reglab/statecodes huggingface dataset:
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 II - Wholesale Distributors and Third-y Logistics Providers › Section 18VAC110-50-60 - Special or limited-use licenses

Current through Register Vol. 40, No. 24, July 15, 2024
The board may issue a limited-use wholesale distributor
					 license, limited-use nonresident wholesale distributor registration,
					 limited-use manufacturer, limited-use nonresident manufacturer, limited-use
					 third-party logistics provider permit, or limited-use nonresident third-party
					 logistics provider registration to entities that do not engage in the wholesale
					 distribution of prescription drugs or in the acts of a third-party logistics
					 provider except medical gases and may waive certain requirements of regulation
					 based on the limited nature of such distribution. The issuance of such a
					 license shall be subject to continuing compliance with the conditions set forth
					 by the board.
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 II - Wholesale Distributors and Third-y Logistics Providers › Section 18VAC110-50-80 - Minimum licensure and permitting qualifications and eligibility; responsible party

Current through Register Vol. 40, No. 24, July 15, 2024
A. The board
				  shall use the following factors in determining the eligibility for licensure of
				  wholesale distributors, registration of nonresident wholesale distributors or
				  nonresident third-party logistics providers, and permitting of third-party
				  logistics providers:
1. The existence of
				  grounds to deny an application as set forth in §
											54.1-3435.1
				  of the Code of Virginia;
2. The
				  applicant's past experience in the manufacture or distribution of drugs or
				  devices;
3. Compliance with the
				  recordkeeping requirements;
4.
				  Prior disciplinary action by a regulatory authority, prior criminal
				  convictions, or ongoing investigations related to the manufacturing,
				  distribution, prescribing, or dispensing of drugs by the responsible party or
				  immediate family members of the responsible party, and owners, directors, or
				  officers; and
5. The responsible
				  party's credentials as set forth in subsection B of this section.
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 II - Wholesale Distributors and Third-y Logistics Providers › Section 18VAC110-50-90 - Minimum requirements for the storage, handling, transport, and shipment of prescription drugs

Current through Register Vol. 40, No. 24, July 15, 2024
A. All locations
				  where prescription drugs are received, stored, warehoused, handled, held,
				  offered, marketed, displayed, or transported from shall:
1. Be of suitable construction to ensure that
				  all drugs and devices in the facilities are maintained in accordance with the
				  labeling of such drugs and devices or with official USP-NF compendium
				  standards;
2. Be of suitable size
				  and construction to facilitate cleaning, maintenance, and proper wholesale
				  distribution operations;
3. Have
				  adequate storage areas to provide adequate lighting, ventilation, temperature,
				  sanitation, humidity, space, equipment, and security conditions;
4. Have a quarantine area for storage of
				  drugs and devices that are outdated, damaged, deteriorated, misbranded,
				  adulterated, counterfeit or suspected of being counterfeit, otherwise unfit for
				  distribution, or that are in immediate or sealed secondary containers that have
				  been opened;
5. Be maintained in a
				  clean and orderly condition; and
6.
				  Be free from infestation of any kind.
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 II - Wholesale Distributors and Third-y Logistics Providers › Section 18VAC110-50-100 - Examination of drug shipments and accompanying documents

Current through Register Vol. 40, No. 24, July 15, 2024
A. Upon receipt, each shipping container
				  shall be visually examined for identity to determine if it may contain
				  contaminated, contraband, counterfeit, suspected of being counterfeit, or
				  damaged drugs, or drugs or devices that are otherwise unfit for distribution.
				  This examination shall be adequate to reveal container damage that would
				  suggest possible contamination, adulteration, misbranding, counterfeiting,
				  suspected counterfeiting, or other damage to the contents.
B. Upon receipt of drugs, a wholesale
				  distributor, nonresident wholesale distributor, third-party logistics provider,
				  or nonresident third-party logistics provider must review records for accuracy,
				  completeness, and the integrity of the drugs considering the total facts and
				  circumstances surrounding the transactions and the wholesale distributor,
				  nonresident wholesale distributor, third-party logistics provider, or
				  nonresident third-party logistics provider involved.
C. Each outgoing shipment shall be carefully
				  inspected for identity of the drugs and to ensure that there is no delivery of
				  drugs that have been damaged in storage or held under improper
				  conditions.
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 II - Wholesale Distributors and Third-y Logistics Providers › Section 18VAC110-50-110 - Returned, damaged, and counterfeit drugs; investigations

