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 XII - Exempted Stimulant or Depressant Drugs and Chemical Preparations › Section 18VAC110-20-600 - Excluded substances

Current through Register Vol. 40, No. 24, July 15, 2024
The list of excluded substances, which may be lawfully sold
					 over the counter without a prescription under the federal Food, Drug and
					 Cosmetic Control Act (
					 21
					 USC 301 ), as set forth in
					 21 CFR §
											1308.22, is adopted pursuant to the authority
					 set forth in §§
										54.1-3443,
					 54.1-3450 and
					 54.1-3452 of the Drug
					 Control Act.
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 XII - Exempted Stimulant or Depressant Drugs and Chemical Preparations › Section 18VAC110-20-610 - Exempted chemical preparations

Current through Register Vol. 40, No. 24, July 15, 2024
The list of exempt chemical preparations pursuant to
					 21 CFR
					 1308.24 and maintained by the administrator
					 of DEA is adopted pursuant to the authority set forth in §§
										54.1-3443,
					 54.1-3450 and
					 54.1-3452 of the Drug
					 Control Act.
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 XII - Exempted Stimulant or Depressant Drugs and Chemical Preparations › Section 18VAC110-20-620 - Exempted prescription products

Current through Register Vol. 40, No. 24, July 15, 2024
The list of exempt prescription products pursuant to
					 21 CFR
					 1308.32 and maintained by the administrator
					 of DEA is adopted pursuant to the authority set forth in §§
										54.1-3443,
					 54.1-3450 and
					 54.1-3452 of the Drug
					 Control Act; the exempted prescription products are drugs which are subject to
					 the provisions of §
										54.1-3455 of the Drug
					 Control Act.
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 XII - Exempted Stimulant or Depressant Drugs and Chemical Preparations › Section 18VAC110-20-621 - Exempted anabolic steroid products

Current through Register Vol. 40, No. 24, July 15, 2024
The list of exempt anabolic steroid products pursuant to
					 21 CFR
					 1308.34 and maintained by the administrator
					 of DEA is adopted pursuant to the authority set forth in §§
										54.1-3443,
					 54.1-3450 and
					 54.1-3452 of the Drug
					 Control Act; the exempted anabolic steroid products are drugs which are subject
					 to the provisions of §
										54.1-3455 of the Drug
					 Control Act.
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 XII - Exempted Stimulant or Depressant Drugs and Chemical Preparations › Section 18VAC110-20-622 - Excluded veterinary anabolic steroid implant products

Current through Register Vol. 40, No. 24, July 15, 2024
The list of excluded veterinary anabolic steroid implant
					 products pursuant to
					 21 CFR
					 1308.26 and maintained by the administrator
					 of DEA is adopted only for legitimate veterinary use pursuant to the authority
					 set forth in §§
										54.1-3443,
					 54.1-3450 and
					 54.1-3452 of the Drug
					 Control Act; the exempted anabolic steroid products are drugs which are subject
					 to the provisions of §
										54.1-3455 of the Drug
					 Control Act when used for implant to cattle or other nonhuman species. These
					 products are not excluded from Schedule III if prescribed, administered,
					 dispensed, or otherwise distributed for human use.
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 XIII - Medical Equipment Suppliers › Section 18VAC110-20-630 - Issuance of a permit as a medical equipment supplier

Current through Register Vol. 40, No. 24, July 15, 2024
A. Any person or entity desiring to obtain a
				  permit as a medical equipment supplier shall file an application with the board
				  on a form approved by the board. An application shall be filed for a new permit
				  or for acquisition of an existing medical equipment supplier. The application
				  shall designate the hours of operation the location will be open to service the
				  public and shall be signed by a person who works at the location address on the
				  application and will act as a responsible party for that location.
B. Any change in the hours of operation
				  expected to last for more than one week shall be reported to the board in
				  writing and a notice posted, at least 14 days prior to the anticipated change,
				  in a conspicuous place to the public.
1. Such
				  notification of a change in hours of operation is not required when the change
				  is necessitated by emergency circumstances beyond the control of the owner or
				  responsible party or when the change will result in an expansion of the current
				  hours of operation.
2. If the
				  medical equipment supplier is unable to post the change in hours 14 days in
				  advance, the responsible party or owner shall ensure the board is notified as
				  soon as he knows of the change and disclose the emergency circumstances
				  preventing the required notification.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIII - Medical Equipment Suppliers › Section 18VAC110-20-680 - Medical equipment suppliers

