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SENATE BILL NO. 1393
AMENDMENT IN THE NATURE OF A SUBSTITUTE
(Proposed by the Senate Committee on Education and Health
on. )
(Patron Prior to Substitute--Senator Saslaw)
A BILL to amend and reenact §§ 53.1-10, 53,1-233, 54.1-3301, and 54.1-3410.2 of the Code of
Virginia, relating to pharmacists; compounding of drugs for use in executions.
Be it enacted by the General Assembly of Virginia:
1. That §§ 53.1-10, 53.1-233, 54.1-3301, and 54,1-3410.2 of the Code of Virginia are amended and
reenacted as follows:
§ 53.1-10. Powers and duties of Director.
‘The Director shall be the chief executive officer of the Department and shall have the following
duties and powers:
1. To supervise and manage the Department and its system of state correctional facilities;
2. To implement the standards and goals of the Board as formulated for local and community
correctional programs and facilities and lock-ups;
3. To employ such personnel and develop and implement such programs as may be necessary to
carry out the provisions of this title, subject to Chapter 29 (§ 2.2-2900 et seq.) of Title 2.2, and within
the limits of appropriations made therefor by the General Assembly;
4. To establish and maintain a general system of schools for persons committed to the institutions
and community-based programs for adults as set forth in §§ 53.1-67.7 and 53.1-67.8. Such system shall
include, as applicable, elementary, secondary, post-secondary, career and technical education, adult, and
special education schools.
a, The Director shall employ a Superintendent who will oversee the operation of educational and
vocational programs in all institutions and community-based programs for adults as set forth in §§ 53.1-
67.7 and 53.1-67.8 operated by the Department. The Department shall be designated as a local education
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agency (LEA) but shall not be eligible to receive state funds appropriated for direct aid to public
education.
b. When the Department employs a teacher licensed by the Board of Education to provide
instruction in the schools of the correctional centers, the Department of Human Resource Management
shall establish salary schedules for the teachers which endeavor to be competitive with those in effect for
the school division in which the correctional center is located.
c. The Superintendent shall develop a functional literacy program for inmates testing below a
selected grade level, which shall be at least at the twelfth grade level. The program shall include
guidelines for implementation and test administration, participation requirements, criteria for
satisfactory completion, and a strategic plan for encouraging enrollment in college or an aceredited
vocational training program or other accredited continuing education program.
d. For the purposes of this section, the term "functional literacy" shall mean those educational
skills necessary to function independently in society, including, but not limited to, reading, writing,
comprehension, and arithmetic computation.
e. In evaluating a prisoner's educational needs and abilities pursuant to § 53.1-32.1, the
Superintendent shall create a system for identifying prisoners with learning disabilities.
5. a. To make and enter into all contracts and agreements necessary or incidental to the
performance of the Department's duties and the execution of its powers under this title, including, but
not limited to, contracts with the United States, other states, and agencies and governmental subdivisions
of this Commonwealth, and contracts with corporations, partnerships, or individuals which include, but
are not limited to, the purchase of water or wastewater treatment services or both as necessary for the
expansion or construction of correctional facilities, consistent with applicable standards and goals of the
Board;
b. Notwithstanding the Director's discretion to make and enter into all contracts and agreements
necessary or incidental to the performance of the Department's duties and the execution of its powers
under this title, upon determining that it shall be desirable to contract with a public or private entity for
the provision of community-based residential services pursuant to Chapter 5 (§ 53.1-177 et seq.), the
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Director shall notify the local governing body of the jurisdiction in which the facility is to be located of
the proposal and of the facility's proposed location and provide notice, where requested, to the chief law-
enforcement officer for such locality when an offender is placed in the facility at issue;
6. To accept, hold and enjoy gifts, donations and bequests on behalf of the Department from the
United States government and ies and instru lities thereof, and any other source, subject to
the approval of the Governor. To these ends, the Director shall have the power to comply with such
conditions and execute such ag: as may be necessary, convenient or desirable, consistent with
applicable standards and goals of the Board;
