reglab/statecodes huggingface dataset:
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart A - Pharmacies, HCEs and HPACs › Section 246-945-445 - Investigational drugs

Current through Register Vol. 24-14, July 15, 2024
(1) The responsible
					 pharmacy manager or their designee is responsible for the storage,
					 distribution, and control of approved investigational drugs used in an
					 institutional facility. The pharmacy shall be responsible for maintaining and
					 providing information on approved investigational drugs.
(2) Under the explicit direction of the
					 authorized principal investigator, coinvestigator(s), or per study protocol
					 requirements, investigational drugs must be properly labeled and stored for
					 use. An appropriate medical staff committee, institution review board, or
					 equivalent committee, shall approve the use of such drugs.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart A - Pharmacies, HCEs and HPACs › Section 246-945-450 - Accessing technology used to dispense-Nursing students

Current through Register Vol. 24-14, July 15, 2024
(1) Nursing students may be given access
					 privileges to technology used to dispense medications for patient
					 administration as provided for in this section.
(2) Nursing students must be enrolled in a
					 nursing program approved by the Washington state nursing care quality assurance
					 commission in accordance with WAC
					 246-840-510.
(3) A facility that provides a clinical
					 opportunity to nursing students must meet the following to grant access to
					 technology used to dispense medications for patient administration:
(a) The facility, in collaboration with the
					 nursing program, shall provide nursing students with orientation and practice
					 experiences that include the demonstration of competency of skills prior to
					 using the dispensing technology;
(b) Nursing programs and participating
					 facilities shall provide adequate training for students accessing dispensing
					 technology;
(c) The nursing
					 programs and participating facilities shall have policies and procedures for
					 nursing students to provide safe administration of medications; and
(d) The nursing program and participating
					 facilities shall develop and have a way of reporting and resolving any nursing
					 student medication errors, adverse events, and alleged diversion.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart A - Pharmacies, HCEs and HPACs › Section 246-945-455 - Drugs stored outside of the pharmacy

Current through Register Vol. 24-14, July 15, 2024
(1)
					 In order for drugs to be stored in a designated area outside the pharmacy
					 including, but not limited to, floor stock, in an emergency cabinet, in an
					 emergency kit, or as emergency outpatient drug delivery from an emergency
					 department at a registered institutional facility, the following conditions
					 must be met:
(a) Drugs stored in such a
					 manner shall remain under the control of, and be routinely monitored by, the
					 supplying pharmacy;
(b) The
					 supplying pharmacy shall develop and implement policies and procedures to
					 prevent and detect unauthorized access, document drugs used, returned and
					 wasted, and regular inventory procedures;
(c) Access must be limited to health care
					 professionals licensed under the chapters specified in
					 RCW
					 18.130.040 acting within their scope, and
					 nursing students as provided in WAC 246-945-450;
(d) The area is appropriately equipped to
					 ensure security and protection from diversion or tampering; and
(e) The facility is able to possess and store
					 drugs.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart A - Pharmacies, HCEs and HPACs › Section 246-945-457 - Remote dispensing sites for opioid use disorder medications

Current through Register Vol. 24-14, July 15, 2024
A pharmacy may extend its license to register a remote
						dispensing site where technology is used to dispense medications used for
						treatment of opioid use disorder or its symptoms. A pharmacy holding this
						registration is the supplying pharmacy and must comply with subsections (1)
						through (5) of this section and all applicable regulations in Title 21 of the
						Code of Federal Regulations.
(1) The
					 supplying pharmacy must separately register each remote dispensing site with
					 the commission by completing and returning an application form supplied by the
					 commission and pay applicable fees established by the secretary.
(2) Medications stored in registered remote
					 dispensing sites shall remain under the control of, and be routinely monitored
					 by, the supplying pharmacy.
(3) The
					 supplying pharmacy shall develop and implement policies and procedures to:
(a) Prevent and detect unauthorized access to
					 the registered remote dispensing site;
(b) Document medications used, returned, and
					 wasted from the registered remote dispensing site;
(c) Require the supplying pharmacy to perform
					 a perpetual inventory of medications stored at the registered remote dispensing
					 site; and
(d) Ensure that only the
					 supplying pharmacy is stocking medications stored at a registered remote
					 dispensing site.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart A - Pharmacies, HCEs and HPACs › Section 246-945-460 - Staffing and supervision of pharmacy staff

Current through Register Vol. 24-14, July 15, 2024
(1) The ratio of pharmacy technicians to
					 pharmacist(s) on duty is to be determined by the responsible pharmacy
					 manager.
(2) The responsible
					 pharmacy manager will ensure that the number of pharmacy technicians on duty
					 can be satisfactorily supervised by the pharmacist(s) on duty.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart A - Pharmacies, HCEs and HPACs › Section 246-945-480 - Facility reporting requirements

