reglab/statecodes huggingface dataset:
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-8 - Technician annual permit requirement

Current through Vol. 41, No. 20, July 1, 2024
(a)
				Each pharmacy technician in Oklahoma shall obtain a permit annually before
				practicing as such. A pharmacy technician must be employed in a licensed
				pharmacy located in Oklahoma to be eligible to renew his pharmacy technician
				permit.
(1) Upon meeting the qualifications
				listed in
				535:15-13-4
				and 535:25, applicants shall apply for a pharmacy technician permit on the form
				provided by the Board. Such application shall be returned accompanied by the
				fee authorized by the legislature and in the agency fee schedule.
(2) After the pharmacy technician has
				completed his portion of the application, he must submit it to the pharmacy
				manager or designated pharmacist who has conducted the technician training for
				review and signature.
(3) The
				pharmacy manager or designated pharmacist must first verify the applicant's
				completion of Phase I of the Board approved pharmacy technician training
				program. The signature by the pharmacist verifying technician training
				indicates that there is written training verification in the pharmacy available
				for Board inspection.
(4) Each
				pharmacy technician who desires to continue to work as a tech shall annually,
				on or before the last day of the registrants' birth month, send to the Board
				the fee authorized by the legislature and in the agency fee schedule, with a
				completed Board renewal application signed by the supervising pharmacist and
				the technician. Renewal notice will be sent to the technician's address on file
				in the Board office either electronically or by mail.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-9 - Technician permit display

Current through Vol. 41, No. 20, July 1, 2024
(a) Each
				pharmacy technician shall conspicuously display a current original permit
				issued by the Board in the pharmacy where the tech is actively engaged as a
				pharmacy technician.
(b) A current
				2 x 2 photo shall be attached in the upper right hand corner of the permit
				while on display in the pharmacy.
Added at 11 Ok Reg 3431,
				  eff 6-27-94; Amended at 18 Ok Reg 2736, eff 7-1-01; Amended at 20 Ok Reg 2982,
				  eff 9-2-03 (emergency); Amended at 21 Ok Reg 2452, eff
				  7-1-04
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-10 - Technician address and employment change, and training at change of employment

Current through Vol. 41, No. 20, July 1, 2024
(a) A pharmacy
				technician must notify the Board, in writing, within ten days of change of
				employment.
(b) A pharmacy manager
				employing a currently permitted technician must document training of that
				technician at the new pharmacy as required in
				535:15-13-13(d).
(c) A pharmacy shall notify the Board, in
				writing, within ten days of the employment termination of a pharmacy
				technician. The pharmacist must share any concern about public safety relating
				to the technician with the Board. (No Board action shall be taken without due
				process.)
(d) A pharmacy technician
				must notify the Board, in writing, within ten days, of a change of
				address.
Added at 11 Ok Reg 3431,
				  eff 6-27-94; Amended at 18 Ok Reg 2736, eff 7-1-01; Amended at 20 Ok Reg 2982,
				  eff 9-2-03 (emergency); Amended at 21 Ok Reg 2452, eff
				  7-1-04
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-11 - Multiple locations of employment

Current through Vol. 41, No. 20, July 1, 2024
(a) A
				pharmacy technician may work in multiple pharmacies providing:
(1) The technician has been properly trained
				for each location (see
				535:15-13-13(d)
				); and,
(2) The training is
				documented in each pharmacy.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-12 - Work schedule display

Current through Vol. 41, No. 20, July 1, 2024
(a) A work
				schedule shall be conspicuously displayed in the pharmacy when both a tech and
				an auxiliary supportive person are working. The schedule shall indicate who is
				working as a tech and hours worked and who is working as an auxiliary
				supportive person and hours worked.
(b) The schedule shall indicate the proper
				ratio of technicians to supervising pharmacists.
(c) If a supportive person is found to be
				performing duties not listed on the schedule (e.g. an auxiliary supportive
				person working as a technician), the auxiliary supportive person, the
				technician, the pharmacy, and the supervising pharmacist will be considered to
				be in violation of this Chapter.
Added at 11 Ok Reg 3431,
				  eff 6-27-94; Amended at 20 Ok Reg 2982, eff 9-2-03 (emergency); Amended at 21
				  Ok Reg 2452, eff 7-1-04
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-13 - Pharmacy technician training