7. To collect data pertaining to the demographic characteristics of adults, and juveniles who are
adjudicated as adults, incarcerated in state correctional institutions, including, but not limited to, the race
or ethnicity, age, and gender of such persons, whether they are a member of a criminal gang, and the
types of and extent to which health-related problems are prevalent among such persons. Beginning July
1, 1997, such data shall be collected, tabulated quarterly, and reported by the Director to the Governor
and the General Assembly at each regular session of the General Assembly thereafter. The report shall
be submitted as provided in the procedures of the Division of Legislative Automated Systems for the
processing of legislative documents and reports;
8. To make application to the appropriate state and federal entities so as to provide any prisoner
who is committed to the custody of the state a Department of Motor Vehicles approved identification
card that would expire 90 days from issuance, a copy of his birth certificate if such person was born in
the Commonwealth, and a social security card from the Social Security Administration;
9. To forward to the Commonwealth's Attorneys' Services Council, updated on a monthly basis,
a list of all identified criminal gang members incarcerated in state correctional institutions. The list shall
contain identifying information for each criminal gang member, as well as his criminal record;
10. To give notice, to the attorney for the Commonwealth prosecuting a defendant for an offense
that occurred in a state correctional facility, of that defendant's known gang membership. The notice
shall contain identifying information for each criminal gang member as weil as his criminal record; and
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11. To designate employees of the Department with internal investigations authority to have the
same power as a sheriff or a law-enforcement officer in the investigation of allegations of criminal
behavior affecting the operations of the Department. Such employees shall be subject to any minimum
training standards established by the Department of Criminal Justice Services under § 9.1-102 for law-
enforcement officers prior to exercising any law-enforcement power granted under this subdivision.
Nothing in this section shall be construed to grant the Department any authority over the operation and
security of local jails not specified in any other provision of law. The Department shall investigate
allegations of criminal behavior in accordance with a written agreement entered into with the
Department of State Police. The Department shall not investigate any action falling within the authority
vested in the Office of the State Inspector General pursuant to Chapter 3.2 (§ 2.2-307 et seq.) of Title 2.2
unless specifically authorized by the Office of the State Inspector General.
12. To make and enter into contracts with a pharmacy or outsourcing facility to compound the
drugs necessary to carry out execution by lethal injection pursuant fo § 53.1-234.
§ 53.1-233. Death chamber; who to execute death sentence.
The Director is hereby authorized and directed to provide and maintain a permanent death
chamber and necessary appurtenant facilities within the confines of a state correctional facility. The
death chamber shall have all the necessary appliances for the proper execution of prisoners by
electrocution or by continuous intravenous injection of a substance or combination of substances
sufficient to cause death. Any such substance.shall be applied until the prisoner is pronounced dead by a
physician licensed in the Commonwealth. All prisoners upon whom the death penalty has been imposed
shall be executed in the death chamber, Each execution shall be conducted by the Director or one or
more assistants designated by him.
The identities of persons designated by the Director to conduct an execution, the identities of
persons or entities engaged to compound drug products for use in the execution, the identities of persons
or entities engaged to manufacture or supply the materials used to compound drug products for use in
the execution, the name_of the materials or components used to compound drug products for use_in the
execution, and any information reasonably calculated to lead to the identities of such persons_or
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materials, including, but not limited to, their names, residential or office addresses, residential or office
telephone numbers, and social security numbers, shall be confidential, shall be exempt from the
Freedom of Information Act (§ 2.2-3700 et seq.), and shall not be subject to discovery or introduction as
evidence in any civil proceeding unless good cause is shown.
All information relating to the execution process and the buildings devoted to the execution
process and all records regarding the equipment used in the execution process shail be exempt from the
Freedom of Information Act (§ 2.2-3700 et seq.) and shall not be subject to discovery or introduction as
evidence in any civil proceeding unless good cause is shown.