Current through Register Vol. 24-14, July 15, 2024
(1)
					 The outgoing and incoming responsible pharmacy manager must report in writing
					 to the commission a change in a responsible manager designation within ten
					 business days of the change.
(2)
					 Unless otherwise specified, when permanently closing a facility, the facility
					 must:
(a) Report to the commission in
					 writing, no later than thirty calendar days prior to closing:
(i) The date the facility will
					 close;
(ii) The names and addresses
					 of the persons who shall have custody of the prescription files, bulk
					 compounding records, repackaging records, invoices and controlled substances
					 inventory records of the pharmacy to be closed; and
(iii) The names and addresses of any
					 person(s) who will acquire any legend drugs from the facility to be closed, if
					 known at the time the notification is filed.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart A - Pharmacies, HCEs and HPACs › Section 246-945-485 - Destruction or return of drugs or devices-Restrictions

Current through Register Vol. 24-14, July 15, 2024
(1) A dispensed drug or prescription device
					 must only be accepted for return and reuse as follows:
(a) Noncontrolled legend drugs that have been
					 maintained in the custody and control of the institutional facility, dispensing
					 pharmacy, or their related facilities under common control may be returned and
					 reused if product integrity can be assured.
(b) Those that qualify for return under the
					 provisions of chapter 69.70 RCW.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart A - Pharmacies, HCEs and HPACs › Section 246-945-486 - Return and reuse of unexpired medications-Department of corrections

Current through Register Vol. 24-14, July 15, 2024
(1) For the
					 purposes of this section, the term "facilities" includes all facilities served
					 by the Washington state department of corrections pharmacy.
(2) The Washington state department of
					 corrections pharmacy may accept for return and reuse noncontrolled legend drugs
					 in unit dose packages, or full or partial multiple dose medication cards from
					 the facilities it serves, if product integrity can be assured and the
					 Washington state department of corrections pharmacy complies with
					 RCW
					 69.70.050(1), (2), and
					 (5).
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart A - Pharmacies, HCEs and HPACs › Section 246-945-488 - Safe donation of unexpired prescription drugs

Current through Register Vol. 24-14, July 15, 2024
(1) For the purposes of this section, the
					 definitions in
					 RCW
					 69.70.010 apply.
(2) A pharmacy that accepts, distributes, or
					 dispenses prescription drugs and supplies under WAC
					 246-945-485(1)(b)
					 that are donated shall:
(a) Comply with the
					 requirements in
					 RCW
					 69.70.020,
					 69.70.030,
					 69.70.040, and
					 69.70.050, when
					 applicable;
(b) Complete and return
					 an attestation form developed and supplied by the commission attesting to
					 participation in the drug donation program;
(c) Notify the commission in writing if it is
					 no longer accepting donated prescription drugs and supplies. This notification
					 must occur within thirty calendar days of the pharmacy no longer accepting
					 donated prescription drugs and supplies;
(d) Not accept donations of prescription
					 drugs and supplies via a drop box;
(e) Ensure that prescription drugs and
					 supplies donated by the person to whom the prescription drug was prescribed or
					 the person's representative are accompanied by the department's drug donation
					 form in accordance with
					 RCW
					 69.70.020(2);
(f) Ensure clear separation of the pharmacy's
					 donated prescription drug stock from the rest of the pharmacy's drug
					 stock;
(g) Maintain a separate
					 inventory of all prescription drugs and supplies donated to the pharmacy;
					 and
(h) Develop and implement
					 policies and procedures addressing:
(i) When
					 prescription drugs or supplies may be accepted and dispensed. The policy and
					 procedure shall require a pharmacist to inspect the donated prescription drugs
					 and supplies; and
(ii) How the
					 pharmacy will respond when it is informed of a recall for donated prescription
					 drugs and supplies.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart A - Pharmacies, HCEs and HPACs › Section 246-945-490 - Nuclear pharmacies

Current through Register Vol. 24-14, July 15, 2024
(1) The
					 commission shall issue a permit to operate a nuclear pharmacy providing
					 radiopharmaceutical services to a qualified nuclear pharmacist. The qualified
					 nuclear pharmacist shall:
(a) Supervise all
					 personnel performing tasks in the preparation and distribution of
					 radiopharmaceuticals.
(b) Be
					 responsible for all operations of the licensed area.
(c) Designate one or more qualified health
					 care professionals licensed under the chapters specified in
					 RCW
					 18.130.040, to have access to the licensed
					 area in emergency situations and in the nuclear pharmacist's absence. These
					 individuals may obtain radiopharmaceuticals for the immediate emergency and
					 must document such withdrawals in the control system.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart A - Pharmacies, HCEs and HPACs › Section 246-945-492 - Nuclear pharmacies-Equipment requirements