Current through Vol. 41, No. 20, July 1, 2024
(a) The
				pharmacy manager shall be responsible for the development and/or implementation
				of a pharmacy technician training program.
(1) The instructional text of the training
				program shall be kept in the pharmacy and only upon request submitted to the
				Board for approval.
(2) The program
				shall be designed to train personnel to perform allowed nonprofessional
				functions, as described in OAC 535:15-5 and 535:15-13.
(3) Minimum standards for technician training
				programs shall be those set out in the Board approved "Pharmacy Technician
				Training Guidelines".
(A) Pharmacy technician
				applicants shall complete Phase I training before they may apply for an
				Oklahoma Pharmacy Technician permit. A pharmacy technician permit must be
				received before performing any of the duties of pharmacy technicians authorized
				in OAC 535:15-5 and 535:15-13.
(B)
				A technician has not met Board requirements until he has successfully completed
				Phase II of pharmacy technician training.
(C) A pharmacy technician must complete Phase
				II within ninety (90) days after issuance of a pharmacy technician
				permit.
(D) Pharmacy technician
				applicants shall not have fully received their permits until they have
				completed Phase II of pharmacy technician training.
(E) If the pharmacy technician fails to
				complete Phase II within 90 days, the pharmacist manager shall notify the Board
				in writing,
(i) If the pharmacy technician
				fails to complete Phase II within 90 days,
(I) the pharmacy technician permit is
				automatically void; and,
(II) the
				pharmacy technician shall return such permit to the Board.
(ii) Such pharmacy technician may apply for a
				new pharmacy technician permit when he has again satisfactorily completed Phase
				I training with an employing pharmacy, provided the provisions of these rules
				have not been violated by the pharmacy technician.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-14 - Pharmacy technician identification

Current through Vol. 41, No. 20, July 1, 2024
The pharmacy technician must be identified as set out in
				  535:15-3-2(e).
Added at 11 Ok Reg 3431,
				  eff 6-27-94; Amended at 14 Ok Reg 3024, eff
				  7-1-97
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-15 - Technician reinstatement requirements

Current through Vol. 41, No. 20, July 1, 2024
(a) A technician
				reinstatement applicant shall be an individual who possesses a technician
				permit that was cancelled at request or cancelled for failure to
				renew.
(b) A technician whose
				permit was revoked is not eligible for a reinstatement without appearing before
				the Board and receiving Board permission to apply.
(c) A technician desiring reinstatement must
				complete a technician reinstatement application.
(d) A technician reinstatement applicant
				shall meet the requirements in the Oklahoma Pharmacy Act, this Title, and
				535:10-13-4 regarding minimum
				requirements.
(e) A technician
				reinstatement applicant shall complete the required Phase I and II training
				again as described in
				535:10-13-13 if their technician
				permit has been lapsed for longer than one year.
(f) Reinstatement applicants shall submit a
				satisfactorily completed Board approved reinstatement application together with
				the required documents and fees.
(g) Applicants may be required to appear
				before the Board to request approval of their application.
(h) Applicants shall complete the Pharmacy
				technician exam. Applicants may be required to take a Board approved law
				exam.
(i) The applicant shall meet
				any additional requirements which the Board may feel necessary to protect
				public health.
(j) After meeting
				the requirements of Board discipline, exception revocation, a technician may
				make application for reinstatement. Such applications may go before the Board
				for approval.
(k) An applicant who
				had an immunization permit must complete and submit verification of 2 hours of
				immunization related ACPE accredited CE to also reinstate their immunization
				permit. If not done at reinstatement, a technician may add an immunization
				permit later by completing a new immunization application.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 15 - Home Care Agency Pharmacy Agreements › Section 535:15-15-1 - 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:
"Administer Drugs"
means the direct application
				  of a drug as defined in Title 59, O.S., Section
				  353.1
"Authorized Employee"
means any employee of a
				  Home Care Agency who in the course of their duties, is licensed by their
				  appropriate Board to administer legend or dangerous drugs.
"Home Care Agency"
or
"HCA"
means
				  an entity required to license under the 1992 Home Care Act with the Oklahoma
				  State Department of Health.
"Pharmacy manager"
or
"PIC"
means
				  the PIC as described in
				  535:15-3-2.
Added at 12 Ok Reg 2593,
				  eff 6-26-95
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 15 - Home Care Agency Pharmacy Agreements › Section 535:15-15-2 - Pharmacy agreements with Home Care Agencies (HCA's)

