Showing posts with label Virginia. Show all posts
Showing posts with label Virginia. Show all posts

Friday, February 7, 2014

Virginia Considering Legislation to Allow Veterinarians to Dispense Compounded Drug Products to Patient in Emergency Situations

2014 SESSION

  • | print version

HB 1035 Veterinarians; dispensing compounded drug products, report.

Introduced by: Robert D. Orrock, Sr. | all patrons    ...    notes | add to my profiles

SUMMARY AS PASSED HOUSE: (all summaries)

Veterinarians; dispensing compounded drug products. Provides that a veterinarian may dispense a 72-hour supply of a compounded drug product for a companion animal that is his patient when the compounded drug product is dispensed to treat an emergency condition and timely access to a compounding pharmacy is not available. The bill also requires pharmacists to label compounded drug products dispensed to veterinarians with the name and strength of the drug product or list of the active ingredients and strengths, the facility's control number, a beyond-use date, the name and address of the pharmacy, and the quantity dispensed

more information found here

Wednesday, January 15, 2014

Virginia Introduces house Bill No. 1119 Relating to Compounding of Drugs

HOUSE BILL NO. 1119
Offered January 13, 2014
A BILL to amend and reenact § 54.1-3410.2 of the Code of Virginia, relating to compounding of drug products; notice.
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Patron-- Habeeb
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Referred to Committee on Health, Welfare and Institutions
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Be it enacted by the General Assembly of Virginia:
1. That § 54.1-3410.2 of the Code of Virginia is amended and reenacted as follows:
§ 54.1-3410.2. Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements.
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 § 54.1-3303 relating to the issuance of prescriptions and the dispensing of drugs.

Saturday, March 30, 2013

Virginia Board of Veterinary Medicine Use of Compounded Drugs in Vetererinary Practice Adopted Februrary 7, 2013-includes office use


Virginia Board of Veterinary Medicine
Use of Compounded Drugs in Veterinary Practice
Applicable Laws

§ 54.1-3401. Definitions.

As used in this chapter, unless the context requires a different meaning:
"Compounding" means the combining of two or more ingredients to fabricate such ingredients into a single preparation and includes the mixing, assembling, packaging, or labeling of a drug or device (i) by a pharmacist, or within a permitted pharmacy, pursuant to a valid prescription issued for a medicinal or therapeutic purpose in the context of a bona fide practitioner-patient-pharmacist relationship, or in expectation of receiving a valid prescription based on observed prescribing patterns; (ii) by or for a practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine as an incident to his administering or dispensing, if authorized to dispense, a controlled substance in the course of his professional practice; or (iii) for the purpose of, or as incident to, research, teaching, or chemical analysis and not for sale or for dispensing. The mixing, diluting, or reconstituting of a manufacturer's product drugs for the purpose of administration to a patient, when performed by a practitioner of medicine or osteopathy licensed under Chapter 29 (§ 54.1-2900 et seq.), a person supervised by such practitioner pursuant to subdivision A 6 or A 19 of § 54.1-2901, or a person supervised by such practitioner or a licensed nurse practitioner or physician assistant pursuant to subdivision A 4 of § 54.1-2901 shall not be considered compounding.

 

§ 54.1-3410.2. Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements.

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 § 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's [Pharmacy] 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'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.
A pharmacist may, however, deliver compounded products dispensed pursuant to valid prescriptions to alternate delivery locations pursuant to § 54.1-3420.2.
A pharmacist may also provide compounded products to practitioners of medicine, osteopathy, podiatry, dentistry, or veterinary medicine to administer 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 practitioners 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; and (v) quantity.
E. Pharmacists shall ensure compliance with USP-NF standards for both sterile and non-sterile compounding.
J. 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.

