54.1-3410.2 - Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements.
§ 54.1-3410.2. Compounding; pharmacists' authority to compound under certainconditions; labeling and record maintenance requirements.
A. A pharmacist may engage in compounding of drug products when thedispensing of such compounded products is (i) pursuant to valid prescriptionsfor specific patients and (ii) consistent with the provisions of § 54.1-3303relating to the issuance of prescriptions and the dispensing of drugs.
Pharmacists shall label all compounded drug products that are dispensedpursuant to a prescription in accordance with this chapter and the Board'sregulations, and shall include on the labeling an appropriate beyond-use dateas determined by the pharmacist in compliance with USP-NF standards forpharmacy compounding.
B. A pharmacist may also engage in compounding of drug products inanticipation of receipt of prescriptions based on a routine, regularlyobserved prescribing pattern.
Pharmacists shall label all products compounded prior to dispensing with (i)the name and strength of the compounded medication or a list of the activeingredients and strengths; (ii) the pharmacy's assigned control number thatcorresponds with the compounding record; (iii) an appropriate beyond-use dateas determined by the pharmacist in compliance with USP-NF standards forpharmacy compounding; and (iv) the quantity.
C. In accordance with the conditions set forth in subsections A and B,pharmacists shall not distribute compounded drug products for subsequentdistribution or sale to other persons or to commercial entities, includingdistribution to pharmacies or other entities under common ownership orcontrol with the facility in which such compounding takes place.
A pharmacist may, however, deliver compounded products dispensed pursuant tovalid prescriptions to alternate delivery locations pursuant to § 54.1-3420.2.
A pharmacist may also provide compounded products to practitioners ofmedicine, osteopathy, podiatry, dentistry, or veterinary medicine toadminister to their patients in the course of their professional practice,either personally or under their direct and immediate supervision.
Pharmacists shall label all compounded products distributed to practitionersfor administration to their patients with (i) the statement "ForAdministering in Prescriber Practice Location Only"; (ii) the name andstrength of the compounded medication or list of the active ingredients andstrengths; (iii) the facility's control number; (iv) an appropriatebeyond-use date as determined by the pharmacist in compliance with USP-NFstandards for pharmacy compounding; and (v) quantity.
D. Pharmacists shall personally perform or personally supervise thecompounding process, which shall include a final check for accuracy andconformity to the formula of the product being prepared, correct ingredientsand calculations, accurate and precise measurements, appropriate conditionsand procedures, and appearance of the final product.
E. Pharmacists shall ensure compliance with USP-NF standards for both sterileand non-sterile compounding.
F. Pharmacists may use bulk drug substances in compounding when such bulkdrug substances:
1. Comply with the standards of an applicable United States Pharmacopoeia orNational Formulary monograph, if such monograph exists, and the United StatesPharmacopoeia chapter on pharmacy compounding; or are drug substances thatare components of drugs approved by the FDA for use in the United States; orare otherwise approved by the FDA;
2. Are manufactured by an establishment that is registered by the FDA; or
3. Are distributed by a licensed wholesale distributor or registerednonresident wholesale distributor, or are distributed by a supplier otherwiseapproved by the FDA to distribute bulk drug substances if the pharmacist canestablish purity and safety by reasonable means, such as lot analysis,manufacturer reputation, or reliability of the source.
G. Pharmacists may compound using ingredients that are not considered drugproducts in accordance with the USP-NF standards and guidance on pharmacycompounding.
H. Pharmacists shall not engage in the following:
1. The compounding for human use of a drug product that has been withdrawn orremoved from the market by the FDA because such drug product or a componentof such drug product has been found to be unsafe. However, this prohibitionshall be limited to the scope of the FDA withdrawal; or
2. The regular compounding or the compounding of inordinate amounts of anydrug products that are essentially copies of commercially available drugproducts. However, this prohibition shall not include (i) the compounding ofany commercially available product when there is a change in the productordered by the prescriber for an individual patient, (ii) the compounding ofa commercially manufactured drug only during times when the product is notavailable from the manufacturer or supplier, or (iii) the mixing of two ormore commercially available products regardless of whether the end product isa commercially available product.
I. Pharmacists shall maintain records of all compounded drug products as partof 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. In addition to other requirements for prescription records, records forproducts compounded pursuant to a prescription order for a single patientwhere only manufacturers' finished products are used as components shallinclude the name and quantity of all components, the date of compounding anddispensing, the prescription number or other identifier of the prescriptionorder, the total quantity of finished product, the signature or initials ofthe pharmacist or pharmacy technician performing the compounding, and thesignature or initials of the pharmacist responsible for supervising thepharmacy technician and verifying the accuracy and integrity of compoundedproducts.
2. In addition to the requirements of subdivision I 1, records for productscompounded in bulk or batch in advance of dispensing or when bulk drugsubstances are used shall include: the generic name and the name of themanufacturer of each component or the brand name of each component; themanufacturer's lot number and expiration date for each component or when theoriginal manufacturer's lot number and expiration date are unknown, thesource of acquisition of the component; the assigned lot number ifsubdivided, the unit or package size and the number of units or packagesprepared; and the beyond-use date. The criteria for establishing thebeyond-use date shall be available for inspection by the Board.
3. A complete compounding formula listing all procedures, necessaryequipment, necessary environmental considerations, and other factors indetail shall be maintained where such instructions are necessary to replicatea compounded product or where the compounding is difficult or complex andmust be done by a certain process in order to ensure the integrity of thefinished product.
4. A formal written quality assurance plan shall be maintained that describesspecific monitoring and evaluation of compounding activities in accordancewith USP-NF standards. Records shall be maintained showing compliance withmonitoring and evaluation requirements of the plan to include training andinitial and periodic competence assessment of personnel involved incompounding, monitoring of environmental controls and equipment calibration,and any end-product testing, if applicable.
J. Practitioners who may lawfully compound drugs for administering ordispensing to their own patients pursuant to §§ 54.1-3301, 54.1-3304 and54.1-3304.1 shall comply with all provisions of this section and the relevantBoard regulations.
(2003, c. 509; 2005, c. 200.)