Current through Vol. 41, No. 20, July 1, 2024
(a) Pharmacies will be allowed to place
				certain drugs with HCA's for the betterment of public health.
(b) The pharmacy shall remain the legal owner
				of the drugs.
(c) A written
				agreement between the pharmacy and the HCA shall document the protocol for
				handling and storage of these drugs by authorized employees and shall be
				approved by the pharmacy manager.
(d) The pharmacy manager shall review the
				protocol to assure safe, secure and accountable handling of the dangerous drugs
				is maintained under the protocol. The protocol should stress the use of these
				drugs should not be for routine use, but for emergency use and the need of the
				patient.
(e) The pharmacy manager
				or a designated pharmacist shall physically inspect and review the drug storage
				and handling at the HCA at a minimum of every four months.
Added at 12 Ok Reg 2593,
				  eff 6-26-95; Amended at 13 Ok Reg 2807, eff 6-27-96; Amended at 14 Ok Reg 3024,
				  eff 7-1-97
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 15 - Home Care Agency Pharmacy Agreements › Section 535:15-15-3 - Home Care Agency protocol

Current through Vol. 41, No. 20, July 1, 2024
Home Care Agency protocol will include, but not be limited
				  to, the following:
(1) safe and secure
				storage of drugs;
(2) access to
				drugs limited to authorized employees;
(3) records of drugs checked out to
				authorized employees and records of drugs, amounts, to whom and by whom
				administered;
(4) prompt
				notification of the pharmacy when a drug is used, including the prescriber,
				patient, drug, dosage form, directions for use, etc.;
(5) billing information;
(6) procedures for handling drugs beyond
				expiration date (outdated drugs shall be returned to the pharmacy, quarantined
				and destroyed in a reasonable time frame); and,
(7) inventory control.
Added at 12 Ok Reg 2593,
				  eff 6-26-95; Amended at 13 Ok Reg 2807, eff
				  6-27-96
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 15 - Home Care Agency Pharmacy Agreements › Section 535:15-15-4 - Drug formulary

Current through Vol. 41, No. 20, July 1, 2024
The following legend or dangerous drugs will be allowed under
				  these agreements:
(1) sterile water
				for injection or irrigation;
(2)
				sterile saline solution for injection or irrigation;
(3) acetic acid for irrigation;
(4) heparin flush solution or kits;
(5) diphenhydramine injectable;
(6) epinephrine injectable;
(7) four (4) I.V.solutions
(A) dextrose 5% in water (D5W)
(B) dextrose 5% in normal saline solution
				(D5S)
(C) lactated ringers
				solution
(D) normal saline
				solution, and
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 16 - Pharmacy Emergency Medication Kits for Use in a Facility › Section 535:15-16-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
(a) This subchapter establishes rules
				regarding drugs that an Oklahoma licensed pharmacy may maintain in an emergency
				medication kit, as authorized under Title 59 O.S. Section 367.8 .
(b) The purpose of these Oklahoma licensed
				pharmacy emergency medication kits for use in a facility is not to relieve a
				pharmacist or an Oklahoma licensed pharmacy of the responsibility for timely
				provision of a facility resident's routine drug needs; but to ensure that an
				emergency medication kit is available to facility residents in need of urgent
				or emergency medications.
Added at 29 Ok Reg 1641,
				  eff 7-12-12
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 16 - Pharmacy Emergency Medication Kits for Use in a Facility › Section 535:15-16-2 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The following words or terms, when used in this chapter,
				  shall have the following meaning, unless the context clearly indicates
				  otherwise:
"Emergency medication kits"
,
"Emergency
				  medication boxes"
, or
"Emergency medication carts"
,
"emergency kits"
,
"kits"
,
"boxes"
or
"carts"
means those drugs which are allowed under these rules that
				  may be required to meet the immediate emergency therapeutic needs of facility
				  residents; and which are not available from any other authorized source in
				  sufficient time to prevent risk of harm or death to residents.
"Facility"
or
"Institution"
means a
				  facility as defined by the Nursing Home Care Act or an Assisted Living Center
				  as defined by the Continuum of Care and Assisted Living Act.
"Remote site"
means a facility location where a
				  Oklahoma licensed pharmacy has placed an emergency medication kit.
"Resident"
means a patient residing at the
				  facility.
"Single dose injectable medication"
means any
				  injectable medication vial in the emergency medication kit.
Added at 29 Ok Reg 1641,
				  eff 7-12-12
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 16 - Pharmacy Emergency Medication Kits for Use in a Facility › Section 535:15-16-3 - Licensing requirements