Current through Register Vol. 24-14, July 15, 2024
(1) A nuclear pharmacy shall have adequate
					 equipment appropriate with the scope of radiopharmaceutical services to be
					 provided. The nuclear pharmacy shall submit to the commission and the radiation
					 control agency a detailed list of equipment and description of use before
					 approval of the license.
(2) The
					 commission may, for good cause shown, waive regulations pertaining to the
					 equipment and supplies required for a nuclear pharmacy handling
					 radiopharmaceuticals exclusively.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart B - Registrations › Section 246-945-500 - Humane societies, animal control agencies, and department of fish and wildlife chemical capture programs-Designated person

Current through Register Vol. 24-14, July 15, 2024
(1) Each registered humane society, animal
					 control agency, and department of fish and wildlife chemical capture program
					 location shall have a designated person.
(2) The designated person is responsible for:
(a) Ordering, possession, safe storage and
					 use of all approved drugs;
(b)
					 Maintaining all records required by WAC 246-945-510; and
(c) Ensuring all records required by WAC
					 246-945-510 are available for inspection by the commission or its
					 designee.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart B - Registrations › Section 246-945-503 - Humane societies, animal control agencies, and department of fish and wildlife chemical capture programs-Authorized personnel

Current through Register Vol. 24-14, July 15, 2024
(1) Each registered humane society, animal
					 control agency, and department of fish and wildlife chemical capture program
					 location shall ensure only authorized personnel possess or administer approved
					 legend drugs and approved controlled substances at the registered
					 location.
(2) For registered humane
					 societies and animal control agencies, authorized personnel are those
					 individuals who have:
(a) Completed a
					 commission-approved training program or training that is substantially
					 equivalent; and
(b) Been approved
					 by the designated person.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart B - Registrations › Section 246-945-505 - Humane societies and animal control agencies-Approved legend drugs and approved controlled substances

Current through Register Vol. 24-14, July 15, 2024
(1)
					 The following legend drugs are designated as "approved legend drugs" for use by
					 registered humane societies and animal control agencies for preeuthanasia
					 sedation:
(a) Acetylpromazine;
(b) Dexmedetomidine;
(c) Medetomidine; and
(d) Xylazine.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart B - Registrations › Section 246-945-507 - Department of fish and wildlife chemical capture programs-Approved legend drugs and approved controlled substances

Current through Register Vol. 24-14, July 15, 2024
(1) The following legend drugs are designated
					 as "approved legend drugs" for use by registered department of fish and
					 wildlife chemical capture programs:
(a)
					 Acetylpromazine;
(b)
					 Atipamezole;
(c)
					 Azaperone;
(d)
					 Detomidine;
(e)
					 Dexmedetomidine;
(f)
					 Isoflurane;
(g)
					 Medetomidine;
(h)
					 Naltrexone;
(i)
					 Tolazoline;
(j) Xylazine;
					 and
(k)
					 Yohimbine.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart B - Registrations › Section 246-945-510 - Humane societies, animal control agencies, and department of fish and wildlife chemical capture programs-Recordkeeping and reports

Current through Register Vol. 24-14, July 15, 2024
(1) Each registered
					 humane society, animal control agency, and department of fish and wildlife
					 chemical capture program location shall record the receipt, use, and
					 disposition of approved drugs in a logbook or electronic record. An electronic
					 record can meet the requirements of this section if the electronic record is
					 legible and in a readily retrievable format, provided federal law does not
					 require them to be kept in a hard copy format.
(2) The logbook or electronic record must
					 have sufficient detail to allow an audit of the drug usage to be performed and
					 must include:
(a) Date and time of
					 administration;
(b) Route of
					 administration;
(c) Identification
					 number or other identifier assigned to the animal;
(d) Estimated weight of the animal;
(e) Estimated age and breed or species of the
					 animal;
(f) Name of drug
					 used;
(g) Dose of drug
					 administered;
(h) Amount of drug
					 wasted; and
(i) Initials of the
					 primary person administering the drug.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart B - Registrations › Section 246-945-515 - Human societies, animal control agencies, and department of fish and wildlife chemical capture programs-Drug storage and field use

