reglab/statecodes huggingface dataset:
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-5.1 - Personnel

Current through Vol. 41, No. 20, July 1, 2024
(a) Manufacturers shall establish and
				maintain for Board inspection a list of each partner, limited liability company
				member or corporate officer and corporate director, as well as designated
				representatives and facility managers, including a description of their duties
				and a summary of their qualifications.
(b) Each manufacturer shall designate, in
				writing on a Board-approved form, a person to serve as the designated facility
				manager of the manufacturer for each location licensed. The facility manager is
				responsible for all aspects of the operation of the manufacturer.
(c) No manufacturer shall have as an owner,
				designated representative or facility manager anyone convicted of any felony
				for conduct relating to manufacturing prescription drugs, any felony for
				violation of 21 U.S.C. § 331(i) or (k) or any felony for violation of 18
				U.S.C. § 1365 relating to product tampering. No manufacturer shall have as
				an owner, designated representative or facility manager anyone who has violated
				federal or state requirements for licensure that presents a threat of serious
				adverse health consequences or death to humans.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-6

Current through Vol. 41, No. 20, July 1, 2024
Added at 9 Ok Reg 2145,
				  eff 6-11-92; Amended at 10 Ok Reg 3175, eff 6-25-93; Amended at 18 Ok Reg 2749,
				  eff 7-1-01; Amended at 25 Ok Reg 1772, eff 5-12-08 (emergency); Amended at 26
				  Ok Reg 2296, eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-6.1

Current through Vol. 41, No. 20, July 1, 2024
Added at 25 Ok Reg 1772,
				  eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-6.2

Current through Vol. 41, No. 20, July 1, 2024
Added at 25 Ok Reg 1772,
				  eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-6.3

Current through Vol. 41, No. 20, July 1, 2024
Added at 25 Ok Reg 1772,
				  eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff 7-1-09; Amended at 27 Ok
				  Reg 2261, eff 7-11-10
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-6.4

Current through Vol. 41, No. 20, July 1, 2024
Added at 25 Ok Reg 1772,
				  eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-6.5

Current through Vol. 41, No. 20, July 1, 2024
Added at 25 Ok Reg 1772,
				  eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-6.6

Current through Vol. 41, No. 20, July 1, 2024
Added at 25 Ok Reg 1772,
				  eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-6.7

Current through Vol. 41, No. 20, July 1, 2024
Added at 25 Ok Reg 1772,
				  eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-6.8

Current through Vol. 41, No. 20, July 1, 2024
Added at 25 Ok Reg 1772,
				  eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-6.9

Current through Vol. 41, No. 20, July 1, 2024
Added at 25 Ok Reg 1772,
				  eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-6.10 - Compliance with federal, state and local laws

Current through Vol. 41, No. 20, July 1, 2024
(a) A manufacturer shall operate in
				compliance with the Federal Food, Drug, and Cosmetic Act Good Manufacturing
				Practices, 21 U.S.C. §§ 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C.
				§§ 216, 262, 263a, 264; and 21 C.F.R. Parts 210 and 211.
(b) A manufacturer shall operate in
				compliance with all applicable federal, state, and local laws and regulations,
				including, but not limited to, the Drug Quality and Security Act of 2013 and
				rules promulgated thereunder and the Act, 59 O.S. Section 353, et seq. and the
				Board's Rules, OAC 535.
(c) A
				manufacturer shall allow the Board and authorized federal, state, and local law
				enforcement officials to enter and inspect its premises and delivery vehicles,
				to audit its records and written operating procedures, and to confiscate
				prescription drugs and records to the extent authorized by law or
				rules.
(d) A manufacturer shall
				only ship to the address listed on the licensee's license.
Added at 25 Ok Reg 1772,
				  eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-6.11

Current through Vol. 41, No. 20, July 1, 2024
Added at 25 Ok Reg 1772,
				  eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-7 - Compressed medical gases

Current through Vol. 41, No. 20, July 1, 2024
Manufacturers of multiple products that include medical gases
				  shall comply with the requirements in 535:20-9 for medical gas
				  distributors.
Added at 18 Ok Reg 2749,
				  eff 7-1-01
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-8

Current through Vol. 41, No. 20, July 1, 2024
Added at 18 Ok Reg 2749,
				  eff 7-1-01
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-9 - Prohibited conduct

