reglab/statecodes huggingface dataset:
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part III - Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances › Section 18VAC110-30-70 - Practitioner in charge in a permitted facility

Current through Register Vol. 40, No. 24, July 15, 2024
A facility with a permit for practitioners of the healing
					 arts to sell controlled substances shall:
1. Designate a practitioner with a license to
				  sell controlled substances who shall be the primary person responsible for the
				  stock, the required inventory, the records of receipt and destruction,
				  safeguards against diversion and compliance with this chapter;
2. Report to the board the name of the
				  licensee and the location of the controlled substance stock on a form provided
				  by the board;
3. Upon a change in
				  the licensee so designated, an inventory of all Schedule II through V
				  controlled substances shall be conducted in the manner set forth in §
										54.1-3404 of the Drug Control
				  Act of the Code of Virginia and such change shall immediately be reported to
				  the board; and
4. Nothing shall
				  relieve the other individual licensees who sell controlled substances at the
				  location of the responsibility for the requirements set forth in this
				  chapter.
Statutory Authority: §§
												54.1-2400,
						54.1-3304.1, and
						54.1-3307 of the Code of
						Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part III - Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances › Section 18VAC110-30-80 - Inspection and notice required

Current through Register Vol. 40, No. 24, July 15, 2024
A.
				  The area designated for the storage and selling of controlled substances shall
				  be inspected by an agent of the board prior to the issuance of the first
				  license to sell controlled substances from that site. Inspection prior to
				  issuance of subsequent licenses at the same location shall be conducted at the
				  discretion of the board.
B.
				  Applications for facility permits that indicate a requested inspection date, or
				  requests that are received after the application is filed, shall be honored
				  provided a 14-day notice to the board is allowed prior to the requested
				  inspection date.
C. 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.
D. At the time of the inspection, the
				  controlled substance selling and storage area shall comply with
				  18VAC110-30-90,
				  18VAC110-30-100,
				  18VAC110-30-110,
				  18VAC110-30-120, and
				  18VAC110-30-130.
E. If an applicant substantially fails to
				  meet the requirements for issuance of a facility permit and a reinspection is
				  required, or if the applicant is not ready for the inspection on the
				  established date and fails to notify the inspector or the board at least 24
				  hours prior to the inspection, the applicant shall pay a reinspection fee as
				  specified in
				  18VAC110-30-15 prior to a
				  reinspection being conducted.
F. No
				  facility permit shall be issued to sell controlled substances until adequate
				  safeguards against diversion have been provided for the controlled substance
				  storage and selling area and approved by the inspector or board
				  staff.
G. The licensee shall notify
				  the board of any substantive changes to the approved selling and storage area
				  including moving the location of the area, making structural changes to the
				  area, or making changes to the alarm system for the area prior to the changes
				  being made and pay a reinspection fee. An inspection shall be conducted prior
				  to approval of the new or altered selling and storage area.
Statutory Authority: §§
												54.1-2400,
						54.1-3304.1, and
						54.1-3307 of the Code of
						Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part III - Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances › Section 18VAC110-30-90 - Physical standards

Current through Register Vol. 40, No. 24, July 15, 2024
Physical standards for the controlled substance selling and
					 storage area:
1. The building in which
				  the controlled substances selling and storage area is located shall be
				  constructed of permanent and secure materials. Trailers and other movable
				  facilities shall not be permitted;
2. There shall be an enclosed area of not
				  less than 40 square feet that is designated as the controlled substances
				  selling and storage area, which shall be used exclusively for storage,
				  preparation, and dispensing. Records related to the sale of controlled
				  substances may be maintained outside the selling and storage area with access
				  limited to the licensee and those persons authorized to assist in the area. The
				  work space used in preparation of the drugs shall be contained within the
				  enclosed area. A controlled substance selling and storage area inspected and
				  approved prior to November 3, 1993, shall not be required to meet the size
				  requirement of this chapter;
3.
				  Controlled substances maintained for ultimate sale shall be maintained
				  separately from any other controlled substances maintained for other purposes.
				  Controlled substances maintained for other purposes such as administration or
				  samples may be stored within the selling and storage area provided they are
				  clearly separated from the stock maintained for sale;
4. The selling and storage area, work counter
				  space and equipment in the area shall be maintained in a clean and orderly
				  manner;
5. A sink with hot and cold
				  running water shall be available within 20 feet of the selling and storage area
				  and not located within an examination room or restroom; and
6. The entire area described in this chapter
				  shall be well lighted and ventilated; the proper storage temperature shall be
				  maintained to meet official specifications for controlled substance storage.
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,
						54.1-3304.1, and
						54.1-3307 of the Code of
						Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part III - Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances › Section 18VAC110-30-100 - Access to selling area

