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 7 - Wholesale Distributor Rules › Section 535:20-7-2 - 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.
Amended at 9 Ok Reg
				  2145, eff 6-11-92; Amended at 10 Ok Reg 3175, eff 6-25-93; Amended at 24 Ok Reg
				  2906, eff 8-1-07 (emergency); Amended at 25 Ok Reg 1976, eff
				  7-1-08
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 535:20-7-3 - Wholesale distributor licensing requirement

Current through Vol. 41, No. 20, July 1, 2024
(a) If Oklahoma is the state in which a
				prescription drug is distributed or is the state from which or into which a
				prescription drug is distributed by a wholesale distributor, that wholesale
				distributor may not distribute in or into or out of Oklahoma unless each
				facility of such wholesale distributor is licensed in Oklahoma. Such license
				shall be renewed annually by application and payment of renewal fees.
(b) If Oklahoma is the state into
				which a prescription drug is shipped by a wholesale distributor, that wholesale
				distributor shall also be licensed as a wholesale distributor by the state from
				which that wholesale distributor ships.
(c) A wholesaler distributor license is only
				valid for the name, ownership and location listed on the license. Changes of
				name, ownership or location require a new wholesale distributor 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 wholesale
				distributor operations are conducted at more than one location, each location
				shall be licensed by the Board.
(f) A wholesale distributor shall not operate
				from a place of residence.
(g) The
				wholesale distributing facility located in Oklahoma shall be located apart and
				separate from any retail pharmacy licensed by the Board.
(h) A wholesale distributor must publicly
				display all licenses and have readily available the most recent state and/or
				federal inspection reports.
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
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 535:20-7-4 - Minimum required information for licensure

Current through Vol. 41, No. 20, July 1, 2024
(a) A wholesale distributor 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 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 date of
				birth;
(E) Evidence of criminal
				background checks and fingerprinting of the applicant, if a person, and all of
				applicant's designated facility managers;
(F) Proof of licensure by the state where the
				applicant is located (home state) and, if applicable, by the U.S. Secretary of
				Health and Human Services, Food and Drug Administration;
(G) Submission of a surety bond meeting the
				requirements of the Drug Supply Chain Security Act of 2013, et seq. and the
				rules promulgated thereunder; and,
(H) Upon the Board's written request, a list
				of all manufacturers, wholesale distributors and dispensers for whom the
				wholesale distributor 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 7 - Wholesale Distributor Rules › Section 535:20-7-5 - 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 wholesale distributors:
(1) Any findings by a law enforcement or
				regulatory agency that the applicant or any of its owners has violated or been
				disciplined by a regulatory agency in any state for violating any federal,
				state, or local 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,
				local, or federal laws;
(3) Any
				finding that the applicant or any of its owners is guilty of or pleaded nolo
				contendere to violating federal, state, or local 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 wholesale drug distributors;
(6) Any licensee who has no record of
				providing wholesaler distributions 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 registrant appearance
				before the Board; and,
(7) Any
				other factors or qualifications 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 7 - Wholesale Distributor Rules › Section 535:20-7-6 - Personnel

Current through Vol. 41, No. 20, July 1, 2024
(a) Wholesale distributors shall establish
				and maintain for Board inspection a list of each partner, corporate officer and
				corporate director or limited liability company member and facilty manager,
				including a description of their duties and a summary of their qualifications .
(b) Each wholesale distributor
				shall designate, in writing on a Board-approved form , a person to serve as the
				facility manager of the wholesale distributor for each location licensed. The
				facility manager is responsible for all aspects of the operation of the
				wholesale distributor.
(c) No
				wholesale distributor shall have as an owner, designated representative or
				facility manager anyone convicted of any felony for conduct relating to
				providing wholesale distribution of prescription drugs, any felony for
				violating 21 U.S.C. Section 331(i) or (k) or any felony for violation of 18
				U.S.C. Section 1365 relating to product tampering. No wholesale distributor
				shall have as an owner, designated representative or facility manager anyone
				who has violated federal or state requirement for licensure that presents a
				threat of serious adverse health consequences or death to humans.
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
				  7-1-081
AGENCY NOTE: 
				  1 Language in subsection (c) moved
				  from 535:20-7-7.9.
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 535:20-7-7

