not available from the manufacturer<\/span> or supplier, (iii) the compounding<\/span> of a commercially manufactured drug whose manufacturer<\/span> has notified the FDA<\/span> that the drug is unavailable due to a current drug shortage, (iv) the compounding<\/span> of a commercially manufactured drug when the prescriber<\/span> has indicated in the oral or written prescription<\/span> for an individual patient that there is an emergent need for a drug that is not readily available within the time medically necessary, or (v) the mixing of two or more commercially available products regardless of whether the end product is a commercially available product; or <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

3.<\/span> The compounding<\/span> of inordinate amounts of any preparation in cases in which there is no observed historical pattern of prescriptions<\/span> and dispensing<\/span> to support an expectation of receiving a valid prescription<\/span> for the preparation. The compounding<\/span> of an inordinate amount of a preparation in such cases shall constitute manufacturing of drugs<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

I.<\/span> Pharmacists shall maintain records of all compounded drug products<\/span> as part of the prescription<\/span>, formula record, formula book, or other log or record. Records may be maintained electronically, manually, in a combination of both, or by any other readily retrievable method. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

1.<\/span> In addition to other requirements for prescription<\/span> records, records for products compounded pursuant to a prescription<\/span> order<\/span> for a single patient where only manufacturers<\/span>’ finished products are used as components shall include the name and quantity of all components, the date of compounding<\/span> and dispensing<\/span>, the prescription<\/span> number or other identifier of the prescription<\/span> order<\/span>, the total quantity of finished product, the signature or initials of the pharmacist or pharmacy technician performing the compounding<\/span>, and the signature or initials of the pharmacist responsible for supervising the pharmacy technician and verifying the accuracy and integrity of compounded products. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

2.<\/span> In addition to the requirements of subdivision I 1, records for products compounded in bulk or batch in advance of dispensing<\/span> or when bulk drug substances<\/span> are used shall include: the generic name and the name of the manufacturer<\/span> of each component or the brand name of each component; the manufacturer<\/span>’s lot number and expiration date for each component or when the original manufacturer<\/span>’s lot number and expiration date are unknown, the source of acquisition of the component; the assigned lot number if subdivided, the unit or package size and the number of units or packages prepared; and the beyond-use date. The criteria for establishing the beyond-use date shall be available for inspection by the Board<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

3.<\/span> A complete compounding<\/span> formula listing all procedures, necessary equipment, necessary environmental considerations, and other factors in detail shall be maintained where such instructions are necessary to replicate a compounded product or where the compounding<\/span> is difficult or complex and must be done by a certain process in order<\/span> to ensure the integrity of the finished product. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

4.<\/span> A formal written quality assurance plan shall be maintained that describes specific monitoring and evaluation of compounding<\/span> activities in accordance with USP-NF<\/span> standards. Records shall be maintained showing compliance with monitoring and evaluation requirements of the plan to include training and initial and periodic competence assessment of personnel involved in compounding<\/span>, monitoring of environmental controls and equipment calibration, and any end-product testing, if applicable. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

J.<\/span> Practitioners<\/span> who may lawfully compound drugs<\/span> for administering or dispensing<\/span> to their own patients pursuant to §§ 54.1-3301<\/a>, 54.1-3304<\/a>, and 54.1-3304.1<\/a> shall comply with all provisions of this section and the relevant Board<\/span> regulations. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