Current through Vol. 41, No. 20, July 1, 2024
(a) The Oklahoma
				licensed pharmacy shall maintain a separate pharmacy emergency medication kit
				permit for each emergency medication kit maintained at each facility remote
				site for an annual fee for each set by the Board.
(b) The Oklahoma licensed pharmacy shall
				contact DEA and OBN and comply with any registration or requirements for each
				remote site prior to providing a controlled dangerous substance in the
				emergency medication kit.
(c) The
				permit for the medication kit will expire at the same time as the license of
				the pharmacy.
Added at 29 Ok Reg 1641,
				  eff 7-12-12
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 16 - Pharmacy Emergency Medication Kits for Use in a Facility › Section 535:15-16-4 - Policies and procedures for use of emergency medication kit drugs

Current through Vol. 41, No. 20, July 1, 2024
(a) The drugs in the emergency medication
				kits shall remain the property of an Oklahoma licensed pharmacy.
(b) Only one Oklahoma licensed pharmacy may
				provide emergency medication kits to each facility.
(c) Emergency medication kits maintained by
				an Oklahoma licensed pharmacy within the facility shall be approved by the
				medical director of the facility and the facility's consultant pharmacist on at
				least an annual basis.
(d)
				Medications may be administered from the facility's emergency medication kit
				only upon a prescriber's order for the emergency medication; and must be
				administered by a licensed nurse, physician, or physician's
				assistant.
(e) The facility
				licensed nurse shall
(1) verbally transmit
				the order for an emergency drug requiring access to the emergency medication
				kit to an Oklahoma licensed pharmacist who is an employee of the Oklahoma
				licensed pharmacy and is physically located within the United States at the
				time the order is transmitted prior to the removal of a medication from the
				emergency medication kit,
(2) or
				may electronically transmit the order to an Oklahoma licensed pharmacy and
				located within the United States following all federal and state regulations
				and rules only if the Oklahoma licensed pharmacy is utilizing technology which
				requires the Oklahoma licensed pharmacist to release the medication from the
				emergency medication kit by electronic means.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 16 - Pharmacy Emergency Medication Kits for Use in a Facility › Section 535:15-16-5 - Security

Current through Vol. 41, No. 20, July 1, 2024
(a) Emergency medication kits shall have
				adequate security and procedures to:
(1)
				Prohibit unauthorized access;
(2)
				Comply with federal and state law and regulations; and
(3) Maintain patient
				confidentiality.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 16 - Pharmacy Emergency Medication Kits for Use in a Facility › Section 535:15-16-6 - Drugs allowed in emergency medication kits

Current through Vol. 41, No. 20, July 1, 2024
(a) An Oklahoma licensed pharmacy and its
				pharmacists shall be responsible for timely provision of a facility resident's
				routine drug needs.
(b) The drugs
				allowed in the emergency medication kit, both Controlled Dangerous Substances
				(CDS) and Non-Controlled dangerous substances (Non-CDS) shall be determined by
				the medical director of the facility and an Oklahoma licensed pharmacist
				employed by the Oklahoma licensed pharmacy providing the kit.
(1) The quantity of each Non-CDS drug shall
				be of sufficient quantity to meet the needs of the patients in that
				facility.
(2) The quantity of each
				CDS drug shall not exceed the limit allowed in 59 O.S. Section 367.8 (D)
				(1).
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 16 - Pharmacy Emergency Medication Kits for Use in a Facility › Section 535:15-16-7 - Violations

