reglab/statecodes huggingface dataset:
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-4 - Staffing requirements

Current through Vol. 41, No. 20, July 1, 2024
(a) The PIC shall
				be assisted by a sufficient number of additional pharmacists (D.Ph.s) to
				operate such a drug room competently, safely and adequately to meet the needs
				of the patients of the hospital facility.
(b) Each hospital drug room shall have
				oversight by a PIC who shall be responsible for certifying that the drug room
				meets the requirements of the Oklahoma Pharmacy Act and the rules of this
				Title. The PIC shall notify the Board, in writing, within 10 days of any change
				of employment.
(c) A drug room
				supervisor must be assigned as designated in the rules of the Oklahoma
				Department of Health under OAC
				310:667-21-2(c)
				et seq.
(1) Designation of the drug room
				supervisor must be reported to the Board, in writing, on the Hospital Drug Room
				initial application and on each subsequent renewal application.
(2) Written notice of change of drug room
				supervisor must be provided to the Board within 10 days of the
				change.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-6 - Physical requirements

Current through Vol. 41, No. 20, July 1, 2024
A hospital drug room shall have sufficient facilities to
				  ensure that drugs are prepared in sanitary, well-lighted and enclosed places,
				  and which meet the other requirements of this Chapter.
(1)
Equipment and materials.
Each hospital drug room shall have sufficient equipment and physical facilities
				for proper compounding, dispensing and storage of drugs.
(2)
Sterile Compounds.
For
				compounded sterile preparations:
(A) If a
				laminar hood is used, a hospital drug room shall comply with
				535:15-9-6 and
				535:15-9-10, 1 through
				5.
(B) If a laminar hood is not
				used, a closed system for parenteral admixtures should be utilized. If sterile
				compounding must be done, an area must be designated for that activity. This
				area must be at least a counter used for only this purpose and be away from
				patient care areas. Acceptable aseptic techniques shall be used.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-6.1 - Hospital drug room library requirements

Current through Vol. 41, No. 20, July 1, 2024
A hospital drug room library shall contain the following
				  current reference books or computer sources:
(1) Library menu. A recent copy of any two of
				the following:
(A) USP/NF (3 years or latest
				edition),
(B) Merck Manual (3 years
				or latest edition),
(C) Remington
				(6 years),
(D) A toxicology
				reference (3 years),
(E) Mosby's
				Drug Consult (2 years),
(F) Facts
				and Comparisons (2 years),
(G)
				ASHP, American Hospital Formulary Service (AHFS) Drug Information (2
				years),
(H) Monthly Prescribing
				Reference (MPR) (2 years),
(I) Drug
				Information Handbook (2 years),
(J)
				Thomson Micromedex, USP-DI (2 years); and/or,
(K) Current computer professional pharmacy
				reference program, approved by the Board (not duplicating a hard copy
				reference) e.g., one or two of the following:
(i) Thomson Micromedex, USP-DI
(ii) Clinical Pharmacology
(iii) Facts and Comparisons
(iv) Natural Medicines Comprehensive
				Database
(v) Trissel's 2 Clinical
				Pharmaceutical Database
(vi)
				Unlimited internet access to internet professional pharmacy reference program,
				e.g., WEB MD
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-7 - Drug distribution and control

Current through Vol. 41, No. 20, July 1, 2024
(a)
General.
The PIC shall establish written procedures for the safe
				and efficient distribution of medicine products. A copy of such procedures
				shall be on hand for inspection by the Board.
(b)
Responsibility.
The PIC
				shall be responsible for the safe and efficient distribution, control, and
				accountability of drugs, see
				535:15-6-5(b).
(c)
Labeling.
Hospital drug room
				labeling requirements shall be as follows:
(1)
Labeling for use inside the
				hospital facility.
All drugs outside of the drug room intended for use
				within the facility shall be adequately labeled by the pharmacist or in their
				original container.
(2)
Labeling for use outside the hospital facility.
All drugs labeled
				by the pharmacist or licensed practitioner for after-hours dispensing to
				discharge or emergency room patients shall be labeled with the following:
(A) Name and address of the hospital
				facility,
(B) Date and identifying
				number,
(C) Name of the
				patient,
(D) Directions for use to
				the patient,
(E) Name of the
				prescriber,
(F) Initials of the
				dispenser,
(G) Required
				precautionary information regarding controlled substances,
(H) Such other accessory or cautionary
				information as may be required or desirable for proper use and safety to the
				patient, and
(I) the name of the
				drug, its strength, and the number of units dispensed.
(3)
Sterile compounded
				admixtures.
When any drugs are added to sterile solutions or
				suspensions, such admixtures shall be labeled whether within or outside the
				direct personal supervision of a pharmacist. This label shall indicate the name
				and amount of the drug added, date and time of such addition, expiration date
				and time of admixture, and the initials of the persons (preparer and the
				verifier) responsible for the admixture.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-8 - Emergency dispensing and pre-packaged medications

