reglab/statecodes huggingface dataset:
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 535:15-10-8.1 - Transfer of compounded prescriptions

Current through Vol. 41, No. 20, July 1, 2024
(a) If a patient requests a transfer of their
				  prescription, a copy of the original prescription shall be transmitted upon the
				  request of the receiving pharmacist.
(b) The information included in the transfer
				  of the prescription shall include:
(1) Active
				  ingredient(s),
(2)
				  Concentration,
(3) Dosage Form e.g.
				  capsule, cream, suspension, injectable, etc.
(4) Route of delivery e.g. oral, injectable,
				  topical, vaginal, etc.
(5) Delivery
				  mechanism e.g. topical, transdermal, immediate release, sublingual,
				  etc.
(6) Dosing Duration e.g. Q12H,
				  Q24H, Q72H, etc.
(7) Details about
				  the compounding procedure must be reasonably available from the transferring
				  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 535:15-10-8.2 - Beyond-use dating

Current through Vol. 41, No. 20, July 1, 2024
(a) Pharmacies
				  engaging in compounding shall assign every compounded preparation an
				  appropriate beyond-use date (BUD).
(b) BUD may be assigned based on criteria
				  different from those applied to assigning expiration dates to manufactured drug
				  products.
(c) BUD are to be
				  assigned conservatively and should be based on the following State Board of
				  Pharmacy regulations standards in (d) through (f) below.
(1) These standards may be exceeded when
				  there is supporting scientific stability information that is directly
				  applicable to the specific preparation (e.g., the same drug concentration
				  range, pH, excipients, vehicle, water content, etc.)
(2) Information to be considered when
				  assigning a BUD includes chemical, physical and microbiological stability;
				  nature of the drug, its chemical degradation mechanism, the container in which
				  it is packaged, expected storage conditions, and the intended duration of
				  therapy.
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 535:15-10-8.3 - Compounding record/ log/ formula worksheet

Current through Vol. 41, No. 20, July 1, 2024
(a) Every pharmacy shall document the drug
				  compounding controls required in
				  535:15-10-8.
				  Each pharmacy shall complete a compounding record/ log/ formula worksheet for
				  each preparation which will include, but not be limited to, the following:
(1) The assigned name of the preparation.
(2) The name and actual measured
				  quantity of each ingredient used.
(3) The lot number, expiration date and
				  manufacturer of each ingredient used.
(4) The total quantity compounded.
(5) The name/initials of the employee that
				  compounded the preparation and the name/initials of the supervising pharmacist
				  that approved the preparation.
(6)
				  The date the compound is prepared.
(7) The lot/batch number assigned to the
				  preparation.
(8) The assigned
				  beyond use date (BUD).
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 535:15-10-9 - Labeling

Current through Vol. 41, No. 20, July 1, 2024
(a) If a component is transferred from the
				  original container to another (e.g., a powder is taken from the original
				  container, weighed, placed in, and stored in another container) the new
				  container shall be identified with the:
(1)
				  Component name,
(2) Lot and BUD if
				  available,
(3) Strength and/or
				  concentration, and;
(4) Weight or
				  measure
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 535:15-10-10 - Records and reports

Current through Vol. 41, No. 20, July 1, 2024
(a) Any procedures
				  or other records required to comply with State Board of Pharmacy regulations
				  shall be retained for the same period of time as required for retention of
				  prescription records; and copies of such records, shall be readily available
				  for authorized inspection.
(b)
				  Computer information and the hard copy of the prescription should indicate that
				  the prescription is to be compounded.
(c) Perpetual inventory is required for all
				  controlled dangerous substances (CDS) and all bulk CDS's utilized for
				  compounding.
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 535:15-10-11

Current through Vol. 41, No. 20, July 1, 2024
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 535:15-10-12 - Compounding for a prescriber's office use [REVOKED]

Current through Vol. 41, No. 20, July 1, 2024
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 535:15-10-13 - Compounding veterinarian preparations

