reglab/statecodes huggingface dataset:
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VI - Labeling and Packaging Standards for Prescriptions › Section 18VAC110-20-321 - Compounding

Current through Register Vol. 40, No. 24, July 15, 2024
A. The compounding
				  of both sterile and nonsterile drug products by a pharmacy that does not share
				  the same physical space with an outsourcing facility shall be performed in
				  accordance with USP-NF compounding standards and §
										54.1-3410.2
				  of the Code of Virginia.
B. The
				  compounding of sterile drug products by an outsourcing facility or by a
				  pharmacy sharing the same physical space with an outsourcing facility shall be
				  performed in accordance with current good manufacturing practices under §
				  501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (
				  21 USC §
											351(a)(2)(B) ).
NOTICE: The following forms used in administering the
					 regulation were filed by the agency. The forms are not being published;
					 however, online users of this issue of the Virginia Register of Regulations may
					 click on the name of a form with a hyperlink to access it. The forms are also
					 available from the agency contact or may be viewed at the Office of the
					 Registrar of Regulations, General Assembly Building, 2nd Floor, Richmond,
					 Virginia 23219.
Statutory Authority: §§
												54.1-2400,
						54.1-3434.05,
						and
						54.1-3434.5
						of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VI - Labeling and Packaging Standards for Prescriptions › Section 18VAC110-20-322 - Placement of chemicals in Schedule I

Current through Register Vol. 40, No. 24, July 15, 2024
A. Pursuant to
				  subsection D of §
										54.1-3443 of the Code of
				  Virginia, the Board of Pharmacy places the following in Schedule I of the Drug
				  Control Act:
1. Synthetic opioid.
				  N,N-diethyl-2-[5-nitro-2-(4-propoxybenzyl)-1H-benzimidazol-1-yl]ethanamine
				  (other name: Protonitazene), its isomers, esters, ethers, salts, and salts of
				  isomers, esters, and ethers, unless specifically excepted, whenever the
				  existence of these isomers, esters, ethers, and salts is possible within the
				  specific chemical designation.
2.
				  Compounds expected to have hallucinogenic properties.
				  1-(1,3-benzodioxol-5-yl)-2-(cyclohexylamino)butan-1-one (other names:
				  Cybutylone, N-cyclohexyl Butylone), its salts, isomers (optical, position, and
				  geometric), and salts of isomers whenever the existence of such salts, isomers,
				  and salts of isomers is possible within the specific chemical
				  designation.
3. Compounds expected
				  to have depressant properties.
				  8-bromo-6-(2-chlorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine
				  (other names: Clobromazolam, Phenazolam), its salts, isomers (optical,
				  position, and geometric), and salts of isomers whenever the existence of such
				  salts, isomers, and salts of isomers is possible within the specific chemical
				  designation.
4. Cannabimimetic
				  agents.
a.
				  5-bromo-N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1H-indazole-3-carboxamide
				  (other name: ADB-5Br-INACA), its salts, isomers, and salts of isomers whenever
				  the existence of such salts, isomers, and salts of isomers is possible within
				  the specific chemical designation.
b.
				  N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-5-bromo-1-butylindazole-3-carboxamide
				  (other name: ADB-5'Br-BUTINACA), its salts, isomers, and salts of isomers
				  whenever the existence of such salts, isomers, and salts of isomers is possible
				  within the specific chemical designation.
The placement of drugs listed in this subsection shall
					 remain in effect until July 31, 2024, unless enacted into law in the Drug
					 Control Act.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VI - Labeling and Packaging Standards for Prescriptions › Section 18VAC110-20-330 - Labeling of prescription as to content and quantity

Current through Register Vol. 40, No. 24, July 15, 2024
Unless otherwise directed by the prescribing practitioner,
					 any drug dispensed pursuant to a prescription shall bear on the label of the
					 container, in addition to other requirements of §§
										54.1-3410
					 and
					 54.1-3463
					 of the Code of Virginia, the following information:
1. The drug name and strength, when strength
				  is applicable:
a. For any drug product
				  possessing a single active ingredient, the generic name of the drug shall be
				  included on the label.
b. If a
				  generic drug is dispensed when a prescription is written for a brand name drug,
				  the label shall contain the generic name followed by the words "generic for"
				  followed by the brand name of the drug prescribed, and the label shall also
				  contain the generic's brand name or the manufacturer or distributor of the drug
				  dispensed.
c. The requirements of
				  subdivisions 1 a and b of this section shall not apply to drugs dispensed to
				  patients of a hospital or long-term care facility where all drugs are
				  administered by persons licensed to administer.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VI - Labeling and Packaging Standards for Prescriptions › Section 18VAC110-20-340 - Packaging standards for dispensed prescriptions