Current through Register Vol. 24-14, July 15, 2024
(1) Each registered
					 humane society, animal control agency, and department of fish and wildlife
					 chemical capture program location must store all approved legend drugs, and
					 approved controlled substances in a substantially constructed securely locked
					 cabinet or drawer.
(2) Only
					 authorized personnel as defined in WAC 246-945-503(2) and (3) shall have access
					 to the drug storage cabinet or drawer at the registered location.
(3) A registered humane society and animal
					 control agency may allow the possession of approved drugs for field use under
					 the following conditions:
(a) The individual
					 meets the requirements of an authorized person in WAC 246-945-503(2);
(b) The individual is either:
(i) A humane officer;
(ii) An animal control enforcement
					 officer;
(iii) An animal control
					 authority; or
(iv) A peace officer
					 authorized by the chief of police, sheriff, or county
					 commissioner.
(c) The
					 approved drugs are stored in a locked metal box securely attached to a
					 vehicle;
(d) A drug inventory is
					 completed at the beginning and end of each shift, and recorded in a logbook or
					 electronic record that meets the requirements of WAC 246-945-510; and
(e) All receipts and use of
					 approved drugs are recorded in a logbook or electronic record that meets the
					 requirements of WAC 246-945-510.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-550 - Manufacturers-Minimum standards

Current through Register Vol. 24-14, July 15, 2024
(1)
					 Manufacturers shall comply with the applicable requirements in 21 C.F.R., Part
					 210, "Current Good Manufacturing Practice in Manufacturing, Processing,
					 Packing, or Holding of Drugs"; and 21 C.F.R., Part 211, "Current Good
					 Manufacturing Practice for Finished Pharmaceuticals; General."
(2) Manufacturers required to register with
					 the FDA as an outsourcing facility as defined in 21 U.S.C. Sec. 353b (d)(4)(A),
					 shall also comply with FDA guidance document.
(3) Virtual manufacturers shall ensure its
					 own drugs are manufactured in compliance with this section.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-553 - Teat dip containers

Current through Register Vol. 24-14, July 15, 2024
The reuse of teat dip containers and closures shall be
						allowed under the following circumstances:
(1) Teat dip containers for reuse must have
					 attached a labeling panel bearing product name, brand name and distributor
					 address if marketed by other than the manufacturer, manufacturer name and
					 address, product strength, quantity, expiration date, directions for use, and
					 appropriate cautionary statements for the product contained within.
(2) All reusable teat dip containers will be
					 hot stamped for permanent identification as teat dip containers. The hot stamp
					 shall imprint on the plastic container, in an immutable manner, the words "teat
					 dip only" and the manufacturer's name. Teat dip manufacturers may only refill
					 containers bearing their company name.
(3) With cooperation from dairy producers,
					 dairy sanitarians will take random samples of teat dip in reusable containers
					 while on regular farm inspections. The samples, along with appropriate label
					 information, will be forwarded to the commission for analysis to ensure that
					 the product meets label specifications and is free of contamination.
(4) Reusable teat dip containers shall not be
					 reactive, additive, or absorptive so as to alter the safety, identity,
					 strength, quantity, or purity of the product.
(5) Upon return to the manufacturer, reusable
					 teat dip containers shall be cleaned and sanitized. To ensure adequate cleaning
					 occurs, the commission may require a manufacturer to submit and have approved a
					 cleaning procedure. Containers showing structural damage, or any signs of being
					 used for substances or materials other than teat dip shall not be reused as
					 teat dip containers.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-555 - Wholesaler-Minimum standards-Scope

Current through Register Vol. 24-14, July 15, 2024
(1) WAC
					 246-945-560 through 246-945-600 establish the minimum standards for facilities
					 licensed as wholesalers, their officers, designated representatives, agents,
					 and employees.
(2) Virtual
					 wholesalers shall ensure drugs they purchase or sell are stored and distributed
					 in compliance with WAC 246-945-560 through 246-945-600.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-560 - Wholesaler-Facility standards

Current through Register Vol. 24-14, July 15, 2024
(1) Facilities
					 used for wholesale drug distribution must:
(a) Be of suitable size, construction, and
					 location to accommodate cleaning, maintenance, and proper operations;
(b) Have storage areas that provide adequate
					 lighting, ventilation, temperature, sanitation, humidity, space, equipment, and
					 security;
(c) Have a quarantine
					 area for storage of drugs that are outdated, damaged, deteriorated, misbranded,
					 adulterated, counterfeit, or suspected of being counterfeit, otherwise unfit
					 for distribution, or that are in immediate or sealed secondary containers that
					 have been opened;
(d) Be maintained
					 in a clean and orderly condition;
(e) Be free from infestation of any
					 kind;
(f) Be a commercial location
					 and not a personal dwelling or residence;
(g) Provide for the secure and confidential
					 storage of information with restricted access and policies and procedures to
					 protect the integrity and confidentiality of information; and
(h) Provide and maintain appropriate
					 inventory controls in order to detect and document any theft, counterfeiting,
					 or diversion of drugs.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-565 - Wholesaler-Drug storage