Current through Register Vol. 40, No. 24, July 15, 2024
A. Any drug or
				  device returned to a manufacturer, another wholesale distributor, or a
				  third-party logistics provider shall be kept under the proper conditions and
				  documentation showing that proper conditions were maintained shall be provided
				  to the manufacturer, wholesale distributor, nonresident wholesale distributor,
				  third-party logistics provider, or nonresident third-party logistics provider
				  to which the drugs are returned.
B.
				  Any drug or device that, or any drug whose immediate or sealed outer or
				  secondary container or labeling, is outdated, damaged, deteriorated,
				  misbranded, adulterated, counterfeited, suspected of being counterfeited or
				  adulterated, or otherwise deemed unfit for human consumption shall be
				  quarantined and physically separated from other drugs and devices until its
				  appropriate disposition.
C. When a
				  drug or device is adulterated, misbranded, counterfeited, or suspected of being
				  counterfeit, or when the immediate or sealed outer or secondary container or
				  labeling of any drug or device is adulterated, misbranded other than
				  misbranding identified by the manufacturer through a recall or withdrawal,
				  counterfeited, or suspected of being counterfeit, the wholesale distributor,
				  nonresident wholesale distributor, third-party logistics provider, or
				  nonresident third-party logistics provider shall:
1. Provide notice to the board and the
				  manufacturer, wholesale distributor, or third-party logistics provider from
				  which such drug or device was acquired within three business days of that
				  determination.
2. Maintain any such
				  drug or device, its containers and labeling, and its accompanying documentation
				  or any evidence of criminal activity until its disposition by the appropriate
				  state and federal government authorities.
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 II - Wholesale Distributors and Third-y Logistics Providers › Section 18VAC110-50-120 - Policies and procedures

Current through Register Vol. 40, No. 24, July 15, 2024
All wholesale distributors, nonresident wholesale
					 distributors, third-party logistics providers, or nonresident third-party
					 logistics providers shall establish, maintain, and adhere to written policies
					 and procedures for the proper receipt, security, storage, inventory, and
					 distribution of prescription drugs. Wholesale distributors, nonresident
					 wholesale distributors, third-party logistics providers, or nonresident
					 third-party logistics providers shall include in their policies and procedures
					 at least the following:
1. A procedure
				  for reporting thefts or losses of prescription drugs to the board and other
				  appropriate authorities;
2. A
				  procedure whereby the oldest approved stock of a prescription drug is
				  distributed first. The procedure may permit deviation from this process
				  provided the deviation is temporary and appropriate for the
				  distribution;
3. A procedure for
				  handling recalls and withdrawals of prescription drugs and devices;
4. Procedures for preparing for, protecting
				  against, and handling emergency situations that affect the security and
				  integrity of drugs or the operations of the wholesale distributor, nonresident
				  wholesale distributor, third-party logistics provider, or nonresident
				  third-party logistics provider;
5.
				  A procedure to ensure that outdated drugs are segregated from other drugs to
				  include the disposition of such drugs;
6. A procedure to ensure initial and ongoing
				  training of all employees;
7. A
				  procedure for ensuring, both initially and on an ongoing basis, that persons
				  with access to prescription drugs have not been convicted of a violation of a
				  drug law or any law related to wholesale distribution of prescription drugs or
				  to third-party logistics providers; and
8. A procedure for reporting counterfeit or
				  suspected counterfeit prescription drugs or counterfeiting or suspected
				  counterfeiting activities to the board and other appropriate law enforcement or
				  regulatory agencies.
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 II - Wholesale Distributors and Third-y Logistics Providers › Section 18VAC110-50-130 - Recordkeeping