Guidance
Q: May a veterinarian prescribe a compounded drug product?
A: A Virginia licensed veterinarian may prescribe a compounded drug product by preparing a valid prescription pursuant to federal and state laws and regulations for an individual patient with which there exists a valid veterinarian-client-patient relationship. The client may obtain the compounded drug product from a pharmacy of their choice that is properly licensed by the Virginia Board of Pharmacy. The payment arrangements for a prescribed compounded drug product are not under the purview of the Board of Veterinary Medicine. However, a pharmacist must be compliant with the Virginia Board of Pharmacy regulation, 18VAC110-20-390(A), which states “A Pharmacist shall not solicit or foster prescription practice with a prescriber of drugs or any other person providing for rebates, ‘kickbacks,’ fee-splitting, or special charges in exchange for prescription orders unless fully disclosed in writing to the patient and any third party payor.”
Q: May a veterinarian obtain compounded drug products from a pharmacy for administration in their office?
A: Yes, a Virginia licensed veterinarian may obtain compounded drug products from a pharmacy that is properly licensed by the Virginia Board of Pharmacy for administration in the course of their professional practice. Pursuant to Virginia Code § 54.1-3410.2(C) the pharmacist is required to label the compounded drug product with the statement “For Administering in Prescriber Practice Location Only.”
Q: May a veterinarian dispense a compounded drug product?
A: A veterinarian may dispense a compounded drug product if compounded by the veterinarian pursuant to Virginia Code § 54.1-3410.2(J).
Q: May a pharmacy provide compounded drug products to a veterinarian for the veterinarian to dispense to his patients?
A: No, Virginia Code § 54.1-3410.2 prohibits pharmacists from distributing compounded drug products for subsequent distribution or sale to other persons.
Q: What is the penalty for a licensee of the Virginia Board of Veterinary Medicine who is found to be dispensing compounded drug product purchased from a pharmacy?
A: The licensee may be subject to disciplinary action.

source found here:  
  1. 54.1-3410.2. Compounding; pharmacists' authority to compound ...

    https://www.dhp.virginia.gov/vet/guidelines/150-5.doc
    File Format: Microsoft Word - Quick View
    Feb 7, 2013 – Use of Compounded Drugs in Veterinary Practice ... as incident to, research, teaching, or chemical analysis and not for sale or for dispensing

Wednesday, February 20, 2013

Virginia Bill to Implement Stricter Inspection Requirements for Nonresident Compounding Pharmacies Under Consideration


 Topics: Compounding
Stricter inspection requirements for nonresident compounding pharmacies and a clarification that distinguishes compounding from manufacturing are among the statutory changes included in House Bill 2312 currently being considered by the Virginia Legislature. If the bill passes, nonresident pharmacies will be required to submit to the Virginia Board of Pharmacy documentation of an inspection conducted within the past six months for new applicants and within the past two years for renewals. The inspection must be conducted by the regulatory agency of the jurisdiction in which the pharmacy is located and must comply with Virginia requirements, including compliance with US Pharmacopeia standards for compounding. 
Continue reading NABP article here

Monday, February 18, 2013

Draft/Unapproved Minutes from Jan. 14, 2013 Meeting of Virginia Board of Pharmacy--Disciplinary action against Christopher K. Currin



VIRGINIA BOARD OF PHARMACY
MINUTES OF TELEPHONE CONFERENCE CALL

Monday, January 14, 2013 Department of Health Professions
Perimeter Center
9960 Mayland Drive, Suite 300
Henrico, Virginia  23233-1463
Orders/Consent Orders referred to in these minutes are available upon request
TIME & PURPOSE: Pursuant to § 54.1-2400(13) of the Code of Virginia, a telephone conference call of the Virginia Board of Pharmacy (“TCC”) was held at 10:25 a.m., on January 14, 2013, to consider the summary restriction of the license of Christopher K. Currin to practice as a pharmacist in the Commonwealth of Virginia.
PRESIDING: David C. Kozera, Chair
MEMBERS PRESENT: R. Crady Adams
Jody H. Allen
Dinny Li
Empsy Munden
Ellen B. Shinaberry
STAFF PRESENT: Caroline D. Juran, Executive Director
Cathy M. Reiniers-Day, Deputy Executive Director
Eusebia L. Joyner, Disciplinary Program Specialist
Mykl Egan, DHP Adjudication Specialist 
Howard Casway, Senior Assistant Attorney General
Wayne T. Halbleib, Senior Assistant Attorney General
Nan Dunaway, DHP Pharmacy Inspector 
Vicki Garrison, DHP Pharmacy Inspector

POLL OF MEMBERS: The Board members were polled as to whether they could have attended a regular meeting at the office in a timely manner for the purpose of hearing evidence in a possible summary suspension case.  The Board members stated that they would not have been able to attend.  
With six (6) members participating and four (4) members unable to participate, it was established that a quorum could not have been convened in a regular meeting to consider this matter.
CHRISTOPHER K. CURRIN
License No. 0202 011727 Wayne T. Halbleib presented a summary of the evidence in this case.