Current through Vol. 41, No. 20, July 1, 2024
(a) Theft or diversion of prescription drugs
				is a violation of state law and these rules.
(1) Violation by a licensed nursing home or
				licensed Assisted Living Center of these rules will be referred to the Oklahoma
				State Health Department and/or other proper authorities for possible
				action.
(2) Violation by a
				registrant of the Board may result in action under 59 O.S. Section
				353.26
				and /or other proper authorities for possible action.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 17 - Nuclear Pharmacy › Section 535:15-17-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
The rules of this Subchapter are to accomplish the purposes
				  of the Oklahoma Pharmacy Act, as specified in 59 O.S., Section 353.18 (A)
				  thereof, by implementing rules of a licensed nuclear pharmacy. Nuclear pharmacy
				  is hereby recognized as a specialty of pharmacy practice. As such, the
				  following rules address those areas specific or unique to this specialty
				  practice. These regulations are intended to supplement the regulations of other
				  state and federal agencies.
Added at 14 Ok Reg 3027,
				  eff 7-11-97
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 17 - Nuclear Pharmacy › Section 535:15-17-7 - Minimum equipment

Current through Vol. 41, No. 20, July 1, 2024
(a) A nuclear
				pharmacy shall be exempt from the physical requirements in Section
				535:15-3-4,
				Subsections (3), (6) and (7).
(b)
				The professional area of the pharmacy shall have at least the following
				equipment:
(1) Radionuclide Dose
				Calibrator;
(2)
				Refrigerator;
(3) Single or
				multiple channel scintillation counter with solid state detector (e.g. NaI(Tl)
				or Ge(Li));
(4) Radiochemical fume
				hood and filter system with suitable air sampling equipment when dispensing or
				preparing volatile radiopharmaceuticals;
(5) Area survey meter;
(6) At least two GM survey meters (including
				one high-range meter);
(7)
				Microscope and hemacytometer, when dispensing or preparing particle size
				dependent radiopharmaceuticals;
(8)
				Laminar airflow hood and appropriate supplies to ensure sterile practices for
				sterile compounded preparation solutions;
(9) Syringe and vial radiation
				shields;
(10) Appropriate shielded
				drawing station;
(11)
				Decontamination supplies;
(12)
				Appropriate supplies to perform quality assurance testing;
(13) Appropriate transport shields for
				syringes and vials; and
(14)
				Transport containers which meet the U.S. Department of Transportation
				regulations, and other labels and supplies for shipping radioactive
				materials.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 17 - Nuclear Pharmacy › Section 535:15-17-9 - Library reference books or computer sources

Current through Vol. 41, No. 20, July 1, 2024
A pharmacy library shall contain the following current
				  reference books or computer sources:
(1)
Oklahoma law books.
The
				latest copy of the Oklahoma State Board of Pharmacy, Laws and Rules and
				Regulations Pertaining to the Practice of Pharmacy and a recent copy of the
				Oklahoma State Bureau of Narcotics & Dangerous Drug Control's Rules and
				Regulations.
(2) Reference
				compendia necessary to practice Nuclear Pharmacy safely within federal and
				state requirements.
Added at 14 Ok Reg 3027,
				  eff 7-11-97
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 17 - Nuclear Pharmacy › Section 535:15-17-11 - Supervision of licensed pharmacy technicians in a licensed nuclear pharmacy