Current through Register Vol. 40, No. 24, July 15, 2024
A. All records and
				  documentation required in this subsection shall be maintained and made
				  available for inspection and photocopying upon request by an authorized agent
				  of the board for a period of three years following the date the record was
				  created or received by the wholesale distributor, nonresident wholesale
				  distributor, third-party logistics provider, or nonresident third-party
				  logistics provider. If records are not maintained onpremises at the address of
				  record, they shall be made available within 48 hours of such request. A
				  wholesale distributor, nonresident wholesale distributor, third-party logistics
				  provider, or nonresident third party logistics provider shall establish and
				  maintain the following:
1. Unless otherwise
				  indicated in federal law, inventories and records of all transactions,
				  including the dates of receipt and distribution or other disposition or
				  provision, and records related to the federal requirements for an electronic,
				  interoperable system to identify, trace, and verify prescription drugs as they
				  are distributed;
2. Records
				  documenting monitoring of environmental conditions to ensure compliance with
				  the storage requirements as required in
				  18VAC110-50-50;
3. Documentation of visual inspection of
				  drugs and accompanying documents required in
				  18VAC110-50-100,
				  including the date of such inspection and the identity of the person conducting
				  the inspection;
4. Documentation of
				  quarantine of any product and steps taken for the proper reporting and
				  disposition of the product , including the handling and disposition of all
				  outdated, damaged, deteriorated, misbranded, or adulterated drugs;
5. An ongoing list of persons or entities
				  from whom it receives prescription drugs and persons or entities to whom it
				  distributes prescription drugs or provides prescription drugs as a third-party
				  logistics provider or nonresident third-party logistics provider; and
6. Copies of the mandated report of thefts or
				  unusual losses of Schedules II through V controlled substances in compliance
				  with the requirements of §
											54.1-3404
				  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 II - Wholesale Distributors and Third-y Logistics Providers › Section 18VAC110-50-140 - Due diligence

Current through Register Vol. 40, No. 24, July 15, 2024
A. Prior to
				  the initial purchase of prescription drugs from another wholesale distributor
				  or third-party logistics provider not residing and licensed in Virginia, a
				  wholesale distributor or third-party logistics provider shall obtain, and
				  update annually, the following information from the selling wholesale
				  distributor or third-party logistics provider:
1. A copy of the license to wholesale
				  distribute or act as a third-party logistics provider from the resident state.
				  If the resident state does not require licensure as a third-party logistics
				  provider, documentation confirming active registration with the U.S. Food and
				  Drug Administration is acceptable;
2. The most recent facility inspection
				  report, if available;
3. A list of
				  other names under which the wholesale distributor or third-party logistics
				  provider is doing business, or was formerly known as;
4. A list of principals, directors, officers,
				  or any shareholder who owns 10% or more of outstanding stock in any nonpublicly
				  held corporation;
5. A list of all
				  disciplinary actions by state and federal agencies;
6. A description, including the address,
				  dimensions, and other relevant information, of each facility or warehouse used
				  for drug storage and distribution or for the legal acts of a third-party
				  logistics provider; and
7. A
				  listing of any manufacturers for whom the wholesale distributor or third-party
				  logistics provider is an authorized distributor of record.
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 III - Manufacturers › Section 18VAC110-50-150 - Good manufacturing practices

Current through Register Vol. 40, No. 24, July 15, 2024
A. The Good Manufacturing Practice for
				  Finished Pharmaceuticals regulations set forth in 21 CFR Part 211 are adopted
				  by reference.
B. Each manufacturer
				  or nonresident manufacturer of drugs shall comply with the requirements set
				  forth in the federal regulations referred to in subsection A of 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 IV - Pedigree Requirements › Section 18VAC110-50-160

Current through Register Vol. 40, No. 24, July 15, 2024
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 IV - Pedigree Requirements › Section 18VAC110-50-170

Current through Register Vol. 40, No. 24, July 15, 2024
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 IV - Pedigree Requirements › Section 18VAC110-50-180