Upon a motion by Ms. Allen and duly seconded by Ms. Shinaberry, the Board voted 6-0, to convene  a closed meeting pursuant to § 2.2-3711(A) (27) of the Code of Virginia (“Code”), for the purpose of deliberation to reach a decision in the matter of Christopher K. Currin.  Additionally, she moved that Caroline Juran, Cathy Reiniers-Day, Eusebia Joyner and Howard Casway attend the closed meeting. 

At approximately, 12:50 p.m., Ms. Juran departed.
 
Reconvene: Having certified that the matters discussed in the preceding closed meeting met the requirements of § 2.2-3712 of the Code, the Board re-convened in open meeting and announced the decision.
Decision: Upon a motion by Ms. Munden and duly seconded by Mr. Adams, the Board unanimously voted 6-0 that, with the evidence presented, the practice as a pharmacist by Christopher K. Currin poses a substantial danger to the public; and therefore, said license to practice pharmacy in the Commonwealth of Virginia be and hereby is Restricted.

Upon a motion by Ms. Allen and seconded by Ms. Shinaberry, the Board voted that a Consent Order for a stay of the restriction with certain terms and conditions be offered to Mr. Currin.
ADJOURN: With all business concluded, the meeting adjourned at 1:10 p.m.
Cathy M. Reiniers-Day
Deputy Executive Director 
Eusebia L. Joyner
Disciplinary Program Specialist
David C. Kozera, Chair
Date


Virginia: Deficiencies Associated With Compounding Sterile Preparations


Deficiencies Associated With
Compounding Sterile Preparations
Certification of the direct compounding area, buffer or clean
room, and ante room is to be performed by a qualified individual
no less than every six months and whenever the device or room
is relocated, altered, or major service to the facility is performed
(refer to Major Deficiencies 22 and 23). Every six months is interpreted
to be six months from the date of the last certification.
For example, a direct compounding area certified as ISO Class 5
on January 17, 2013, requires certification on or before July 17,
2013. The inspector will ask for documentation of at least the two
most recent certifications to ensure that the areas comply with the
appropriate ISO class.
Individuals preparing compounded sterile preparations (CSP)
must complete media-fill testing annually when preparing low and
medium-risk CSPs and semiannually when preparing high-risk level
CSPs (refer to Major Deficiencies 25a and 26). The terms “annually”
and “semiannually” as used in USP Chapter <797> are defined
to mean every 12 months and every six months, respectively. In
the event an individual fails a media-fill test, that individual may
not perform high-risk level compounding prior to retraining and
receipt of a passing media-fill test (refer to Major Deficiency 25c).
Individuals preparing low or medium-risk level CSPs must provide
documentation of passing the media-fill test within 45 days of the
failed test (refer to Major Deficiency 26a). Records associated
with annual and semiannual requirements shall be maintained in
accordance with USP standards. The records may be maintained as
an electronic image that provides an exact image of the document
that is clearly legible provided such electronic image is retrievable
and made available at the time of inspection. The inspector will
ask for documentation that each individual who prepares CSPs has
completed the required media-fill testing and retesting if required.
Compounded sterile preparations must be assigned an appropriate
beyond-use date (BUD) in compliance with USP-NF standards
(Major Deficiencies 25 and 33). In the absence of sterility testing,
the BUD for low, medium, and high-risk CSPs are:
Low Risk Medium Risk High Risk
Controlled
Room
Temperature
48 hours 30 hours 24 hours
2° to 8°C (36°
and 46°F) 14 days 9 days 3 days
-25° to -10°C
(-4° and 14°F)
or colder
45 days 45 days 45 days
If performed, sterility and endotoxin testing must comply with
USP Chapters <51> Antimicrobial Effectiveness Testing, <71>
Sterility Test, or <85> Bacterial Endotoxin Testing in addition to
USP Chapter <797> Pharmaceutical Compounding: Sterile Preparations.
The inspector will ask for documentation for sterility or
endotoxin testing.