Current through Vol. 41, No. 20, July 1, 2024
(a) The following
				shall be considered prohibited conduct and be a violation of these rules:
				Failure to follow all applicable requirements of state and federal statutes and
				regulations, including, but not limited to, the Drug Quality and Security Act
				of 2013 and rules promulgated thereunder, the Act, 59 O.S. Section 353, et seq.
				and the Board's rules, OAC 535.
(b)
				Any violation of the rules of registrant conduct in 535:25-9 is prohibited
				conduct.
Added at 25 Ok Reg 1772,
				  eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 3 - Manufacturers › Section 535:20-3-10 - Violations and penalties

Current through Vol. 41, No. 20, July 1, 2024
(a) Penalties
				for violations of this Subchapter and of federal, state and local laws and
				regulations are listed in 59 O.S. Section 353, et seq.
(b) Rules of conduct, violations of the rules
				of conduct and other requirements of all applicants can be found in
				535:25.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-1

Current through Vol. 41, No. 20, July 1, 2024
Added at 9 Ok Reg 2145,
				  eff 6-11-92; Amended at 10 Ok Reg 3175, eff 6-25-93; Amended at 13 Ok Reg 2809,
				  eff 6-27-96; Amended at 18 Ok Reg 2749, eff 7-1-01; Amended at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-1.1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
(a) The rules in this Subchapter set the
				minimum requirements for licensure as a repackager.
(b) The rules of this Subchapter are to
				implement the Federal Food, Drug, and Cosmetic Act, as amended by the Drug
				Quality and Security Act of 2013, other applicable federal statutes and rules
				and the Act, 59 O.S. Section 353 et seq. and the Board's Rules, OAC
				535.
Added at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-2

Current through Vol. 41, No. 20, July 1, 2024
Added at 9 Ok Reg 2145,
				  eff 6-11-92; Amended at 11 Ok Reg 3441, eff 6-27-94; Amended at 18 Ok Reg 2749,
				  eff 7-1-01; Amended at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-2.1 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The words or terms defined in 59 O.S. Section
				  353.1 and
				  21
				  U.S.C. §
										360eee shall have the same
				  meaning when used in this Subchapter as defined in these statutes, unless the
				  context clearly indicates otherwise.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-3

Current through Vol. 41, No. 20, July 1, 2024
Added at 9 Ok Reg 2145,
				  eff 6-11-92; Amended at 18 Ok Reg 2749, eff 7-1-01; Amended at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-3.1 - Repackager licensing requirement

Current through Vol. 41, No. 20, July 1, 2024
(a) If
				Oklahoma is the state in which a prescription drug is repackaged or is the
				state from which or into which a prescription drug of a repackager is shipped,
				this prescription drug may not be repackaged and/or shipped into or out of
				Oklahoma unless each facility of such repackager is licensed in Oklahoma. Such
				license shall be renewed annually by application and payment of renewal
				fees.
(b) A repackager shall also
				be licensed as a repackager by the Secretary of the U.S. Department of Health
				and Human Services, Food and Drug Administration.
(c) A repackager license is only valid for
				the name, ownership and location listed on the license. Changes of name,
				ownership or location require a new repackager license.
(d) Changes in any information required for
				licensure must be reported to the Board, in writing, within ten (10) days (e.g.
				facility manager, designated representative, telephone number, etc.).
(e) When repackager operations are conducted
				at more than one location, each location shall be licensed by the
				Board.
(f) A repackager shall not
				operate from a place of residence.
(g) The repackaging facility shall be located
				apart and separate from any retail pharmacy licensed by the Board.
(h) A repackager must publicly display all
				licenses and have readily available the most recent state and/or federal
				inspection reports.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-4

Current through Vol. 41, No. 20, July 1, 2024
Added at 9 Ok Reg 2145,
				  eff 6-11-92; Amended at 10 Ok Reg 3175, eff 6-25-93; Amended at 18 Ok Reg 2749,
				  eff 7-1-01; Amended at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-4.1 - Minimum required information for licensure