Current through Vol. 41, No. 20, July 1, 2024
(a) The ratio of pharmacy technicians to
				supervising pharmacists shall be set by the pharmacist in charge (PIC) and
				shall be a ratio that would be considered safe and reasonable by the certifying
				pharmacist.
(b) This ratio shall
				not exceed three pharmacy technicians to one supervising pharmacist. Such
				technicians shall be supervised as described in
				535:15-13-5(a)
				(b) (e) and (f).
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 18 - Customized Adherence Medication Package (Camp) › Section 535:15-18-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
The rules of this Subchapter are to provide standards for the
				  preparation and labeling of customized adherence medication packaging by
				  licensed pharmacies, pursuant to orders or prescriptions. Pharmacists, the
				  pharmacy manager and pharmacies are responsible for meeting the requirements of
				  this subchapter.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 18 - Customized Adherence Medication Package (Camp) › Section 535:15-18-2 - 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 content clearly indicates
				  otherwise:
"Customized Adherence Medication Package"
or
"CAMP"
means packaging for dispensed drugs that is comprised of
				  units containing two or more medications and designed to assist the user in
				  administering or self-administering the drugs in accordance with directions for
				  use.
"USER"
means patient or
				  caregiver.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 18 - Customized Adherence Medication Package (Camp) › Section 535:15-18-3 - Packaging requirements

Current through Vol. 41, No. 20, July 1, 2024
Pharmacists, the pharmacy manager and pharmacies are
				  responsible for meeting the following requirements:
(1) In place of dispensing two or more
				prescribed drug products in separate containers, a pharmacist may, with the
				consent of the patient, the patient's caregiver, or a pre-scriber, provide a
				CAMP. The CAMP is designed and labeled to indicate the day and time or period
				of time that the contents within each CAMP are to be taken. The dispensing
				pharmacy shall instruct the patient or caregiver on the use of the
				CAMP.
(2) In the absence of more
				stringent packaging requirements for any of the drug products contained in the
				CAMP, each CAMP shall be in compliance with the United States Pharmacopeia
				(USP) and National Formulary (NF). Each container shall be designed as to show
				evidence of tampering. CAMP packaging shall comply with all provisions of the
				poison prevention packaging act.
(3) When preparing a CAMP, the dispenser
				shall take into account any applicable USP Compendial requirements or
				guidelines, the physical and chemical compatibility of the dosage forms placed
				within each container, and any therapeutic incompatibilities that may affect
				the simultaneous administration of the medications. Medications shall not be
				dispensed in CAMP in any of the following situations:
(A) The USP monograph or official labeling of
				a medication requires dispensing in the original container.
(B) The drugs or dosage forms are
				incompatible with packaging components or each other.
(C) The drugs are therapeutically
				incompatible when administered simultaneously.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 18 - Customized Adherence Medication Package (Camp) › Section 535:15-18-4 - Labeling

Current through Vol. 41, No. 20, July 1, 2024
(a) Packaging must bear, at a minimum, the
				labeling requirements as stated in Title 59, Section
				353.20.1(B);
				and,
(1) Physical description of medication
				(i.e. imprint, description) or be separately packaged;
(2) Expiration date;
(3) Lot number(s), if required;
(4) Date and time to be given
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 19 - Automation Rules › Section 535:15-19-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
These rules of this Subchapter are to establish standards for
				  automated dispensing systems by licensed pharmacies. Pharmacists, the pharmacy
				  manager and pharmacies are responsible for meeting the rules of this
				  subchapter.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 19 - Automation Rules › Section 535:15-19-2 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The following words or terms, when used in this Subchap-ter,
				  shall have the following meaning, unless the content clearly indicates
				  otherwise:
"Automated dispensing system"
means an automated
				  system used by a pharmacy licensed by the state of Oklahoma to assist in
				  dispensing a prescription drug order by selecting, labeling, filling, or
				  sealing medication for dispensing. An "automated dispensing system" does not
				  include automated devices used solely to count medication that is then subject
				  to
final product check by a pharmacist prior to dispensing,
				  vacuum tube drug delivery systems, or automated dispensing and storage systems
				  used to dispense medication directly to a patient or to an authorized health
				  care practitioner for immediate distribution or administration to the
				  patient.
"Electronic verification system"
means an
				  electronic verification, bar code verification, weight verification, radio
				  frequency identification (RFID), or similar electronic process or system that
				  accurately verifies medication has been properly dispensed and labeled by, or
				  loaded into, an automated dispensing system.
"Manufacturer'sunit of usepackage"
means a drug
				  dispensed in the manufacturer's original and sealed packaging, or in the
				  original and sealed packaging of a repackager, without additional manipulation
				  or preparation by the pharmacy, except for application of the pharmacy
				  label.
"Prepacked"
for the purposes of this chapter
				  means any drug that has been removed from the original packaging of the
				  manufacturer or an FDA repackager and is placed in a properly labeled
				  dispensing container by a pharmacy for the purpose of dispensing to the
				  ultimate user from the pharmacy in which the prepacking
				  occurred.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 19 - Automation Rules › Section 535:15-19-3 - Medication stocking