Source found here

Virginia: Compounding Sterile Preparations


Compounding Sterile Preparations
Virginia Board of Pharmacy Regulation 18VAC110-20-321
states compounding of both sterile and nonsterile drug products
shall be performed in accordance with United States Pharmacopeia-
National Formulary (USP-NF) compounding standards and
§54.1-3410.2 of the Code of Virginia. While pharmacists often
associate sterile compounding requirements with USP Chapter
<797> Pharmaceutical Compounding: Sterile Preparations, it is
important not to overlook the requirements in USP Chapters <1>
Injections, <51> Antimicrobial Effectiveness Testing, <71> Sterility
Test, and <85> Bacterial Endotoxin Testing.
At the December 12, 2012 Board meeting, the Board addressed
several issues in Guidance Document 110-9 Pharmacy Inspection
Deficiency Monetary Penalty Guide, related to compliance with
USP-NF standards regarding the compounding of sterile preparations.
Modifications, including changes for when an inspector
should cite a deficiency, were made to Major Deficiencies 20, 21,
22, 24, 25, 26, and 33, and Minor Deficiencies 30, 31, and 32. To
access Guidance Document 110-9, visit www.dhp.virginia.gov/
Pharmacy/pharmacy_guidelines.htm.

Source found here

Tuesday, January 29, 2013

Virginia Bill 2312 Dealing With Compounding Introduced

On January 18, 2013,  VA Bill 2312, was introduced into legislation.  This bill includes new definitions and regulation of compounding. The bill would permit the Virginia Board of Pharmacy to revoke or suspend a pharmacy permit if the Board believes the actions of the pharmacy are of imminent threat to the citizens of the state. Language also is proposed that provides additional explanation to anticipatory compounding and defines compounding activities in "inordinate quantities" over anticipated patterns of prescribing and dispensing as manufacturing.

To view this bill click here

Sunday, December 30, 2012

Friday, July 13, 2012

Virginia Passes Bill to Expand Pharmacist's Compounding Authority: HB 733

Virginia laws now grant pharmacists additional authority to compound.  The article below explains the new law and can be found here

Pharmacists; compounding authority. (HB733)

Introduced By

Progress

Introduced
Passed Committee
Passed House
Passed Senate
Signed by Governor
Became Law

Description

Pharmacists; compounding authority.  Increases pharmacists' authority to compound to allow the compounding of (i) a commercially manufactured drug whose manufacturer has notified the FDA that the drug is unavailable due to a current drug shortage, or (ii) a commercially manufactured drug when the prescriber has indicated in the prescription for an individual patient that there is an emergent need for a drug that is not readily available. Amends § 54.1-3410.2 (“Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements.”), of the Code of Virginia.

Outcome

Bill Has Passed
View Bill's History

Inspection Report for Veterinary Practices in Virginia

In May 2012, Virginia revised its inspection report for Veterinary Practices operating in its state.  That report can be found here.  The report contains the following section:

Bulk Reconstitution of Injectable, Bulk Compounding or Prepackaging
 17  Major 18VAC150-20-190(J) Veterinary establishments in which bulk reconstitution of injectable, bulk compounding or the prepackaging of drugs is
performed shall maintain adequate control records for a period of one year or until the expiration whichever is greater.
 18 Major 18VAC150-20-190(J) Reconstitution, compounding and prepackaging records shall show the following:
1. Name of the drug(s) used;
2. Strength, if any;
3. Date repackaged;
4. Quantity prepared;
5. Initials of the veterinarian verifying the process;
6. Assigned lot or control number;
7. Manufacturer’s or distributor’s name and lot or control number; and
8. Expiration date.
Guidance: When drugs are taken from a stock bottle and put into another container prior to prescribing in anticipation of future dispensing, the drugs are considered to be prepackaged. Dispensing, labeling and recordkeeping requirements must be followed when prepackaging drugs. 
Transferring drugs to another container can affect the stability of the product. Expiration dates play an important role in maintaining the stability of a drug. The expiration date for a drug prepackaged is the same as the original stock bottle or is one year from the date of transfer whichever is less. Drugs should be stored under conditions which meet the United States Pharmacopeia and the National Formulary (USP-NF) specifications or manufacturers’ suggested storage for each drug.