Current through Vol. 41, No. 20, July 1, 2024
(a) Prescriptions
				  for animals may be compounded based on an order or prescription from a licensed
				  prescriber.
(b) Compounded
				  preparations must comply with federal statutes, rules and FDA
				  guidance.
(c) Caution should be
				  taken as to not violate federal patent laws by duplicating an available product
				  in inordinate quantities.
(d)
				  Compounding with bulk chemicals for food-producing animals is not
				  permitted.
(e) It is acceptable for
				  any licensed pharmacy to compound animal drugs from bulk substances for office
				  use without patient-specific prescriptions for nonfood-producing animals if:
(1) The drug is compounded by or under the
				  direct supervision of a pharmacist in a state-licensed pharmacy or a federal
				  facility,
(2) The drug is intended
				  for use in a nonfood-producing species and is compounded from a bulk drug
				  substance listed on FDA's "List of Bulk Drug Substances for Compounding Office
				  Stock Drugs for Use in Nonfood-Producing Animals",
(3) The drug is compounded in full compliance
				  with state laws and regulations governing drugs, pharmacy, and veterinary
				  medicine. All bulk drug substances, inactive ingredients, and finished drug
				  products used in compounding meet the standards set in any applicable USP-NF
				  monograph and comply with other FD&C Act requirements for drug
				  components,
(4) Upon becoming aware
				  of any adverse event or product defect associated with an animal drug
				  compounded from a bulk drug substance, the pharmacist that compounded the drug
				  reports the event on Form FDA 1932a within 15 business days, and
(5) The labeling of the compounded drug
				  includes all the following:
(A) Name of
				  drug,
(B) Strength of
				  drug,
(C) Species of the patient(s)
				  and indication(s) for which the drug will be used,
(D) Name, address, and contact information
				  for the compounding pharmacy,
(E)
				  BUD,
(F) The statement, "Report
				  suspected adverse reactions to the [pharmacist who compounded the drug] and to
				  the FDA using online Form 1932a",
(G) The statement, "This is a compounded
				  drug. Not an FDA approved or indexed drug.",
(H) The statement, "Not for use in
				  food-producing animals", and
(I)
				  The statement, "Caution: Federal law restricts this drug to use by or on the
				  order of a licensed veterinarian."
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 535:15-10-15

Current through Vol. 41, No. 20, July 1, 2024
Added 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 535:15-10-16 - Violations

Current through Vol. 41, No. 20, July 1, 2024
It shall be a violation to fail to comply with State Board
					 of Pharmacy regulations.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-50 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
(a) The objective of this chapter is to
				  describe conditions and practices to prevent harm, including death, to patients
				  that could result from (1) microbial contamination (non-sterility), (2)
				  excessive bacterial endotoxins, (3) variability in the intended strength of
				  correct ingredients that exceeds either monograph limits for official articles
				  or 10% for nonofficial articles, (4) unintended chemical and physical
				  contaminants, and (5) ingredients of inappropriate quality in compounded
				  sterile preparations (CSPs). Contaminated CSPs are potentially most hazardous
				  to patients when administered into body cavities, central nervous and vascular
				  systems, eyes, and joints, and when used as baths for live organs and tissues.
				  When CSPs contain excessive bacterial endotoxins they are potentially most
				  hazardous to patients when administered into the central nervous
				  system.
(b) To achieve the above
				  five conditions and practices, this part 3 of subchapter 10 provides minimum
				  practice and quality standards for CSPs of drugs and nutrients based on current
				  scientific information and best sterile compounding practices. The use of
				  technologies, techniques, materials, and procedures other than those described
				  in this part 3 of subchapter 10 is not prohibited so long as they have been
				  proven to be equivalent or superior with statistical significance to those
				  described herein. The standards in this part 3 of subchapter 10 do not pertain
				  to the clinical administration of CSPs to patients via application,
				  implantation, infusion, inhalation, injection, insertion, instillation, and
				  irrigation, which are the routes of administration. Four specific categories of
				  CSPs are described in this chapter: low-risk level, medium-risk level, and
				  high-risk level, and immediate use. For the purposes of this chapter, CSPs
				  include, but are not limited to the following:
(1) Compounded biologics, diagnostics, drugs,
				  nutrients, and radiopharmaceuticals, including but not limited to the following
				  dosage forms that must be sterile when they are administered to patients:
				  aqueous bronchial and nasal inhalations, baths and soaks for live organs and
				  tissues, injections (e.g., colloidal dispersions, emulsions, solutions,
				  suspensions), irrigations for wounds and body cavities, ophthalmic drops and
				  ointments, and tissue implants.
(2)
				  Manufactured sterile products prepared according to the instructions in
				  manufacturers' approved labeling. Product package inserts usually refer to
				  aseptic technique, but do not usually describe environmental quality controls,
				  storage, or BUD and times for radiopharmaceuticals.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-52 - 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) Every pharmacist engaging in drug
				  compounding must be familiar with all details of USP Compounding Standards.
(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 Sterile Preparations
				  from the pharmacy.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-53 - General requirements