Current through Vol. 41, No. 20, July 1, 2024
(a)
Emergency dispensing.
A
				pharmacist or licensed practitioner on duty may label and dispense an
				appropriate supply of a medication from the hospital drug room when ordered by
				a prescriber for a patient of the hospital to take with them when dismissed. An
				appropriate supply would include only sufficient doses required from the time
				of dismissal until resumption of normal business hours of local
				pharmacies.
(b)
Pre-packaged
				medications.
A pharmacist may pre-package medications in sufficient
				amounts to meet the immediate needs of patients of the hospital. The
				pre-dispensed medications must be labeled and packaged properly as required
				under sub-section
				535:15-6-7(c)
				Labeling, excepting items B, C, D, and E, and adding the medication expiration
				date and lot number. Such pre-packaged medications shall be securely stored,
				and an accurate accounting of their use shall be kept.
(1) When such medications are ordered by
				prescriber, to be used after dismissal from the hospital, the prescriber [with
				dispensing privileges] shall complete the medication label with the appropriate
				information including the patient's name, the prescriber's name, appropriate
				directions for use, the date the medication is distributed to the patient, and
				an identifying number.
(2) The
				prescriber who orders the medication shall be responsible for appropriate
				patient counseling and drug information dissemination.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-9 - Emergency room pre-packaged medications formulary

Current through Vol. 41, No. 20, July 1, 2024
(a) Each hospital drug room may choose the
				medicines to be included in their emergency room (ER) pre-packaged medications
				formulary within the requirements and limits listed below. This formulary shall
				be included within the policies and procedures of the hospital drug room. These
				pre-packaged medications shall be administered only as allowed in
				535:15-6-8
				for a maximum of a 72-hour supply.
(b) Type of Medication defined or parameters
				for choice
[
Limits
]
(1) Controlled Dangerous Substances (CDS):
(A) Codeine/acetaminophen combination
				[one]
(B) Tramadol [one]
(C) Codeine containing antitussive
				preparation [one]
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-10 - Access to drugs in absence of PIC or drug room supervisor

Current through Vol. 41, No. 20, July 1, 2024
(a)
Absence of the PIC or the drug room
				supervisor.
Advance arrangements shall be made for provision of drugs to
				the medical staff and other authorized personnel of the hospital facility by
				use of night cabinets and in emergency circumstances, by access to the drug
				room by authorized personnel during such times as the drug room may be
				unattended.
(b)
Night
				cabinets.
IF NIGHT CABINETS ARE USED THE FOLLOWING SHOULD PREVAIL:
(1) In the absence of a pharmacist (D.Ph.), a
				supply of controlled dangerous substances may be kept in locked cabinet(s) or
				other enclosure(s) constructed and located outside of the hospital drug room
				area, to which only specifically authorized personnel may obtain access by key
				or combination, and which is sufficiently secure to deny access to an
				unauthorized person by force or otherwise.
(2) The PIC shall, in conjunction with the
				appropriate committee of the hospital facility, develop inventory listings of
				those drugs to be included in such cabinet(s) and shall insure that:
(A) Such drugs, available therein, are
				properly labeled;
(B) Only
				prepackaged drugs are available therein, in amounts sufficient for immediate
				therapeutic requirements;
(C)
				Whenever access to such cabinet(s) shall have been gained, written ALI
				practitioner's orders and proofs of use, if applicable, are provided;
(D) A method of documenting responsibility
				for the key(s) at all times, and their transfer from one authorized person to
				another, is established;
(E) All
				drugs therein are monitored weekly, and discrepancies are reported in the PIC's
				report.
(F) A complete review of
				all activity concerning such cabinet(s) is conducted no less than once per
				month; and,
(G) Written policies
				and procedures are established to implement the requirements of this
				paragraph.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-11 - Administration of drugs to patients

Current through Vol. 41, No. 20, July 1, 2024
(a)
General provisions.
Drugs shall be administered at a hospital
				facility in accordance with the policies and procedures of that
				facility.
(b)
Self-Administration.
Self-administration of drugs by patients shall
				be permitted per hospital policy only when specifically authorized by the
				prescriber per hospital policy, provided the drugs to be self-administered have
				been identified by a licensed pharmacist or prescriber.
(c)
Administration only.
The
				drugs supplied or provided from a drug room shall be for administration only to
				patients of the hospital. No drugs may be provided to employees nor to
				individuals who are not patients of the hospital.
Added at 20 Ok Reg 2479,
				  eff 1-1-04; Amended at 26 Ok Reg 2274, eff
				  7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-12 - Medication from other sources