Current through Register Vol. 40, No. 24, July 15, 2024
Access to stock rooms, rest rooms, and other areas other
					 than an office that is exclusively used by the licensee shall not be through
					 the selling and storage area. The selling and storage area may be in an office
					 that is exclusively used by the licensee and to which only the licensee has
					 access, provided the office is at least 40 square feet in area; provided the
					 drugs are stored in a cabinet, closet, or other lockable area that can be
					 locked when the practitioner is using the office for purposes other than
					 dispensing; and provided the office meets all other requirements of
					 18VAC110-30-90,
					 18VAC110-30-120, and
					 18VAC110-30-130.
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 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part III - Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances › Section 18VAC110-30-110 - Minimum equipment

Current through Register Vol. 40, No. 24, July 15, 2024
The licensee shall be responsible for maintaining the
					 following equipment in the designated area:
1. A current dispensing information reference
				  source, either hard copy or electronic;
2. A refrigerator with a monitoring
				  thermometer, located in the selling area, if any controlled substances
				  requiring refrigeration are maintained;
3. Equipment consistent with requirements of
				  § 54.1-3410.2 of the Code of Virginia and USP-NF standards, if sterile
				  products are to be prepared;
4.
				  Prescription balances, sensitive to 15 milligrams, and weights or an electronic
				  scale, if the licensee is engaged in dispensing activities that require the
				  weighing of components; and
5.
				  Other equipment, supplies, and references consistent with the practitioner's
				  scope of practice and with the public safety.
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 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part III - Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances › Section 18VAC110-30-120 - Safeguards against diversion of controlled substances

Current through Register Vol. 40, No. 24, July 15, 2024
A device for the detection of breaking shall be installed
					 in the controlled substances selling and storage area. The installation and the
					 device shall be based on accepted burglar alarm industry standards, and shall
					 be subject to the following conditions:
1. The device shall be a sound, microwave,
				  photoelectric, ultrasonic, or any other generally accepted and suitable
				  device;
2. The device shall be
				  maintained in operating order;
3.
				  The device shall fully protect the immediate controlled substance selling and
				  storage areas and shall be capable of detecting breaking by any means
				  whatsoever in the area when the area is closed;
4. The alarm system must have an auxiliary
				  source of power;
5. The alarm
				  system shall be capable of being activated and operated separately from any
				  other alarm system in the area or the business in which the controlled
				  substance selling and storage area is located;
6. The alarm system is controlled only by the
				  licensee; and
7. An emergency key
				  or access code to the system may be maintained as set forth in
				  18VAC110-30-130 B of this
				  chapter.
Statutory Authority
§§ 54.1-113, 54.1-2400 and 54.1-3304.1 of the
						Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part III - Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances › Section 18VAC110-30-130 - Selling area enclosures

Current through Register Vol. 40, No. 24, July 15, 2024
A. The
				  controlled substance selling and storage area of the licensee shall be provided
				  with enclosures subject to the following conditions:
1. The enclosure shall be constructed in such
				  a manner that it protects the controlled substance stock from unauthorized
				  entry and from pilferage at all times whether or not the licensee is on duty
.
2.
				  The enclosure shall be locked and alarmed at all times when the licensee is not
				  on duty.
3. The enclosure shall be
				  capable of being locked in a secure manner at any time the licensee on duty is
				  not present in the storage and selling area.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part III - Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances › Section 18VAC110-30-140 - Prescriptions awaiting delivery

