The licensee shall:

1. (1) Maintain the pharmacy in the hospital in a safe, clean, and sanitary condition;
2. (2) Provide evidence of current approval of pharmacy services by the Washington state board of pharmacy under chapter 18.64 RCW;

3. (3) Develop and implement procedures for prescribing, storing, and administering medications according to state and federal laws and rules, including:

   1. (a) Assuring professional staff who prescribe are authorized to prescribe under chapter 69.41 RCW;

   2. (b) Assuring orders and prescriptions for medications administered and self-administered include:

      1. (i) Date and time;
      2. (ii) Type and amount of drug;
      3. (iii) Route of administration;
      4. (iv) Frequency of administration; and
      5. (v) Authentication by professional staff;
   3. (c) Administering drugs;
   4. (d) Self-administering drugs;
   5. (e) Receiving and recording or transcribing verbal or telephone drug orders by authorized staff;
   6. (f) Authenticating verbal and telephone orders by prescriber in a timely manner, not to exceed forty-eight hours for inpatients;

   7. (g) Use of medications and drugs owned by the patient but not dispensed by the hospital pharmacy, including:

      1. (i) Specific written orders;
      2. (ii) Identification and administration of drug;
      3. (iii) Handling, storage and control;
      4. (iv) Disposition; and
      5. (v) Pharmacist and physician inspection and approval prior to patient use to ensure proper identification, lack of deterioration, and consistency with current medication profile;
   8. (h) Maintaining drugs in patient care areas of the hospital including:
   9. (i) Hospital pharmacist or consulting pharmacist responsibility;
   10. (ii) Legible labeling with generic and/or trade name and strength as required by federal and state laws;
   11. (iii) Access only by staff authorized access under hospital policy;

   12. (iv) Storage under appropriate conditions specified by the hospital pharmacist or consulting pharmacist, including provisions for:

       1. (A) Storing medicines, poisons, and other drugs in a specifically designated, well-illuminated, secure space;
       2. (B) Separating internal and external stock drugs; and
       3. (C) Storing Schedule II drugs in a separate locked drawer, compartment, cabinet, or safe; and
       4. (i) Preparing drugs in designated rooms with ample light, ventilation, sink or lavatory, and sufficient work area;
       5. (j) Prohibiting the administration of outdated or deteriorated drugs, as indicated by label;

       6. (k) Restricting access to pharmacy stock of drugs to:

          1. (i) Legally authorized pharmacy staff; and

          2. (ii) Except for Schedule II drugs, to a registered nurse designated by the hospital when all of the following conditions are met:

             1. (A) The pharmacist is absent from the hospital;
             2. (B) Drugs are needed in an emergency, and are not available in floor supplies; and
             3. (C) The registered nurse, not the pharmacist, is accountable for the registered nurse's actions;

4. (4) The appropriate professional staff committee shall approve all policies and procedures on drugs, after documented consultation with:

   1. (a) The pharmacist or pharmacist consultant directing hospital pharmacy services; and
   2. (b) An advisory group comprised of representatives from the professional staff, hospital administration, and nursing services;

5. (5) When planning new construction of a pharmacy:

   1. (a) Follow the general design requirements for architectural components, electrical service, lighting, call systems, hardware, interior finishes, heating, plumbing, sewerage, ventilation/air conditioning, and signage in WAC 246-318-540;
   2. (b) Provide housekeeping facilities within or easily accessible to the pharmacy;

   3. (c) Locate pharmacy in a clean, separate, secure room with:

      1. (i) Storage, including locked storage for Schedule II controlled substances;
      2. (ii) All entrances equipped with closers;
      3. (iii) Automatic locking mechanisms on all entrance doors to preclude entrance without a key or combination;
      4. (iv) Perimeter walls of the pharmacy and vault, if used, constructed full height from floor to ceiling;
      5. (v) Security devices or alarm systems for perimeter windows and relites;
      6. (vi) An emergency signal device to signal at a location where twenty-four-hour assistance is available;
      7. (vii) Space for files and clerical functions;
      8. (viii) Break-out area separate from clean areas; and
      9. (ix) Electrical service including emergency power to critical pharmacy areas and equipment;

   4. (d) Provide a general compounding and dispensing unit, room, or area with:

      1. (i) A work counter with impermeable surface;
      2. (ii) A corrosion-resistant sink, suitable for handwashing, mounted in counter or integral with counter;
      3. (iii) Storage space;
      4. (iv) A refrigeration and freezing unit; and
      5. (v) Space for mobile equipment;

   5. (e) If planning a manufacturing and unit dose packaging area or room, provide with:

      1. (i) Work counter with impermeable surface;
      2. (ii) Corrosion-resistant sink, suitable for handwashing, mounted in counter or integral with counter; and
      3. (iii) Storage space;

   6. (f) Locate admixture, radiopharmaceuticals, and other sterile compounding room, if planned, in a low traffic, clean area with:

      1. (i) A preparation area;
      2. (ii) A work counter with impermeable surface;
      3. (iii) A corrosion-resistant sink, suitable for handwashing, mounted in counter or integral with counter;
      4. (iv) Space for mobile equipment;
      5. (v) Storage space;
      6. (vi) A laminar flow hood in admixture area; and
      7. (vii) Shielding and appropriate ventilation according to WAC 246-318-540 (3)(m) for storage and preparation of radiopharmaceuticals;

   7. (g) If a satellite pharmacy is planned, comply with the provisions of:

      1. (i) Subsection (5)(a), (5)(c)(i), (ii), (iii), (iv), (v), and (vi) of this section when drugs will be stored;
      2. (ii) Subsection (5)(c)(vii), (viii), and (ix) of this section, if appropriate; and
      3. (iii) Subsections (5)(d) and (g) of this section if planned;
   8. (h) If a separate outpatient pharmacy is planned, comply with the requirements for a satellite pharmacy including:
   9. (i) Easy access;
   10. (ii) A conveniently located toilet meeting accessibility requirements in WAC 51-20-3100; and
   11. (iii) A private counseling area.

[Statutory Authority: Chapter 71.12 RCW and RCW 43.60.040. WSR 95-22-013, § 246-324-210, filed 10/20/95, effective 11/20/95.]