Current through Vol. 41, No. 20, July 1, 2024
(a) Compounding a
				  drug preparation that is commercially available in the marketplace or that is
				  essentially a copy of an available FDA-approved drug product is generally
				  prohibited unless patient therapy is compromised.
(b) However, in special circumstances a
				  pharmacist may compound an appropriate quantity of a drug that is different
				  from an FDA-approved drug that is commercially available based on documentation
				  provided by the prescribing physician of a patient specific medical need (e.g.
				  the physician requests an alternate product due to hypersensitivity to
				  excipients or preservative in the FDA-approved product, or the physician
				  requests an effective alternate dosage form) or if the drug product is not
				  commercially available.
(1) The
				  unavailability of such drug product must be documented prior to
				  compounding.
(2) This or similar
				  documentation must be available when requested by the Board.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-54 - CSP microbial contamination risk levels

Current through Vol. 41, No. 20, July 1, 2024
(a)
Sterile preparations.
Pharmacies and pharmacists dispensing sterile preparations shall comply with
				  all applicable federal, state, and local law and regulation concerning
				  pharmacy. If the PEC (primary engineering control) is a compounding aseptic
				  isolator that does not meet the environmental requirements described in USP or
				  is a laminar air-flow workbench (LAFW) or a biological safety cabinet (BSC)
				  that cannot be located within an ISO Class 7 buffer area, then only low-risk
				  level nonhazardous CSPs pursuant to a physician's order for a specific patient
				  may be prepared, and administration of such CSPs shall commence within 12 hours
				  of preparation or as recommended in the manufacturers' package insert,
				  whichever is less. Low-risk level CSPs with a 12-hour or less BUD shall meet
				  all of the following criteria:
(1) PECs
				  (LAFWs, BSCs, CAIs, CACIs,) shall be certified and maintain ISO Class 5 as
				  described in USP for exposure of critical sites and shall be in a segregated
				  compounding area restricted to sterile compounding activities that minimize the
				  risk of CSP contamination.
(2) The
				  segregated compounding area shall not be in a location that has unsealed
				  windows or doors that connect to the outdoors or high traffic flow, or that is
				  adjacent to construction. Sinks should not be located adjacent to the ISO Class
				  5 PEC. Sinks should be separated from the immediate area of the ISO Class 5 PEC
				  device.
(3) Personnel shall follow
				  proper procedures for personnel cleansing and garbing prior to compounding and
				  maintain proper competency of aseptic work practices.
(4) Personnel will follow proper procedures
				  in ensure cleaning and disinfection of sterile compounding areas. Additionally,
				  viable and non-viable environmental air sampling must be performed according to
				  facility written procedures.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-56 - 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 or 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 from
				  contamination.
(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. Equipment
				  dedicated for specific use (i.e. penicillin) shall be clearly designated as
				  such.
Added 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 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-57 - 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 a
				  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 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 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-58 - 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 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 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-59 - 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 preparations 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 the identical prescription at a future
				  date.
(c) Procedures 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. In addition,
				  all equipment and utensils and the container/closure system, relevant to the
				  sterility and stability of the intended use of the drug 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 product compounded (e.g., degree of variation) to ensure
				  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 verify 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)
				  Adequacy of mixing to assure uniformity and homogeneity;
(B) Clarity, completeness or pH of
				  solutions.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-60 - Transfer of sterile compounded prescriptions