Current through Register Vol. 24-14, July 15, 2024
(1) Drugs must be
					 stored at temperatures and under conditions required by the labeling of the
					 drugs, if any, or by the requirements of the 43rd edition of USP and 38th
					 edition of the National Formulary (USP/NF), to preserve product identity,
					 strength, quality, and purity. The USP/NF is available for public inspection at
					 the commission's office at Department of Health, Town Center 2, 111 Israel Road
					 S.E., Tumwater, WA 98501. Requestors may also contact USP directly to obtain
					 copies.
(2) If no storage
					 requirements are established for a drug, the drug may be held at "controlled"
					 room temperature, as defined in an official compendium, to help ensure that its
					 identity, strength, quality, and purity are not adversely affected.
(3) Temperature and humidity recording
					 equipment, devices, and/or logs shall be used to document proper storage of
					 drugs.
(4) Controlled substance
					 drugs should be isolated from noncontrolled substance drugs and stored in a
					 secured area.
(5) Drugs that are
					 outdated, damaged, deteriorated, misbranded, or adulterated must be physically
					 separated from other drugs in a designated quarantine area until destroyed or
					 returned to the original manufacturer or third party returns
					 processor.
(6) Used drugs and those
					 whose immediate or sealed outer or sealed secondary containers have been opened
					 are adulterated and must be quarantined.
(7) Drugs must be quarantined under any
					 condition that causes doubt as to a drug's safety, identity, strength, quality,
					 or purity unless under examination, testing, or other investigation the drug is
					 proven to meet required standards.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-570 - Wholesaler-Drug shipment inspection

Current through Register Vol. 24-14, July 15, 2024
(1)
					 Each outside shipping container must be visually examined on receipt for
					 identity and to avoid acceptance of drugs that are contaminated or otherwise
					 unfit for distribution.
(2)
					 Outgoing shipments must be inspected to verify the accuracy and product
					 integrity of the shipment contents.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-575 - Wholesaler-Recordkeeping

Current through Register Vol. 24-14, July 15, 2024
(1) Wholesalers and
					 other entities engaged in wholesale drug distribution must establish and
					 maintain inventories and records of transactions pertaining to the receipt and
					 distribution or other disposition of drugs. The records must include at least:
(a) The source of the drugs, including the
					 name and principal address of the seller or transferor;
(b) The identity and quantity of the drugs
					 received and distributed or disposed of; and
(c) The dates of receipt and distribution or
					 other disposition of the drugs.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-580 - Wholesaler-Personnel

Current through Register Vol. 24-14, July 15, 2024
(1) A wholesaler
					 must establish and maintain a list of officers, directors, managers, a
					 designated representative, and other persons responsible for wholesale drug
					 distribution, storage, and handling and must include a description of each
					 individual's duties and a summary of their qualifications.
(2) A wholesaler must employ personnel in
					 sufficient numbers and with adequate education, training, and experience to
					 safely and lawfully engage in wholesale drug distribution activities.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-585 - Wholesaler-Suspicious orders and due diligence

Current through Register Vol. 24-14, July 15, 2024
(1)
					 Wholesalers shall design and operate a system to identify and report suspicious
					 orders of controlled substances and drugs of concern to the commission.
(a) Suspicious orders shall be submitted
					 electronically through a commission approved system or to the commission or
					 within five business days of the order being identified as suspicious by the
					 wholesaler, and must include, but not necessarily limited to:
(i) Customer name;
(ii) Customer address;
(iii) Customer DEA registration number;
(iv) State license number(s);
(v) Transaction date;
(vi) Drug name;
(vii) NDC number;
(viii) Quantity ordered; and
(ix) Indication of whether the drug was
					 shipped, and if not, the factual basis for the refusal to
					 supply.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-590 - Wholesaler-Policies and procedures

Current through Register Vol. 24-14, July 15, 2024
Wholesalers shall establish, maintain, and adhere to
						written policies and procedures, which shall be followed for the receipt,
						security, storage, inventory, transport, and shipping and wholesale
						distribution of drugs, including policies and procedures for identifying,
						recording, and reporting losses or thefts and for correcting all errors and
						inaccuracies in inventories. Wholesalers shall include the following in their
						written policies and procedures:
(1) A
					 procedure to be followed for handling recalls and withdrawals of drugs. Such
					 procedure shall be adequate to deal with recalls and withdrawals due to:
(a) Any action initiated at the request of
					 FDA or any other federal, state, or local law enforcement or other government
					 agency, including the commission; or
(b) Any volunteer action by the manufacturer
					 to remove defective or potentially defective drugs from the market.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-595 - Wholesaler and manufacturer-Prohibited acts