Current through Register Vol. 40, No. 24, July 15, 2024
A. A drug shall be dispensed only in
				  packaging approved by the current U.S.P.-N.F. for that drug. In the absence of
				  such packaging standard for that drug, it shall be dispensed in a well-closed
				  container.
B. Drugs may be
				  dispensed in compliance packaging for self-administration when requested by the
				  patient or for use in hospitals or long-term care facilities provided that such
				  packaging meets all current U.S.P.-N.F. standards for packaging, labeling and
				  recordkeeping. Compliance packaging that is comprised of a series of individual
				  containers or pockets labeled with the specific date and time when the contents
				  of that container are to be taken, and which may contain more than one
				  different drug, shall comply with USP-NF standards for customized patient
				  medication packages to include:
1. If the
				  packaging allows for the separation of the individual containers, the labels
				  for each individual container shall be labeled with the identity of each of the
				  drug products contained within; and
2. The main packaging label shall contain all
				  the required elements for any outpatient prescription label and shall contain a
				  physical description identifying each solid dosage form contained within the
				  individual containers.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VI - Labeling and Packaging Standards for Prescriptions › Section 18VAC110-20-350 - Special packaging

Current through Register Vol. 40, No. 24, July 15, 2024
A. Each
				  drug dispensed to a person in a household shall be dispensed in special
				  packaging except when otherwise directed in a prescription by a practitioner,
				  when otherwise requested by the purchaser, or when such drug is exempted from
				  16 CFR §
											1702.1 et seq. promulgated pursuant to the
				  Poison Prevention Packaging Act of 1970 (
				  15
				  USC §§
											1471-
				  1476
				  ).
B. If nonspecial packaging is
				  requested, a notation shall be made on the dispensing record or other
				  retrievable record.
Statutory Authority
§
												54.1-2400
						and Chapters 33 (§
												54.1-3300 et seq.)
						and 34 (§
												54.1-3400 et seq.) of
						Title 54.1 of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VI - Labeling and Packaging Standards for Prescriptions › Section 18VAC110-20-355 - Pharmacy repackaging of drug; records required; labeling requirements

Current through Register Vol. 40, No. 24, July 15, 2024
A. Pharmacies in
				  which bulk reconstitution of injectable, bulk compounding, or the repackaging
				  or prepackaging of drugs is performed shall maintain adequate control records
				  for a period of one year or until the expiration, whichever is greater. The
				  records shall show the name of the drugs used; strength, if any; date
				  repackaged; quantity prepared; initials of the pharmacist verifying the
				  process; the assigned lot or control number; the manufacturer's or
				  distributor's name and lot or control number; and an expiration date.
B. The drug name; strength, if any; the
				  assigned lot or control number or the manufacturer's or distributor's name and
				  lot or control number; and an appropriate expiration date determined by the
				  pharmacist in accordance with USP guidelines shall appear on any subsequently
				  repackaged or reconstituted units.
C. Repackaging of drugs shall be performed in
				  compliance with USP-NF standards.
D. Pharmacies using automated counting
				  devices or dispensers in which drugs are removed from manufacturer's original
				  packaging and placed in bulk bins shall comply with the following requirements:
1. A bin filling record shall be maintained
				  manually or in a computerized record for a period of one year from date of
				  filling from which information can be readily retrieved for each bin including:
a. The drug name and strength, if
				  any;
b. The name of the
				  manufacturer or distributor;
c.
				  Manufacturer's control or lot numbers and expiration date for all lots placed
				  into the bin at the time of filling;
d. Any assigned lot number;
e. An expiration date determined according to
				  USP guidelines for repackaging;
f.
				  The date of filling; and
g. The
				  pharmacist's initials verifying the accuracy of the process.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VII - Standards for Prescription Transactions › Section 18VAC110-20-360 - Issuing a copy of a prescription that can be filed or refilled

Current through Register Vol. 40, No. 24, July 15, 2024
A. Consistent with
				  federal laws and regulations, a copy of a prescription shall be given upon
				  request by one pharmacy to another pharmacy provided the drug can be filled or
				  refilled pursuant to §§
										54.1-3410
				  and
				  54.1-3411
				  of the Code of Virginia and provided the patient has given permission for the
				  transfer.
B. The transfer of
				  original prescription information for a drug listed in Schedules III through VI
				  for the purpose of dispensing is permissible between pharmacies if the transfer
				  is communicated directly between the two pharmacies either orally by direct
				  communication between the transferring pharmacist and the receiving pharmacist,
				  or by facsimile machine or by electronic transmission, provided:
1. The transferring pharmacy:
a. Records the word "VOID" on the face of the
				  invalidated prescription;
b.
				  Records on the reverse of the invalidated prescription the name, address, and,
				  except for a prescription for a Schedule VI drug, the DEA number of the
				  pharmacy to which it was transferred, and, for an oral transfer, the name of
				  the pharmacist receiving the prescription information;
c. Records the date of the transfer and, in
				  the case of an oral transfer, the name of the pharmacist transferring the
				  information; and
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VII - Standards for Prescription Transactions › Section 18VAC110-20-390 - Kickbacks, fee-splitting, interference with supplier