Current through Vol. 41, No. 20, July 1, 2024
(a)
Drugs from outside sources.
Whenever drugs or pharmaceutical
				services are obtained from outside of the hospital facility on a regular basis,
				arrangements shall be made to insure that such outside pharmacists provide
				their services in a manner that assures the safety of the patients and properly
				serves the need of the hospital drug room. Such arrangements shall be made in
				writing and shall at a minimum specify that:
(1) A pharmacist shall act in the capacity of
				a PIC, and therefore, shall be subject to these rules and
				regulations.
(2) A pharmacist shall
				provide on-call services at all times.
(3) The hospital drug room shall provide
				adequate storage facilities for such drugs.
(4) All drugs supplied shall be labeled so as
				to insure that recalls can be affected and that proper control and supervision
				of such drugs may be exercised. (Unit dose packaging is recommended.)
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-13 - Investigational drugs

Current through Vol. 41, No. 20, July 1, 2024
(a)
Use
				within hospital.
Policies and procedures of the drug room shall reflect
				the use of investigational drugs within the hospital facility.
(b)
Approval for use.
The
				appropriate committee of the hospital shall approve all investigational drugs
				for use within a hospital.
(c)
Labeling and administration information.
All investigational drugs
				shall be labeled in accordance with this Subchapter with the drug's
				investigational status identified on the label. In addition, the individual
				responsible for the administration of the drug must be provided with complete
				information regarding its use.
(d)
Storage.
Investigational drugs shall be stored in an area
				separated from approved pharmaceuticals and shall be secured.
Added at 20 Ok Reg 2479,
				  eff 1-1-04
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-14 - Drug storage stock inspections

Current through Vol. 41, No. 20, July 1, 2024
(a)
				The PIC or his appropriate designee shall conduct an inspection of all drug
				storage areas within the hospital on at least a monthly basis.
(b) This monthly drug storage area stock
				inspection shall verify at least the following (see
				535:15-6-5(a)
				for additional requirements):
(1) Drugs for
				internal use are stored separately from drugs and disinfectants for external
				use.
(2) Drugs requiring special
				storage conditions to insure their stability are properly stored.
(3) No outdated drugs are stocked in the
				facility and are removed from the facility not more than 6 months after the
				expiration date.
(4) Distribution
				and administration of controlled substances are properly and adequately
				documented and reported.
(5)
				Emergency drugs are adequate and in proper supply.
(6) All necessary and required security and
				storage standards are met.
(7)
				Metric-apothecaries' weight and measure conversion tables and charts are
				reasonably available to all medical personnel.
(8) Policies and procedures of the hospital
				drug room are followed.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-15 - Non-distributive roles of pharmacists

Current through Vol. 41, No. 20, July 1, 2024
The policies and procedures of the hospital drug room shall
				  reflect the scope of non-distributive roles carried out by the pharmacist of
				  the hospital system.
Added at 20 Ok Reg 2479,
				  eff 1-1-04
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-16 - Performance improvement

Current through Vol. 41, No. 20, July 1, 2024
(a)
Purpose.
As a part of the hospital or health system's performance
				improvement program, the quality and appropriateness of patient care services
				provided by the drug room shall be monitored and evaluated through a planned
				and systematic approach to improving performance.
(b)
Responsibility.
The PIC is
				responsible for assuring that the process described in this section is
				implemented to assure safe use of drugs for good patient outcomes.
(1) The Board recommends the PIC serve as a
				voting member of the hospital wide Performance Improvement Committee.
(2) The Board recommends the PIC assume a
				leadership role within the hospital or health system for the medication-use
				process performance improvement (including dispensing, administration,
				monitoring, prescribing, and education) across the continuum of care.
(3) The PIC shall work in collaboration with
				patients, prescribers, nurses, and other health care providers in improving the
				medication use process.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-17 - Board of Pharmacy inspections

Current through Vol. 41, No. 20, July 1, 2024
(a) The
				Board's qualified designee shall inspect all aspects of the management and
				operation of all hospital drug rooms in the State of Oklahoma.
(b) This allows verification of compliance
				with the law, the State Board of Pharmacy regulations, and such other standards
				as may be appropriate to insure the health, safety and welfare of patients of
				the facility serviced by the hospital drug room.
(c) Any discrepancies or deficiencies noted
				at inspection shall be corrected.
Added at 20 Ok Reg 2479,
				  eff 1-1-04
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-18 - Drug room training area

Current through Vol. 41, No. 20, July 1, 2024
(a) A licensed
				hospital drug room may apply for a training area certificate after meeting the
				requirement in 535:10-5 and 535:25.
(b) If approved by the Board, such training
				area certificate enables the drug room to serve as a licensed training area so
				long as a qualified pharmacist preceptor is present and supervising each intern
				working in the drug room, as required in 535:10-5.
(c) Each drug room training area, pharmacist
				preceptor and intern shall meet requirements in 535:10-5.
Added at 20 Ok Reg 2479,
				  eff 1-1-04
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-19 - Violations