Current through Vol. 41, No. 20, July 1, 2024
Amended at 10 Ok Reg
				  3175, eff 6-25-93; Amended at 11 Ok Reg 3441, eff 6-27-94; 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
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 535:20-7-7.1

Current through Vol. 41, No. 20, July 1, 2024
Added 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
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 535:20-7-7.2

Current through Vol. 41, No. 20, July 1, 2024
Added 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
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 535:20-7-7.3

Current through Vol. 41, No. 20, July 1, 2024
Added 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; 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 7 - Wholesale Distributor Rules › Section 535:20-7-7.4

Current through Vol. 41, No. 20, July 1, 2024
Added 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
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 535:20-7-7.5

Current through Vol. 41, No. 20, July 1, 2024
Added 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
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 535:20-7-7.6

Current through Vol. 41, No. 20, July 1, 2024
Added 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
				  7-1-081
AGENCY NOTE: 
				  1 Language in 535:20-7-7.6 (h)
				  previously in 535:20-7.7.11
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 535:20-7-7.7

Current through Vol. 41, No. 20, July 1, 2024
Added 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 1772, eff 5-12-08 (emergency); Amended at 25 Ok Reg 1976, eff 7-1-08;
				  Amended at 26 Ok Reg 417, eff 12-11-08 (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 7 - Wholesale Distributor Rules › Section 535:20-7-7.8

Current through Vol. 41, No. 20, July 1, 2024
Added 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
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 535:20-7-7.9 - Responsible persons [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 18 Ok Reg 2749,
				  eff 7-1-01; Revoked at 24 Ok Reg 2906, eff 8-1-07 (emergency); Revoked at 25 Ok
				  Reg 1976, eff 7-1-081
AGENCY NOTE: 
				  1Moved to
				  535:20-7-6.
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 535:20-7-7.10 - Compliance with federal, state and local laws

Current through Vol. 41, No. 20, July 1, 2024
(a) A wholesale distributor shall operate in
				compliance with applicable federal, state, and local laws and regulations,
				including, but not limited to, the Drug Supply Chain Security Act of 2013 and
				the rules promulgated thereunder and the Act, 59 O.S. Section 353 et seq., and
				the Board rules, OAC 535. A wholesale distributor shall comply with 21 C.F.R.
				Part 205 , e.g. facilities, security, storage and written policies and
				procedures.
(b) A wholesale
				distributor shall allow the Board and authorized federal, state, and local law
				enforcement officials to enter and inspect their premises and delivery
				vehicles, to audit its records and written operating procedures, and to
				confiscate records to the extent authorized by law or rules.
(c) A wholesaler distributor shall ship only
				to the address listed on the license.
Added 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
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 535:20-7-7.11 - Salvaging and reprocessing [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
Added at 18 Ok Reg 2749,
				  eff 7-1-01; Revoked at 24 Ok Reg 2906, eff 8-1-07 (emergency); Revoked at 25 Ok
				  Reg 1976, eff 7-1-08
AGENCY NOTE: See
				  535:20-7-7.6 (h)
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 535:20-7-8 - Compressed medical gases

Current through Vol. 41, No. 20, July 1, 2024
Wholesalers of multiple products that include medical gases
				  shall comply with the requirements in 535:20-9 for medical gas
				  distributors.
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 7 - Wholesale Distributor Rules › Section 535:20-7-9

Current through Vol. 41, No. 20, July 1, 2024
Added at 10 Ok Reg 3175,
				  eff 6-25-93; Amended at 11 Ok Reg 3441, eff 6-27-94; Amended 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 7 - Wholesale Distributor Rules › Section 535:20-7-9.1 - 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 Supply Chain Security Act of 2013 and rules promulgated thereunder and the
				  Act, 59 O.S. Section 353, et seq. and Board rules, OAC 535.
Added at 24 Ok Reg 2906,
				  eff 8-1-07 (emergency); Added at 25 Ok Reg 1976, eff 7-1-08; 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 7 - Wholesale Distributor Rules › Section 535:20-7-10 - 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 8 - Third-Party Logistics Providers › Section 535:20-8-1 - 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 third-party logistics
				provider.
(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., 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 8 - Third-Party Logistics Providers › Section 535:20-8-2 - 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 8 - Third-Party Logistics Providers › Section 535:20-8-3 - Third-party logistics provider licensing requirement