Current through Register Vol. 40, No. 24, July 15, 2024
A.
				  A medical equipment supplier's location shall be inspected by the board prior
				  to engaging in business. The location shall be clean and sanitary and shall
				  have a system of temperature control to provide for specified storage
				  conditions for any Schedule VI drug or device.
B. Hypodermic needles and syringes and
				  Schedule VI drugs shall not be placed on open display or in an open area where
				  patrons will have access to such items. No Schedule VI devices shall be placed
				  in an area where responsible parties cannot exercise reasonable supervision and
				  control.
C. A medical equipment
				  supplier shall receive a valid order from a practitioner prior to dispensing
				  and shall maintain this order on file on the premises for a period of two years
				  from date of last dispensing. The original order may be kept at a centralized
				  office as long as it is readily retrievable within 48 hours and a copy of the
				  order is kept on the premises of the dispensing supplier. In lieu of a hard
				  copy, an electronic image of an order may be maintained in an electronic
				  database provided it preserves and provides an exact image of the order that is
				  clearly legible and made available within 48 hours of a request by a person
				  authorized by law to have access to prescription information.
D. Medical equipment suppliers shall make a
				  record at the time of dispensing. This record shall be maintained on the
				  premises for two years from date of dispensing and shall include:
1. Name and address of patient;
2. Item dispensed and quantity, if
				  applicable; and
3. Date of
				  dispensing.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-685 - Definitions for controlled substances registration

Current through Register Vol. 40, No. 24, July 15, 2024
For purposes of this part, the following definitions shall
					 apply:
"BHA" means a behavioral health authority facility licensed
					 by the Department of Behavioral Health and Developmental Services that holds a
					 controlled substances registration issued by the board.
"CSB" means a community services board facility licensed by
					 the Department of Behavioral Health and Developmental Services that holds a
					 controlled substances registration issued by the board.
"PACE" means a program of all-inclusive care for the
					 elderly overseen by the Department of Medical Assistance Services in accordance
					 with §
										32.1-330.3
					 of the Code of Virginia.
Statutory Authority: §§
												54.1-2400
						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 XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-690 - Persons or entities authorized or required to obtain a controlled substances registration

Current through Register Vol. 40, No. 24, July 15, 2024
A. A person
				  or entity that maintains or intends to maintain a supply of Schedules II
				  through Schedule VI controlled substances, other than manufacturers' samples,
				  in accordance with provisions of the Drug Control Act (§
										54.1-3400 et seq. of the
				  Code of Virginia) may apply for a controlled substances registration on forms
				  approved by the board.
B. Persons
				  or entities that may be registered by the board shall include hospitals without
				  in-house pharmacies, nursing homes without in-house pharmacies that use
				  automated drug dispensing systems, ambulatory surgery centers, outpatient
				  clinics, alternate delivery sites, crisis stabilization units, persons
				  authorized by the Department of Behavioral Health and Developmental Services to
				  train individuals on the administration of naloxone and to dispense naloxone
				  for opioid overdose reversal, and emergency medical services agencies provided
				  such persons or entities are otherwise authorized by law and hold required
				  licenses or appropriate credentials to administer the drugs for which the
				  registration is being sought.
C. In
				  determining whether to register an applicant, the board shall consider factors
				  listed in subsections A and D of §
										54.1-3423
				  of the Code of Virginia and compliance with applicable requirements of this
				  chapter.
1. The proposed location shall be
				  inspected by an authorized agent of the board prior to issuance of a controlled
				  substances registration.
2.
				  Controlled substances registration applications that indicate a requested
				  inspection date or requests that are received after the application is filed
				  shall be honored provided a 14-day notice is allowed prior to the requested
				  inspection date.
3. Requested
				  inspection dates that do not allow a 14-day notice to the board may be adjusted
				  by the board to provide 14 days for the scheduling of the inspection.
4. Any person wishing to change an approved
				  location of the drug stock, make structural changes to an existing approved
				  drug storage location, or make changes to a previously approved security system
				  shall file an application with the board and be inspected.
5. Drugs shall not be stocked within the
				  proposed drug storage location or moved to a new location until approval is
				  granted by the board.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-700 - Requirements for supervision for controlled substances registrants