Nothing in this section shall prohibit the Board of Pharmacy from inspecting or investigating a
pharmacy or outsourcing facility compounding drugs pursuant to this section or investigating a person
authorized to compound drugs pursuant to this section. Any documents or information related to any
such inspection or investigation conducted by the Board of Pharmacy shall be confidential, shall be
exempt from the Freedom of Information Act (§ 2.2-3700 et seq.) and shall not be subject to discovery
or introduction as evidence in any civil proceeding unless good cause is shown.
§ 54.1-3301. Exceptions.
This chapter shall not be construed to:
1. Interfere with any legally qualified practitioner of dentistry, or veterinary medicine or any
physician acting on behalf of the Virginia Department of Health or local health depariments, in the
compounding of his prescriptions or the purchase and possession of drugs as he may require;
2. Prevent any legally qualified practitioner of dentistry, or veterinary medicine or any
prescriber, as defined in § 54,1-3401, acting on behalf of the Virginia Department of Health or local
health departments, from administering or supplying to his patients the medicines that he deems proper
under the conditions of § 54.1-3303 or from causing drugs to be administered or dispensed pursuant to
§§ 32.1-42.1 and 541-3408, except that a veterinarian shall only be authorized to dispense a
compounded drug, distributed from a pharmacy, when (i) the animal is his own patient, (ii) the animal is
a companion animal as defined in regulations promulgated by the Board of Veterinary Medicine, (iii) the
quantity dispensed is no more than a 72-hour supply, (iv) the compounded drug is for the treatment of an
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emergency condition, and (v) timely access to a compounding pharmacy is not available, as determined
by the prescribing veterinarian;
3. Prohibit the sale by merchants and retail dealers of proprietary medicines as defined in
Chapter 34 (§ 54.1-3400 et seq.}-of thistitle;
4, Prevent the operation of automated drug dispensing systems in hospitals pursuant to Chapter
34 (§ 54.1-3400 et seq. -of thistitle;
5. Prohibit the employment of ancillary personnel to assist a pharmacist as provided in the
regulations of the Board;
6. Interfere with any legally qualified practitioner of medicine, osteopathy, or podiatry from
pt i pc ing or administering controlled sv
P SF 'S
to his own patients or providing
controlled substances to his own patients in a bona fide medical emergency or providing manufacturers’
professional samples to his own patients;
7. Interfere with any legally qualified practitioner of optometry, certified or licensed to use
diagnostic pharmaceutical agents, from purchasing, px ing or administering those controlled
substances as specified in § 54.1-3221 or interfere with any legally qualified practitioner of optometry
certified to prescribe therapeutic pharmaceutical agents from purchasing, possessing, or administering to
his own patients those controlled aibstauicas as specified in § 54.1-3222 and the TPA formulary,
providing manufacturers' samples of these drugs to his own patients, or dispensing, administering, or
selling ophthalmic devices as authorized in § 54.1-3204;
8. Interfere with any physician assistant with prescriptive authority receiving and dispensing to
his own patients manufacturers’ professional samples of controlled substances and devices that he is
authorized, in compliance with the provisions of § 54.1-2952.1, to prescribe according to his practice
setting and a written agreement with a physician or podiatrist;
9. Interfere with any licensed nurse practitioner with prescriptive authority receiving and
dispensing to his own patients manufacturers' professional samples of controlled substances and devices
that he is authorized, in compliance with the provisions of § 54.1-2957.01, to prescribe according to his
practice setting and a written or electronic agreement with a physician;
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10. Interfere with any legally qualified practitioner of medicine or osteopathy participating in an
indigent patient program offered by a pharmaceutical manufacturer in which the practitioner sends a
prescription for one of his own patients to the manufacturer, and the manufacturer donates a stock bottle
of the prescription drug ordered at no cost to the practitioner or patient. The practitioner may dispense
such medication at no cost to the patient without holding a license to dispense from the Board of
Pharmacy. However, the container in which the drug is dispensed shall be labeled in accordance with the
requirements of § 54.1-3410, and, unless directed otherwise by the practitioner or the patient, shall meet
standards for special packaging as set forth in § 54.1-3426 and Board of Pharmacy regulations. In lieu of
dispensing directly to the patient, a practitioner may transfer the donated drug with a valid prescription
to a pharmacy for dispensing to the patient. The practitioner or pharmacy participating in the program
shall not use the donated drug for any purpose other than dispensing to. the patient for whom it was
originally donated, except as authorized by the donating manufacturer for another patient meeting that
