Section R4-23-1211. Responsibilities of the Physician-in-charge or Pharmacist-in-charge of a Participating Physician’s Office, Pharmacy, or Health Care Institution

The physician-in-charge of a participating physician’s office; the pharmacist-in-charge of a participating pharmacy; or the physician- in-charge or pharmacist-in-charge of dispensing for a participating health care institution shall, either personally or through a designee:

1.        Coordinate the receipt of prescription medications donated by manufacturers or health care institutions or through medical practitioners, pharmacies, or health care institutions from eligible donors;

2.        Check each donated prescription medication against the invoice and any additional alternate record and resolve any discrepancies;

3.        Store and secure donated prescription medications as required by federal and state law;

4.        Inspect each donated prescription medication for adulter- ation;

5.        Certify that each donated prescription medication has been stored in compliance with the manufacturer’s pack- age insert;

6.        Ensure that expired, adulterated, or unidentifiable donated prescription medication is not dispensed;

7.        Ensure that prescription medications identified under subsection (6) are destroyed within 30 days of identifica- tion as specified in subsection (9);

8.        Ensure safety in drug recalls by destroying any donated prescription medication that may be subject to recall if its lot number cannot exclude it from recall;

9.        Ensure destruction of expired, adulterated, unidentifiable, and recalled donated prescription medication by:

a.         Following federal, state, and local guidelines for drug destruction;

b.        Creating a list of expired, adulterated, unidentifi- able, or recalled donated prescription medications to be destroyed;

c.         Following the destruction, signing the list described in subsection (9)(b) and having the list signed by a witness verifying the destruction; and

d.        Keeping the list described in subsection (9)(b) on file for three years from the date of destruction;

10.     Redact or remove all previous patient or pharmacy label- ing on a donated prescription medication before dispens- ing the donated prescription medication;

11.     Ensure that all dispensed donated prescription medica- tions comply with the labeling requirements of A.R.S. § 32-1968(D);

12.     Place on the label of each dispensed donated prescription medication a beyond-use-date that does not exceed the beyond-use-date or expiration date from the original label of the donated prescription medication or, if the dis- pensed donated prescription medication comes from mul- tiple packages, the earliest beyond-use-date or expiration date from the donated prescription medication packages; and

13.     Maintain the records required in this Article.

Historical Note

New Section made by final rulemaking at 14 A.A.R.

4320, effective January 3, 2009 (Supp. 08-4).