Current through Vol. 41, No. 20, July 1, 2024
(a) If Oklahoma is the state in which a
				prescription drug is shipped or is the state from which or into which a
				prescription drug is shipped by a third-party logistics provider, that
				third-party logistics provider may not ship in, into or out of Oklahoma unless
				each facility of such third-party logistics provider is licensed in Oklahoma.
				Such license shall be renewed annually by application and payment of renewal
				fees.
(b) If Oklahoma is the state
				into which a prescription drug is shipped by a third-party logistics provider,
				that third-party logistics provider shall also be licensed as a third-party
				logistics provider by the state from which that third-party logistics provider
				ships.
(c) A third-party logistics
				provider license is only valid for the name, ownership and location listed on
				the license. Changes of name, ownership or location require a new third-party
				logistics provider 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 third-party logistics provider
				operations are conducted at more than one location, each location shall be
				licensed by the Board.
(f) A
				third-party logistics provider shall not operate from a place of
				residence.
(g) The third-party
				logistics provider facility shall be located apart and separate from any retail
				pharmacy licensed by the Board.
(h)
				A third-party logistics provider 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 8 - Third-Party Logistics Providers › Section 535:20-8-4 - Minimum required information for licensure

Current through Vol. 41, No. 20, July 1, 2024
(a) A third-party logistics provider
				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 state where the
				applicant is located (home state) and/or, if applicable, by the U.S. Secretary
				of Health and Human Services, Food and Drug Administration; and
(G) Upon the Board's written request, a list
				of all manufacturers, wholesale distributors, and dispensers for whom the
				third-party logistics provider 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 8 - Third-Party Logistics Providers › Section 535:20-8-5 - 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 third-party logistics providers:
(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;
(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 third-party logistics providers;
(6) Any licensee who has no record of
				providing third-party logistics services involving 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 8 - Third-Party Logistics Providers › Section 535:20-8-6 - Personnel

Current through Vol. 41, No. 20, July 1, 2024
(a) Third-party logistics providers 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 third-party logistics provider shall
				designate, in writing on a Board-approved form, a person to serve as the
				designated facility manager of the third-party logistics provider for each
				location licensed. The facility manager is responsible for all aspects of the
				operation of the third-party logistics provider.
(c) No third-party logistics provider shall
				have as an owner, designated representative or facility manager anyone
				convicted of any felony for conduct relating to providing third-party logistics
				services involving 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 third-party logistics provider 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 8 - Third-Party Logistics Providers › Section 535:20-8-7 - Compliance with federal, state and local laws

Current through Vol. 41, No. 20, July 1, 2024
(a) A third-party logistics provider shall
				operate in compliance with all applicable federal, state, and local laws and
				regulations, including, but not limited to, the Drug Supply Chain 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. A third-party logistics provider shall
				comply with the storage practices set out in 21 U.S.C. § 360eee - 3(d)(2)
				( C).
(b) A third-party logistics
				provider 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.
(c) When shipping to
				licensees, a third-party logistics provider 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 8 - Third-Party Logistics Providers › Section 535:20-8-8 - 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 Supply Chain 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 8 - Third-Party Logistics Providers › Section 535:20-8-9 - 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 9 - Medical Gas Suppliers and Distributors › Section 535:20-9-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
This subchapter is to establish rules specific to medical
				  gases due to the fact that its labeling, packaging, distribution and handling
				  is unique.
Added at 10 Ok Reg 3175,
				  eff 6-25-93
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 9 - Medical Gas Suppliers and Distributors › Section 535:20-9-2 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The following words or terms, when used in this Subchapter,
				  shall have the following meaning, unless the context clearly indicates
				  otherwise:
"Drug order"
means a prescription drug order
				  issued by a licensed prescriber for medical gas.
"Medical gas"
means those gases and liquid
				  oxygen upon which the manufacturer or distributor has, in compliance with
				  federal law and regulations, placed one of several cautions, such as: "RX Only"
				  that replaces "Caution - Federal Law prohibits dispensing without
				  prescription".
"Medical gas distributor"
means a person
				  licensed to distribute medical gases on drug orders and to suppliers or other
				  entities licensed to use, administer, or distribute medical gases.
"Medical gas supplier"
means a person licensed
				  to supply medical gases only on drug orders.
Added at 10 Ok Reg 3175,
				  eff 6-25-93; Amended at 18 Ok Reg 2749, eff 7-1-01; Amended at 21 Ok Reg 2458,
				  eff 7-1-04
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 9 - Medical Gas Suppliers and Distributors › Section 535:20-9-3 - Medical gas suppliers