Current through Register Vol. 40, No. 24, July 15, 2024
A. A practitioner
				  licensed in Virginia shall provide supervision for all aspects of practice
				  related to the maintenance and use of controlled substances as follows:
1. In a hospital or nursing home without an
				  in-house pharmacy, a pharmacist shall supervise.
2. In an emergency medical services agency,
				  the operational medical director shall supervise.
3. For any other type of applicant or
				  registrant, a pharmacist or a prescriber whose scope of practice is consistent
				  with the practice of the applicant or registrant and who is approved by the
				  board may provide the required supervision.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-710 - Requirements for storage and security for controlled substances registrants

Current through Register Vol. 40, No. 24, July 15, 2024
A. Drugs shall be
				  stored under conditions that meet USP-NF specifications or manufacturers'
				  suggested storage for each drug.
B.
				  Any drug that has exceeded the expiration date shall not be administered; it
				  shall be separated from the stock used for administration and maintained in a
				  separate, locked area until properly disposed.
C. If a controlled substances registrant
				  wishes to dispose of unwanted or expired Schedules II through VI drugs, he
				  shall transfer the drugs to another person or entity authorized to possess and
				  to provide for proper disposal of such drugs.
D. Drugs shall be maintained in a lockable
				  cabinet, cart, device, or other area that shall be locked at all times when not
				  in use. The keys or access code shall be restricted to the supervising
				  practitioner and persons designated access in accordance with 18VAC110-20-700
				  C.
E. In a facility not staffed 24
				  hours a day, the drugs shall be stored in a fixed and secured room, cabinet or
				  area that has a security device for the detection of breaking that meets the
				  following conditions:
1. The device shall be
				  a sound, microwave, photoelectric, ultrasonic, or any other generally accepted
				  and suitable device.
2. The
				  installation and device shall be based on accepted alarm industry
				  standards.
3. The device shall be
				  maintained in operating order, have an auxiliary source of power, be monitored
				  in accordance with accepted industry standards, be maintained in operating
				  order; and shall be capable of sending an alarm signal to the monitoring entity
				  if breached and the communication line is not operational.
4. The device shall fully protect all areas
				  where prescription drugs are stored and shall be capable of detecting breaking
				  by any means when activated.
5.
				  Access to the alarm system shall be restricted to only designated and necessary
				  persons, and the system shall be activated whenever the drug storage areas are
				  closed for business.
6. An alarm
				  system is not required for researchers, animal control officers, humane
				  societies, alternate delivery sites as provided in
				  18VAC110-20-275,
				  emergency medical services agencies stocking only intravenous fluids with no
				  added drug, persons authorized by the Department of Behavioral Health and
				  Developmental Services to train individuals on the administration of naloxone
				  and to dispense naloxone for opioid overdose reversal, and teaching
				  institutions possessing only Schedule VI drugs.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-720 - Requirements for recordkeeping

Current through Register Vol. 40, No. 24, July 15, 2024
The person named as the responsible party on the controlled
					 substances registration shall be responsible for recordkeeping for Schedule II
					 through VI drugs in accordance with provisions of §
										54.1-3404
					 of the Code of Virginia and the following:
1. Inventories and administration records of
				  Schedule II drugs shall be maintained separately from all other records and
				  shall be kept in chronological order by date of administration.
2. All records shall be maintained at the
				  same location as listed on the controlled substances registration or, if
				  maintained in an off-site database, retrieved and made available for inspection
				  or audit within 48 hours of a request by the board or an authorized
				  agent.
3. In the event that an
				  inventory is taken as the result of a theft of drugs, the inventory shall be
				  used as the opening inventory within the current biennial period. Such an
				  inventory does not preclude the taking of the required inventory on the
				  required biennial inventory date. All inventories required by §
										54.1-3404
				  of the Code of Virginia shall be signed and dated by the person taking the
				  inventory and shall indicate whether the inventory was taken prior to the
				  opening or after the close of business on that date. An entity which is open 24
				  hours a day shall clearly document whether the receipt or distribution of drugs
				  on the inventory date occurred before or after the inventory was
				  taken.
4. Any computerized system
				  used to maintain records shall also provide retrieval via computer monitor
				  display or printout of the history for drugs administered during the past two
				  years. It shall also have the capacity of producing a printout of any data
				  which the registrant is responsible for maintaining under the Drug Control Act
				  (§
										54.1-3400 et seq. of the
				  Code of Virginia).
5. The
				  Department of Forensic Science may exclude from any inventory quantities of
				  controlled substances used to conduct chemical analyses and controlled
				  substances received for analyses as evidentiary material as provided in §
										54.1-3404G
				  of the Code of Virginia.
Statutory Authority
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 XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-725 - Repackaging by a CSB , BHA, or PACE site