Current through Register Vol. 40, No. 24, July 15, 2024
A. A pharmacy 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.
B. A pharmacy
				  shall not interfere with the patient's right to choose his supplier of
				  medication or cooperate with any person in denying a patient the opportunity to
				  select his supplier of prescribed medications.
Statutory Authority: §§
												54.1-2400
						and
						54.1-3307
						of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VII - Standards for Prescription Transactions › Section 18VAC110-20-391 - Prescription blanks

Current through Register Vol. 40, No. 24, July 15, 2024
If a pharmacy provides prescription blanks to prescribers,
					 no advertising or other information shall be on the face of the prescription
					 blank other than prompts for essential information required by law to be on a
					 written prescription. Any nonessential information such as coupons or pharmacy
					 name may be placed on the back of the prescription blank or on a separate sheet
					 of paper, but shall not be on or attached to the face of the
					 blank.
Statutory Authority
§
												54.1-2400
						and Chapters 33 (§
												54.1-3300 et seq.)
						and 34 (§
												54.1-3400 et seq.) of
						Title 54.1 of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VII - Standards for Prescription Transactions › Section 18VAC110-20-395 - Purchase of drugs

Current through Register Vol. 40, No. 24, July 15, 2024
Except for an emergency purchase from another pharmacy, a
					 pharmacist may only purchase Schedule II through VI drugs from a wholesale
					 distributor or warehouser licensed or registered by the
					 board.
Statutory Authority
§
												54.1-2400
						and Chapters 33 (§
												54.1-3300 et seq.)
						and 34 (§
												54.1-3400 et seq.) of
						Title 54.1 of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VII - Standards for Prescription Transactions › Section 18VAC110-20-400 - Returning of drugs and devices

Current through Register Vol. 40, No. 24, July 15, 2024
Drugs may be accepted for return or exchange by any
					 pharmacist or pharmacy for resale in accordance with the provisions of §
										54.1-3411.1
					 of the Code of Virginia. Devices may be accepted for return or exchange
					 provided the device is in the manufacturer's original sealed packaging.
Statutory Authority
§§
												54.1-2400
						and
						54.1-3307
						of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VII - Standards for Prescription Transactions › Section 18VAC110-20-410 - Permitted physician licensed by the board

Current through Register Vol. 40, No. 24, July 15, 2024
A. Pursuant to §
										54.1-3304
				  of the Code of Virginia, physicians licensed by the board to dispense drugs,
				  when pharmacy services are not reasonably available, shall be subject to the
				  following sections of this chapter. For purposes of this section, the terms
				  "pharmacist," "pharmacist-in-charge," "pharmacy," and "PIC" in the following
				  shall be deemed to mean the physician permitted by the board:
1.
											18VAC110-20-110
				  C and D;
2.
											18VAC110-20-130
				  A;
3.
											18VAC110-20-140
				  A and C;
4.
											18VAC110-20-150
				  except that these requirements shall not apply to physicians licensed prior to
				  August 25, 2004, unless the dispensing area is relocated or
				  remodeled;
5.
											18VAC110-20-160;
6.
											18VAC110-20-180;
7.
											18VAC110-20-190
				  A, B and C;
8.
											18VAC110-20-200;
9.
											18VAC110-20-210;
				  and
10.
											18VAC110-20-240
				  through 18VAC110-20-410.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part VII - Standards for Prescription Transactions › Section 18VAC110-20-418 - Continuous quality improvement programs