Current through Vol. 41, No. 20, July 1, 2024
(a)
Licensing
				requirement.
Before conducting interstate and/or intrastate transactions
				in Oklahoma, a medical gas supplier shall register annually with the Board.
(1) A medical gas supplier license is only
				valid for the name, ownership and location listed on the license. Changes of
				name, ownership or location shall require a new medical gas supplier
				license.
(2) Changes in any
				information required for licensure must be reported to the Board within ten
				(10) days (e.g., manager, contact person, phone, etc.)
(3) Each location shall possess a medical gas
				supplier license. A medical gas supplier license entitles the license holder to
				store and supply medical gas (prescription drugs) at the licensed
				location.
(4) A medical gas
				supplier shall not operate from a place of residence.
(5) A medical gas supplier shall not operate
				from a storage unit.
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 9 - Medical Gas Suppliers and Distributors › Section 535:20-9-4 - Medical gas distributors

Current through Vol. 41, No. 20, July 1, 2024
(a)
Licensing
				requirement.
Before conducting interstate and or intrastate transactions
				in Oklahoma, a medical gas distributor shall register annually with the Board.
(1) A medical gas distributor license is only
				valid for the name, ownership and location listed on the license. Changes of
				name, ownership or location shall require a new medical gas distributor
				license.
(2) Changes in any
				information required for licensure must be reported to the Board within ten
				(10) days (e.g., manager, contact person, phone, etc.)
(3) Each location shall possess a medical gas
				distributor license. Medical gas distributor license entitles the holder to
				store and distribute medical gas (prescription drugs) at the licensed
				location.
(4) A medical gas
				distributor shall not operate from a place of residence.
(5) A medical gas distributor shall not
				operate from a storage unit.
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 9 - Medical Gas Suppliers and Distributors › Section 535:20-9-5 - 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
				.
Added at 10 Ok Reg 3175,
				  eff 6-25-93; Amended at 11 Ok Reg 3441, eff 6-27-94; Amended 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 9 - Medical Gas Suppliers and Distributors › Section 535:20-9-6 - 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 Act, 59 O.S. Section
				353,
				et seq. and the Board's rules, OAC 535.
(1)
				Engaging in medical gas distributing of drugs
(A) with intent to defraud or deceive,
				failing to maintain or provide a complete and accurate record, when required;
(B) destroying, altering,
				concealing, or failing to maintain complete and accurate records for any drug
				packaging, when required;
(C)
				knowingly purchasing or receiving drugs from a person, not authorized to
				distribute drugs, or,
(D) selling,
				bartering, brokering, or transferring drugs to a person not authorized to
				purchase drugs, under the jurisdiction in which the person receives the
				drug(s).
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 10 - Durable Medical Equipment (DME) Suppliers and Combined DME and Medical Gas Distributors (MGD) › Section 535:20-10-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
This subchapter implements 59 OS Sections 375.1 through 375.5
				  the Oklahoma Durable Medical Equipment Licensing Act. This subchapter
				  establishes rules for DME Suppliers and combined DME suppliers and medical gas
				  distributors.
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 10 - Durable Medical Equipment (DME) Suppliers and Combined DME and Medical Gas Distributors (MGD) › Section 535:20-10-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
(a) This subchapter
				implements 59 OS Sections 375.1 through 375.5, the Oklahoma Durable Medical
				Equipment Licensing Act.
(b) This
				subchapter is to establish rules specific to DME Suppliers and to set out the
				minimum requirements for licensure.
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 10 - Durable Medical Equipment (DME) Suppliers and Combined DME and Medical Gas Distributors (MGD) › Section 535:20-10-2 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The following words or terms, when used in this Subchapter,
				  shall have the following meaning, unless the context clearly indicates
				  otherwise:
"Durable medical equipment"
or
"DME"
means equipment for which a prescription is required,
				  including for repair and replacement parts, and that:
(A) can stand repeated use,
(B) has an expected useful life of at least
				three (3) years,
(C) is primarily
				and customarily used to serve a medical purpose,
(D) is not generally useful to a person in
				the absence of illness or injury,
(E) is appropriate for use in the home, and
(F) is intended for use by the
				consumer.
(G) Durable medical
				equipment includes, but is not limited to:
(i) ambulating assistance equipment,
(ii) mobility equipment,
(iii) rehabilitation seating,
(iv) oxygen care and oxygen
				delivery systems,
(v) respiratory
				equipment and respiratory disease management devices,
(vi) rehabilitation environmental control
				equipment,
(vii) ventilators,
(viii) apnea monitors,
(ix) diagnostic equipment,
(x) feeding pumps,
(xi) beds prescribed by physicians to
				alleviate medical conditions,
(xii)
				transcutaneous electrical nerve stimulators, and
(xiii) sequential compression
				devices.
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 10 - Durable Medical Equipment (DME) Suppliers and Combined DME and Medical Gas Distributors (MGD) › Section 535:20-10-2 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The following words or terms, when used in this Subchapter,
				  shall have the following meaning, unless the context clearly indicates
				  otherwise:
"Durable medical equipment"
or
"DME"
means equipment for which a prescription is required,
				  including for repair and replacement parts, and that:
(A) can stand repeated use,
(B) has an expected useful life of at least
				three (3) years,
(C) is primarily
				and customarily used to serve a medical purpose,
(D) is not generally useful to a person in
				the absence of illness or injury,
(E) is appropriate for use in the home,
				and
(F) is intended for use by the
				consumer.
(G) Durable medical
				equipment includes, but is not limited to:
(i) ambulating assistance
				equipment,
(ii) mobility
				equipment,
(iii) rehabilitation
				seating,
(iv) oxygen care and
				oxygen delivery systems,
(v)
				respiratory equipment and respiratory disease management devices,
(vi) rehabilitation environmental control
				equipment,
(vii)
				ventilators,
(viii) apnea
				monitors,
(ix) diagnostic
				equipment,
(x) feeding
				pumps,
(xi) beds prescribed by
				physicians to alleviate medical conditions,
(xii) transcutaneous electrical nerve
				stimulators, and
(xiii) sequential
				compression devices.
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 10 - Durable Medical Equipment (DME) Suppliers and Combined DME and Medical Gas Distributors (MGD) › Section 535:20-10-3 - DME Suppliers and combined DME+MGD Suppliers