Current through Register Vol. 40, No. 24, July 15, 2024
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 IV - Pedigree Requirements › Section 18VAC110-50-190

Current through Register Vol. 40, No. 24, July 15, 2024
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 › Form - FORMS (18VAC110-50)

Current through Register Vol. 40, No. 24, July 15, 2024
Application
				  for License as a Wholesale Distributor (rev. 11/2021)
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 Registration as a Nonresident Manufacturer (rev. 10/2020)
Application
				  for a Permit as a Warehouser (rev. 10/2020)
Application
				  for Registration as a Nonresident Warehouser (rev. 10/2020)
Application
				  for License as a Wholesale Distributor (rev. 10/2020)
Application
				  for Non-Resident Wholesale Distributor Registration (rev.
				  11/2021)
Application
				  for a Non-Resident Third-Party Logistics Provider Registration (rev.
				  11/2021)
Application
				  for a Permit as a Third-Party Logistics Provider (rev. 11/2021)
Application
				  for a Re-Inspection of Facility (rev. 10/2020)
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 › Section (18VAC110-50) - DOCUMENTS INCORPORATED BY REFERENCE

Current through Register Vol. 40, No. 24, July 15, 2024
The United States Pharmacopeia and National Formulary,
				  USP29-NF 24, revised June 2006, revisions official August 1, 2006, United
				  States Pharmacopeial Convention, Inc. (
http://www.usp.org/USPNF
)
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part I - General Provisions › Section 18VAC110-60-10

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part I - General Provisions › Section 18VAC110-60-20

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part II - Requirements for Practitioners and Patients › Section 18VAC110-60-30

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part II - Requirements for Practitioners and Patients › Section 18VAC110-60-40

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part II - Requirements for Practitioners and Patients › Section 18VAC110-60-50

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part II - Requirements for Practitioners and Patients › Section 18VAC110-60-60

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part II - Requirements for Practitioners and Patients › Section 18VAC110-60-70

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part II - Requirements for Practitioners and Patients › Section 18VAC110-60-80

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part II - Requirements for Practitioners and Patients › Section 18VAC110-60-90

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part III - Application and Approval Process for Pharmaceutical Processors and Cannabis Dispensing Facilities › Section 18VAC110-60-100

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part III - Application and Approval Process for Pharmaceutical Processors and Cannabis Dispensing Facilities › Section 18VAC110-60-110

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part III - Application and Approval Process for Pharmaceutical Processors and Cannabis Dispensing Facilities › Section 18VAC110-60-120

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part III - Application and Approval Process for Pharmaceutical Processors and Cannabis Dispensing Facilities › Section 18VAC110-60-130

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part III - Application and Approval Process for Pharmaceutical Processors and Cannabis Dispensing Facilities › Section 18VAC110-60-135

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part III - Application and Approval Process for Pharmaceutical Processors and Cannabis Dispensing Facilities › Section 18VAC110-60-136

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part III - Application and Approval Process for Pharmaceutical Processors and Cannabis Dispensing Facilities › Section 18VAC110-60-140

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part III - Application and Approval Process for Pharmaceutical Processors and Cannabis Dispensing Facilities › Section 18VAC110-60-150

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part III - Application and Approval Process for Pharmaceutical Processors and Cannabis Dispensing Facilities › Section 18VAC110-60-160

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part IV - Requirements for Pharmaceutical Processor or Cannabis Dispensing Facility Personnel › Section 18VAC110-60-170

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part IV - Requirements for Pharmaceutical Processor or Cannabis Dispensing Facility Personnel › Section 18VAC110-60-180

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part IV - Requirements for Pharmaceutical Processor or Cannabis Dispensing Facility Personnel › Section 18VAC110-60-190

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part IV - Requirements for Pharmaceutical Processor or Cannabis Dispensing Facility Personnel › Section 18VAC110-60-195

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part IV - Requirements for Pharmaceutical Processor or Cannabis Dispensing Facility Personnel › Section 18VAC110-60-200