Current through Vol. 41, No. 20, July 1, 2024
(a) Unlawful acts are described in the
				Oklahoma Pharmacy Act.
(b) Hospital
				drug room rules of conduct, violations of rules of conduct, and rules for all
				applicants are found in 535:25.
(c)
				Rules of conduct and violations of rules of conduct for PIC are found in
				535:10-3.
(d) Penalties for
				violations of this Title, the Oklahoma Pharmacy Act and federal and state laws
				and rules are listed in Title 59 O.S. Section 353.26 .
Added at 20 Ok Reg 2479,
				  eff 1-1-04
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 6 - Hospital Drug Room › Section 535:15-6-20 - Remote medication order processing

Current through Vol. 41, No. 20, July 1, 2024
(a) Hospitals, the pharmacist manager and the
				director of pharmacy at the hospital that allow remote medication order
				processing shall establish and maintain policies and procedures related to
				remote medication order processing.
(1) Such
				registrants remain responsible to assure the hospital drug room meets
				requirements under Oklahoma laws and rules.
(2) Such registrants shall be responsible to
				assure RMOP, if used, is reviewed at least annually and that proper
				credentialing, review and that oversight is established, maintained and
				exercised.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 7 - Drug Supplier Permits › Section 535:15-7-1 - 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:
"Drug supplier"
means a licensed retail pharmacy
				  which supplies legend drugs to licensed prescribers for their office
				  administration and/or which supplies legend drugs to hospitals and other
				  licensed pharmacies for their dispensing.
"Legend drugs"
means including, but not limited
				  to, drugs, medicines, poisons, and/or chemicals (as defined in 59 O.S. Section
				  353
				  et seq.) which bear the legend "Caution: Federal Law Prohibits Dispensing
				  Without Prescription" or "RX Only", or any other label FDA may require which
				  restricts drugs to dispensing with a practitioner's
				  prescription.
Amended at 11 Ok Reg
				  3431, eff 6-27-94; Amended at 17 Ok Reg 2626, eff
				  7-1-00
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 7 - Drug Supplier Permits › Section 535:15-7-2 - Drug supplier requirements

Current through Vol. 41, No. 20, July 1, 2024
(a)
Permit eligibility.
In order to obtain and maintain a drug
				supplier permit, the applicant must have a valid retail pharmacy
				license.
(b)
Total annual
				sales.
The total annual sales of the drug supplier shall not exceed five
				percent (5%) of the total annual sales of the pharmacy.
(c)
Records.
Separate records of
				sales will be kept on file by the pharmacy. The files will include, but not be
				limited to, invoices of sales with name and address of purchaser, quantity
				sold, drug description, price, and date of transaction. These files must be
				readily available for inspection.
(d)
Controlled Dangerous
				Substances.
Sales of controlled dangerous substances must conform with
				statutes and regulations of the Oklahoma Bureau of Narcotics and Dangerous
				Drugs Control, the Federal Drug Enforcement Administration and/or any other
				federal, state or municipal laws, ordinances or regulations.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 7 - Drug Supplier Permits › Section 535:15-7-3 - Drug supplier restriction

Current through Vol. 41, No. 20, July 1, 2024
(a) Retail
				pharmacies shall not sell or otherwise supply or provide dangerous substances,
				prescription drugs, controlled dangerous substances, or a compounded
				preparation to a wholesaler, manufacturer or repackager, outsourcing facility
				or logistics provider. Return of a drug to the wholesaler from whom it was
				purchased is allowed.
(b) This
				restriction does not apply to packaging services provided to a pharmacy where
				the ownership of the pharmacy's drug does not change hands.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 9 - Sterile Compounded Preparations Pharmacy Permits › Section 535:15-9-1 - Scope and purpose

Current through Vol. 41, No. 20, July 1, 2024
The rules of this Subchapter provide standards for the
				  preparation, labeling, and distribution of sterile compounded preparations by
				  licensed retail pharmacies, pursuant to an order or prescription. These
				  standards are intended to apply to all sterile compounded preparations,
				  notwithstanding the location of the patient.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 9 - Sterile Compounded Preparations Pharmacy Permits › Section 535:15-9-2 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The definitions for this Subchapter shall be the same as
				  those defined in
				  535:15-10-51, as well
				  as the following words or terms, when used in this Subchapter, shall have the
				  following meaning, unless the context clearly indicates otherwise:
"Sterile preparation pharmacy"
means a licensed
				  retail pharmacy with an additional specialized board-approved sterile
				  preparation permit to allow the compounding and dispensing of sterile
				  preparations by an Oklahoma licensed pharmacist pursuant to a prescription
				  order.
"Sterile preparations"
means sterile compounded
				  preparations and may include nutrition and/or hazardous or antineoplastic
				  agents and/or sterile irrigation solutions and/or sterile solutions for
				  nebulization and/or sterile eye drops, which are free from living
				  micro-organisms (aseptic) and for parenteral preparations pyrogen and endotoxin
				  free as well.
Amended at 12 Ok Reg
				  2593, eff 6-26-95; Amended at 17 Ok Reg 2626, eff
				  7-1-00
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 9 - Sterile Compounded Preparations Pharmacy Permits › Section 535:15-9-3 - Sterile compounding preparation permit requirements