Current through Register Vol. 40, No. 24, July 15, 2024
A. Definition. For purposes of this section,
				  "repackaging" shall mean removing a drug from a container already dispensed and
				  labeled by a pharmacy or medical practitioner authorized to dispense, for a
				  particular client of a CSB , BHA, or PACE site, and placing it in a container
				  designed for a person to be able to repackage his own dispensed prescription
				  medications to assist with self-administration and compliance with dosage
				  instructions. Such repackaging shall not include the preparation of a
				  patient-specific label that includes drug name, strength, or directions for use
				  or any other process restricted to a pharmacist or pharmacy technician under
				  the direct supervision of a pharmacist.
B. Persons authorized to repackage.
				  Repackaging shall be performed by a pharmacist, pharmacy technician, nurse, or
				  such other person who has successfully completed a board-approved training
				  program for repackaging of prescription drug orders as authorized in §
										54.1-3420.2
				  of the Code of Virginia. A CSB , BHA, or PACE site using such other person
				  shall maintain documentation of completion of an approved training program for
				  at least one year from date of termination of employment or cessation of
				  repackaging activities.
C.
				  Requirements for repackaging.
1. The
				  repackaging of a dispensed prescription drug order pursuant to §
											54.1-3420.2
				  of the Code of Virginia shall only be done at a CSB , BHA, or PACE
				  site.
2. The repackaging of
				  dispensed prescription drugs shall be restricted to solid oral dosage forms and
				  a maximum of a 14-day supply of drugs.
3. The drug container used for repackaging
				  pursuant to this section shall bear a label containing the client's first and
				  last name and name and 24-hour contact information for the CSB , BHA, or PACE
				  site.
4. A clean, well-closed
				  container that assists the client with self-administration shall be used when
				  multiple doses of a repackaged drug are provided to the client at one
				  time.
5. A prescription drug order
				  shall not be repackaged beyond the assigned expiration date noted on the
				  prescription label of the dispensed drug, if applicable, or beyond one year
				  from the date the drug was originally dispensed by a pharmacy, whichever date
				  is earlier.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-726 - Criteria for approval of repackaging training programs

Current through Register Vol. 40, No. 24, July 15, 2024
A. Application. Any person wishing to apply
				  for approval of a repackaging training program shall submit the application fee
				  prescribed in
				  18VAC110-20-20
				  and an application on a form approved by the board and shall meet the criteria
				  established in this section. The application shall name a program director who
				  is responsible for compliance with this section.
B. Curriculum. The curriculum for a
				  repackaging training program shall include instruction in current laws and
				  regulations applicable to a CSB , BHA, or PACE site for the purpose of
				  assisting a client with self-administration pursuant to §
										54.1-3420.2
				  of the Code of Virginia and in the following repackaging tasks:
1. Selection of an appropriate
				  container;
2. Proper preparation of
				  a container in accordance with instructions for administration;
3. Selection of the drug;
4. Counting of the drug;
5. Repackaging of the drug within the
				  selected container;
6. Maintenance
				  of records;
7. Proper storage of
				  drugs;
8. Translation of medical
				  abbreviations;
9. Review of
				  administration records and prescriber's orders for the purpose of identifying
				  any changes in dosage administration;
10. Reporting and recording the client's
				  failure to take medication;
11.
				  Identification, separation, and removal of expired or discontinued drugs;
				  and
12. Prevention and reporting of
				  repackaging errors.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-727 - Pharmacists repackaging for clients of a CSB , BHA or PACE