Current through Vol. 41, No. 20, July 1, 2024
(a) If a patient requests a transfer of their
				  prescription, a copy of the original prescription shall be transmitted upon the
				  request of the receiving pharmacist.
(b) The information included in the transfer
				  of the prescription shall include:
(1) Active
				  ingredient(s)
(2)
				  Concentration
(3) Dosage
				  Form
(4) Route of
				  delivery
(5) Delivery
				  mechanism
(6) Dosing Duration i.e.
				  Q12H, Q24H, Q72H
(7) Details about
				  the compounding procedure must be reasonably available from the transferring
				  pharmacy.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-61 - Beyond use dating (BUD)

Current through Vol. 41, No. 20, July 1, 2024
(a) BUDs shall
				  be assigned to all compounded sterile preparations. The shorter of the chemical
				  stability (established by the manufacturer, or listed in a current
				  authoritative reference, or established by direct testing following USP
				  standards or equivalent) and microbial limits of sterility (USP <797>
				  standards) shall be used to determine the date. If a pharmacy does not have a
				  program of sterility and endotoxin testing in place and additional
				  documentation for longer dates, then the following BUDs are to be used for
				  compounded sterile preparations as follows and as illustrated in the Appendix B
				  Chart:
(1) If USP <797> Risk Level is
				  "Immediate Use" BUD, and if kept
(A) at room
				  temperature; use within 1 hour,
(B)
				  refrigerated; use within 1 hour, or
(C) in freezer, N/A.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-62 - Labeling

Current through Vol. 41, No. 20, July 1, 2024
(a) If a component is transferred from the
				  original container to another (e.g., a powder is taken from the original
				  container, weighed, placed in, and stored in another container) the new
				  container shall be identified with the:
(1)
				  Component name,
(2) Lot and BUD if
				  available,
(3) Strength and/or
				  concentration, and;
(4) Weight or
				  measure
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-63 - Records and reports

Current through Vol. 41, No. 20, July 1, 2024
(a) Any procedures
				  or other records required to comply with Good Compounding Practices shall be
				  retained for the same period of time as required for retention of prescription
				  records and copies of such records shall be readily available for authorized
				  inspection.
(b) Computer
				  information and the hard copy of the prescription should indicate that the
				  prescription is to be compounded.
(c) Adequate records must be kept of
				  controlled dangerous substances (Scheduled drugs) used in
				  compounding.
(d) Adequate records
				  must be kept showing that compounded drug products have been compounded using
				  ingredients from FDA approved manufacturers.
(e) Adequate records must be kept showing
				  that all ingredients have been purchased from suppliers which are licensed by
				  the Board to lawfully ship such into Oklahoma.
Added 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 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-64 - Compounding for institution and/or practitioner administration [Revoked]

Current through Vol. 41, No. 20, July 1, 2024
Added at 26 Ok Reg 2276, eff 7-1-09; Amended at 30 Ok Reg
						2013, eff 7-25-13
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-64.1 - Compounding veterinarian sterile preparations

Current through Vol. 41, No. 20, July 1, 2024
(a)
				  Prescriptions for animals may be compounded based on an order or prescription
				  from a licensed prescriber.
(b)
				  Compounded preparations must comply with federal statutes, rules and FDA
				  guidance.
(c) Caution should be
				  taken as to not violate federal patent laws by duplicating an available product
				  in inordinate quantities.
(d)
				  Compounding with bulk chemicals for food-producing animals is not
				  permitted.
(e) It is acceptable for
				  any licensed pharmacy to compound animal drugs from bulk substances for office
				  use without patient-specific prescriptions for nonfood-producing animals if:
(1) The drug is compounded by or under the
				  direct supervision of a pharmacist in a state-licensed pharmacy or a federal
				  facility,
(2) The drug is intended
				  for use in a nonfood-producing species and is compounded from a bulk drug
				  substance listed on FDA's "List of Bulk Drug Substances for Compounding Office
				  Stock Drugs for Use in Nonfood-Producing Animals",
(3) The drug is compounded in full compliance
				  with state laws and regulations governing drugs, pharmacy, and veterinary
				  medicine. All bulk drug substances, inactive ingredients, and finished drug
				  products used in compounding meet the standards set in any applicable USP-NF
				  monograph and comply with other FD&C Act requirements for drug
				  components,
(4) Upon becoming aware
				  of any adverse event or product defect associated with an animal drug
				  compounded from a bulk drug substance, the pharmacist that compounded the drug
				  reports the event on Form FDA 1932a within 15 business days, and
(5) The labeling of the compounded drug
				  includes all the following:
(A) Name of
				  drug,
(B) Strength of
				  drug,
(C) Species of the patient(s)
				  and indication(s) for which the drug will be used,
(D) Name, address, and contact information
				  for the compounding pharmacy,
(E)
				  BUD,
(F) The statement, "Report
				  suspected adverse reactions to the [pharmacist who compounded the drug] and to
				  the FDA using online Form 1932a",
(G) The statement, "This is a compounded
				  drug. Not an FDA approved or indexed drug.",
(H) The statement, "Not for use in
				  food-producing animals", and
(I)
				  The statement, "Caution: Federal law restricts this drug to use by or on the
				  order of a licensed veterinarian."
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-65 - Compounding of sterile hazardous drugs