Current through Vol. 41, No. 20, July 1, 2024
The following are required to obtain and maintain a sterile
				  compounding preparation pharmacy permit:
(1)
Valid retail license.
The
				applicant must have a valid retail or non-resident pharmacy license.
(2)
Equipment and supplies.
The
				pharmacy must have the required equipment and supplies pursuant to the rules
				and regulations of the Oklahoma Board regarding sterile compounding preparation
				pharmacy permits.
(3)
Manager.
The pharmacy manager of sterile compounding preparation
				pharmacy will have sufficient knowledge, education and/or experience in the
				practice of sterile compounding preparation pharmacy.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 9 - Sterile Compounded Preparations Pharmacy Permits › Section 535:15-9-4 - Permit issuance

Current through Vol. 41, No. 20, July 1, 2024
(a)
Required
				permit.
A sterile compounding preparation pharmacy permit will be
				required of all pharmacies compounding sterile preparations.
(b)
Fee.
The sterile compounding
				preparation permit fee will be set by the Board.
(c)
Renewal.
The sterile
				compounding preparation pharmacy permit will be renewed annually with the
				retail or non-resident pharmacy license.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 9 - Sterile Compounded Preparations Pharmacy Permits › Section 535:15-9-5 - Policy and procedure manual

Current through Vol. 41, No. 20, July 1, 2024
(a)
Availability.
To obtain a sterile compounding preparation pharmacy
				permit, a policy and procedure manual as it relates to sterile preparations and
				services that are provided shall be available for inspection at the pharmacy
				location.
(b)
Review.
The policy and procedure manual shall be reviewed and/or
				revised on an annual basis. A copy of the policy and procedure manual shall be
				available for inspection and submitted to the Board upon request by the
				Board.
(c)
Pre-approval by
				Board.
The Board may choose to pre-approve all policy and procedure
				manuals prior to inspection of the sterile preparation pharmacy area.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 9 - Sterile Compounded Preparations Pharmacy Permits › Section 535:15-9-6 - Pharmacy sterile compounding physical requirements

Current through Vol. 41, No. 20, July 1, 2024
(a) Pharmacies and personnel who engage in
				sterile compounding are responsible for complying with State Board of Pharmacy
				regulations.
(b) Reference
				materials.
(1) The sterile compounding
				preparation pharmacy shall have, in addition to the library reference material
				required for retail licensure, one or more reference materials from the
				following list:
(A) Handbook of Injectable
				Drugs
(B) King's Guide to
				Parenteral Admixtures
(C)
				Micromedex
(D) Lexicomp
(E) Applicable USP standards
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 9 - Sterile Compounded Preparations Pharmacy Permits › Section 535:15-9-7 - Manager

Current through Vol. 41, No. 20, July 1, 2024
Each sterile compounding preparations pharmacy shall be
				  managed by a pharmacist who is licensed to practice pharmacy in the State of
				  Oklahoma, and who is knowledgeable in the specialized functions of compounding,
				  preparing and dispensing sterile preparations, including the principles of
				  aseptic technique and quality assurance. This knowledge may be obtained through
				  residency training programs, continuing education programs and/or experience in
				  an infusion admixture facility.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 9 - Sterile Compounded Preparations Pharmacy Permits › Section 535:15-9-8 - Pharmacist accessibility

Current through Vol. 41, No. 20, July 1, 2024
Each sterile compounding pharmacy and pharmacy manager shall
				  assure that a qualified pharmacist is accessible and available to respond to
				  patients and healthcare professional questions and needs at all times. A
				  24-hour telephone number shall be provided.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 9 - Sterile Compounded Preparations Pharmacy Permits › Section 535:15-9-9 - Drug distribution and control

Current through Vol. 41, No. 20, July 1, 2024
(a)
Labeling.
Each preparation dispensed to patients by a sterile
				compounding preparation pharmacy shall be labeled with the following
				information with a permanent label:
(1) Name,
				address, and telephone number of the pharmacy;
(2) Date and prescription number;
(3) Patient's name;
(4) Name, strength, and amount of each
				drug;
(5) Directions for use,
				including infusion rate where applicable;
(6) Prescriber's name;
(7) Required controlled substance transfer
				warnings, where applicable;
(8)
				Date of compounding;
(9) Expiration
				date and time;
(10) Identity of
				pharmacist compounding and dispensing;
(11) Storage requirements;
(12) Auxiliary labels, where
				applicable;
(13) Hazardous drug
				auxiliary labels, where applicable.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 9 - Sterile Compounded Preparations Pharmacy Permits › Section 535:15-9-10 - Cytotoxic or Hazardous drugs