Current through Register Vol. 40, No. 24, July 15, 2024
Prescriptions prepared for delivery to the patient may be
					 placed in a secure place outside of the controlled substance selling area and
					 access to the prescriptions restricted by the licensee to designated
					 assistants. The prepared prescriptions may be transferred to the patient
					 whether or not the licensee is on duty with prior approval of the
					 licensee.
Statutory Authority
§§ 54.1-113, 54.1-2400 and 54.1-3304.1 of the
						Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part III - Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances › Section 18VAC110-30-150 - Expired controlled substances; security

Current through Register Vol. 40, No. 24, July 15, 2024
Any controlled substance which has exceeded the expiration
					 date shall not be dispensed or sold and shall be separated from the stock used
					 for selling but shall be maintained in the selling and storage area prior to
					 the disposal of the expired controlled substances.
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 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part III - Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances › Section 18VAC110-30-160 - Disposal of Schedule II through VI controlled substances

Current through Register Vol. 40, No. 24, July 15, 2024
A. If a licensee
				  wishes to dispose of unwanted Schedule II through VI controlled substances, he
				  shall use one of the following procedures:
1.
				  Transfer the drugs to another person or entity authorized to possess Schedule
				  II through VI drugs; or
2. Destroy
				  the drugs by burning in an incinerator in compliance with all applicable local,
				  state, and federal laws and regulations.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part IV - Written Prescription and Record Keeping Standards › Section 18VAC110-30-170 - Sign and written prescription requirements

Current through Register Vol. 40, No. 24, July 15, 2024
A. The licensee shall conspicuously display a
				  sign in the public area of the office and in each patient examination room
				  advising patients of their right to choose where they have their prescriptions
				  filled.
B. The licensee shall
				  advise patients of their right to obtain the controlled substance from him or
				  from a pharmacy.
C. If the patient
				  chooses to obtain the controlled substance from a pharmacy, the licensee shall
				  either provide the patient with a written prescription or transmit the
				  prescription orally, electronically or by fax to a pharmacy of his
				  choice.
D. If the patient chooses
				  to purchase the controlled substance from the licensee, the licensee shall
				  either:
1. Have the patient sign the written
				  prescription and return it to the licensee. If the licensee chooses to use the
				  hard copy prescription as his record of sale, he shall record all information
				  and file as required by
				  18VAC110-30-190. If the licensee
				  chooses to record the sale in book form or maintain it in an automated data
				  system, he shall mark the prescription void, file chronologically, and maintain
				  for a period of two years; or
2. In
				  lieu of a written prescription, have the patient sign a separate waiver form to
				  be maintained for at least two years with the dispensing records according to
				  date of dispensing. The waiver form may not be kept in the patient's
				  chart.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part IV - Written Prescription and Record Keeping Standards › Section 18VAC110-30-180 - Manner of maintaining inventory records for licensees selling controlled substances

Current through Register Vol. 40, No. 24, July 15, 2024
Each licensee shall maintain the inventories and records of
					 controlled substances as follows:
1.
				  Inventories and records of all controlled substances listed in Schedule II
				  shall be maintained separately from all other records of the
				  licensee;
2. Inventories and
				  records of controlled substances listed in Schedules III, IV and V may be
				  maintained separately or with records of Schedule VI controlled substances but
				  shall not be maintained with other records of the licensee;
3. All records of Schedule II through V
				  controlled substances shall be maintained at the same location as the stock of
				  controlled substances to which the records pertain except that records
				  maintained in an off-site database shall be retrieved and made available for
				  inspection within 48 hours of a request by the board or an authorized
				  agent;
4. In the event that an
				  inventory is taken as the result of a theft of controlled substances pursuant
				  to § 54.1-3404 of the Drug Control Act of the Code of Virginia, 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;
5. 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 of business or after close of business; and
6. All records required by this section shall
				  be filed chronologically.
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 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part IV - Written Prescription and Record Keeping Standards › Section 18VAC110-30-190 - Manner of maintaining records for Schedule II through VI controlled substances sold