Current through Register Vol. 40, No. 24, July 15, 2024
A. Notwithstanding practices constituting
				  unprofessional practice indicated in
				  18VAC110-20-25,
				  any pharmacy that actively reports dispensing errors and the analysis of such
				  errors to a patient safety organization consistent with §
										54.1-3434.03
				  of the Code of Virginia and
				  18VAC110-20-10 shall
				  be deemed in compliance with this section. A record indicating the date a
				  report was submitted to a patient safety organization shall be maintained for
				  12 months from the date of reporting. If no dispensing errors have occurred
				  within the past 30 days, a zero report with date shall be recorded on the
				  record.
B. Pharmacies not actively
				  reporting to patient safety organizations, consistent with §
										54.1-3434.03
				  and
				  18VAC110-20-10, shall
				  implement a program for continuous quality improvement in compliance with this
				  section.
1. Notification requirements:
a. A pharmacy intern or pharmacy technician
				  who identifies or learns of a dispensing error shall immediately notify a
				  pharmacist on duty of the dispensing error.
b. A pharmacist on duty shall appropriately
				  respond to the dispensing error in a manner that protects the health and safety
				  of the patient.
c. A pharmacist on
				  duty shall immediately notify the patient or the person responsible for
				  administration of the drug to the patient and communicate steps to avoid injury
				  or mitigate the error if the patient is in receipt of a drug involving a
				  dispensing error, that may cause patient harm or affect the efficacy of the
				  drug therapy. Additionally, reasonable efforts shall be made to determine if
				  the patient self-administered or was administered the drug involving the
				  dispensing error. If it is known or reasonable to believe the patient
				  self-administered or was administered the drug involving the dispensing error,
				  the pharmacist shall immediately assure that the prescriber is
				  notified.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part IX - Pharmacy Services to Hospitals › Section 18VAC110-20-440 - Responsibilities of the pharmacist-in-charge

Current through Register Vol. 40, No. 24, July 15, 2024
A. The PIC in a pharmacy located within a
				  hospital or the PIC of any outside pharmacy providing pharmacy services to a
				  hospital shall be responsible for establishing procedures for and assuring
				  maintenance of the proper storage, security, and dispensing of all drugs used
				  throughout the hospital.
B. The PIC
				  of a pharmacy serving a hospital shall be responsible for maintaining a policy
				  and procedure for providing reviews of drug therapy to include at a minimum any
				  irregularities in drug therapy consistent with §
										54.1-3319A
				  of the Code of Virginia.
C. Prior
				  to the opening of a satellite pharmacy within the hospital, the PIC shall
				  notify the board as required by
				  18VAC110-20-140
				  and shall ensure compliance with subsections B through G of
				  18VAC110-20-150,
				  18VAC110-20-160,
				  18VAC110-20-170,
				  18VAC110-20-180
				  and
				  18VAC110-20-190.
				  No drugs shall be stocked in a satellite pharmacy until an inspection has been
				  completed and approval given for opening.
D. For the following list of Schedule VI
				  controlled substances, the PIC of a pharmacy serving a hospital may authorize
				  the storage in an area of the hospital outside the pharmacy, and may delegate
				  the ordering and distribution within the hospital to nonpharmacy personnel
				  provided the conditions for proper storage and adequate security and the
				  procedures for distribution are set forth in the pharmacy's policy and
				  procedure manual, and provided that the PIC assures that these storage areas
				  are checked monthly for compliance. The storage areas must be locked when
				  authorized staff is not present in the area. Except for nitrous oxide, medical
				  gases may be stored in an unlocked area.
1.
				  Large volume parenteral solutions that contain no active therapeutic drugs
				  other than electrolytes;
2.
				  Irrigation solutions;
3. Contrast
				  media;
4. Medical gases;
5. Sterile sealed surgical trays that may
				  include a Schedule VI drug; and
6.
				  Blood components and derivatives, and synthetic blood components and products
				  that are classified as prescription drugs.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part IX - Pharmacy Services to Hospitals › Section 18VAC110-20-450 - After-hours access to the pharmacy

Current through Register Vol. 40, No. 24, July 15, 2024
A. When authorized by the PIC, an authorized
				  nurse may have access to a supply of drugs maintained by the pharmacy at a
				  location outside the pharmacy in order to obtain emergency medication during
				  hours the pharmacy is closed, provided that such drug is available in the
				  manufacturer's original package or in units which have been prepared and
				  labeled by a pharmacist and provided further that a separate record shall be
				  made and left at the location of the stock of drugs on a form prescribed by the
				  PIC and such records are maintained within the pharmacy for a period of one
				  year showing:
1. The date of
				  withdrawal;
2. The patient's
				  name;
3. The name of the drug,
				  strength, dosage form and dose prescribed;
4. Number of doses removed; and
5. The signature of the authorized nurse.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part IX - Pharmacy Services to Hospitals › Section 18VAC110-20-460 - Floor stock drugs; proof of delivery; distribution records