Current through Vol. 41, No. 20, July 1, 2024
Automated dispensing systems may be stocked or loaded by a
				  pharmacist, or by an intern or pharmacy technician under the direct supervision
				  of a pharmacist.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 19 - Automation Rules › Section 535:15-19-4 - Pharmacist verification

Current through Vol. 41, No. 20, July 1, 2024
(a) A licensed
				pharmacist shall inspect and verify the accuracy of the contents of any final
				dispensing container filled or packaged by an automated dispensing system, and
				any label affixed thereto, prior to dispensing.
(b) The pharmacist verification requirements
				of Subsection (a) shall be deemed satisfied if:
(1) Individual unit-dose, bar-coded
				medications are employed by the automated system, and
(2) The process of filling / loading the
				system includes bar-code verification to prevent errors, and
(3) The process includes a pharmacist
				verification step either prior to or after loading the automated system.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 19 - Automation Rules › Section 535:15-19-5 - Policies and procedures

Current through Vol. 41, No. 20, July 1, 2024
(a) Written
				policies and procedures shall be established by and reviewed annually by the
				pharmacist-in-charge, be maintained in the pharmacy, and be available for
				review upon inspection.
(b) At a
				minimum, the pharmacy and pharmacy personnel shall establish and follow
				policies and procedures for the following:
(1)
				accurate filling, loading, and stocking of the system;
(2) sanitary operations of the system and
				preventing cross-contamination of cells, cartridges, containers, cassettes, or
				packages;
(3) investigating and
				addressing dispensing errors and system malfunctions;
(4) tracking and documenting prescription
				errors related to the system that are not corrected prior to dispensing to the
				patient;
(5) testing the proper
				function of the system and any accompanying electronic verification system; at
				a minimum, the system and electronic verification system shall be tested before
				the first use of the system or restarting the system and upon any modification
				to the system or electronic verification system that changes or alters the
				dispensing or electronic verification process;
(6) written documentation of training persons
				authorized to access, stock, or load the system in equipment use and operations
				which shall be maintained in the pharmacy and be available for
				inspection;
(7) preventing
				unauthorized access to the system, including, assigning, discontinuing, or
				changing security access;
(8)
				identifying and recording persons responsible for stocking, loading, and
				filling the system
(9) conducting
				routine and preventive maintenance and, if applicable, calibration;
(10) removing expired, adulterated,
				misbranded, or recalled drugs;
(11)
				ensuring proper drug storage within the system, consistent with the
				manufacturer's specifications and the USP;
(12) maintaining an ongoing quality assurance
				program that monitors performance of the system and any electronic verification
				system to ensure proper and accurate functioning; and
(13) ensuring compliance with state and
				federal law, including, all applicable labeling, storage, and security
				requirements.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 19 - Automation Rules › Section 535:15-19-6 - Recordkeeping

Current through Vol. 41, No. 20, July 1, 2024
Records and documentation required by this chapter shall be
				  maintained in the pharmacy's records electronically or in writing for a minimum
				  of two (2) years. Records shall be made readily available for inspection and
				  produced to the board inspector upon request.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 19 - Automation Rules › Section 535:15-19-7 - Prepacking by automation