K.<\/span> Every pharmacist-in-charge<\/span> or owner of a permitted pharmacy or a registered nonresident pharmacy engaging in sterile compounding<\/span> shall notify the Board<\/span> of its intention to dispense<\/span> or otherwise deliver<\/span> a sterile compounded drug product<\/span> into the Commonwealth. Upon renewal of its permit or registration, a pharmacy or nonresident pharmacy shall notify the Board<\/span> of its intention to continue dispensing<\/span> or otherwise delivering sterile compounded drug products<\/span> into the Commonwealth. Failure to provide notification to the Board<\/span> shall constitute a violation of Chapter 33 (§ 54.1-3300<\/a> et seq.) or Chapter 34 (§ 54.1-3400<\/a> et seq.). The Board<\/span> shall maintain this information in a manner that will allow the production<\/span> of a list identifying all such sterile compounding<\/span> pharmacies. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nCOMPOUNDING; PHARMACISTS’ AUTHORITY TO COMPOUND UNDER CERTAIN CONDITIONS;\nLABELING AND RECORD MAINTENANCE REQUIREMENTS (\u00a7 54.1-3410.2)\n\nA. A pharmacist may engage in compounding of drug products when the dispensing\nof such compounded products is (i) pursuant to valid prescriptions for specific\npatients and (ii) consistent with the provisions of § 54.1-3303 relating to\nthe issuance of prescriptions and the dispensing of drugs.\n\t\t\tPharmacists shall label all compounded drug products that are dispensed\npursuant to a prescription in accordance with this chapter and the Board’s\nregulations, and shall include on the labeling an appropriate beyond-use date as\ndetermined by the pharmacist in compliance with USP-NF standards for pharmacy\ncompounding.\n\nB. A pharmacist may also engage in compounding of drug products in anticipation\nof receipt of prescriptions based on a routine, regularly observed prescribing\npattern.\n\t\t\tPharmacists shall label all products compounded prior to dispensing with (i)\nthe name and strength of the compounded medication or a list of the active\ningredients and strengths; (ii) the pharmacy’s assigned control number\nthat corresponds with the compounding record; (iii) an appropriate beyond-use\ndate as determined by the pharmacist in compliance with USP-NF standards for\npharmacy compounding; and (iv) the quantity.\n\nC. In accordance with the conditions set forth in subsections A and B,\npharmacists shall not distribute compounded drug products for subsequent\ndistribution or sale to other persons or to commercial entities, including\ndistribution to pharmacies or other entities under common ownership or control\nwith the facility in which such compounding takes place, except for distribution\nwithin health systems under common ownership when the compounded drug products\nare administered only to patients within the hospital or health system; however,\na pharmacist may distribute to a veterinarian in accordance with federal law.\n\t\t\tCompounded products for companion animals, as defined in regulations\npromulgated by the Board of Veterinary Medicine, and distributed by a pharmacy\nto a veterinarian for further distribution or sale to his own patients shall be\nlimited to drugs necessary to treat an emergent condition when timely access to\na compounding pharmacy is not available as determined by the prescribing\nveterinarian.\n\t\t\tA pharmacist may, however, deliver compounded products dispensed pursuant to\nvalid prescriptions to alternate delivery locations pursuant to §\n54.1-3420.2.\n\t\t\tA pharmacist may provide a reasonable amount of compounded products to\npractitioners of medicine, osteopathy, podiatry, or dentistry to administer to\ntheir patients, either personally or under their direct and immediate\nsupervision, if there is a critical need to treat an emergency condition, or as\nallowed by federal law or regulations. A pharmacist may also provide compounded\nproducts to practitioners of veterinary medicine for office-based administration\nto their patients.\n\t\t\tPharmacists who provide compounded products for office-based administration\nfor treatment of an emergency condition or as allowed by federal law or\nregulations shall label all compounded products distributed to practitioners\nother than veterinarians for administration to their patients with (i) the\nstatement “For Administering in Prescriber Practice Location Only”;\n(ii) the name and strength of the compounded medication or list of the active\ningredients and strengths; (iii) the facility’s control number; (iv) an\nappropriate beyond-use date as determined by the pharmacist in compliance with\nUSP-NF standards for pharmacy compounding; (v) the name and address of the\npharmacy; and (vi) the quantity.\n\t\t\tPharmacists shall label all compounded products for companion animals, as\ndefined in regulations promulgated by the Board of Veterinary Medicine, and\ndistributed to a veterinarian for either further distribution or sale to his own\npatient or administration to his own patient with (a) the name and strength of\nthe compounded medication or list of the active ingredients and strengths; (b)\nthe facility’s control number; (c) an appropriate beyond-use date as\ndetermined by the pharmacist in compliance with USP-NF standards for pharmacy\ncompounding; (d) the name and address of the pharmacy; and (e) the quantity.\n\nD. Pharmacists shall personally perform or personally supervise the compounding\nprocess, which shall include a final check for accuracy and conformity to the\nformula of the product being prepared, correct ingredients and calculations,\naccurate and precise measurements, appropriate conditions and procedures, and\nappearance of the final product.\n\nE. Pharmacists shall ensure compliance with USP-NF standards for both sterile\nand non-sterile compounding.\n\nF. Pharmacists may use bulk drug substances in compounding when such bulk drug\nsubstances:\n\n 1. Comply with the standards of an applicable United States Pharmacopoeia or\n National Formulary monograph, if such monograph exists, and the United States\n Pharmacopoeia chapter on pharmacy compounding; or are drug substances that are\n components of drugs approved by the FDA for use in the United States; or are\n otherwise approved by the FDA; or are manufactured by an establishment that is\n registered by the FDA; and\n\n 2. Are distributed by a licensed wholesale distributor or registered\n nonresident wholesale distributor, or are distributed by a supplier otherwise\n approved by the Board and the FDA to distribute bulk drug substances if the\n pharmacist can establish purity and safety by reasonable means, such as lot\n analysis, manufacturer reputation, or reliability of the source.