Current through Register Vol. 40, No. 24, July 15, 2024
A. A hard copy
				  prescription shall be placed on file for every new prescription dispensed and
				  be maintained for two years from date of last refill. All prescriptions shall
				  be filed chronologically from date of initial dispensing. In lieu of a hard
				  copy prescription, a licensee may have an alternative record of all drugs sold
				  maintained for two years from date of dispensing or of refilling an order. Such
				  record shall be in chronological order by date of initial dispensing with
				  refills listed with initial dispensing information or by date of
				  dispensing.
B. The hard copy
				  prescription or records of sale for Schedule II controlled substances shall be
				  maintained as follows:
1. They shall be
				  maintained separately from other records; and
2. They shall be maintained in chronological
				  order and shall show the selling date, a number which identifies the sale, the
				  name and address of the patient, the name and strength of the controlled
				  substance, the initials of the licensee, and the quantity sold.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part IV - Written Prescription and Record Keeping Standards › Section 18VAC110-30-200 - Automated data processing records of sale

Current through Register Vol. 40, No. 24, July 15, 2024
A. An automated data processing system may be
				  used for the storage and retrieval of the sale of controlled substances instead
				  of manual recordkeeping requirements, subject to the following conditions:
1. Any computerized system shall also provide
				  retrieval via computer monitor display or printout of the sale of all
				  controlled substances during the past two years, the listing to be in
				  chronological order and shall include all information required by the manual
				  method; and
2. If the system
				  provides a printout of each day's selling activity, the printout shall be
				  verified, dated and signed by the licensee. The licensee shall verify that the
				  data indicated is correct and then sign the document in the same manner as he
				  would sign a check or legal document (e.g., J.H. Smith or John H. Smith). In
				  place of such printout, the licensee shall maintain a bound log book, or
				  separate file, in which the licensee shall sign a statement each day, in the
				  manner previously described, attesting to the fact that the selling information
				  entered into the computer that day under his initials has been reviewed by him
				  and is correct as shown.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part V - Packaging, Repackaging and Label Standards › Section 18VAC110-30-210 - Repackaging of controlled substances; records required; labeling requirements

Current through Register Vol. 40, No. 24, July 15, 2024
A. A
				  licensee repackaging controlled substances 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 controlled substances repackaged,
				  strength, if any, quantity prepared, initials of the licensee supervising the
				  process, the assigned control number, or the manufacturer's or distributor's
				  name and control number, and an expiration date.
B. The controlled substance name, strength,
				  if any, the assigned control number, or the manufacturer's or distributor's
				  name and control number, and an appropriate expiration date determined by the
				  licensee in accordance with USP-NF guidelines shall appear on any subsequently
				  repackaged or reconstituted units.
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 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part V - Packaging, Repackaging and Label Standards › Section 18VAC110-30-220 - Labeling of prescription as to content and quantity

Current through Register Vol. 40, No. 24, July 15, 2024
Any controlled substances sold by a licensee shall bear on
					 the label of the container, in addition to other requirements, the following
					 information:
1. The name and address
				  of the practitioner and the name of the patient;
2. The date of the dispensing;
3. 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; and
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part V - Packaging, Repackaging and Label Standards › Section 18VAC110-30-230 - Packaging standards for controlled substance sold

Current through Register Vol. 40, No. 24, July 15, 2024
A controlled substance shall be sold only in packaging
					 approved by the current U.S.P.-N.F. for the controlled substance. In the
					 absence of such packaging standard for the controlled substance, it shall be
					 dispensed in a well-closed container.
Statutory Authority
§§ 54.1-113, 54.1-2400 and 54.1-3304.1 of the
						Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part V - Packaging, Repackaging and Label Standards › Section 18VAC110-30-240 - Special packaging