Current through Vol. 41, No. 20, July 1, 2024
(a)
Licensing requirement.
Before conducting interstate and/or intrastate transactions in Oklahoma, a
				Durable Medical Equipment supplier (DME) or a combined DME Supplier and Medical
				Gas Distributor (DME+MGD) shall register annually with the Board.
(1) A DME or DME+MGD license is only valid
				for the name, ownership and location listed on the license. Changes of name,
				ownership or location shall require a new DME supplier license.
(2) Changes in any information required for
				licensure must be reported to the Board within ten (10) days (e.g., manager,
				contact person, phone, etc.).
(3)
				Each location shall possess a DME or DME+MGD license. A DME or DME+MGD license
				entitles the license holder to store and supply DME at the licensed
				location.
(4) Each facility at
				which DME is stored, warehoused, handled, held, offered, marketed, or displayed
				shall be licensed by the Board and be of suitable size and construction to
				facilitate cleaning, maintenance, and proper operations.
(5) As allowed under 59 OS Section 375.3 (D)
				an out-of-state DME supplier will not be required to maintain a physical office
				or place of business within Oklahoma or within one hundred (100) miles of a
				resident of Oklahoma being served by the DME supplier if the following
				conditions are met,
(A) They are supplying a
				specialized DME product/device,
(B)
				The specialized DME product/device is not available through standard local DME
				channels, and
(C) They are
				accredited by an organization that is recognized by the Centers for Medicare
				and Medicaid Services.
(6) A DME supplier shall not operate from a
				place of residence.
(7) A DME
				supplier shall not operate from a storage unit.
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 10 - Durable Medical Equipment (DME) Suppliers and Combined DME and Medical Gas Distributors (MGD) › Section 535:20-10-4 - 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.