Current through Register Vol. 40, No. 24, July 15, 2024
A. A pharmacist
				  shall check all Schedule II-VI drugs delivered to a hospital unit as
				  floor-stock before the drugs leave the pharmacy and shall initial or sign
				  manually or electronically the record of distribution verifying the accuracy of
				  the distribution.
B. A delivery
				  receipt shall be obtained for Schedule II through V drugs supplied as floor
				  stock. This record shall include the date, drug name and strength, quantity,
				  hospital unit receiving drug and the manual or electronic signatures of the
				  dispensing pharmacist and the receiving nurse.
C. A record of disposition/administration
				  shall be used to document administration of Schedule II through V drugs when a
				  floor stock system is used for such drugs. The record shall be returned to the
				  pharmacy within three months of its issue. The PIC or his designee shall:
1. Match returned records with delivery
				  receipts to verify that all records are returned;
2. Periodically audit returned administration
				  records for completeness as to patient's names, dose, date and time of
				  administration, signature or initials of person administering the drug, and
				  date the record is returned;
3.
				  Verify that all additions to inventory are recorded, that all additions to and
				  deductions from inventory are correctly calculated, that sums carried from one
				  record to the next are correctly recorded, and periodically verify that doses
				  documented on administration records are reflected in the medical record;
				  and
4. Initial the returned
				  record.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part IX - Pharmacy Services to Hospitals › Section 18VAC110-20-470 - Emergency room

Current through Register Vol. 40, No. 24, July 15, 2024
All drugs in the emergency department shall be under the
					 control and supervision of the PIC and shall be subject to the following
					 additional requirements:
1. All drugs
				  kept in the emergency room shall be in a secure place from which unauthorized
				  personnel and the general public are excluded.
2. Oral orders for medications shall be
				  reduced to writing and shall be signed by the prescriber.
3. A medical practitioner may dispense drugs
				  to his patients if in a bona fide medical emergency or when pharmaceutical
				  services are not readily available and if permitted to do so by the hospital;
				  the drug container and the labeling shall comply with the requirements of this
				  chapter and the Drug Control Act.
4. A record shall be maintained of all drugs
				  administered in the emergency room.
5. A separate record shall be maintained on
				  all drugs, including drug samples, dispensed in the emergency room. The records
				  shall be maintained for a period of two years showing:
a. Date and time dispensed;
b. Patient's name;
c. Prescriber's name; and
d. Name of drug dispensed, strength, dosage
				  form, quantity dispensed, and dose.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part IX - Pharmacy Services to Hospitals › Section 18VAC110-20-490 - Automated devices for dispensing and administration of drugs

Current through Register Vol. 40, No. 24, July 15, 2024
A. A hospital may
				  use automated devices for the dispensing and administration of drugs pursuant
				  to §
										54.1-3301 of the Code
				  of Virginia and §§
										54.1-3401
				  and
				  54.1-3434.02
				  of the Drug Control Act and in accordance with
				  18VAC110-20-270,
				  18VAC110-20-420, or 18VAC110-20-460 as applicable.
B. Policy and procedure manual; access codes.
1. Proper use of the automated dispensing
				  devices and means of compliance with requirements shall be set forth in the
				  pharmacy's policy and procedure manual, which shall include provisions for
				  granting and terminating user access.
2. Personnel allowed access to an automated
				  dispensing device shall have a specific access code that records the identity
				  of the person accessing the device. The device may verify access codes using
				  biometric identification or other coded identification after the initial log-on
				  in order to eliminate sharing or theft of access codes.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part IX - Pharmacy Services to Hospitals › Section 18VAC110-20-505 - Use of radio-frequency identification

Current through Register Vol. 40, No. 24, July 15, 2024
A hospital pharmacy may use radio-frequency identification
					 (RFID) to verify the accuracy of drugs placed into a kit for licensed emergency
					 medical services pursuant to
					 18VAC110-20-500
					 or other kits used as floor stock throughout the hospital under the following
					 conditions:
1. A pharmacist shall be
				  responsible for performing and verifying the accuracy of the following tasks:
a. The addition, modification, or deletion of
				  drug information into the RFID database for assignment of a RFID tag to an
				  individual drug; and
b. The
				  development of the contents of the kit in the RFID database and the associated
				  drug-specific RFID tags.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part IX - Pharmacy Services to Hospitals › Section 18VAC110-20-510 - Identification for medical intern or resident prescription form in hospitals

Current through Register Vol. 40, No. 24, July 15, 2024
The prescription form for the prescribing of drugs for use
					 by medical interns or residents who prescribe only in a hospital shall bear the
					 prescriber's signature, the legibly printed name, address, and telephone number
					 of the prescriber and an identification number assigned by the hospital. The
					 identification number shall be the Drug Enforcement Administration number
					 assigned to the hospital pharmacy plus a suffix assigned by the institution.
					 The assigned number shall be valid only within the course of duties as part of
					 the residency program.
Statutory Authority
§§
												54.1-103
						and
						54.1-2400
						and Chapters 33 (§
												54.1-3300 et seq.)
						and 34 (§
												54.1-3400 et seq.) of
						Title 54.1 of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part IX - Pharmacy Services to Hospitals › Section 18VAC110-20-515 - Remote prescription order processing for hospitals and long-term care facilities