Current through Vol. 41, No. 20, July 1, 2024
(a) A repackager applicant must submit a
				satisfactorily completed Board-approved application together with the required
				fee.
(1) New applicants shall provide, at
				least, the following:
(A) Applicant's full
				name, all trade or business names used, full business address and telephone
				number;
(B) Type of ownership,
				e.g. individual, partnership, limited liability company or
				corporation;
(C) Name(s) of the
				owner(s) of the applicant, including:
(i) if a
				person, the name, address, Social Security number and date of birth;
(ii) if other than a person, the name,
				address, and Social Security number and date of birth of each partner, limited
				liability company member, or corporate officer and corporate director and the
				federal employer identification number;
(iii) if a corporation, the State of
				incorporation; and
(iv) if a
				publicly traded corporation, the information in (a)(1)(C)(ii) is not required
				for corporate officers and corporate directors.
(D) Names of designated representatives and
				facility managers of the applicant, their Social Security numbers and dates of
				birth;
(E) Evidence of criminal
				background checks and fingerprinting of the applicant, if a person, and of all
				of applicant's designated representatives and facility managers;
(F) Proof of licensure by the U.S. Secretary
				of Health and Human Services, Food and Drug Administration, and, if applicable,
				by the state where the applicant is located (home state); and,
(G) Upon the Board's written request, a list
				of all manufacturers, wholesale distributors, third-party logistics providers
				and dispensers for whom the repackager provides services at such facility.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-4.2 - Minimum qualifications

Current through Vol. 41, No. 20, July 1, 2024
(a) The Board
				shall consider, at a minimum, the following factors in determining the
				eligibility for and renewal of licensure of repackagers:
(1) Any finding by a law enforcement agency
				or regulatory agency that the applicant or any of its owners have violated any
				federal, state, or local laws or foreign laws;
(2) Suspension, revocation or any other
				sanction against a license currently or previously held by the applicant or any
				of its owners for violations of state or federal laws;
(3) Any finding that the applicant or any of
				its owners are guilty of or pleaded guilty or nolo contendere to violating
				federal, state, or local criminal laws;
(4) The furnishing by the applicant of false
				or fraudulent material in any application;
(5) Failure to maintain and/or make available
				to the Board or to federal, state, or local law enforcement officials those
				records required to be maintained by repackagers;
(6) Any licensee who has no record of
				repackaging prescription drugs during routine inspection may have its
				subsequent renewal application referred to the Board for review and possible
				approval or disapproval, and such review may require the licensee to appear
				before the Board; and,
(7) Any
				other factors or qualifications that the Board considers relevant to and
				consistent with the public health and safety.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-5

Current through Vol. 41, No. 20, July 1, 2024
Added at 9 Ok Reg 2145,
				  eff 6-11-92; Amended at 10 Ok Reg 3175, eff 6-25-93; Amended at 18 Ok Reg 2749,
				  eff 7-1-01; Amended at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-5.1 - Personnel

Current through Vol. 41, No. 20, July 1, 2024
(a) Repackagers shall establish and maintain
				for Board inspection a list of each partner, limited liability company member
				or corporate officer and corporate director, as well as designated
				representatives and facility managers, including a description of their duties
				and a summary of their qualifications.
(b) Each repackager shall designate, in
				writing on a Board-approved form, a person to serve as the designated facility
				manager of the repackager for each location licensed. The facility manager is
				responsible for all aspects of the operation of the repackager.
(c) No repackager shall have as an owner,
				designated representative or facility manager anyone convicted of any felony
				for conduct relating to repackaging prescription drugs, any felony for
				violation of 21 U.S.C. § 331(i) or (k) or any felony for violation of 18
				U.S.C. § 1365 relating to product tampering. No repackager shall have as
				an owner, designated representative or facility manager anyone who has violated
				federal or state requirements for licensure that presents a threat of serious
				adverse health consequences or death to humans.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-6

Current through Vol. 41, No. 20, July 1, 2024
Added at 9 Ok Reg 2145,
				  eff 6-11-92; Amended at 10 Ok Reg 3175, eff 6-25-93; Amended at 18 Ok Reg 2749,
				  eff 7-1-01; Amended at 26 Ok Reg 2296, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-6.1

Current through Vol. 41, No. 20, July 1, 2024
Added at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-6.2

Current through Vol. 41, No. 20, July 1, 2024
Added at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-6.3

Current through Vol. 41, No. 20, July 1, 2024
Added at 26 Ok Reg 2296,
				  eff 7-1-09; Amended at 27 Ok Reg 2261, eff
				  7-11-10
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-6.4

Current through Vol. 41, No. 20, July 1, 2024
Added at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-6.5

Current through Vol. 41, No. 20, July 1, 2024
Added at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-6.6

Current through Vol. 41, No. 20, July 1, 2024
Added at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-6.7

Current through Vol. 41, No. 20, July 1, 2024
Added at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-6.8