Virginia Board of Pharmacy Revisions to Compliance Requirements of 797

In June 12, 2012, th e Virginia Board of Pharmacy revised its police on compliance requirements of USP Chapter 797 for facilities engaged in sterile compounding.  Those revisions can be found here and state as follows:

Guidance Document: 110-36  Revised:  June 12, 2012
June 8, 2004
Revised: June 7, 2005, June 5, 2006, June 4, 2008, June 12 2012
Virginia Board of Pharmacy
COMPLIANCE WITH USP STANDARDS FOR COMPOUNDING
§54.1-3410.2 requires pharmacies performing sterile or non-sterile compounding to comply with USP
Standards.  USP standards for sterile and non-sterile compounding may be found in the current editions
of the USP-NF.  In accordance with 18VAC110-20-170, the Board requires a pharmacy to maintain
references consistent with the pharmacy’s scope of practice and with public safety.  
USP Chapter 795 lists the requirements for non-sterile compounding including information about the
compounding environment, equipment, stability criteria and beyond-use dating and records. USP
Chapter 797 lists requirements for policies and procedures, training and evaluation of personnel
performing sterile compounding, determining risk levels and the physical standards for the sterile
compounding area. The Board expects that the requirements of Chapters 795 and 797 will be found in
compliance at time of inspection.
The terms “annually” and “semiannually” as used in USP Chapters 795 and 797 are defined to mean
every 12 months and every 6 months, respectively.  Records associated with annual and semiannual
requirements shall be maintained for 2 years from the date performed.  Such records may be
maintained in offsite storage or as an electronic image that provides an exact image of the document
that is clearly legible provided such offsite or electronic storage is retrievable and made available for
inspection or audit within 48 hours of a request by the Board or an authorized agent.





Saturday, July 7, 2012

Virginia Pharmacy Board Statement Regarding Compliance With USP 795 and 797


From Page 4 – July 2012, of The Virginia Board of Pharmacy News found here:

Compliance with USP Standards for
Compounding
Media-fill testing is required when performing low, medium,
and high-risk level compounding of compounded sterile preparations
(CSPs). USP35-NF30 states:
Media-Fill Test Procedure – This test or an equivalent
test is performed at least annually by each person
authorized to compound in a low-risk level environment
under conditions that closely simulate the most
challenging or stressful conditions encountered during
compounding of low-risk level CSPs. Once begun,
this test is completed without interruption. Quality
assurance procedures for medium-risk level CSPs
include all those for low-risk level CSPs, as well as
a more challenging media-fill test passed annually
or more frequently. In addition, a media-fill test that
represents high-risk level compounding is performed
semiannually by each person authorized to compound
high-risk level CSPs.
On June 12, 2012, the Board approved changes to Guidance
Document 110-36. The terms “annually” and “semiannually”
as used in United States Pharmacopeia (USP) Chapters 795 and
797 are defined to mean every 12 months and every six months,
respectively. Records associated with annual and semiannual
requirements shall be maintained for two years from the date
performed. Such records may be maintained in off-site storage
or as an electronic image that provides an exact image of the
document that is clearly legible provided such off-site or electronic
storage is retrievable and made available for inspection or
audit within 48 hours of a request by the Board or an authorized
agent. Board of Pharmacy guidance documents are available at
www.dhp.virginia.gov/Pharmacy/pharmacy_guidelines.htm.

Tuesday, June 5, 2012

New Legislation in Virginia Dealing With Compounding

New Legislation in Virginia Dealing with Compounding:

VIRGINIA ACTS OF ASSEMBLY -- 2012 SESSION
CHAPTER 173
An Act to amend and reenact § 54.1-3410.2 of the Code of Virginia, relating to pharmacists' authority
to compound.
[H 733]
Approved March 8, 2012
Be it enacted by the General Assembly of Virginia:
1. That § 54.1-3410.2 of the Code of Virginia is amended and reenacted as follows:
§ 54.1-3410.2. Compounding; pharmacists' authority to compound under certain conditions; labeling
and record maintenance requirements.
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 § 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 inaccordance 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. 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'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.
A pharmacist may, however, deliver compounded products dispensed pursuant to valid prescriptions
to alternate delivery locations pursuant to § 54.1-3420.2.
A pharmacist may also provide compounded products to practitioners of medicine, osteopathy,
podiatry, dentistry, or veterinary medicine to administer 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 practitioners 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; and (v) 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;
2. Are manufactured by an establishment that is registered by the FDA; or
3. Are distributed by a licensed wholesale distributor or registered nonresident wholesale distributor,
or are distributed by a supplier otherwise approved by 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; or
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, or (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.
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' 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'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. 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 §§ 54.1-3301, 54.1-3304, and 54.1-3304.1 shall comply with all provisions of this section and the relevant Board regulations.