Current through Register Vol. 40, No. 24, July 15, 2024
A. Remote
				  processing of a prescription does not include the dispensing of a drug, but
				  does include any of the following activities related to the dispensing process:
1. Receiving, interpreting, analyzing, or
				  clarifying prescriptions;
2.
				  Entering prescription and patient data into a data processing system;
3. Transferring prescription
				  information;
4. Performing a
				  prospective drug review to include an evaluation of a prescription order and
				  patient records for over- or under-utilization of medication, therapeutic
				  duplication of medication, drug disease contraindications, drug interactions,
				  incorrect drug dosage or duration of drug treatment, or clinical abuse or
				  misuse of medication;
5. Obtaining
				  substitution authorizations, or otherwise communicating with the prescriber
				  concerning a patient's order;
6.
				  Interpreting or acting on clinical data;
7. Performing therapeutic
				  interventions;
8. Providing drug
				  information to the medical or nursing staff of the hospital or long-term care
				  facility; or
9. Authorizing the
				  administration of the drug to the patient by appropriate hospital or long-term
				  care facility staff.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part X - Pharmacy Services to Long-Term Care Facilities › Section 18VAC110-20-520 - Drugs in long-term care facilities

Current through Register Vol. 40, No. 24, July 15, 2024
Prescription drugs, as defined in the Drug Control Act,
					 shall not be floor stocked by a long-term care facility, except those in the
					 stat drug box or emergency drug box or as provided for in 18VAC110-20-560
					 within this chapter.
Statutory Authority
§
												54.1-2400
						and Chapters 33 (§
												54.1-3300 et seq.)
						and 34 (§
												54.1-3400 et seq.) of
						Title 54.1 of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part X - Pharmacy Services to Long-Term Care Facilities › Section 18VAC110-20-535 - Repackaging of already dispensed prescriptions

Current through Register Vol. 40, No. 24, July 15, 2024
The primary provider pharmacy for a long-term care facility
					 may, but shall not be required to, repackage a resident's prescription drugs
					 dispensed by another pharmacy into the unit-dose or compliance packaging system
					 used by the long-term care facility to assist in maintaining a uniform or more
					 accurate system of administration.
1.
				  Such repackaging shall only be done at the provider pharmacy.
2. Unit dose repackaging shall comply with
				  requirements of 18VAC110-20-420 and compliance packaging shall comply with
				  18VAC110-20-340 B.
3. Records shall
				  be maintained of all such repackaging of previously dispensed medications to
				  include date; repackaging pharmacist's initials (or those of the checking
				  pharmacist); and the pharmacy name, address, and prescription number of the
				  original dispensing.
4. Any portion
				  of a resident's medication not placed into unit dose or compliance packaging
				  may be returned to the resident or kept for subsequent repackaging at the
				  provider pharmacy in the original labeled container. If kept at the pharmacy,
				  the medication shall be stored within the prescription department but separate
				  from any working stock of drugs used for dispensing by the pharmacy, and shall
				  only be used for the patient to whom the medication was originally
				  dispensed.
Statutory Authority
§
												54.1-2400
						and Chapters 33 (§
												54.1-3300 et seq.)
						and 34 (§
												54.1-3400 et seq.) of
						Title 54.1 of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part X - Pharmacy Services to Long-Term Care Facilities › Section 18VAC110-20-536 - Prescription drugs sent outside the facility

Current through Register Vol. 40, No. 24, July 15, 2024
A. The provider pharmacy shall assure that
				  residents who leave a long-term care facility for short periods of time or are
				  discharged and who are allowed to take dispensed prescription medications with
				  them, do so only in appropriate packaging, properly labeled for outpatient
				  use.
B. Pharmacies that provide
				  medication to residents in compliance packaging that meets the requirements of
				  18VAC110-20-340 B, shall assure that if the facility separates and sends only
				  the individual containers needed during the time the resident is away without
				  the main package label, that the resident is also given a copy of the main
				  package label or other appropriate documentation that contains the complete
				  labeling information on the main package label.
Statutory Authority
§
												54.1-2400
						and Chapters 33 (§
												54.1-3300 et seq.)
						and 34 (§
												54.1-3400 et seq.) of
						Title 54.1 of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part X - Pharmacy Services to Long-Term Care Facilities › Section 18VAC110-20-540 - Emergency drug kit