Current through Vol. 41, No. 20, July 1, 2024
Pharmacies and personnel who engage in sterile compounding
				  are responsible for complying with State Board of Pharmacy regulations.
Amended at 9 Ok Reg
				  2141, eff 6-11-92
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 9 - Sterile Compounded Preparations Pharmacy Permits › Section 535:15-9-11 - Quality assurance

Current through Vol. 41, No. 20, July 1, 2024
Pharmacies and personnel who engage in sterile compounding
				  are responsible for complying with State Board of Pharmacy regulations.
Amended at 12 Ok Reg
				  2593, eff 6-26-95
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 9 - Sterile Compounded Preparations Pharmacy Permits › Section 535:15-9-12 - Pharmacist manager responsibility

Current through Vol. 41, No. 20, July 1, 2024
The pharmacist manager of the pharmacy dispensing sterile
				  compounded preparations shall provide the following or assure that they are
				  provided prior to providing medications.
(1)
Training.
The pharmacist must
				assure that the patient is properly trained, if self-administering.
(2)
Nurses.
In situations where a
				pharmacy or pharmacist employs a nurse to administer medications, the pharmacy
				manager must:
(A) Employ a registered
				nurse.
(B) Assure that proper
				records are maintained and are in compliance with laws and
				regulations.
(C) Make these records
				available to inspectors from appropriate agencies.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 1 - GOOD COMPOUNDING PRACTICES FOR NON-STERILE PREPARATIONS › Section 535:15-10-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
The rules of this subchapter describe the requirements of
					 minimum current good compounding practices for the compounding of drug
					 preparations by Oklahoma licensed pharmacies for dispensing and/or
					 administration to humans or animals.
Added at 17 Ok Reg
					 2633, eff 7-1-00
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 1 - GOOD COMPOUNDING PRACTICES FOR NON-STERILE PREPARATIONS › Section 535:15-10-2 - 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:
"
Beyond-Use Date (BUD)
" means the date and
					 time, as appropriate, after which administration is not to begin of a
					 compounded preparation; and such date is determined from the date the
					 preparation is compounded.
"
Biological Safety Cabinet (BSC)
" means a
					 ventilated cabinet for hazardous drugs, personnel, product, and environmental
					 protection having an open front with inward airflow for personnel protection,
					 downward high-efficiency particulate air (HEPA)-filtered laminar airflow for
					 product protection, and HEPA filtered exhausted air for environmental
					 protection meeting USP standards.
"
Compounder
" means a compounder is a
					 pharmacist or anyone compounding under the direct supervision of a pharmacist
					 pursuant to a prescription order by a licensed prescriber.
"
Compounding
" means compounding as defined
					 in 59 O.S. Section 353.1 et seq.
"
Component
" means any ingredient used in the
					 compounding of a drug preparation, including those that may not appear on the
					 labeling of such a preparation.
"
Inordinate Amount
" means an amount of
					 compounded drug that exceeds the amount a pharmacy anticipates may be used or
					 dispensed before the BUD of the compounded drug and/or is unreasonable
					 considering the intended use of the compounded drug.
"
Isolator
" means a device that is sealed or
					 is supplied with air through a microbial retentive filtration system (HEPA
					 minimum) and may be reproducibly decontaminated.
"
Labeling
" means all labels and other
					 written, printed, or graphic matter on an immediate container of an article or
					 preparation or on, or in, any package or wrapper in which it is enclosed,
					 except any outer shipping container. The term 'label' designates that part of
					 the labeling on the immediate container.
"
Manufacturing
" means manufacturing as
					 defined in 59 O.S. Section 353.1 et seq.
"
Personal Protective Equipment (PP
E)" means
					 items such as gloves, gowns, respirators, goggles, face shields, and others
					 that protect individual workers from hazardous physical or chemical exposures.
"
Preparation
" means an article compounded in
					 a licensed pharmacy pursuant to the order of a licensed prescriber.
"
Product
" means a commercially manufactured
					 drug or nutrient that has been evaluated for safety and efficacy by the FDA.
					 Products are accompanied by full prescribing information, which is commonly
					 known as the FDA-approved manufacturer's labeling or product package insert.
"
USP
" means "United States Pharmacopeia".
Added at 17 Ok Reg
					 2633, eff 7-1-00; Amended at 26 Ok Reg 2276, eff
					 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 1 - GOOD COMPOUNDING PRACTICES FOR NON-STERILE PREPARATIONS › Section 535:15-10-3 - Pharmacist responsibilities