Current through Vol. 41, No. 20, July 1, 2024
(a) Although the potential therapeutic
				  benefits of compounded sterile and non-sterile hazardous drug preparations
				  outweigh the risks of their adverse effects in ill patients, exposed healthcare
				  workers risk similar adverse effects with no therapeutic benefit. Occupational
				  exposure to hazardous drugs can result in:
(1) Acute effects, such as skin
				  rashes;
(2) Chronic effects,
				  including adverse reproductive events; and
(3) Possibly cancer. Each facility must have
				  a communication program that identifies hazardous drugs and communicates this
				  list to all workers that participate in product acquisition, storage,
				  transportation, housekeeping, and waste disposal.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-66

Current through Vol. 41, No. 20, July 1, 2024
Added 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 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-67 - Compounding of sterile allergen extracts

Current through Vol. 41, No. 20, July 1, 2024
(a) Allergen extracts as CSPs are single-dose
				  and multiple-dose
intradermal or subcutaneous injections
that
				  are prepared by specially trained physicians and pharmacy personnel under their
				  direct supervision. Allergen extracts as CSPs are not subject to the personnel,
				  environmental, and storage requirements for all
CSP Microbial
				  Contamination Risk Levels
in this chapter only when all of the
				  following criteria are met:
(1) The
				  compounding process involves simple transfer via sterile needles and syringes
				  of commercial sterile allergen products and appropriate sterile added
				  substances (e.g., glycerin, phenol in sodium chloride injection).
(2) All allergen extracts as CSPs shall
				  contain appropriate substances in effective concentrations to prevent the
				  growth of microorganisms. Non-preserved allergen extracts shall comply with the
				  appropriate CSP risk level requirements in the chapter.
(3) Before beginning compounding activities,
				  personnel perform a thorough hand cleansing procedure by removing debris from
				  under fingernails using a nail cleaner under running warm water followed by
				  vigorous hand and arm washing to the elbows for at least 30 seconds with either
				  non-antimicrobial or antimicrobial soap and water.
(4) Compounding personnel don hair covers,
				  facial hair covers, gowns, and face masks.
(5) Compounding personnel perform antiseptic
				  hand cleansing with an alcohol based surgical hand scrub with persistent
				  activity.
(6) Compounding personnel
				  don powder-free sterile gloves that are compatible with sterile 70% isopropyl
				  alcohol (IPA) before beginning compounding manipulations.
(7) Compounding personnel disinfect their
				  gloves intermittently with sterile 70% IPA when preparing multiple allergen
				  extracts as CSPs.
(8) Ampul necks
				  and vial stoppers on packages of manufactured sterile ingredients are
				  disinfected by careful wiping with sterile 70% IPA swabs to ensure that the
				  critical sites are wet for at least 10 seconds and allowed to dry before they
				  are used to compound allergen extracts as CSPs.
(9) The aseptic compounding manipulations
				  minimize direct contact contamination (e.g., from glove fingertips, blood,
				  nasal and oral secretions, shed skin and cosmetics, other non-sterile
				  materials) of critical sites (e.g., needles, opened ampuls, vial stoppers).
(10) The label of each
				  multiple-dose vial (MDV) of allergen extracts as CSPs lists the name of one
				  specific patient and a BUD and storage temperature range that is assigned based
				  on manufacturers' recommendations or peer-reviewed publications.
(11) Single-dose allergen extracts as CSPs
				  shall not be stored for subsequent additional use.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-68 - Violations