Current through Register Vol. 40, No. 24, July 15, 2024
A. Each
				  controlled substance sold to a person in a household shall be sold in special
				  packaging, except when otherwise requested by the purchaser, or when such
				  controlled substance is exempted from such requirements promulgated pursuant to
				  the Poison Prevention Packaging Act of 1970, 15 USC §§ 1471 -
				  1476.
B. Each licensee may have a
				  sign posted near the compounding and selling area advising the patients that
				  nonspecial packaging may be requested.
C. If nonspecial packaging is requested, a
				  signed release of such request shall be obtained from the patient or the
				  patient's authorized agent and maintained for two years from the date of
				  dispensing.
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 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part VI - Patient's Choice of Supplier, Purchase of Drugs, and Return of Controlled Substances › Section 18VAC110-30-250 - Choice of controlled substance supplier

Current through Register Vol. 40, No. 24, July 15, 2024
A licensee shall neither interfere with the patient's right
					 to choose his supplier of medication nor cooperate with any person or persons
					 in denying a patient the opportunity to select his supplier of prescribed
					 medications.
Statutory Authority
§§ 54.1-113, 54.1-2400 and 54.1-3304.1 of the
						Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part VI - Patient's Choice of Supplier, Purchase of Drugs, and Return of Controlled Substances › Section 18VAC110-30-255 - Purchase of drugs

Current through Register Vol. 40, No. 24, July 15, 2024
Except for an emergency purchase from another licensee or
					 pharmacy, a licensee may only purchase Schedule II through VI drugs from a
					 wholesale distributor licensed or registered by the board.
Statutory Authority
§§ 54.1-2400 and 54.1-3304 of the Code of
						Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part VI - Patient's Choice of Supplier, Purchase of Drugs, and Return of Controlled Substances › Section 18VAC110-30-260 - Returning of controlled substances

Current through Register Vol. 40, No. 24, July 15, 2024
Controlled substances shall not be accepted for return or
					 exchange by any licensee for resale after such controlled substances have been
					 taken from the premises where sold, unless such controlled substances are in
					 the manufacturer's original sealed container or in a unit-dose container which
					 meets the U.S.P.-N.F. Class A or Class B container requirement, have been
					 stored under conditions in which official compendium storage requirements can
					 be assured and provided such return or exchange is consistent with federal law
					 and regulation.
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 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Part VII - Grounds for Disciplinary Action › Section 18VAC110-30-270 - Grounds for disciplinary action

Current through Register Vol. 40, No. 24, July 15, 2024
In addition to those grounds listed in § 54.1-3316 of
					 the Code of Virginia, the board may revoke, suspend, refuse to issue or renew a
					 license to sell controlled substances or may deny any application if it finds
					 that the licensee or applicant has had his license to practice medicine,
					 osteopathic medicine, or podiatry or license as a physician assistant or nurse
					 practitioner suspended or revoked in Virginia or in any other state or no
					 longer holds a current active license to practice in the Commonwealth of
					 Virginia.
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 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Form - FORMS (18VAC110-30)

Current through Register Vol. 40, No. 24, July 15, 2024
Application
				  for a Controlled Substances Registration Certificate (rev.
				  10/2020)
Controlled
				  Substances Registration Inspection Report (rev. 1/2020)
Application
				  for a License to Sell Controlled Substances by a Practitioner of the Healing
				  Arts (rev. 3/2023)
Application
				  for Limited Use Facility Dispensing Permit for Nonprofit (rev.
				  8/2023)
Application
				  for Limited Use Practitioner Dispensing License for Nonprofit (rev.
				  8/2023)
Statutory Authority: §§
											54.1-2400,
					 54.1-3304.1, and
					 54.1-3307 of the Code of
					 Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 30 - REGULATIONS FOR PRACTITIONERS OF THE HEALING ARTS TO SELL CONTROLLED SUBSTANCES › Section (18VAC110-30) - DOCUMENTS INCORPORATED BY REFERENCE

Current through Register Vol. 40, No. 24, July 15, 2024
United States Pharmacopeia - National Formulary.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 40 - REGULATIONS GOVERNING COLLABORATIVE PRACTICE AGREEMENTS › Section 18VAC110-40-10 - Definitions