Current through Register Vol. 40, No. 24, July 15, 2024
A. The
				  pharmacist providing services may prepare an emergency kit for a long-term care
				  facility in which access to the kit is restricted to a licensed nurse,
				  pharmacist, or prescriber and only these licensed individuals may administer a
				  drug taken from the kit and only under the following conditions:
1. The contents of the emergency kit shall be
				  of such a nature that the absence of the drugs would threaten the survival of
				  the patients.
2. The contents of
				  the kit or an automated drug dispensing system, as provided in subsection B of
				  this section, shall be determined by the provider pharmacist in consultation
				  with the medical and nursing staff of the institutions and shall be limited to
				  drugs for administration by injection or inhalation only, except that
				  Nitroglycerin SL , diazepam rectal gel , and the intranasal spray formulation
				  of naloxone may be included.
3. The
				  kit is sealed in such a manner that it will preclude any possible loss of the
				  drug.
a. The dispensing pharmacy must have a
				  method of sealing such kits so that once the seal is broken, it cannot be
				  reasonably resealed without the breach being detected.
b. If a seal is used, it shall have a unique
				  numeric or alphanumeric identifier to preclude replication, resealing, or both.
				  The pharmacy shall maintain a record of the seal identifiers when placed on a
				  box or kit and maintain the record until such time as the seal is
				  replaced.
c. In lieu of seals, a
				  kit with a built-in mechanism preventing resealing or relocking once opened
				  except by the provider pharmacy is also acceptable.
4. The kit shall have a form to be filled out
				  upon opening the kit and removing contents to write the name of the person
				  opening the kit, the date, time , and name and quantity of items removed. The
				  opened kit is maintained under secure conditions and returned to the pharmacy
				  within 72 hours for replenishing.
5. Any drug used from the kit shall be
				  covered by a prescription, signed by the prescriber, when legally required,
				  within 72 hours.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part X - Pharmacy Services to Long-Term Care Facilities › Section 18VAC110-20-550 - Stat-drug box

Current through Register Vol. 40, No. 24, July 15, 2024
A. An additional
				  drug box called a stat-drug box may be prepared by a pharmacy to provide for
				  initiating therapy prior to the receipt of ordered drugs from the pharmacy.
				  Access to the stat-drug box is restricted to a licensed nurse, pharmacist, or
				  prescriber and only these licensed individuals may administer a drug taken from
				  the stat-drug box. Additionally, a valid prescription or lawful order of a
				  prescriber must exist prior to the removal of any drug from the stat-drug box.
				  A stat-drug box shall be subject to the following conditions:
1. The box is sealed in such a manner that
				  will preclude the loss of drugs.
a. The
				  dispensing pharmacy must have a method of sealing such boxes so that once the
				  seal is broken, it cannot be reasonably resealed without the breach being
				  detected.
b. If a seal is used, it
				  shall have a unique numeric or alphanumeric identifier to preclude replication
				  or resealing, or both. The pharmacy shall maintain a record of the seal
				  identifiers when placed on a box and maintain the record until such time as the
				  seal is replaced.
c. In lieu of
				  seals, a box with a built-in mechanism preventing resealing or relocking once
				  opened except by the provider pharmacy is also acceptable.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part X - Pharmacy Services to Long-Term Care Facilities › Section 18VAC110-20-555 - Use of automated dispensing devices