Current through Vol. 41, No. 20, July 1, 2024
A pharmacist, or an intern or pharmacy technician under the
				  direct supervision of a licensed pharmacist, may prepack drugs for other than
				  immediate dispensing purposes provided that the following conditions are
				  met:
(1) prepacking occurs at the
				licensed pharmacy utilizing the system;
(2) only products which will be dispensed
				directly to the patient may be prepacked;
(3) containers utilized for prepacking shall
				meet standards specified by the USP, which has been incorporated herein by
				reference (e.g. preservation, packaging, storage and labeling section of the
				general notices and requirements); and where needed, light resistant containers
				shall be used;
(4) any prepacked
				drug must have a label affixed to it which contains, at a minimum, the name and
				strength of the drug, quantity, NDC number, the expiration date and lot number,
				and the date prepacked; and
(5) a
				record of drugs prepacked must be kept, and include the following: the name and
				strength of the drug, lot number, NDC number, expiration date, date of
				prepack-ing, total number of dosage units (tabs, caps) prepacked, quantity per
				prepacked container, initials of prepacker and of pharmacist performing
				verification of prepack.
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 1 - General Purpose › Section 535:20-1-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
(a) The rules in this Chapter regulate the
				manufacture, repackaging, distribution, compounding and sale or storage of
				drugs, medicines, chemicals and poisons and the dispensing of drugs and
				medicines in all places where drugs and medicines are compounded, dispensed or
				stored. The rules regulate any and all places, including premises, vehicles,
				equipment, contents and records, where drugs, medicines, chemicals or poisons
				are sold, stored, vended, given away, compounded, dispensed , manufactured ,
				repackaged or distributed.
(b) The
				rules in this Chapter further concern the Board's authority and duty to
				confiscate all drugs, medicines, chemicals or poisons found to be sold, stored,
				vended, given away, compounded, dispensed , manufactured , repackaged or
				distributed contrary to the provisions of 59 O.S. Section 353 et seq.
(c) The rules in this Chapter prescribe
				minimum standards, for the issuance of new or renewal licenses , with respect
				to floor space and other physical characteristics necessary to the maintenance
				of professional surroundings and to the protection of the safety and welfare of
				the public.
(d) The rules of this
				Chapter are necessary to protect the health, safety, and welfare of the
				public.
(e) The rules in this
				Chapter 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.
Amended at 11 Ok Reg
				  3441, eff 6-27-94
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 535:20-3-1 - Manufacturer permit [REVOKED]

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 20 Ok Reg 2488,
				  eff 7-11-03; Amended at 25 Ok Reg 1772, eff 5-12-08 (emergency); Revoked 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 535:20-3-1.1 - 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 manufacturer .
(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.
Reserved 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 535:20-3-1.2 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The words or terms defined in 59 O.S. Section
				  353.1 and
				  in 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.
Reserved 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 535:20-3-2

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 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 535:20-3-3 - Manufacturer licensing requirements

Current through Vol. 41, No. 20, July 1, 2024
(a) If
				Oklahoma is the state in which a prescription drug is manufactured or is the
				state from which or into which a prescription drug of a manufacturer is
				shipped, this prescription drug may not be manufactured in and/or shipped into
				or out of Oklahoma unless each facility of such manufacturer is licensed in
				Oklahoma. Such license shall be renewed annually by application and payment of
				renewal fees.
(b) A manufacturer
				shall also be licensed as a manufacturer by the Secretary of the U.S.
				Department of Health and Human Services, Food and Drug Administration.
(c) A manufacturer license is only
				valid for the name, ownership and location listed on the license. Changes of
				name, ownership or location require a new manufacturer 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 manufacturer operations are
				conducted at more than one location, each location shall be licensed by the
				Board.
(f) A manufacturer shall not
				operate from a place of residence.
(g) The manufacturing facility shall be
				located apart and separate from any retail pharmacy licensed by the
				Board.
(h) A manufacturer must
				publicly display all licenses and have readily available the most recent state
				and/or federal inspection reports.
Added at 9 Ok Reg 2145,
				  eff 6-11-92; 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 535:20-3-4 - Minimum required information for licensure

Current through Vol. 41, No. 20, July 1, 2024
(a) A manufacturer 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 manufacturer 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 3 - Manufacturers › Section 535:20-3-4.1 - 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 manufacturers:
(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 manufacturers;
(6) Any licensee who has no record of
				manufacturing 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 3 - Manufacturers › Section 535:20-3-5

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 25 Ok Reg 1772, eff 5-12-08 (emergency); Amended at 26
				  Ok Reg 2296, eff 7-1-09