Current through Register Vol. 40, No. 24, July 15, 2024
The following words and terms when used in this chapter shall
				  have the following meanings unless the context clearly indicates
				  otherwise:
"Agreement" means a collaborative practice agreement as
				  defined in § 54.1-3300 of the Code of Virginia.
"Committee" means an Informal Conference Committee,
				  comprised of two members of the Board of Pharmacy and two members of the Board
				  of Medicine.
"Pharmacist" means a pharmacist who holds an active license
				  to practice pharmacy from the Virginia Board of Pharmacy.
"Practitioner" means a person authorized to have an
				  agreement with a pharmacist and his designated alternative pharmacists as
				  prescribed in the definition of a collaborative agreement in § 54.1-3300
				  of the Code of Virginia.
Statutory Authority: §§ 54.1-2400 and 54.1-3300.1
					 of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 40 - REGULATIONS GOVERNING COLLABORATIVE PRACTICE AGREEMENTS › Section 18VAC110-40-20 - Signed authorization for an agreement

Current through Register Vol. 40, No. 24, July 15, 2024
A. The signatories to an agreement shall be a
				practitioner involved directly in patient care and a pharmacist involved
				directly in patient care. Within the agreement, the pharmacist may designate
				alternate pharmacists, provided the alternates are involved directly in patient
				care at a single physical location where patients receive services.
B. An agreement shall only be implemented for
				an individual patient pursuant to an order from the practitioner for that
				patient.A patient who meets the criteria for inclusion in the category of
				patients whose care is subject to a collaborative agreement and who chooses to
				not participate in a collaborative procedure shall notify the prescriber of the
				patient's refusal to participate in such collaborative procedure.
1. The patient may decline to participate or
				withdraw from participation at any time.
2. The patient shall be informed by the
				practitioner or the pharmacist of the collaborative procedures that will be
				used pursuant to an agreement, and such discussion shall be documented in the
				patient record.
3. The practitioner
				and the pharmacist shall provide written disclosure to the patient of any
				contractual arrangement with any other party or any financial incentive that
				may impact one of the party's decisions to participate in the
				agreement.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 40 - REGULATIONS GOVERNING COLLABORATIVE PRACTICE AGREEMENTS › Section 18VAC110-40-30 - Approval of protocols outside the standard of care

Current through Register Vol. 40, No. 24, July 15, 2024
A. If a practitioner and a pharmacist intend
				to manage or treat a condition or disease state for which there is not a
				protocol that is clinically accepted as the standard of care, the practitioner
				and pharmacist shall apply for approval. The committee shall, in accordance
				with § 2.2-4019 of the Code of Virginia, receive and review the proposed
				treatment protocol and recommend approval or disapproval to the
				boards.
B. Application and approval
				are not needed for treatment of conditions for which there is an accepted
				standard of care, but for which the practitioner wants to increase the
				monitoring and oversight of the condition over what the protocol
				recommends.
C. In order to apply
				for approval of a protocol outside the standard of care, the practitioner and
				the pharmacist shall submit:
1. An
				application and required fee of $750;
2. A copy of the proposed protocol;
				and
3. Supporting documentation
				that the protocol is safe and effective for the particular condition or disease
				state for which the practitioner and the pharmacist intend to manage or treat
				through an agreement.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 40 - REGULATIONS GOVERNING COLLABORATIVE PRACTICE AGREEMENTS › Section 18VAC110-40-40 - Content of an agreement and treatment protocol

Current through Register Vol. 40, No. 24, July 15, 2024
A. An agreement shall contain treatment
				protocols that are clinically accepted as the standard of care within the
				medical and pharmaceutical professions.
B. The treatment protocol shall describe the
				disease state or condition, drugs or drug categories, drug therapies,
				laboratory tests, medical devices, and substitutions authorized by the
				practitioner.
C. The treatment
				protocol shall contain a statement by the practitioner that describes the
				activities the pharmacist is authorized to engage in, including:
1. The procedures, decision criteria, or plan
				the pharmacist shall follow when providing drug therapy management;
2. The procedures the pharmacist shall follow
				for documentation; and
3. The
				procedures the pharmacist shall follow for reporting activities and results to
				the practitioner.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 40 - REGULATIONS GOVERNING COLLABORATIVE PRACTICE AGREEMENTS › Section 18VAC110-40-50 - Record retention

