§ 27.16. Construction and equipment requirements.

 (a)  Approval of plans. The following requirements are applicable to approval of plans:

   (1)  New pharmacy or change-of-location. Plans for construction of a new pharmacy or new location for an existing pharmacy may be submitted to the Board for approval prior to proceeding with construction. Within 90 days of receiving the plans, the Board will notify the applicant of its approval of the planned pharmacy or of its disapproval and the reasons for disapproval. The plans, including dimensions, must demonstrate compliance with applicable regulations and show the layout and fixtures for the prescription area and the immediately adjacent area.

   (2)  Alterations. The practice of pharmacy shall cease while substantial alterations in the layout or fixtures of an approved pharmacy are being made unless:

     (i)   The pharmacy makes the alterations and takes adequate precautions so that the health and safety of professionals, employees and the public is protected during the continuing operation of the pharmacy.

     (ii)   The plans for the alterations and a description of the precautions are submitted to the Board at least 30 days before the beginning of alteration work. If the Board raises no objection during that time, the pharmacy is authorized to proceed with the alterations as planned.

 (b)  Building standards. The following apply to building standards:

   (1)  Minimum size.

     (i)   The minimum size of the prescription area must be at least 250 square feet, and must be large enough, considering the level of activity, to carry on the practice of pharmacy in a manner that protects the health and safety of professionals, employees and the public. Within the prescription area, there must be a prescription working counter of at least 10 linear feet in length and 2 linear feet in width. If more than two pharmacists are on duty simultaneously, the minimum counter length shall be increased by 5 linear feet for an additional pharmacist. Institutions with special considerations may apply to the Board for a waiver.

     (ii)   A pharmacy operating as a central processing center need not conform to the minimum space requirements in subparagraph (i).

   (2)  Pharmacies in retail establishments. Pharmacies located within retail establishments whose business hours differ shall adhere to the following standards:

     (i)   The pharmacy can be securely sealed off from the remainder of the retail establishment.

     (ii)   The barrier devices which seal off the pharmacy must be capable of providing security for the pharmacy. The barrier devices must reach from floor to ceiling, shall be impenetrable by hand or the use of a reach extender, and be securely locked whenever a licensed pharmacist is not present and on duty.

     (iii)   The pharmacy shall be closed whenever a licensed pharmacist is not present in the immediate building and on duty. For purposes of this section, the term ‘‘immediate building’’ has the same meaning given to it in §  27.11(c)(1) (relating to pharmacy permit and pharmacist manager).

     (iv)   Safes, electrical equipment or other facilities of the retail establishment may not be located in or approached through the pharmacy unless a pharmacist is on duty whenever staff from the retail establishment need access to these facilities.

     (v)   The hours of the pharmacy shall be posted at all points of public access.

     (vi)   Protocols for access to the pharmacy when it is closed by nonpharmacist staff for bona fide emergencies, such as fires, natural disasters or police matters, must include notification to the pharmacist manager.

   (3)  Locked compartment. Space shall be provided in the prescription area for a substantially constructed cabinet or safe to contain controlled substances unless the pharmacy disperses controlled substances throughout the stock of noncontrolled substances in a manner that obstructs the theft of controlled substances. If the pharmacy stocks Schedule I controlled substances, these substances shall be stored in a securely locked, substantially constructed cabinet or safe.

   (4)  Telephone. At least one telephone shall be accessible in the prescription area, and the telephone number must be the telephone number printed on the prescription label.

   (5)  Sanitary facilities. Except for pharmacies operating as central processing centers, pharmacies shall be equipped with a sink within the prescription area to be used solely for pharmaceutical purposes. The sink must be connected properly to supply hot and cold water. Restroom facilities for employees of the pharmacy shall be provided reasonably close to, but outside of the prescription area.

   (6)  Lighting and ventilation. The pharmacy must be well lighted and ventilated.

   (7)  Television set. A television set may not be placed within the prescription area or so situated in the pharmacy that its viewing screen may be seen when looking at it from within the prescription area.

   (8)  Physical arrangement. The prescription area must be arranged so that prescription drugs and devices are inaccessible to an unlicensed or unauthorized person. The prescription area may not be used for storage of merchandise or other items other than those used in the preparation, dispensing or delivery of drugs. Animals may not be allowed in a prescription area except for security reasons.

   (9)  Existing pharmacies. Existing pharmacies licensed by the Board prior to the effective date of this chapter may continue if they reasonably conform, or are made to reasonably conform, to the intent of this chapter. The Board will determine what constitutes reasonable conformity consonant with the public interest, health, safety and welfare.

Authority

   The provisions of this §  27.16 amended under sections 4(j) and 6(k)(1) and (9) of the Pharmacy Act (63 P. S. § §  390-4(j) and 390-6(k)(1) and (9)).

Source

   The provisions of this §  27.16 amended November 28, 1997, effective November 29, 1997, 27 Pa.B. 6218; amended September 4, 1998, effective September 5, 1998, 28 Pa.B. 4532; amended May 26, 2006, effective May 27, 2006, 36 Pa.B. 2518; amended September 5, 2008, effective September 6, 2008, 38 Pa.B. 4895; amended December 11, 2009, effective December 12, 2009, 39 Pa.B. 7005. Immediately preceding text appears at serial pages (342126), (336893) to (336894) and (342127).

Cross References

   This section cited in 6 Pa. Code §  22.62 (relating to conditions of provider participation); 28 Pa. Code §  113.14 (relating to space); 28 Pa. Code §  113.15 (relating to locked storage); 28 Pa. Code §  561.14 (relating to space); 28 Pa. Code §  561.15 (relating to locked storage); 49 Pa. Code §  27.203 (relating to centralized prescription processing); and 49 Pa. Code §  43b.7 (relating to schedule of civil penalties—pharmacists and pharmacies).



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