Current through Vol. 41, No. 20, July 1, 2024
(a) All
				  Pharmacists who engage in drug compounding, shall be proficient in compounding
				  and should continually expand their compounding knowledge by participating in
				  seminars and/or studying appropriate literature.
(b) All pharmacists and personnel engaging in
				  drug compounding shall be familiar with State Board of Pharmacy regulations and
				  should be familiar with patent regulations.
(c) The pharmacist has the responsibility to:
(1) Ensure the validity of all prescriptions
(2) Certify all prescriptions.
(3) Approve or reject all
				  components, drug product containers, closures, in-process materials, and
				  labeling.
(4) Ensure preparations
				  are of acceptable strength, quality, and purity.
(5) Verify all critical processes to ensure
				  that procedures will consistently result in the expected qualities in the
				  finished preparation.
(6) Prepare
				  and review all compounding records to ensure that no errors have occurred in
				  the compounding process.
(7)
				  Ensure appropriate stability evaluation is performed or determined from the
				  literature for establishing reliable beyond-use dating.
(8) Ensure the proper maintenance,
				  cleanliness, and use of all equipment used in a prescription compounding
				  practice; and,
(9) Ensure only
				  authorized personnel shall be in the immediate vicinity of the drug compounding
				  operation.
(10) Perform final
				  check of preparations prior to their release from the pharmacy.
(A) A check for compounding accuracy must
				  ensure accuracy of the label and volumes or quantities of all drugs and
				  solutions
(B) A visual examination
				  procedure must ensure:
(i) Comparison with
				  original order for initial dispensing;
(ii) Accuracy of calculations;
(iii) Use of proper solutions, additives and
				  equipment;
(iv) Labels are
				  complete;
(v) Proper assignment of
				  beyond use date and time;
(vi) The
				  integrity of the container, including checking for visual defects;
(vii) Proper storage; and,
(viii) Absence of particulate matter,
				  precipitates, turbidity, discoloration, evidence of contamination or other
				  signs that the preparation should not be used.
(C) The pharmacist shall reject and destroy
				  all preparations that do not pass the final examination.
(D) Pharmacists shall document final
				  preparation examinations prior to releasing the Compounded Preparations from
				  the pharmacy.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 1 - GOOD COMPOUNDING PRACTICES FOR NON-STERILE PREPARATIONS › Section 535:15-10-4 - Drug compounding facilities

Current through Vol. 41, No. 20, July 1, 2024
(a)
				  Pharmacies engaging in compounding shall have a specifically designated and
				  adequate space for the orderly compounding of prescriptions, including the
				  placement and storage of equipment and materials.
(b) The area used for the compounding of
				  non-sterile compounded preparations shall be in an area separate and distinct
				  from the area used for the compounding and aseptic processing of sterile
				  preparations.
(c) The area(s) used
				  for the compounding of drugs shall be maintained in a good state of repair.
				  These area(s) shall also be maintained in a clean and sanitary condition.
				  Adequate washing facilities are to be provided and sewage, trash and other
				  refuse in the compounding area is to be disposed of in a safe, sanitary, and
				  timely manner.
(d) Hazardous drugs
				  shall be prepared within a certified Biological Safety Cabinet (Powder
				  Containment hood). Hazardous drug compounding shall be prepared in compliance
				  with applicable USP standards. When asepsis is not required, a Class I BSC,
				  powder containment hood or an isolator intended for containment applications
				  may be sufficient. Do not use a ventilated cabinet that re-circulates air
				  inside the cabinet or exhausts air back into the room environment unless the
				  hazardous drug(s) in use will not volatize while they are being handled or
				  after they are captured by the HEPA filter.
(e) Bulk drugs and other chemicals or
				  materials used in the compounding of drugs must be stored as directed by the
				  manufacturer, or according to USP monograph requirements, in a clean, dry area,
				  under appropriate temperature conditions (controlled room temperature,
				  refrigerator, or freezer in adequately labeled containers). Bulk drugs shall
				  also be stored such that they are protected from contamination.
(f) Adequate lighting and ventilation shall
				  be provided in all compounding areas.
(g) Potable water shall be supplied under
				  continuous positive pressure in a plumbing system free of defects that could
				  contribute contamination to any compounded drug preparation.
(h) Purified water must be used for
				  compounding non-sterile drug preparations when formulations indicate the
				  inclusion of water.
Added at 17 Ok Reg
					 2633, eff 7-1-00; Amended at 26 Ok Reg 2276, eff
					 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 1 - GOOD COMPOUNDING PRACTICES FOR NON-STERILE PREPARATIONS › Section 535:15-10-5 - Compounding equipment