Current through Register Vol. 40, No. 24, July 15, 2024
A.
				Signatories to an agreement shall keep a copy of the agreement on file at their
				primary places of practice.
B. An
				order for a specific patient from the prescribing practitioner authorizing the
				implementation of drug therapy management pursuant to the agreement shall be
				noted in the patient's medical record and kept on file by the
				pharmacist.
C. The patient's
				documented informed consent shall be retained by the practitioner in the
				patient record .
Statutory Authority
§§ 54.1-2400, 54.1-3300, and 54.1-3300.1 of the
					 Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 40 - REGULATIONS GOVERNING COLLABORATIVE PRACTICE AGREEMENTS › Section 18VAC110-40-60 - Rescindment or alteration of the agreement

Current through Register Vol. 40, No. 24, July 15, 2024
A. A signatory may rescind or a patient may
				withdraw from an agreement at any time.
B. A practitioner may override the
				collaborative agreement whenever he deems such action necessary or appropriate
				for a specific patient.
Statutory Authority
§§ 54.1-2400, 54.1-3300, and 54.1-3300.1 of the
					 Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 40 - REGULATIONS GOVERNING COLLABORATIVE PRACTICE AGREEMENTS › Section 18VAC110-40-70 - Compliance with statutes and regulations

Current through Register Vol. 40, No. 24, July 15, 2024
Any collaborative agreement or referral under an agreement
				  governed by this chapter shall be in compliance with the requirements of the
				  Practitioner Self-Referral Act (§ 54.1-2410 et seq. of the Code of
				  Virginia) and with Chapters 29 (§ 54.1-2900 et seq.), 33 (§ 54.1-3300
				  et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of
				  Virginia and regulations promulgated pursuant thereto.
Statutory Authority
§§ 54.1-2400, 54.1-3300, and 54.1-3300.1 of the
					 Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 50 - Regulations Governing Wholesale Distributors, Manufacturers, Third-Party Logistics Providers, and Warehousers › Part I - General Provisions › Section 18VAC110-50-10 - Definitions

Current through Register Vol. 40, No. 24, July 15, 2024
In addition to words and terms defined in §§
										54.1-3300 and
					 54.1-3401 of the Code of
					 Virginia, the following words and terms when used in this chapter shall have
					 the following meanings unless the context clearly indicates otherwise:
"Authorized collector" means a registered manufacturer,
					 wholesale distributor, or reverse distributor that is authorized by the U.S.
					 Drug Enforcement Administration to receive drugs from an ultimate user, a
					 person lawfully entitled to dispose of an ultimate user decedent's property, or
					 a long-term care facility on behalf of an ultimate user who resides or has
					 resided at that facility for the purpose of destruction.
"Authorized distributor of record" means a wholesale
					 distributor with whom a manufacturer has entered into a written agreement under
					 which such wholesale distributor is either authorized to distribute all of that
					 manufacturer's prescription drug products, or only those products listed in the
					 agreement, for such a period of time or number of shipments as specified in the
					 agreement.
"Control number" means the unique identifying customer
					 number assigned by the Virginia Department of Motor Vehicles to an individual
					 when issuing a driver's license, learner's permit, or official identification
					 card. This number is displayed on the driver's license or ID card in lieu of
					 the social security number.
"DEA" means the U.S. Drug Enforcement
					 Administration.
"Drop shipment" means the sale and distribution of a
					 prescription drug in which a manufacturer or a third-party logistics provider
					 directly ships the prescription drug to a pharmacy, chain drug warehouse, or
					 other person authorized to dispense or administer the prescription drug, and
					 the pharmacy, chain drug warehouse or other authorized person is invoiced by a
					 wholesale distributor that took title to the prescription drug during the
					 shipping, but did not take physical possession of the prescription drug.
"Expiration date" means that date placed on a drug package
					 by the manufacturer or repacker beyond which the product may not be dispensed
					 or used.
"FDA" means the U.S. Food and Drug Administration.
"Ultimate user" means a person who has lawfully obtained,
					 and who possesses, a controlled substance for his own use or for the use of a
					 member of his household or for an animal owned by him or a member of his
					 household.
"USP-NF" means the United States Pharmacopeia-National
					 Formulary.
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 50 - Regulations Governing Wholesale Distributors, Manufacturers, Third-Party Logistics Providers, and Warehousers › Part I - General Provisions › Section 18VAC110-50-40 - Safeguards against diversion of drugs