Current through Register Vol. 40, No. 24, July 15, 2024
A. As an
				  alternative to repackaging as defined in 18VAC110-20-725, a pharmacist at a CSB
				  , BHA, or PACE site may repackage a client's prescription drugs that have been
				  dispensed by another pharmacy into compliance packaging under the following
				  conditions:
1. A prescription drug order
				  shall not be repackaged beyond the assigned expiration date noted on the
				  prescription label of the dispensed drug, if applicable, or beyond one year
				  from the date the drug was originally dispensed by a pharmacy, whichever date
				  is earlier.
2. The compliance
				  packaging shall comply with the requirements of 18VAC110-20-340 B.
3. A record of repackaging shall be made and
				  maintained for one year from the date of repackaging and shall include the
				  following:
a. Date of repackaging;
b. Name of client;
c. Prescription number of the originally
				  dispensed prescription drug order;
d. Pharmacy name;
e. Drug name and strength;
f. Quantity of drug repackaged; and
g. Initials of the person performing the
				  repackaging and verifying the accuracy of the repackaged drug
				  container.
4. Any
				  portion of a prescription drug order remaining at the CSB , BHA, or PACE site
				  that has exceeded any labeled expiration date or one year from the original
				  pharmacy dispensing date on the label shall be separated from unexpired drugs,
				  stored within a designated area of the board-approved drug storage location,
				  and destroyed within 30 days of expiration with the written agreement of the
				  client. Remaining portions of discontinued prescription drug orders retained by
				  the CSB , BHA, or PACE site shall also be separated from active stock and
				  either returned to the client or destroyed within 30 days of discontinuance
				  with the written agreement of the client.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-728 - Drugs for immediate treatment in crisis stabilization units

Current through Register Vol. 40, No. 24, July 15, 2024
A. In accordance
				  with §
										54.1-3423
				  of the Code of Virginia, a crisis stabilization unit shall apply for and obtain
				  a controlled substances registration in order to maintain a stock of Schedule
				  VI controlled substances for immediate treatment of patients in crisis.
				  Schedule II through V controlled substances shall not be stocked. The
				  responsible party listed on the application shall be a nurse who regularly
				  administers controlled substances at the crisis stabilization unit and the
				  supervising practitioner shall be either the medical director for the unit or a
				  pharmacist from a provider pharmacy.
B. In consultation with a provider
				  pharmacist, the medical director for the unit shall determine the list of
				  controlled substances to be stocked at the crisis stabilization unit. The list
				  shall be limited to Schedule VI controlled substances and only those drugs
				  routinely used for treatment of patients admitted for crisis stabilization.
				  Only drugs on this drug list may be stocked.
C. A nurse administering a drug from this
				  stock pursuant to an oral order of a prescriber in accordance with §
										54.1-3423
				  of the Code of Virginia shall record such order in the patient's medical
				  record.
D. Records.
1. A record shall be maintained of all drugs
				  received as stock by the crisis stabilization unit.
2. A record shall be made documenting
				  administration or other authorized disposition of stocked drugs that includes
				  the following:
a. Name of patient;
b. Date and time of administration;
c. Drug name, strength, and quantity
				  administered;
d. Name or initials
				  of person administering; and
e.
				  Prescriber name.
3.
				  Records shall be maintained at the same location listed on the controlled
				  substances registration or, if maintained in an off-site database, retrieved
				  and made available for inspection or audit within 48 hours of a request by the
				  board or an authorized agent. Any computerized system used to maintain records
				  shall also provide retrieval via computer monitor display or printout of the
				  history for drugs administered during the past two years. It shall also have
				  the capacity of producing a printout of any data which the registrant is
				  responsible for maintaining.
4.
				  Manual records may be maintained as an electronic image that provides an exact
				  image of the document and is clearly legible.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-730 - Requirements for practitioner of medicine or osteopathy in free clinics

