Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-18 - OPIOID TREATMENT PROGRAM CLINIC PHARMACIES › Rule 480-18-.06 - Drug Distribution and Control

Current through Rules and Regulations filed through June 27, 2024
(1) General. A drug distribution system is
			 the entirety of that mechanism by which a physician's drug order is executed,
			 from the time the practitioner transmits the order either orally, in writing,
			 or electronically to a licensed health care professional to the time the
			 ordered drug is administered to the patient or delivered to the patient for
			 self-administration. No drugs can be dispensed or administered without a
			 physician's medication drug order.
(2) Responsibility. The Director shall be
			 responsible for the safe and efficient distribution, control, and
			 accountability for drugs. The other professional staff, including the
			 physicians, at the OTP clinic shall cooperate with the Director in meeting this
			 responsibility and in ordering, administering, and accounting for the drugs and
			 devices so as to achieve this purpose.
(a) The
			 Director shall establish written policies and procedures for the distribution
			 of medications including emergency kits, etc. to achieve this goal.
1. The drugs must be identified up to the
			 point of administration;
2. The
			 pharmacy must receive a direct, electronic (only for drugs to be administered
			 on site) or mechanical copy of a physician's order before the first dose of
			 medication is dispensed as defined by the clinic stat order policy.
3. At a minimum, the pharmacy must maintain a
			 patient profile for each OTP clinic patient for use in prospective and
			 retrospective drug reviews, for comparing with the central registry as required
			 by the DHR and to report violators to the GDNA and DHR, for discharge from
			 another OTP, and for urine or blood tests to check for drug positive test
			 results.
4. Records of all
			 transactions of the OTP clinic pharmacy, such as daily drug dosing summaries,
			 daily drug inventory sheets, patient medication profiles, and bulk drug
			 inventory records must be maintained by the clinic pharmacy as may be required
			 by law, and as may be necessary to maintain accurate control over and
			 accountability for all drugs and devices within the scope of the clinic
			 practice.
5. All drug invoices must
			 be attached to their accompanying DEA form 222 order form and must be filed
			 separately from all other drug records. A biennial inventory of all controlled
			 substances on hand must be taken every two years from the date of the pharmacy
			 opening for business. This inventory must be an accurate count of all such
			 drugs, signed in indelible ink by the pharmacist taking the inventory and dated
			 on the date it is taken.
6. Any
			 drug compounded by the pharmacy must be accounted for by use of a compounding
			 log form. This form, at a minimum must display the date the drug was
			 compounded, the name of the drug, the strength, quantity made, manufacturer's
			 lot number, manufacturer's expiration date, and the signature of the pharmacist
			 compounding the drug.
7. Nothing in
			 this section shall prohibit the use of computerized records, where such records
			 meet all other requirements of the law. An OTP clinic pharmacy may not dispense
			 or administer prescription medications other than OTP program medications;
			 and
8. The pharmacy must participate
			 in those aspects of the OTP clinic patient care evaluation program which relate
			 to drug and device utilization and effectiveness.