1. (a)

   1. (1) The size and type of services to be provided in the pharmacy can largely depend upon the:

      1. (A) Type of medication distribution system used;
      2. (B) Number of patients to be served; and
      3. (C) Extent of shared or purchased services.
   2. (2) This shall be described in the narrative functional program.

   3. (3) The pharmacy room or suite shall be located for:

      1. (A) Convenient access;
      2. (B) Staff control; and
      3. (C) Security.
   4. (4) Facilities and equipment shall be as necessary to accommodate the functions of the program.
   5. (5) See 20 CAR § 47-121(e), pharmaceutical service, for additional requirements.

2. (b) At a minimum, the following elements shall be included:

   1. (1)

      1. (A) Dispensing.
      2. (B) A pickup and receiving area.
      3. (C) An area for reviewing and recording.
      4. (D) An extemporaneous compounding area that includes:

3. (i) A sink; and

   1. (ii) Sufficient counter space for medication preparation.

      1. (E) Work counters and space for automated and manual dispensing activities.
      2. (F) An area for temporary storage, exchange, and restocking of carts.
      3. (G) Security provisions for medications and personnel in the dispensing counter area;

   2. (2)

      1. (A) Manufacturing.
      2. (B) A bulk compounding area.
      3. (C) Provisions for packaging and labeling.
      4. (D) A quality control area;

   3. (3)

      1. (A) Storage (may be cabinets, shelves, and/or separate rooms or closets).
      2. (B) Bulk storage.
      3. (C) Active storage.
      4. (D) Refrigerated storage.
      5. (E) Volatile fluids and alcohol storage constructed according to applicable fire safety codes for the substances involved.
      6. (F) Double-locked storage for controlled substances.
      7. (G) Storage for general supplies and equipment not in use;

   4. (4)

      1. (A) Administration.

      2. (B)

         1. (i) An area for education and training.
         2. (ii) May be in a multipurpose room shared with other departments.
      3. (C) A separate area for office functions; and

   5. (5)

      1. (A) Other.
      2. (B) Hand washing facilities stations shall be provided within each separate room where open medication is handled and readily accessible.
      3. (C) Provide for convenient access to toilet and locker.
      4. (D) If unit dose procedure is used, provide additional space and equipment for supplies, packaging, labeling, and storage, as well as for the carts.

      5. (E)

         1. (i) If IV solutions are prepared in the pharmacy, provide a sterile work area with a laminar-flow workstation designed for product protection.
         2. (ii) The laminar-flow system shall:
4. (a) (a) Include a nonhygroscopic HEPA filter rated at ninety-nine and ninety-seven hundredths percent (99.97%) as tested by DOP tests; and

5. (b) (b) Have a visible pressure gauge for detection of filter leaks or defects.

   1. (F) Hoods used for chemotherapy shall be one hundred percent (100%) exhausted to the exterior.

      1. (G) At a minimum, the partitions enclosing the pharmacy shall extend from the floor to the deck above with gypsum board on both sides of metal studs.

Codification Notes: “DOP” means dispersed oil particulate. "HEPA" means high efficiency particulate air. "IV" means intravenous.