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part V - Operation of a Pharmaceutical Processor › Section 18VAC110-60-210

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part V - Operation of a Pharmaceutical Processor › Section 18VAC110-60-215

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part V - Operation of a Pharmaceutical Processor › Section 18VAC110-60-220

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part V - Operation of a Pharmaceutical Processor › Section 18VAC110-60-230

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part V - Operation of a Pharmaceutical Processor › Section 18VAC110-60-240

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part V - Operation of a Pharmaceutical Processor › Section 18VAC110-60-250

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part V - Operation of a Pharmaceutical Processor › Section 18VAC110-60-251

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part V - Operation of a Pharmaceutical Processor › Section 18VAC110-60-260

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part V - Operation of a Pharmaceutical Processor › Section 18VAC110-60-270

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part VI - Cultivation, Production, and Dispensing of Cannabis Oil › Section 18VAC110-60-280

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part VI - Cultivation, Production, and Dispensing of Cannabis Oil › Section 18VAC110-60-281

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part VI - Cultivation, Production, and Dispensing of Cannabis Oil › Section 18VAC110-60-285

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part VI - Cultivation, Production, and Dispensing of Cannabis Oil › Section 18VAC110-60-290

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part VI - Cultivation, Production, and Dispensing of Cannabis Oil › Section 18VAC110-60-295

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part VI - Cultivation, Production, and Dispensing of Cannabis Oil › Section 18VAC110-60-300

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part VI - Cultivation, Production, and Dispensing of Cannabis Oil › Section 18VAC110-60-310

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part VI - Cultivation, Production, and Dispensing of Cannabis Oil › Section 18VAC110-60-320

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part VI - Cultivation, Production, and Dispensing of Cannabis Oil › Section 18VAC110-60-321

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Part VI - Cultivation, Production, and Dispensing of Cannabis Oil › Section 18VAC110-60-330

Current through Register Vol. 40, No. 24, July 15, 2024
Chapters 740 and 773 of the 2023 Acts of
						Assembly.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 60 - REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS › Form - FORMS (18VAC110-60)

Current through Register Vol. 40, No. 24, July 15, 2024
Registration
				  of Cannabis Products (rev. 9/2021)
Application
				  for Registration as a Practitioner for Medical Cannabis (rev.
				  5/2023)
Application
				  for Registration as a Patient for Cannabis Oil (rev. 3/2021)
Application
				  for Registration as a Parent/Guardian for Cannabis Oil (rev.
				  3/2021)
Application
				  for Registration as a Registered Agent for Cannabis Oil (rev.
				  3/2021)
How
				  to Register with the Board as a Patient, Parent or Legal Guardian (rev.
				  7/2020)
Application
				  for a Pharmaceutical Processor Permit (rev. 9/2021)
Practitioner
				  Reporting Requirements (eff. 6/2019)
Registration
				  of CBD or THC-A Oil Products (eff. 6/2019)
Pharmaceutical
				  Processor & Dispensing Facility Inspection Report (rev.
				  3/2021)
Application
				  for Registration as a Registered Agent (eff. 12/2019)
Request
				  for Visitor Approval (eff. 5/2020)
Statutory Authority: §§
											54.1-3442.6
					 and
					 54.1-3447
					 of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 112 - BOARD OF PHYSICAL THERAPY › Chapter 11 - PUBLIC PARTICIPATION GUIDELINES › Part I - Purpose and Definitions › Section 18VAC112-11-10 - Purpose

Current through Register Vol. 40, No. 24, July 15, 2024
The purpose of this chapter is to promote public
					 involvement in the development, amendment or repeal of the regulations of the
					 Board of Physical Therapy. This chapter does not apply to regulations,
					 guidelines, or other documents exempted or excluded from the provisions of the
					 Administrative Process Act (§ 2.2-4000 et seq. of the Code of
					 Virginia).
Statutory Authority
§§ 2.2-4007.02 and 54.1-2400 of the Code of
						Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 112 - BOARD OF PHYSICAL THERAPY › Chapter 11 - PUBLIC PARTICIPATION GUIDELINES › Part II - Notification of Interested Persons › Section 18VAC112-11-30 - Notification list