Current through Register Vol. 40, No. 24, July 15, 2024
A. Any practitioner
				  of medicine or osteopathy who provides controlled substances that have been
				  donated pursuant to subdivision 11 of §
										54.1-3301 of the Code
				  of Virginia shall apply for a controlled substances registration.
B. A practitioner in a free clinic may only
				  accept donated drugs pursuant to this registration if they are donated by an
				  entity or practitioner who holds a current active license, permit, or
				  registration issued by the board authorizing the dispensing or distribution of
				  drugs.
C. A practitioner shall
				  store such donated drugs for dispensing in compliance with the storage and
				  security requirements set forth in 18VAC110-20-710, and a drug that has
				  exceeded its expiration date shall not be dispensed. A practitioner shall be
				  responsible for maintaining and complying with a written procedure for
				  reviewing inventory for the purpose of removing expired drugs.
D. A practitioner shall package any dispensed
				  drugs in accordance with the provisions of §§
										54.1-3426
				  and
				  54.1-3427
				  of the Code of Virginia and 18VAC110-20-340 and 18VAC110-20-350.
E. A practitioner shall label any dispensed
				  drugs in accordance with the provisions of §§
										54.1-3410
				  and
				  54.1-3463
				  of the Code of Virginia and 18VAC110-20-330 to include the free clinic name and
				  address; name of the prescriber; patient name; date of dispensing; drug name to
				  include the generic name if the drug has a single active ingredient; drug
				  strength, if applicable; quantity; and directions for use.
F. A practitioner shall comply with all
				  recordkeeping requirements of §
										54.1-3404
				  of the Code of Virginia and shall also maintain a chronological record of all
				  Schedule II through VI drugs dispensed showing patient name and address; date
				  of dispensing; drug name, strength, and quantity dispensed; and name or
				  initials of the dispensing practitioner.
G. A practitioner under this section may
				  enter into a contract or written agreement with a pharmacy whereby the pharmacy
				  maintains all or part of the donated stock, dispenses the prescription pursuant
				  to a written prescription by a prescriber at the free clinic, and delivers the
				  dispensed prescription to the free clinic for pick up by the patient in
				  accordance with subsection C of
				  18VAC110-20-275.
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 XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-735 - Requirements for dispensing of naloxone by trained individuals

Current through Register Vol. 40, No. 24, July 15, 2024
A. Persons
				  authorized by the Department of Behavioral Health and Developmental Services to
				  train individuals on the administration of naloxone and dispense naloxone for
				  opioid overdose reversal pursuant to subsection Y of §
										54.1-3408
				  of the Code of Virginia shall maintain the following records:
1. The prescriber's standing order issued in
				  accordance with subsection Y of §
											54.1-3408
				  of the Code of Virginia authorizing the trained individual to dispense
				  naloxone.
2. Invoices or other
				  records showing receipts of naloxone shall be maintained, but may be stored in
				  an electronic database or record as an electronic image that provides an exact,
				  clearly legible image of the document or in secured storage either on site or
				  off site. All records in off-site storage or database shall be retrieved and
				  made available for inspection or audit within 48 hours of a request by the
				  board or an authorized agent.
3. A
				  manual or electronic log indicating the name, strength, lot, expiration date,
				  and quantity of naloxone transferred to and from the controlled substances
				  registration location to the off-site training location, along with date of
				  transfer and the name of the trained individual approved by the Department of
				  Behavioral Health and Developmental Services.
4. Record of dispensing indicating the name
				  of the person receiving naloxone, address or contact information if available,
				  date of dispensing, drug name, strength, quantity, lot number, expiration date,
				  and the name of the trained individual approved by the Department of Behavioral
				  Health and Developmental Services to dispense naloxone.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-740 - Drug donation sites

Current through Register Vol. 40, No. 24, July 15, 2024
Any pharmacy with a current active pharmacy permit may
					 apply on a form provided by the board for registration as a drug donation site.
					 A registered drug donation site may receive eligible donated drugs, transfer
					 such donated drugs to another registered drug donation site, or redispense the
					 donated drugs in accordance with §
										54.1-3411.1
					 of the Code of Virginia to patients of clinics organized in whole or in part
					 for the delivery of health care services to the indigent. Drugs collected under
					 the drug donation program may not be dispensed to any other patient, sold, or
					 otherwise distributed except as authorized in 18VAC110-20-770 or
					 18VAC110-20-790.
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 XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-750 - Eligible drugs

Current through Register Vol. 40, No. 24, July 15, 2024
A. Drugs may be
				  accepted by a registered drug donation site only if the following criteria are
				  met:
1. Official compendium storage
				  requirements are assured and the drugs are in manufacturers' original sealed
				  containers or in sealed individual dose or unit dose packaging that meets
				  official compendium Class A or B container requirements, or better, as set
				  forth in §
											54.1-3411.1A
				  2 of the Code of Virginia;
2. The
				  drugs bear an expiration date that is not less than 90 days from the date the
				  drug is donated; and
3. The drugs
				  have not been adulterated or misbranded.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-760 - Procedures for collecting eligible donated drugs