Current through Register Vol. 40, No. 24, July 15, 2024
Nursing homes licensed pursuant to Chapter 5 (§
										32.1-123 et seq.) of
					 Title 32.1 of the Code of Virginia may use automated drug dispensing systems,
					 as defined in §
										54.1-3401
					 of the Code of Virginia, upon meeting the following conditions:
1. Drugs placed in an automated drug
				  dispensing system in a nursing home shall be under the control of the pharmacy
				  providing services to the nursing home, the pharmacy shall have online
				  communication with and control of the automated drug dispensing system, and
				  access to any drug for a patient shall be controlled by the pharmacy.
2. A nursing home without an in-house
				  pharmacy shall obtain a controlled substances registration prior to using an
				  automated dispensing system, unless the system is exclusively stocked with
				  drugs that would be kept in a stat-drug box pursuant to 18VAC110-20-550 or an
				  emergency drug kit pursuant to 18VAC110-20-540 and are solely administered for
				  stat or emergency administration.
3. For facilities not required to obtain a
				  controlled substance registration, access to the automated dispensing device
				  shall be restricted to a licensed nurse, pharmacist, or prescriber, or a
				  registered pharmacy technician for the purpose of stocking or
				  reloading.
4. Removal of drugs from
				  any automated drug dispensing system for administration to patients can only be
				  made pursuant to a valid prescription or lawful order of a prescriber under the
				  following conditions:
a. A drug, including a
				  drug that would be stocked in a stat-drug box pursuant to subsection B of
				  18VAC110-20-550, may not be administered to a patient from an automated
				  dispensing device until a pharmacist has reviewed the prescription order and
				  electronically authorized the access of that drug for that particular patient
				  in accordance with the order.
b.
				  The PIC of the provider pharmacy shall ensure that a pharmacist who has online
				  access to the system is available at all times to review a prescription order
				  as needed and authorize administering pursuant to the order reviewed.
c. Drugs that would be stocked in an
				  emergency drug kit pursuant to 18VAC110-20-540 may be accessed prior to
				  receiving electronic authorization from the pharmacist provided that the
				  absence of the drugs would threaten the survival of the patients.
d. Automated dispensing devices shall be
				  capable of producing a hard-copy record of distribution that shall show patient
				  name, drug name and strength, dose withdrawn, dose to be administered, date and
				  time of withdrawal from the device, and identity of person withdrawing the
				  drug.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part X - Pharmacy Services to Long-Term Care Facilities › Section 18VAC110-20-560 - Floor stock

Current through Register Vol. 40, No. 24, July 15, 2024
In addition to an emergency box or stat-drug box, a
					 long-term care facility in which only those persons licensed to administer are
					 administering drugs may maintain a stock of intravenous fluids, irrigation
					 fluids, heparin flush kits, medicinal gases, sterile water and saline, and
					 prescription devices. Such stock shall be limited to a listing to be determined
					 by the provider pharmacist in consultation with the medical and nursing staff
					 of the institution.
Statutory Authority
§§
												54.1-2400,
						54.1-3307,
						and
						54.1-3312
						of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XI - Other Institutions and Facilities › Section 18VAC110-20-570 - Drugs in infirmaries/first aid rooms

Current through Register Vol. 40, No. 24, July 15, 2024
A. Prescription drugs purchased by an
				  institution, agency, or business within the Commonwealth, having been purchased
				  in the name of a practitioner licensed by the Commonwealth of Virginia and who
				  is employed by an institution, agency, or business which does not hold a
				  pharmacy permit, shall be used only for administering to those persons at that
				  institution, agency, or business.
B. All prescription drugs shall be maintained
				  and secured in a suitable locked storage area, the key to which will be in the
				  possession of the practitioner or nurse who is under the direction and
				  supervision of the practitioner.
C.
				  Such institution, agency, or business shall adopt a specific protocol for the
				  administration of prescription drugs, listing the inventory of such drugs
				  maintained, and authorizing the administering of such drugs in the absence of a
				  practitioner in an emergency situation when the timely prior verbal or written
				  order of a prescriber is not possible. Administering of such drugs shall be
				  followed by written orders.
1. For the
				  purpose of this chapter, "emergency" means a circumstance requiring
				  administration of prescription drugs necessary to preserve life or to prevent
				  significant or permanent injury or disability.
2. The protocol shall be maintained for
				  inspection and documentation purposes.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XI - Other Institutions and Facilities › Section 18VAC110-20-580 - Animal shelters

Current through Register Vol. 40, No. 24, July 15, 2024
An animal shelter, after having obtained the proper
					 registrations pursuant to state and federal laws, may purchase, possess and
					 administer controlled substances in accordance with provisions of §
										54.1-3423
					 of the Code of Virginia provided that these procedures are followed:
1. Drugs ordered by a public or private
				  animal shelter, as defined in §
										3.2-6500 of the Code
				  of Virginia, shall only be stored and administered at the address of the
				  shelter.
2. A veterinarian shall
				  provide general supervision for the facility and shall provide and certify
				  training in accordance with guidelines set forth by the State Veterinarian to
				  the persons responsible for administration of the drugs. Certification of
				  training signed by the veterinarian providing the training shall be maintained
				  at the facility for each person administering drugs and must be retained for
				  not less than two years after the person ceases administering.
3. The person in charge of administration of
				  drugs for the facility shall obtain the required permit and controlled
				  substances registration from the board and shall be responsible for maintaining
				  proper security and required records of all controlled substances obtained and
				  administered.
a. If that person ceases
				  employment with the facility or relinquishes his position, he shall immediately
				  return the registration to the board and shall take a complete and accurate
				  inventory of all drugs in stock.
b.
				  An application for a new registration shall be filed with the required fee
				  within 14 days on a form provided by the board. At that time, the new
				  responsible person shall take a complete and accurate inventory of all drugs in
				  stock.