Current through Vol. 41, No. 20, July 1, 2024
Added at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-6.9

Current through Vol. 41, No. 20, July 1, 2024
Added at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-6.10 - Compliance with federal, state and local laws

Current through Vol. 41, No. 20, July 1, 2024
(a) A repackager shall operate in compliance
				with the Federal Food, Drug, and Cosmetic Act Good Manufacturing Practices, 21
				U.S.C. §§ 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. §§
				216, 262, 263a, 264; and 21 C.F.R. Parts 210 and 211.
(b) A repackager shall operate in compliance
				with all applicable federal, state, and local laws and regulations, including,
				but not limited to, the Drug Quality and Security Act of 2013 and rules
				promulgated thereunder and the Act, 59 O.S. Section 353, et seq. and the
				Board's Rules, OAC 535.
(c) A
				repackager shall allow the Board and authorized federal, state, and local law
				enforcement officials to enter and inspect its premises and delivery vehicles,
				to audit its records and written operating procedures, and to confiscate
				prescription drugs and records to the extent authorized by law or
				rules.
(d) A repackager shall ship
				only to the address listed on the licensee's license.
Added at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-6.11

Current through Vol. 41, No. 20, July 1, 2024
Added at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-7 - Compressed medical gases

Current through Vol. 41, No. 20, July 1, 2024
Packager of multiple products that include medical gases
				  shall comply with the requirements in 535:20-9 for medical gas
				  distributors.
Added at 9 Ok Reg 2145,
				  eff 6-11-92; Revoked at 10 Ok Reg 3175, eff 6-25-93; Added at 18 Ok Reg 2749,
				  eff 7-1-01
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-8

Current through Vol. 41, No. 20, July 1, 2024
Added at 18 Ok Reg 2749,
				  eff 7-1-01
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-9 - Prohibited conduct

Current through Vol. 41, No. 20, July 1, 2024
(a) The following
				shall be considered prohibited conduct and be a violation of these rules:
				Failure to follow all applicable requirements of state and federal statutes and
				regulations, including, but not limited to, the Drug Quality and Security Act
				of 2013 and rules promulgated thereunder, the Act, 59 O.S. Section 353, et seq.
				and the Board's rules, OAC 535.
(b)
				Any violation of the rules of registrant conduct in 535:25-9 is prohibited
				conduct.
Added at 26 Ok Reg 2296,
				  eff 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 5 - Repackagers › Section 535:20-5-10 - Violations and Penalties

Current through Vol. 41, No. 20, July 1, 2024
(a) Penalties
				for violations of this Subchapter and of federal, state and local laws and
				regulations are listed in 59 O.S. Section 353, et seq.
(b) Rules of conduct, violations of the rules
				of conduct and other requirements of applicants can be found in
				535:25.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 6 - Outsourcing Facilities › Section 535:20-6-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
(a) The rules in this Subchapter set out the
				minimum requirements for licensure as an outsourcing facility.
(b) The rules in this Subchapter are to
				implement the Federal Food, Drug, and Cosmetic Act, as amended by the Drug
				Quality and Security Act of 2013, other applicable federal statutes and rules
				and the Act, 59 O.S. Section 353 et seq. and the Board's Rules, OAC
				535.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 6 - Outsourcing Facilities › Section 535:20-6-2 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The words or terms defined in 59 O.S. Section
				  353.1 and
				  21
				  U.S.C. §
										360eee shall have the same
				  meaning when used in this Subchapter as defined in these statutes, unless the
				  context clearly indicates otherwise.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 6 - Outsourcing Facilities › Section 535:20-6-3 - Outsourcing facility licensing requirement