Current through Register Vol. 24-14, July 15, 2024
It is unlawful for a wholesaler or manufacturer to
						perform, cause the performance of, or aid and abet any of the following acts in
						Washington state:
(1) The manufacture,
					 repackaging, sale, delivery, or holding or offering for sale any drug that is
					 adulterated, misbranded, counterfeit, suspected of being counterfeit, or has
					 otherwise been rendered unfit for distribution or wholesale
					 distribution;
(2) The adulteration,
					 misbranding, or counterfeiting of any drug;
(3) The alteration, mutilation, destruction,
					 obliteration, or removal of the whole or any part of the product labeling of a
					 drug or the commission of any other act with respect to a drug that results in
					 the drug being misbranded;
(4) The
					 forging, counterfeiting, simulating, or falsely representing of any drug
					 without the authority of the manufacturer, or using any mark, stamp, tag,
					 label, or other identification device without the authorization of the
					 manufacturer;
(5) The purchase or
					 receipt of a drug from a person that is not authorized to distribute drugs to
					 that purchaser or recipient;
(6)
					 The sale or transfer of a drug to a person who is not legally authorized to
					 receive a drug;
(7) The sale or
					 transfer of a drug from pharmacies to distributors for resale;
(8) The failure to maintain or provide
					 records as required by laws and rules;
(9) Providing the commission or any of its
					 representatives or any state or federal official with false or fraudulent
					 records or making false or fraudulent statements regarding any matter within
					 the provisions of these laws and rules;
(10) The obtaining of or attempting to obtain
					 a drug by fraud, deceit, misrepresentation or engaging in misrepresentation or
					 fraud in the distribution or wholesale distribution of a drug;
(11) The distribution of a drug to the
					 patient without a prescription from a practitioner licensed by law to use or
					 prescribe the drug; and
(12) The
					 distribution or wholesale distribution of a drug that was previously dispensed
					 by a pharmacy or distributed by a practitioner.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-600 - Salvaging and reprocessing

Current through Register Vol. 24-14, July 15, 2024
Wholesalers shall be subject to the provisions of any
						applicable federal, state, or local laws or rules that relate to prescription
						drug salvaging or reprocessing, including Chapter 21, Parts 207, 210, and 211k
						of the Code of Federal Regulations.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-990 - Pharmaceutical licensing fees and renewal cycle

Current through Register Vol. 24-14, July 15, 2024
(1) Pharmacist, pharmacy technician, pharmacy
					 intern, and pharmacy assistant credentials must be renewed every two years on
					 the practitioner's birthday as provided in chapter 246-12 WAC.
(2) Pharmacy location credentials, controlled
					 substance researcher registration, drug dog handler K9 registration, and other
					 Controlled Substances Act registrations will expire on June 1st of each
					 year.
(3) All other credentials,
					 including health care entity, will expire on October 1st of each year, except
					 the shopkeeper endorsement which expires annually associated with a business
					 license issued by the department of revenue.
(4) The following nonrefundable fees will be
					 charged for pharmacy professionals:
(a) All
					 pharmacy professionals:
Title of fee
Fee
Verification of credential
$25.00
Duplicate credential
10.00
(b) Pharmacist:
Initial credential
$400.00
Renewal
530.00
Late renewal penalty
265.00
Expired credential reissuance
265.00
Inactive credential renewal
265.00
Retired active credential status application
50.00
Retired active credential status
								  renewal
50.00
Temporary practice permit
100.00
Reciprocity (license by license transfer)
465.00
(c) Pharmacy technician:
Initial credential
$140.00
Renewal
140.00
Late renewal penalty
70.00
Expired credential reissuance
70.00
(d) Pharmacy intern:
Initial credential
$90.00
Renewal
90.00
Late renewal penalty
50.00
Verification of internship hours
25.00
Expired credential reissuance
45.00
(e) Pharmacy assistant:
Initial credential
$70.00
Renewal
70.00
Late renewal penalty
50.00
Expired credential reissuance
35.00
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-991 - Hospital pharmacy associated clinics fees and renewal cycle