Current through Register Vol. 40, No. 24, July 15, 2024
A. The agency shall
				  maintain a list of persons who have requested to be notified of regulatory
				  actions being pursued by the agency.
B. Any person may request to be placed on a
				  notification list by registering as a public user on the Town Hall or by making
				  a request to the agency. Any person who requests to be placed on a notification
				  list shall elect to be notified either by electronic means or through a postal
				  carrier.
C. The agency may maintain
				  additional lists for persons who have requested to be informed of specific
				  regulatory issues, proposals, or actions.
D. When electronic mail is returned as
				  undeliverable on multiple occasions at least 24 hours apart, that person may be
				  deleted from the list. A single undeliverable message is insufficient cause to
				  delete the person from the list.
E.
				  When mail delivered by a postal carrier is returned as undeliverable on
				  multiple occasions, that person may be deleted from the list.
F. The agency may periodically request those
				  persons on the notification list to indicate their desire to either continue to
				  be notified electronically, receive documents through a postal carrier, or be
				  deleted from the list.
Statutory Authority
§§ 2.2-4007.02 and 54.1-2400 of the Code of
						Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 112 - BOARD OF PHYSICAL THERAPY › Chapter 11 - PUBLIC PARTICIPATION GUIDELINES › Part II - Notification of Interested Persons › Section 18VAC112-11-40 - Information to be sent to persons on the notification list

Current through Register Vol. 40, No. 24, July 15, 2024
A. To persons
				  electing to receive electronic notification or notification through a postal
				  carrier as described in
				  18VAC112-11-30, the agency shall
				  send the following information:
1. A notice
				  of intended regulatory action (NOIRA).
2. A notice of the comment period on a
				  proposed, a reproposed, or a fast-track regulation and hyperlinks to, or
				  instructions on how to obtain, a copy of the regulation and any supporting
				  documents.
3. A notice soliciting
				  comment on a final regulation when the regulatory process has been extended
				  pursuant to § 2.2-4007.06 or 2.2-4013C of the Code of Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 112 - BOARD OF PHYSICAL THERAPY › Chapter 11 - PUBLIC PARTICIPATION GUIDELINES › Part III - Public Participation Procedures › Section 18VAC112-11-50 - Public comment

Current through Register Vol. 40, No. 24, July 15, 2024
A. In
				  considering any nonemergency, nonexempt regulatory action, the agency shall
				  afford interested persons an opportunity to (i) submit data, views, and
				  arguments, either orally or in writing, to the agency; and (ii) be accompanied
				  by and represented by counsel or other representative. Such opportunity to
				  comment shall include an online public comment forum on the Town Hall.
1. To any requesting person, the agency shall
				  provide copies of the statement of basis, purpose, substance, and issues; the
				  economic impact analysis of the proposed or fast-track regulatory action; and
				  the agency's response to public comments received.
2. The agency may begin crafting a regulatory
				  action prior to or during any opportunities it provides to the public to submit
				  comments.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 112 - BOARD OF PHYSICAL THERAPY › Chapter 11 - PUBLIC PARTICIPATION GUIDELINES › Part III - Public Participation Procedures › Section 18VAC112-11-60 - Petition for rulemaking

Current through Register Vol. 40, No. 24, July 15, 2024
A. As
				  provided in § 2.2-4007 of the Code of Virginia, any person may petition
				  the agency to consider a regulatory action.
B. A petition shall include but is not
				  limited to the following information:
1. The
				  petitioner's name and contact information;
2. The substance and purpose of the
				  rulemaking that is requested, including reference to any applicable Virginia
				  Administrative Code sections; and
3. Reference to the legal authority of the
				  agency to take the action requested.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 112 - BOARD OF PHYSICAL THERAPY › Chapter 11 - PUBLIC PARTICIPATION GUIDELINES › Part III - Public Participation Procedures › Section 18VAC112-11-70 - Appointment of regulatory advisory panel