Current through Vol. 41, No. 20, July 1, 2024
(a) If Oklahoma is the state in which a
				prescription drug is compounded or is the state from which or into which a
				prescription drug of an outsourcing facility is shipped, this prescription drug
				may not be compounded in and/or shipped into or out of Oklahoma unless each
				facility of such outsourcing facility is licensed in Oklahoma. Such license
				shall be renewed annually by application and payment of renewal fees.
(b) An outsourcing facility shall also be
				licensed as an outsourcing facility by the Secretary of the U. S. Department of
				Health and Human Services, Food and Drug Administration.
(c) An outsourcing facility license is only
				valid for the name, ownership and location listed on the license. Changes of
				name, ownership or location require a new outsourcing facility
				license.
(d) Changes in any
				information required for licensure must be reported to the Board, in writing,
				within ten (10) days (e.g. facility manager, designated representative,
				telephone number, etc.).
(e) When
				outsourcing facility operations are conducted at more than one location, each
				location shall be licensed by the Board.
(f) An outsourcing facility shall not operate
				from a place of residence.
(g) The
				outsourcing facility may be located in a facility where a retail pharmacy
				licensed by the Board is located.
(h) An outsourcing facility which receives
				patient specific prescriptions and fills the prescriptions in Oklahoma or ships
				the filled prescriptions into Oklahoma shall also have an Oklahoma pharmacy or
				non-resident pharmacy license.
(i)
				An outsourcing facility must publicly display all licenses and have readily
				available the most recent state and/or federal inspection reports.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 6 - Outsourcing Facilities › Section 535:20-6-4 - Minimum required information for licensure

Current through Vol. 41, No. 20, July 1, 2024
(a) An outsourcing facility applicant must
				submit a satisfactorily completed Board-approved application together with the
				required fee.
(1) New applicants shall
				provide, at least, the following:
(A)
				Applicant's full name, all trade or business names used, full business address,
				telephone number and unique facility identifier;
(B) Type of ownership, e.g. individual,
				partnership, limited liability company or corporation;
(C) Name(s) of the owner(s) of the applicant,
				including:
(i) if a person, the name, address,
				Social Security number and date of birth;
(ii) if other than a person, the name,
				address, and Social Security number and date of birth of each partner, limited
				liability company member, or corporate officer and corporate director and the
				federal employer identification number;
(iii) if a corporation, the State of
				incorporation; and
(iv) if a
				publicly traded corporation, the information in (a)(1)(C)(ii) is not required
				for corporate officers and corporate directors.
(D) Names of designated representatives,
				facility managers, and, if applicable, pharmacist-in-charge of the applicant,
				their Social Security numbers and dates of birth;
(E) Evidence of criminal background checks
				and fingerprinting of the applicant, if a person, and of all of applicant's
				designated representatives and facility managers;
(F) Proof of licensure by the U.S. Secretary
				of Health and Human Services, Food and Drug Administration, and, if applicable,
				by the state where the applicant is located (home state); and
(G) Upon the Board's written request, a list
				of all dispensers for whom the outsourcing facility provides services at such
				facility.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 6 - Outsourcing Facilities › Section 535:20-6-5 - Minimum qualifications

Current through Vol. 41, No. 20, July 1, 2024
(a) The Board
				shall consider, at a minimum, the following factors in determining the
				eligibility for and renewal of licensure of outsourcing facilities:
(1) Any finding by a law enforcement agency
				or regulatory agency that the applicant or any of its owners have violated any
				federal, state, or local laws or foreign laws;
(2) Suspension, revocation or any other
				sanction against a license currently or previously held by the applicant or any
				of its owners for violations of state or federal laws;
(3) Any finding that the applicant or any of
				its owners are guilty of or pleaded guilty or nolo contendere to violating
				federal, state, or local criminal laws;
(4) The furnishing by the applicant of false
				or fraudulent material in any application;
(5) Failure to maintain and/or make available
				to the Board or to federal, state, or local law enforcement officials those
				records required to be maintained by outsourcing facilities;
(6) Any licensee who has no record of
				compounding prescription drugs during routine inspection may have its
				subsequent renewal application referred to the Board for review and possible
				approval or disapproval, and such review may require the licensee to appear
				before the Board; and
(7) Any other
				factors or qualifications that the Board considers relevant to and consistent
				with the public health and safety.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 6 - Outsourcing Facilities › Section 535:20-6-6 - Personnel