Current through Register Vol. 40, No. 24, July 15, 2024
A. A pharmacist or a pharmacy technician
				  under the personal supervision of a pharmacist shall receive and conduct the
				  initial screening for eligibility of donated drugs.
B. At the time of accepting donated drugs,
				  the drug donation site shall ensure that a donor form is completed. The drug
				  donation site shall give a copy of the donor form to the person donating the
				  drug at the time of the donation and shall maintain the original donor form. A
				  donor form is not required for drugs donated by a patient residing in a
				  long-term care facility or other facility where drugs are administered to that
				  patient if the drugs are donated directly to the provider pharmacy for that
				  facility and such provider pharmacy is registered as a drug donation
				  site.
C. A donor form shall include
				  the following information:
1. A statement
				  that the donor is the patient or patient's agent for whom the prescription drug
				  was dispensed;
2. A statement that
				  the donor intends to voluntarily donate the prescription drug for
				  redispensing;
3. A statement
				  attesting that the drugs have been properly stored at all times while in the
				  possession of the patient according to official compendium storage
				  requirements;
4. Contact
				  information for the patient or patient's agent;
5. The date of donation;
6. A listing of the donated drugs to include
				  name, strength, and quantity;
7. A
				  statement that private health information will be protected;
8. The signature of the patient or patient's
				  agent; and
9. The initials of the
				  receiving pharmacist, or the initials of the receiving pharmacy technician and
				  supervising pharmacist.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-770 - Procedure for transferring donated prescription drugs

Current through Register Vol. 40, No. 24, July 15, 2024
A. A drug donation site may transfer eligible
				  donated prescription drugs to another drug donation site for the purpose of
				  redispensing.
B. The transferring
				  drug donation site shall provide a transfer record to the receiving drug
				  donation site that includes the following:
1.
				  The names and addresses of the transferring site and the receiving
				  site;
2. The name, strength, and
				  quantity of each donated drug being transferred; and
3. The date of transfer.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-780 - Procedure for dispensing donated prescription drugs

Current through Register Vol. 40, No. 24, July 15, 2024
A. A drug donation site redispensing donated
				  prescription drugs shall comply with applicable federal and state laws and
				  regulations for dispensing prescription drugs.
B. The pharmacy redispensing donated drugs
				  shall not charge for cost of donated drugs, but may charge a dispensing or
				  administrative fee for each such drug redispensed, consistent with the
				  provisions of subdivision 10 of §
										54.1-3301 of the Code
				  of Virginia.
C. Recipients of a
				  redispensed donated drug shall sign a form prior to receiving the drug that
				  includes a statement that the recipient understands that the drug received has
				  been donated for the purpose of redispensing pursuant to §
										54.1-3411.1
				  of the Code of Virginia. The drug donation site shall maintain this
				  form.
D. A drug donation site is
				  under no obligation to obtain a prescription drug that is not in inventory at
				  the time of a request for such drug.
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 XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-790 - Procedures for disposing of donated prescription drugs

Current through Register Vol. 40, No. 24, July 15, 2024
A. A drug donation site in possession of
				  donated prescription drugs ineligible for redispensing shall dispose of such
				  drugs in compliance with
				  18VAC110-20-210.
B. A drug donation site shall maintain
				  records of disposal or transfer for disposal of donated prescription drugs
				  separately from other pharmacy disposal records.
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 XIV - Controlled Substances Registration for Other Persons or Entities › Section 18VAC110-20-800 - Records

Current through Register Vol. 40, No. 24, July 15, 2024
A. All records
				  required for drug donation programs shall be maintained chronologically for two
				  years.
B. Records and prescriptions
				  related to donated drugs shall be maintained separately from other pharmacy
				  records.
C. Storage of records.
1. Transfer, dispensing, and disposal records
				  may be stored in an electronic database or record.
2. Prescriptions and signed forms, as well as
				  any other records, may be stored as an electronic image that provides an exact,
				  clearly legible image of the document.
3. Records may be stored in secured storage,
				  either on or offsite.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Part XIV - Controlled Substances Registration for Other Persons or Entities › Section (18VAC110-20) - DOCUMENTS INCORPORATED BY REFERENCE

Current through Register Vol. 40, No. 24, July 15, 2024
The United States Pharmacopeia and National Formulary,
					 USP27-NF 22, revised June 2004, revisions official August 1, 2004, United
					 States Pharmacopeial Convention, Inc.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 20 - REGULATIONS GOVERNING THE PRACTICE OF PHARMACY › Form - FORMS (18VAC110-20)