Current through Vol. 41, No. 20, July 1, 2024
It shall be a violation to fail to comply with State Board
					 of Pharmacy regulations.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 11 - Charitable Clinic Pharmacies › Section 535:15-11-1 - Charitable clinic pharmacy license

Current through Vol. 41, No. 20, July 1, 2024
(a) A
				charitable clinic pharmacy license may be issued by the Board to clinics
				operating on a non-profit basis to furnish medical care to poor and
				underprivileged persons and in which drugs are dispensed or administered
				without charge to such persons on orders or prescriptions of prescribers
				authorized by law to prescribe or administer said drugs.
(b) Charitable clinic pharmacies must assure
				that the pharmacy area be secured during the pharmacist's absence.
(c) The minimum of (40) hours for a lock out
				pharmacy shall not apply to charitable clinic pharmacies.
(d) All dangerous drugs for patients shall be
				on an individual prescription basis, and the pharmacist shall dispense drugs
				properly labeled, and adhere to the requirements for proper storage,
				safeguarding, preparation and recordkeeping for prescription drugs.
(e) Before a charitable clinic pharmacy
				license is issued, all pharmacy policies and procedures must first be approved
				by the Board.
(f) A charitable
				clinic pharmacy can be part of a medical clinic that utilizes a mobile clinic
				to provide medical services to indigent patients provided that;
(1) The charitable clinic pharmacy has a
				permanent location where all dangerous drugs and records are stored,
(2) All dangerous drugs are returned to the
				permanent location each day and stored there,
(3)The permanent location is the address of record for the
				pharmacy, and
(4) A charitable
				clinic that utilizes mobile clinics shall not have controlled dangerous
				substances (CDS). No CDS are allowed in mobile clinics.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-1 - Purpose

Current through Vol. 41, No. 20, July 1, 2024
In an effort to assist the pharmacist with regular, routine,
				  non-judgmental, mechanical and nondiscretionary tasks so that the pharmacist
				  may counsel patients and improve pharmaceutical care and therapeutic outcomes,
				  this Subchapter allows certain tasks to be performed by and describes the role
				  of pharmacy supportive personnel as authorized at 59 O.S., Section353.18A.
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 535:15-13-2 - Hospital pharmacy technicians definitions and duties

Current through Vol. 41, No. 20, July 1, 2024
Hospital pharmacy technician definitions and duties are
				  enumerated in OAC 535:15-5.
Added at 11 Ok Reg 3431,
				  eff 6-27-94
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-3 - 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:
"Auxiliary supportive personnel"
or
"auxiliary supportive person"
means all persons, other than
				  pharmacists, interns and techs, who are regularly paid employees of the
				  pharmacy and who work or perform tasks in the pharmacy that do not require a
				  permit or license (e.g. clerk, typist, delivery or data entry person, etc.).
"Certify a prescription"
means the confirmation
				  by the supervising pharmacist of the accuracy and completeness of the acts,
				  tasks or functions undertaken by supportive personnel to assist the pharmacist
				  in the practice of pharmacy. This process shall be completed before the
				  prescription is given to the patient.
"Pharmacy technician"
,
"Technician"
, or
"Rx Tech"
means a person who has
				  been issued a permit by the Board to assist the pharmacist and perform
				  nonjudgmental, technical, manipulative, non-discretionary functions in the
				  prescription department under the pharmacist's immediate and direct
				  supervision.
"Significant compounding"
means compounding
				  activity which equals at least ten percent (10%) of the prescription volume of
				  the pharmacy.
"Supportive personnel"
means supportive
				  personnel as defined in 59 O.S. Section 353.1 et seq.
Added at 11 Ok Reg 3431,
				  eff 6-27-94; Amended at 17 Ok Reg 2626, eff 7-1-00; 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 535:15-13-4 - Pharmacy technician qualifications and training