Current through Vol. 41, No. 20, July 1, 2024
(a) Outsourcing facilities shall establish
				and maintain for Board inspection a list of each partner, limited liability
				company member or corporate officer and corporate director, as well as
				designated representatives and facility managers, including a description of
				their duties and a summary of their qualifications.
(b) Each outsourcing facility shall
				designate, in writing on a Board-approved form, a person to serve as the
				designated facility manager of the outsourcing facility for each location
				licensed.
(c) Each outsourcing
				facility shall designate, in writing on a Board-approved form, a person to
				serve as the PIC who is a pharmacist licensed by the Board.
(d) No pharmacist may serve as the PIC for
				more than one outsourcing facility and/or pharmacy at a time unless they are
				located at the same physical address and are dually licensed with the
				Board.
(e) The PIC shall be present
				and practicing at the outsourcing facility for which he holds the PIC position
				no less than 20 hour per week during the outsourcing facility's ordinary course
				of business. In the event the outsourcing facility's normal hours of business
				are less than 40 hour per week the PIC shall be present and practicing at least
				50 percent of the normal business hours.
(f) A PIC shall work sufficient hours in the
				outsourcing facility to exercise control and meet the responsibilities of the
				PIC.
(g) A non-resident outsourcing
				facility registrant may request, in writing, that the Board allow additional
				time for a new pharmacist-in-charge to obtain an Oklahoma license in emergency
				or urgent situations. If the Board determines circumstances warrant it, the
				Board may grant up to a 90-day extension.
(h) No outsourcing facility shall have as an
				owner, designated representative, facility manager, or pharmacist- in-charge
				anyone convicted of any felony for conduct relating to compounding prescription
				drugs, any felony for violation of
				21 U.S.C. §
										331(i) or
				(k) or any felony for violation of
				18 U.S.C. §
										1365 relating to product tampering.
(i) No outsourcing facility shall have as an
				owner, designated representative, facility manager or pharmacist-in-charge
				anyone who has violated federal or state requirements for licensure that
				presents a threat of serious adverse health consequences or death to
				humans.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 6 - Outsourcing Facilities › Section 535:20-6-7 - Compliance with federal, state and local laws

Current through Vol. 41, No. 20, July 1, 2024
(a) An outsourcing facility shall operate in
				compliance with the Federal Food, Drug, and Cosmetic Act Good Manufacturing
				Practices, 21 U.S.C. §§ 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C.
				§§ 216, 262, 263a, 264; and 21 C.F.R. Parts 210 and 211: and meet the
				requirements of Current Good Manufacturing Practice - Interim Guidance for
				Human Drug Compounding Outsourcing Facilities under Section 503B of the
				FD&C Act or any revision to the document as finalized.
(b) An outsourcing facility shall operate in
				compliance with all applicable federal, state, and local laws and regulations,
				including, but not limited to, the Drug Quality and Security Act of 2013 and
				rules promulgated thereunder and the Act, 59 O.S. Section 353, et seq. and the
				Board's Rules, OAC 535.
(c) An
				outsourcing facility shall allow the Board and authorized federal, state, and
				local law enforcement officials to enter and inspect its premises and delivery
				vehicles, to audit its records and written operating procedures, and to
				confiscate prescription drugs and records to the extent authorized by law or
				rules.
(d) When shipping to
				licensees, an outsourcing facility shall ship only to the address listed on the
				licensee's license.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 6 - Outsourcing Facilities › Section 535:20-6-8 - Prohibited conduct

Current through Vol. 41, No. 20, July 1, 2024
The following shall be considered prohibited conduct and be a
				  violation of these rules: Failure to follow all applicable requirements of
				  state and federal statutes and regulations, including, but not limited to, the
				  Drug Quality and Security Act of 2013 and rules promulgated thereunder, the
				  Act, 59 O.S. Section 353, et seq. and the Board's rules, OAC
				  535.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 6 - Outsourcing Facilities › Section 535:20-6-9 - Violations and penalties

Current through Vol. 41, No. 20, July 1, 2024
(a) Penalties
				for violations of this Subchapter and of federal, state and local laws and
				regulations are listed in 59 O.S. Section 353, et seq.
(b) Rules of conduct, violations of the rules
				of conduct and other requirements of all applicants can be found in
				535:25.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD) › Subchapter 7 - Wholesale Distributor Rules › Section 535:20-7-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
(a) The rules in this Subchapter set out the
				minimum requirements for licensure as a wholesaler distributor. .
(b) The rules in this Subchapter are to
				implement the Federal Food, Drug, and Cosmetic Act, as amended by the Drug
				Supply Chain Security Act of 2013, 21 U.S.C. § 360eee, et seq., 21 C.F.R.
				Part 205, other applicable federal statutes and rules and the Act, 59 O.S.
				Section 353 et seq. and the Board's Rules, OAC 535.
Amended at 10 Ok Reg
				  3175, eff 6-25-93; Amended at 18 Ok Reg 2749, eff 7-1-01; Amended at 24 Ok Reg
				  2906, eff 8-1-07 (emergency); Amended at 25 Ok Reg 1976, eff
				  7-1-08