§ 27.405. Recordkeeping.
(a) A pharmacist who administers an injectable medication, biological or immunization or who supervises the administration by a pharmacy intern shall maintain the following records regarding each administration for a minimum of 2 years:
(1) The name, address and date of birth of the patient.
(2) The date of the administration and site of the injection.
(3) The name, dose, manufacturer, lot number and expiration date of the medication, biological or immunization.
(4) The name and address of the patient’s primary health care provider, as identified by the patient.
(5) The name or identifiable initials of the administering pharmacist. If the administration was performed by a pharmacy intern, the name or identifiable initials of the pharmacy intern and the supervising pharmacist.
(6) Documentation of informed consent for administration of injectable medications, biologicals and immunizations, and in the case of influenza immunizations administered to patients under 18 years of age, documentation of written parental consent.
(7) The nature of an adverse reaction and who was notified.
(b) A pharmacist who administers an immunization or supervises the administration by a pharmacy intern shall also maintain the following records regarding each administration for a minimum of 2 years:
(1) An identification of the Vaccine Information Statement (VIS) that was provided.
(2) The date of publication of the VIS.
(3) The date and to whom the VIS was provided.
(c) In an institution, the information required to be maintained in subsections (a) and (b) may be maintained in the patients’ medical records.
Authority The provisions of this § 27.405 amended under sections 4(j), 6(k)(1) and (9) and 9.2(a) of the Pharmacy Act (63 P.S. § § 390-4(j), 390-6(k)(1) and (9) and 390-9.2(a)).
Source The provisions of this § 27.405 adopted June 30, 2006, effective July 1, 2006, 36 Pa.B. 3237; amended July 8, 2022, effective July 9, 2022, 52 Pa.B. 3822. Immediately preceding text appears at serial pages (347438) to (347439).
Cross References This section cited in 49 Pa. Code § 27.12 (relating to practice of pharmacy and delegation of duties).
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