\n\nG. Pharmacists may compound using ingredients that are not considered drug\nproducts in accordance with the USP-NF standards and guidance on pharmacy\ncompounding.\n\nH. Pharmacists shall not engage in the following:\n\n 1. The compounding for human use of a drug product that has been withdrawn or\n removed from the market by the FDA because such drug product or a component of\n such drug product has been found to be unsafe. However, this prohibition shall\n be limited to the scope of the FDA withdrawal;\n\n 2. The regular compounding or the compounding of inordinate amounts of any\n drug products that are essentially copies of commercially available drug\n products. However, this prohibition shall not include (i) the compounding of\n any commercially available product when there is a change in the product\n ordered by the prescriber for an individual patient, (ii) the compounding of a\n commercially manufactured drug only during times when the product is not\n available from the manufacturer or supplier, (iii) the compounding of a\n commercially manufactured drug whose manufacturer has notified the FDA that\n the drug is unavailable due to a current drug shortage, (iv) the compounding\n of a commercially manufactured drug when the prescriber has indicated in the\n oral or written prescription for an individual patient that there is an\n emergent need for a drug that is not readily available within the time\n medically necessary, or (v) the mixing of two or more commercially available\n products regardless of whether the end product is a commercially available\n product; or\n\n 3. The compounding of inordinate amounts of any preparation in cases in which\n there is no observed historical pattern of prescriptions and dispensing to\n support an expectation of receiving a valid prescription for the preparation.\n The compounding of an inordinate amount of a preparation in such cases shall\n constitute manufacturing of drugs.\n\nI. Pharmacists shall maintain records of all compounded drug products as part of\nthe prescription, formula record, formula book, or other log or record. Records\nmay be maintained electronically, manually, in a combination of both, or by any\nother readily retrievable method.\n\n 1. In addition to other requirements for prescription records, records for\n products compounded pursuant to a prescription order for a single patient\n where only manufacturers’ finished products are used as components shall\n include the name and quantity of all components, the date of compounding and\n dispensing, the prescription number or other identifier of the prescription\n order, the total quantity of finished product, the signature or initials of\n the pharmacist or pharmacy technician performing the compounding, and the\n signature or initials of the pharmacist responsible for supervising the\n pharmacy technician and verifying the accuracy and integrity of compounded\n products.\n\n 2. In addition to the requirements of subdivision I 1, records for products\n compounded in bulk or batch in advance of dispensing or when bulk drug\n substances are used shall include: the generic name and the name of the\n manufacturer of each component or the brand name of each component; the\n manufacturer’s lot number and expiration date for each component or when\n the original manufacturer’s lot number and expiration date are unknown,\n the source of acquisition of the component; the assigned lot number if\n subdivided, the unit or package size and the number of units or packages\n prepared; and the beyond-use date. The criteria for establishing the\n beyond-use date shall be available for inspection by the Board.\n\n 3. A complete compounding formula listing all procedures, necessary equipment,\n necessary environmental considerations, and other factors in detail shall be\n maintained where such instructions are necessary to replicate a compounded\n product or where the compounding is difficult or complex and must be done by a\n certain process in order to ensure the integrity of the finished product.\n\n 4. A formal written quality assurance plan shall be maintained that describes\n specific monitoring and evaluation of compounding activities in accordance\n with USP-NF standards. Records shall be maintained showing compliance with\n monitoring and evaluation requirements of the plan to include training and\n initial and periodic competence assessment of personnel involved in\n compounding, monitoring of environmental controls and equipment calibration,\n and any end-product testing, if applicable.\n\nJ. Practitioners who may lawfully compound drugs for administering or dispensing\nto their own patients pursuant to §§ 54.1-3301, 54.1-3304, and\n54.1-3304.1 shall comply with all provisions of this section and the relevant\nBoard regulations.\n\nK. Every pharmacist-in-charge or owner of a permitted pharmacy or a registered\nnonresident pharmacy engaging in sterile compounding shall notify the Board of\nits intention to dispense or otherwise deliver a sterile compounded drug product\ninto the Commonwealth. Upon renewal of its permit or registration, a pharmacy or\nnonresident pharmacy shall notify the Board of its intention to continue\ndispensing or otherwise delivering sterile compounded drug products into the\nCommonwealth. Failure to provide notification to the Board shall constitute a\nviolation of Chapter 33 (§ 54.1-3300 et seq.) or Chapter 34 (§\n54.1-3400 et seq.). The Board shall maintain this information in a manner that\nwill allow the production of a list identifying all such sterile compounding\npharmacies.\n\nHISTORY: 2003, c. 509; 2005, c. 200; 2012, c. 173; 2013, c. 765; 2014, c. 147;\n2015, c. 300; 2016, c. 221; 2025, cc. 48, 71.","edition":{"id":1,"name":"2025","slug":"2025","date_created":"2026-06-21 22:39:22","date_modified":"2026-06-21 22:39:22","current":1,"order_by":1,"last_import":null}}