Current through Register Vol. 24-14, July 15, 2024
(1) Parent hospital
					 pharmacy licenses with one or more hospital pharmacy associated clinics (HPAC)
					 expire on June 1st of each year.
(2) A parent hospital pharmacy must submit
					 fees for HPACs in addition to fees set in WAC 246-945-990(5). HPAC fees are due
					 annually, except as provided under subsection (3)(d) of this section.
(3) A parent hospital pharmacy must submit
					 the following nonrefundable fees based on category and number of HPACs as
					 defined in WAC
					 246-945-233(3)
					 added to the parent hospital pharmacy license.
(a)
Category 1 HPAC.
A parent
					 hospital pharmacy must submit the Category 1 HP AC fee according to the number
					 of Category 1 HPACs under the parent hospital pharmacy license.
HPAC tier
Number of Category 1 HPACs under parent
								  hospital pharmacy license
Total annual fee
A
1-10
$895.00
B
11-50
$2,240.00
C
51-100
$3,125.00
D
Over 100
$4,025.00
(b)
Category 2 HPAC.
A parent
					 hospital pharmacy must submit the Category 2 HPAC fee for each Category 2 HPAC
					 under the parent hospital pharmacy license.
Category 2 HPAC fee
$755.00
(c) The department charges a processing fee
					 of fifty-five dollars for an amended license to change the number of
					 HPACs.
(d) If at any time a parent
					 hospital pharmacy submits an addendum increasing the number of HPACs on the
					 parent hospital pharmacy license, which changes the applicable HPAC tier to a
					 higher fee amount, the parent hospital pharmacy shall submit the difference in
					 fees with the addendum.
(e) The
					 department will not refund fees when a tier reduction occurs between renewal
					 periods.
Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 4 - OPERATIONAL STANDARDS › Subpart C - Drug Distributors › Section 246-945-992 - Fee payment

Current through Register Vol. 24-14, July 15, 2024
(1) A licensed
					 pharmacy, wholesaler, or manufacturer shall pay a facility inspection fee in
					 lieu of the original license fee when there is only a change of facility
					 location within the premises identified by the license address. Any change of
					 location to a different address shall require a new application and payment of
					 the original license fee.
(2) An
					 original license fee shall be paid whenever there is any change in ownership,
					 including change in business structure or organizational structure such as a
					 change from sole proprietorship to a corporation, or a change of more than
					 fifty percent ownership in a corporation.
(3) All fees for pharmacy professionals are
					 charged on a biennial basis and will not be prorated.
(4) All fees for pharmaceutical firms are
					 charged on an annual basis and will not be prorated.
Washington Administrative Code › Title 246 - Health, Department of › TRAUMA/EMERGENCY MEDICAL SERVICES › Chapter 246-976 - Emergency medical services and trauma care systems › Section 246-976-001 - Purpose

Current through Register Vol. 24-14, July 15, 2024
The purpose of these rules is to implement
				  RCW
				  18.71.200 through
				  18.71.215, and
				  chapters
				  18.73 and 70.168 RCW; and
				  those sections of
				  chapter
				  70.24 RCW relating to EMS
				  personnel and services.
(1) This
				chapter establishes criteria for:
(a)
				Training and certification of EMS providers;
(b) Licensure and inspection of ambulance
				services and aid services;
(c)
				Verification of prehospital trauma services;
(d) Development and operation of a statewide
				trauma registry;
(e) The
				designation process and operating requirements for designated trauma care
				services;
(f) A statewide emergency
				medical communication system;
(g)
				Administration of the statewide EMS/TC system.
Washington Administrative Code › Title 246 - Health, Department of › TRAUMA/EMERGENCY MEDICAL SERVICES › Chapter 246-976 - Emergency medical services and trauma care systems › TRAINING › Section 246-976-024 - EMS specialized training

Current through Register Vol. 24-14, July 15, 2024
(1)
				  MPDs may submit a proposal to conduct pilot training programs to determine the
				  need for skills, techniques, or equipment that is not included in standard
				  course curricula/instructional guidelines. A pilot program allows the MPD to
				  conduct field research to determine:
(a) The
				  effectiveness of the training;
(b)
				  EMS provider knowledge and skills competency;
(c) EMS provider ability to provide proper
				  patient care after the training.
Washington Administrative Code › Title 246 - Health, Department of › TRAUMA/EMERGENCY MEDICAL SERVICES › Chapter 246-976 - Emergency medical services and trauma care systems › TRAINING › Section 246-976-031 - Senior EMS instructor (SEI) approval

Current through Register Vol. 24-14, July 15, 2024
(1)
Responsibilities and
				  requirements.
(a) The SEI is
				  responsible for the overall instructional quality and the administrative
				  paperwork associated with initial EMR or EMT courses, under the general
				  supervision of the MPD.
(b) The SEI
				  must:
(i) Follow department-approved
				  curricula/instructional guidelines identified in WAC
				  246-976-023;
(ii) Ensure course applicants meet the course
				  application requirements in WAC
				  246-976-041; and
Washington Administrative Code › Title 246 - Health, Department of › TRAUMA/EMERGENCY MEDICAL SERVICES › Chapter 246-976 - Emergency medical services and trauma care systems › TRAINING › Section 246-976-033 - Denial, suspension, modification or revocation of SEI recognition