Current through Register Vol. 40, No. 24, July 15, 2024
A. The agency may appoint a regulatory
				  advisory panel (RAP) to provide professional specialization or technical
				  assistance when the agency determines that such expertise is necessary to
				  address a specific regulatory issue or action or when individuals indicate an
				  interest in working with the agency on a specific regulatory issue or
				  action.
B. Any person may request
				  the appointment of a RAP and request to participate in its activities. The
				  agency shall determine when a RAP shall be appointed and the composition of the
				  RAP.
C. A RAP may be dissolved by
				  the agency if:
1. The proposed text of the
				  regulation is posted on the Town Hall, published in the Virginia Register, or
				  such other time as the agency determines is appropriate; or
2. The agency determines that the regulatory
				  action is either exempt or excluded from the requirements of the Administrative
				  Process Act.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 112 - BOARD OF PHYSICAL THERAPY › Chapter 11 - PUBLIC PARTICIPATION GUIDELINES › Part III - Public Participation Procedures › Section 18VAC112-11-80 - Appointment of negotiated rulemaking panel

Current through Register Vol. 40, No. 24, July 15, 2024
A. The agency may appoint a negotiated
				  rulemaking panel (NRP) if a regulatory action is expected to be
				  controversial.
B. An NRP that has
				  been appointed by the agency may be dissolved by the agency when:
1. There is no longer controversy associated
				  with the development of the regulation;
2. The agency determines that the regulatory
				  action is either exempt or excluded from the requirements of the Administrative
				  Process Act; or
3. The agency
				  determines that resolution of a controversy is unlikely.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 112 - BOARD OF PHYSICAL THERAPY › Chapter 11 - PUBLIC PARTICIPATION GUIDELINES › Part III - Public Participation Procedures › Section 18VAC112-11-90 - Meetings

Current through Register Vol. 40, No. 24, July 15, 2024
Notice of any open meeting, including meetings of a RAP or
					 NRP, shall be posted on the Virginia Regulatory Town Hall and Commonwealth
					 Calendar at least seven working days prior to the date of the meeting. The
					 exception to this requirement is any meeting held in accordance with §
					 2.2-3707D of the Code of Virginia allowing for contemporaneous notice to be
					 provided to participants and the public.
Statutory Authority
§§ 2.2-4007.02 and 54.1-2400 of the Code of
						Virginia.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 112 - BOARD OF PHYSICAL THERAPY › Chapter 11 - PUBLIC PARTICIPATION GUIDELINES › Part III - Public Participation Procedures › Section 18VAC112-11-100 - Public hearings on regulations

Current through Register Vol. 40, No. 24, July 15, 2024
A. The agency shall indicate in its notice of
				  intended regulatory action whether it plans to hold a public hearing following
				  the publication of the proposed stage of the regulatory action.
B. The agency may conduct one or more public
				  hearings during the comment period following the publication of a proposed
				  regulatory action.
C. An agency is
				  required to hold a public hearing following the publication of the proposed
				  regulatory action when:
1. The agency's basic
				  law requires the agency to hold a public hearing;
2. The Governor directs the agency to hold a
				  public hearing; or
3. The agency
				  receives requests for a public hearing from at least 25 persons during the
				  public comment period following the publication of the notice of intended
				  regulatory action.
Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 112 - BOARD OF PHYSICAL THERAPY › Chapter 11 - PUBLIC PARTICIPATION GUIDELINES › Part III - Public Participation Procedures › Section 18VAC112-11-110 - Periodic review of regulations

Current through Register Vol. 40, No. 24, July 15, 2024
A. The agency shall conduct a periodic review
				  of its regulations consistent with:
1. An
				  executive order issued by the Governor pursuant to § 2.2-4017 of the
				  Administrative Process Act to receive comment on all existing regulations as to
				  their effectiveness, efficiency, necessity, clarity, and cost of compliance;
				  and
2. The requirements in §
				  2.2-4007.1 of the Administrative Process Act regarding regulatory flexibility
				  for small businesses.