Current through Register Vol. 40, No. 24, July 15, 2024
Application
				  for a Pharmacy Permit (rev. 10/2020)
Application
				  for a Non-resident Pharmacy Registration (rev. 10/2020)
Application
				  for a Non-Resident Wholesale Distributor Registration (rev.
				  10/2020)
Application
				  for Registration as Nonresident Manufacturer (rev. 10/2020)
Application
				  for a Non-Resident Third Party Logistics Provider Registration (rev.
				  10/2020)
Application
				  for Registration as a Nonresident Warehouser (rev. 10/2020)
Application
				  for a Non-resident Outsourcing Facility Registration (rev.
				  10/2020)
Application
				  for an Outsourcing Facility Permit (rev. 10/2020)
Application
				  for a Medical Equipment Supplier Permit (rev. 10/2020)
Application
				  for a Permit as a Restricted Manufacturer (rev. 10/2020)
Application
				  for a Permit as a Non-Restricted Manufacturer (rev. 10/2020)
Application
				  for a License as a Wholesale Distributor (rev. 10/2020)
Application
				  for a Permit as Warehouser (rev. 10/2020)
Application
				  for a Permit as a Third-Party Logistics Provider (rev. 10/2020)
Application
				  for Registration as a Non-resident Medical Equipment Supplier (rev.
				  10/2020)
Application
				  for a Controlled Substances Registration Certificate (rev.
				  10/2020)
Closing
				  of a Pharmacy (rev. 5/2018)
Application
				  for Approval of an Innovative (Pilot) Program (rev. 8/2023)
Registration
				  for a Pharmacy to be a Collection Site for Donated Drugs (rev.
				  5/2018)
Application
				  for Approval of a Repackaging Training Program (rev. 10/2020)
Registration
				  for a Facility to be an Authorized Collector for Drug Disposal (rev.
				  5.2018)
Application
				  for Re-inspection of a Facility (rev. 3/2023)
Notification
				  of Distribution Cessation due to Suspicious Orders (rev. 5/2018)
Staffing
				  Requests or Concerns Form (eff. 9/2023)
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 › Form - FORMS (18VAC110-20)

Current through Register Vol. 40, No. 24, July 15, 2024
Application
				  for a Pharmacy Permit (rev. 1/2024)
Application
				  for a Nonresident Pharmacy Registration (rev. 1/2024)
Application
				  for a Nonresident Wholesale Distributor Registration (rev.
				  4/2024)
Application
				  for Registration as Nonresident Manufacturer (rev. 10/2020)
Application
				  for a Nonresident Third-Party Logistics Provider Registration (rev.
				  4/2024)
Application
				  for Registration as a Nonresident Warehouser (rev. 10/2020)
Application
				  for a Nonresident Outsourcing Facility Registration (rev.
				  10/2020)
Application
				  for an Outsourcing Facility Permit (rev. 10/2020)
Application
				  for a Medical Equipment Supplier Permit (rev. 10/2020)
Application
				  for a Permit as a Restricted Manufacturer (rev. 10/2020)
Application
				  for a Permit as a Nonrestricted Manufacturer (rev. 10/2020)
Application
				  for a Wholesale Distributor Permit (rev. 4/2024)
Application
				  for a Permit as Warehouser (rev. 10/2020)
Application
				  for a Permit as a Third-Party Logistics Provider (rev. 4/2024)
Application
				  for Registration as a Nonresident Medical Equipment Supplier (rev.
				  10/2020)
Application
				  for a Controlled Substances Registration Certificate (rev.
				  10/2020)
Closing
				  of a Pharmacy (rev. 5/2018)
Application
				  for Approval of an Innovative (Pilot) Program (rev. 8/2023)
Registration
				  for a Pharmacy to be a Collection Site for Donated Drugs (rev.
				  5/2018)
Application
				  for Approval of a Repackaging Training Program (rev. 10/2020)
Registration
				  for a Facility to be an Authorized Collector for Drug Disposal (rev.
				  5/2018)
Application
				  for Reinspection of a Facility (rev. 3/2023)
Notification
				  of Distribution Cessation due to Suspicious Orders (rev. 5/2018)
Statutory Authority: § 54.1-2400 of the Code of
					 Virginia.