Current through Register Vol. 24-14, July 15, 2024
(1) The secretary
				  may deny, suspend, modify or revoke an SEI's recognition when it finds the SEI
				  has:
(a) Violated
				  chapter
				  18.130 RCW, the Uniform
				  Disciplinary Act;
(b) Failed to:
(i) Maintain EMS certification;
(ii) Update the following personal
				  information with the department as changes occur:
(A) Name;
(B) Address;
(C) Home and work phone numbers;
(iii) Maintain knowledge of
				  current EMS training and certification statutes, WAC, the UDA, and course
				  administration;
(iv) Comply with
				  requirements in WAC
				  246-976-031(1);
(v) Participate in the instructor candidate
				  evaluation process in an objective and professional manner without cost to the
				  individual being reviewed or evaluated;
(vi) Complete all forms and maintain records
				  in accordance with this chapter;
(vii) Demonstrate all skills and procedures
				  based on current standards;
(viii)
				  Follow the requirements of the Americans with Disabilities Act; or
(ix) Maintain security on all
				  department-approved examination materials.
Washington Administrative Code › Title 246 - Health, Department of › TRAUMA/EMERGENCY MEDICAL SERVICES › Chapter 246-976 - Emergency medical services and trauma care systems › TRAINING › Section 246-976-041 - To apply for training

Current through Register Vol. 24-14, July 15, 2024
(1) An
				  applicant for EMS training must be at least seventeen years old at the
				  beginning of the course. Variances will not be allowed for the age
				  requirement.
(2) An applicant for
				  training at the intermediate (AEMT) level, must be currently certified as an
				  EMT with at least one year of experience.
(3) An applicant for training at the advanced
				  life support (paramedic) level, must have at least one year of experience as a
				  certified EMT, or equivalent prehospital experience and meet all entry
				  requirements of the state approved paramedic training program.
Statutory Authority:
						Chapters
						18.71,
						18.73, and 70.168 RCW. 11-07-078,
						§ 246-976-041, filed 3/22/11, effective 5/15/11; 00-08-102, §
						246-976-041, filed 4/5/00, effective
						5/6/00.
Washington Administrative Code › Title 246 - Health, Department of › TRAUMA/EMERGENCY MEDICAL SERVICES › Chapter 246-976 - Emergency medical services and trauma care systems › CERTIFICATION › Section 246-976-142 - To obtain reciprocal (out-of-state) EMS certification, based on a current out-of-state or national EMS certification approved by the department

Current through Register Vol. 24-14, July 15, 2024
To apply for certification, an applicant must submit to the
					 department:
(1) A completed
				  certification application on forms provided by the department; and
(2) Proof of meeting the requirements
				  identified in Table A of this section.
Table A Reciprocity -- Out-of-State Applicants
					 Seeking EMS Certification
REQUIREMENTS
EMS educational program:
EMS courses conducted according to the U.S.
								  Department of Transportation, national EMS training course standards.
After June 30, 1996, paramedic training program
								  must be accredited by a national accrediting organization approved by the
								  department.
Additional education:
Provide proof of a department-approved four-hour
								  infectious disease course or a seven-hour HIV/AIDS course as required by
								  chapter
								  70.24 RCW.
Current credential:
Provide proof of valid EMS certification from
								  another state or national certifying agency approved by the department.
Certification examination:
Provide proof of a passing score on a
								  department-approved certification examination for the level of certification.
								  The score is valid for twelve months from the date of the examination. After
								  twelve months, a passing score on a department-approved certification
								  examination is required. Applicants will have three attempts within twelve
								  months from the first examination date to pass the examination.
Certification application:
High school diploma or GED: Required for EMT,
								  AEMT and paramedic only.
Provide proof of identity - State or federal
								  photo I.D. (military ID, driver's license, passport).
Provide proof of age - At least eighteen years of
								  age. Variances to this age requirement will not be granted.
Provide proof of EMS agency association - Active
								  membership, paid or volunteer with:
Licensed aid or ambulance service;
Law enforcement agency;
Business with organized industrial safety
								  team;
Senior EMS instructors or training coordinators,
								  teaching at department-approved EMS training programs, who are unable to be
								  associated with approved agencies above.
Recommendation of county medical program director
								  - required. MPD must sign application.
Background check - required. May include
								  requirement for fingerprint card and FBI background check.
Statutory Authority:
						Chapters
						18.71,
						18.73, and 70.168 RCW. 11-07-078,
						§ 246-976-142, filed 3/22/11, effective
						5/15/11.