Current through Vol. 41, No. 20, July 1, 2024
(a) A
				pharmacy technician must have completed a high school education, HiSet
				Examination, or G.E.D. equivalence, and shall be of good moral character, be
				non-impaired (e.g., alcohol or drugs) and have adequate education to perform
				assigned duties.
(b) A pharmacy
				manager employing a currently permitted technician must document training of
				that technician within 10 days of hire.
(c) The pharmacy technician must, at a
				minimum, satisfactorily complete a pharmacy technician on-the-job training
				(OJT) program described in
				535:15-13-13.
(d) To be eligible for a pharmacy technician
				permit, an applicant must maintain compliance with the requirements in this
				Title, 535:25 and 535:15.
Added at 11 Ok Reg 3431,
				  eff 6-27-94; Amended at 17 Ok Reg 2626, eff 7-1-00; 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 535:15-13-5 - Supervision of pharmacy technicians

Current through Vol. 41, No. 20, July 1, 2024
(a) All
				tasks performed by pharmacy technicians must be in a licensed pharmacy located
				in Oklahoma and must be accomplished under the immediate and direct supervision
				of a pharmacist who is currently licensed by the Board.
(1) Failure by the licensed pharmacy and
				pharmacist manager (PIC) to provide adequate supervision; and/or failure of a
				pharmacist to adequately supervise a technician is a violation of these State
				Board of Pharmacy regulations.
(2)
				An intern cannot supervise a technician.
(3) Failure to adequately supervise a
				pharmacy technician is a violation of these State Board of Pharmacy regulations
				by the pharmacist, pharmacy and pharmacist manager.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-6 - Duties

Current through Vol. 41, No. 20, July 1, 2024
(a) The following tasks may be performed by
				auxiliary supportive personnel:
(1) retrieval
				tasks such as retrieving prescriptions or files as necessary;
(2) clerical tasks such as data entry, typing
				labels and maintaining patient profiles;
(3) secretarial tasks such as telephoning,
				filing, and typing;
(4) accounting
				tasks such as record keeping, maintaining accounts receivables, third party
				billing and posting;
(5) inventory
				control tasks including monitoring, pricing, dating, invoicing, stocking
				pharmacy, and preparation of purchase orders; and
(6) help maintain a clean and orderly
				pharmacy.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-6.1 - Technician rules for administering immunizations

Current through Vol. 41, No. 20, July 1, 2024
(a) In
				order to obtain and maintain eligibility to administer immunizations, an
				applicant must be permitted as a pharmacy technician in Oklahoma and have
				successfully completed an Accreditation Council for Pharmacy Education (ACPE)
				accredited immunization training program for pharmacy technicians.
(b) A pharmacy technician with immunization
				registration must complete a minimum of 1 hour of immunization related ACPE
				accredited, or Board approved Continuing Education (CE) annually.
(c) A pharmacy technician must maintain
				current Cardiopulmonary Resuscitation (CPR) certification.
(d) The pharmacist in charge and pharmacy
				technician are responsible for maintaining training and education
				documentation.
(e) A pharmacy
				technician with proper training may administer vaccines delegated by the
				pharmacist on duty if:
(1) The vaccine is
				authorized, approved, or licensed by the Food and Drug Administration
				(FDA).
(2) The vaccine is ordered
				and administered according to Centers for Disease Control (CDC)/Advisory
				Committee on Immunization Practices (ACIP) recommendations.
(3) The delegating pharmacist is readily and
				immediately available to the immunizing pharmacy technician.
(4) The delegating pharmacist is registered
				with the Board as an immunizing pharmacist and is current on all other
				requirements of the Board.
Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 13 - Pharmacy Supportive Personnel › Section 535:15-13-7 - Prohibited duties

Current through Vol. 41, No. 20, July 1, 2024
These duties shall not be performed by supportive personnel:
(1) The pharmacist must interpret the
				original prescription.
(2) The
				pharmacist must perform the prospective drug utilization review and determine
				action to be taken when there is an indication of a drug interaction.
(3) The pharmacist must receive new orally
				communicated prescriptions from prescribers or their agents.
(4) The pharmacist must determine product
				selection if substitution is requested or approved.
(5) The pharmacist must certify, by
				reviewing, the completed prescription for accuracy and completeness before the
				prescription is released from the prescription department. This process shall
				be completed before the prescription is given to the patient.
(6) The pharmacist must provide patient
				counseling or drug information as necessary.
(7) The pharmacist must take verbal
				authorizations from licensed prescriber or licensed prescriber's authorized
				agent (when allowed) for any refill of a controlled substance or any
				non-controlled prescription that has changes to strength or
				directions.
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