manufacturer's requirements for the indigent patient program. Neither the practitioner nor the pharmacy
shall charge the patient for any medication provided through a manufacturer's indigent patient program
pursuant to this subdivision. A participating pharmacy, including a pharmacy participating in bulk
donation programs, may charge a reasonable dispensing or administrative fee to offset the cost of
dispensing, not to exceed the actual costs of such dispensing. However, if the patient is unable to pay
such fee, the dispensing or administrative fee shall be waived;
11. Interfere with any legally qualified practitioner of medicine or osteopathy from providing
controlled substances to his own patients in a free clinic without charge when such controlled substances
are donated by an entity other than a pharmaceutical manufacturer as authorized by subdivision 10. The
practitioner shall first obtain a controlled substances registration from the Board and shall comply with
the labeling and packaging requirements of this chapter and the Board's regulations; or
12. Prevent any pharmacist from providing free health care to an underserved population in
Virginia who (i) does not regularly practice pharmacy in Virginia, (ii) holds a current valid license or
certificate to practice pharmacy in another state, territory, district or possession of the United States, (iii)
volunteers to provide free health care to an underserved area of this Commonwealth under the auspices
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of a publicly supported all volunteer, nonprofit organization that sponsors the provision of health care to
populations of underserved people, (iv) files a copy of the license or certificate issued in such other
jurisdiction with the Board, (v) notifies the Board at least five business days prior to the voluntary
provision of services of the dates and location of such service, and (vi) acknowledges, in writing, that
such licensure exemption shall only be valid, in compliance with the Board's regulations, during the
limited period that such free health care is made available through the volunteer, nonprofit organization
on the dates and at the location filed with the Board. The Board may deny the right to practice in
Virginia to any pharmacist whose license has been previously suspended or revoked, who has been
convicted of a felony or who is otherwise found to be in violation of applicable laws or regulations.
However, the Board shall allow a pharmacist who meets the above criteria to provide volunteer services
without prior notice for a period of up to three days, provided the nonprofit organization verifies that the
practitioner has a valid, unrestricted license in another state.
13. Prevent the compounding of drug products for use_by the Department of Corrections
pursuant to Chapter 13 (§ 53.1-232 et seq.) of Title 53.1.
This section shall not be construed as exempting any person from the licensure, registration,
permitting and record keeping requirements of this chapter or Chapter 34-of thistitle (§ 54.1-3400 et
seq.).
§ 54.1-3410.2, C ding; phar ists' authority to compound under certain
Pp
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 Gi) 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 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.
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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 commen ownership or
control with the facility in which such compounding takes place; 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 § 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 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.
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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'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.
A pharmacist may provide compounded products upon written request by the Director of the
Department of Corrections certifying that the requested drugs are necessary pursuant to Chapter 13 (§
53.1-232 et seq.) of Title 53.1. Pharmacists shall label all such products with (i) the name and strength of
the compounded medication or list of the active ingredients and strengths; (ii) the facility's contro]
number; (iii) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-
NF standards for pharmacy compounding; (iv) the name and address of the pharmacy or outsourcing
facility; and (v) 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;
2. Are manufactured by an establishment that is registered by the FDA; or
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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 shal] 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.
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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
¢
wer of each cc or the brand name of each component; the
IP!
and the name of 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
Jot 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,
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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.
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 (§ 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.
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