Current through Vol. 41, No. 20, July 1, 2024
(a) Equipment used
				  in the compounding of drug preparations shall be of appropriate design and
				  capacity as well as suitably located to facilitate operations for its intended
				  use, cleaning and maintenance.
(b)
				  Compounding equipment shall be of suitable composition so the surfaces that
				  contact components shall neither be reactive, additive nor absorptive therefore
				  not affecting or altering the purity of the compounded preparation.
(c) Equipment and utensils used for
				  compounding shall be thoroughly cleaned promptly after every use to prevent
				  contamination and must be stored in a manner to protect them from
				  contamination. A cleaning log is recommended.
(d) Defective equipment shall be clearly
				  labeled as such.
(e) Automated,
				  mechanical, electronic, limited commercial scale manufacturing or testing
				  equipment, and other types of equipment may be used in the compounding of drug
				  products. If such equipment is used, it shall be routinely inspected,
				  calibrated as necessary or checked to ensure proper performance. An equipment
				  calibration log must be maintained.
(f) When drug products with special
				  precautions (antibiotics and hazardous materials) are involved appropriate
				  measures must be utilized in order to prevent cross-contamination and proper
				  disposal procedures must be followed. These measures include either the
				  dedication of equipment for such operations or the meticulous cleaning of
				  equipment prior to its use for the preparation of other drugs. A cleaning log
				  must be maintained. Equipment dedicated for specific use (i.e. penicillin)
				  shall be clearly designated as such.
Added at 17 Ok Reg
					 2633, eff 7-1-00; Amended at 26 Ok Reg 2276, eff
					 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 1 - GOOD COMPOUNDING PRACTICES FOR NON-STERILE PREPARATIONS › Section 535:15-10-6 - Component selection requirements

Current through Vol. 41, No. 20, July 1, 2024
(a)
				  The pharmacist shall first attempt to use USP-NF drug substances and inactive
				  components that have been made in an FDA registered facility.
(b) If components are not obtainable from an
				  FDA registered facility or if the FDA and/or the company cannot document FDA
				  registration, pharmacists compounding prescriptions shall use their
				  professional judgment in first receiving, storing or using drug components that
				  meet official compendia requirements or another high quality source.
(c) If components of compendial quality are
				  not obtainable, components of high quality such as those that are chemically
				  pure, analytical reagent grade, American Chemical Society-certified, or Food
				  Chemicals Codex grade may be used.
(d) Components shall be stored off the floor,
				  handled and stored to prevent contamination, and rotated so that the oldest
				  stock is used first.
Added at 17 Ok Reg
					 2633, eff 7-1-00; Amended at 26 Ok Reg 2276, eff
					 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 1 - GOOD COMPOUNDING PRACTICES FOR NON-STERILE PREPARATIONS › Section 535:15-10-7 - Control of drug product containers

Current through Vol. 41, No. 20, July 1, 2024
(a)
				  Drug product containers and closures shall be handled and stored in a manner to
				  prevent contamination and to permit inspection and cleaning of the work
				  area.
(b) Containers and closures
				  shall be of suitable material as to not alter the compounded drug as to
				  quality, strength or purity of the compounded preparation.
Added at 17 Ok Reg
					 2633, eff 7-1-00; Amended at 26 Ok Reg 2276, eff
					 7-1-09
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 1 - GOOD COMPOUNDING PRACTICES FOR NON-STERILE PREPARATIONS › Section 535:15-10-8 - Drug compounding controls

Current through Vol. 41, No. 20, July 1, 2024
(a) There
				  shall be written procedures for the compounding of drug preparations to assure
				  that the finished products have the identity, strength, quality and purity they
				  purport to have. These procedures should be available in either written form or
				  electronically stored with printable documentation.
(b) The objective of the documentation is to
				  allow another compounder to reproduce an equivalent prescription at a future
				  date.
(c) Documentation shall
				  include a listing of the components, their amounts (in weight or volume), the
				  order of component mixing, and a description of the compounding process (e.g.
				  log, formula worksheet, original prescription, etc.) In addition, all equipment
				  and utensils and the container/closure system, relevant to the compounding
				  procedure shall be listed.
(d)
				  These written procedures shall be followed in the execution of the compounding
				  procedure and are designed to enable a compounder, whenever necessary, to
				  systematically trace, evaluate, and replicate the steps included throughout the
				  preparation process of a compounded preparation.
(e) Components shall be accurately weighed,
				  measured, and subdivided as appropriate. These operations should be checked and
				  rechecked by the compounding pharmacist, at each stage of the process, to
				  ensure that each weight and measure is correct as stated in the written
				  compounding procedures.
(f) Written
				  procedures shall be established and followed that describe the tests or
				  examinations to be conducted on the preparation compounded (e.g., degree of
				  weight variation among capsules) to assure reasonable uniformity and integrity
				  of compounded drug preparations. Unless otherwise indicated or appropriate,
				  compounded preparations are to be prepared to ensure that each preparation
				  shall contain not less than 90% and not more than 110% of the theoretically
				  calculated and labeled quantity of active ingredient per unit weight or volume
				  and not less than 90% and not more than 110% of the theoretically calculated
				  weight or volume per unit of the preparation.
(1) Such control procedures shall be
				  established to monitor the output and to validate the performance of those
				  compounding processes that may be responsible for causing variability in the
				  final drug preparation. These procedures shall include, but are not limited to,
				  the following (where appropriate):
(A)
				  Capsule weight variation to ensure that each unit shall be not less than 90%
				  and not more than 110% of the theoretically calculated weight for each
				  unit;
(B) Adequacy of mixing to
				  assure uniformity and homogeneity;
(C) Clarity, completeness or pH of
				  solutions.