Current through Register Vol. 40, No. 24, July 15, 2024
A. The holder of the license as a wholesale
				  distributor or permit as a manufacturer, warehouser, or third-party logistics
				  provider, or registration as a nonresident wholesale distributor, nonresident
				  warehouser, nonresident third-party logistics provider, or nonresident
				  manufacturer shall restrict access to all areas in which prescription drugs are
				  stored or kept for sale to only those persons specifically designated as
				  necessary for the manufacture, receipt, storage, distribution, or quality
				  control of the controlled substance inventory and shall provide reasonable
				  security measures to include appropriate locking devices on all access doors to
				  these areas and adequate lighting both inside and outside the facility to deter
				  unauthorized entry and diversion.
B. The holder of the license, permit, or
				  registration, except for those distributors of only medical gases other than
				  nitrous oxide, shall install a device for the detection of breaking subject to
				  the following conditions:
1. The device shall
				  be a sound, microwave, photoelectric, ultrasonic, or any other generally
				  accepted and suitable device.
2.
				  One communication line installation shall be hardwired and both the
				  installation and device shall be based on accepted burglar alarm industry
				  standards to include wireless motion sensors.
3. The device shall be maintained in
				  operating order, shall have an auxiliary source of power, and shall be capable
				  of sending an alarm signal to the monitoring entity when breached if 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 the person named on the
				  application as the responsible party or to persons specifically designated in
				  writing in a policy and procedure manual.
6. The system shall be activated whenever the
				  drug storage areas are closed for business.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 50 - Regulations Governing Wholesale Distributors, Manufacturers, Third-Party Logistics Providers, and Warehousers › Part I - General Provisions › Section 18VAC110-50-50 - Storage

Current through Register Vol. 40, No. 24, July 15, 2024
A. All prescription
				  drugs and devices shall be stored at appropriate temperatures and under
				  appropriate conditions in accordance with requirements, if any, in the labeling
				  of such drugs, or with requirements of USP-NF.
B. If no specific storage requirements are
				  established for a drug or a device, it may be held at controlled room
				  temperature, as defined in USP-NF, to help ensure that its identity, strength,
				  quality, and purity are not adversely affected.
C. Appropriate manual, electromechanical, or
				  electronic temperature and humidity recording equipment, or logs shall be
				  utilized to document proper storage of prescription drugs.
D. Packaging of the prescription drugs should
				  be in accordance with USP-NF standards.
E. Schedule II-V controlled substances shall
				  be separated from Schedule VI prescription drugs and stored in a secure area in
				  accordance with DEA security requirements and standards.
F. Any facility shall be of adequate size and
				  construction and have the proper equipment necessary for the proper storage of
				  prescription drugs and devices as set forth in this section.
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 50 - Regulations Governing Wholesale Distributors, Manufacturers, Third-Party Logistics Providers, and Warehousers › Part I - General Provisions › Section 18VAC110-50-51 - Disposal of drugs by authorized collectors

Current through Register Vol. 40, No. 24, July 15, 2024
Any manufacturer, wholesale distributor, or reverse
					 distributor wishing to accept for return a previously dispensed drug in
					 Schedules II through V for the purpose of destruction from an ultimate user, or
					 a person lawfully entitled to dispose of an ultimate user decedent's property,
					 shall first be authorized by the DEA as a collector. The process used to
					 collect and destroy drugs, along with any required recordkeeping, shall comply
					 with federal and state law.
1. Prior
				  to collecting drugs, an authorized collector shall submit in writing to the
				  board:
a. The name, address, and license
				  number, if applicable, of the facility;
b. The intended method or methods of
				  collection (i.e., collection receptacle or mail-back program); and
c. Signature of the responsible
				  party.