                                 CODE OF VIRGINIA

COMPOUNDING; PHARMACISTS&#8217; AUTHORITY TO COMPOUND UNDER CERTAIN CONDITIONS;
LABELING AND RECORD MAINTENANCE REQUIREMENTS (§ 54.1-3410.2)

A. 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 &#xA7; 54.1-3303 relating to
the issuance of prescriptions and the dispensing of drugs.
			Pharmacists shall label all compounded drug products that are dispensed
pursuant to a prescription in accordance with this chapter and the Board&#8217;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. A pharmacist may also engage in compounding of drug products in anticipation
of receipt of prescriptions based on a routine, regularly observed 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 active
ingredients and strengths; (ii) the pharmacy&#8217;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. 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.
			Compounded 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.
			A pharmacist may, however, deliver compounded products dispensed pursuant to
valid prescriptions to alternate delivery locations pursuant to &#xA7;
54.1-3420.2.
			A 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.
			Pharmacists 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 &#8220;For Administering in Prescriber Practice Location Only&#8221;;
(ii) the name and strength of the compounded medication or list of the active
ingredients and strengths; (iii) the facility&#8217;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.
			Pharmacists 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&#8217;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. 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.

E. Pharmacists shall ensure compliance with USP-NF standards for both sterile
and non-sterile compounding.

F. Pharmacists may use bulk drug substances in compounding when such bulk drug
substances:

   1. 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

   2. 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.

G. Pharmacists may compound using ingredients that are not considered drug
products in accordance with the USP-NF standards and guidance on pharmacy
compounding.

H. Pharmacists shall not engage in the following:

   1. 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;

   2. 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

   3. 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.

I. 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.

   1. In addition to other requirements for prescription records, records for
   products compounded pursuant to a prescription order for a single patient
   where only manufacturers&#8217; 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. 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&#8217;s lot number and expiration date for each component or when
   the original manufacturer&#8217;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. 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.

   4. 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.

J. Practitioners who may lawfully compound drugs for administering or dispensing
to their own patients pursuant to &#xA7;&#xA7; 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. 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 (&#xA7; 54.1-3300 et seq.) or Chapter 34 (&#xA7;
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.

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.