Title 34

Pharmacists compounding prescriptions shall use their professional judgment in first receiving, storing, or using drug components that meet official compendia requirements or other high quality sources. Bulk drugs and other chemicals or materials used in the compounding of drugs …

Drug product containers and closures shall be handled and stored in a manner to prevent contamination and to permit inspection and cleaning of the work area. Containers and closures shall be of suitable material in order not to alter the compounded drug as to quality, strength, o…

The board shall establish written procedures for the compounding of drug products to assure that the finished products have the identity, strength, quality, and purity they purport to have or are represented to possess. The procedures shall include, but not be limited to, a listi…

(a) If a component is transferred from the original container to another container, including, but not limited to, a powder being taken from the original container and stored in another container, the new container shall be identified with the following information: (1) Component…

Any procedures or other records required to comply with good compounding practices shall be retained for the same period of time as required for retention of prescription records. All records required to be retained under good compounding practices, or copies of such records, sha…

A pharmacy may prepare a compounded drug product to be sold over the counter without a prescription order. The product shall not contain an ingredient which exceeds recommended strengths and doses for over the counter drugs. The finished product shall not be one for which a presc…

(a) A pharmacy may prepare a compounded drug product for a prescriber’s office use. An order by a prescriber indicating the formula and quantity ordered shall be filed in the pharmacy. The product shall be administered in the prescriber’s office and shall not be dispensed to the …

Drugs for animals may be compounded based upon an order or prescription. Prescriptions for animals shall be handled and filled in the same manner as are prescriptions for humans. (Act 2003-389, p. 1094, §12.)

The board shall promulgate such rules and regulations as are necessary for the implementation, administration, and enforcement of this article. (Act 2003-389, p. 1094, §13.)

This article shall be known and may be cited as “The Pharmacy Audit Integrity Act.” (Act 2012-306, p. 668, §1.)

The following words shall have the following meanings as used in this article: (1) HEALTH BENEFIT PLAN. Any individual or group plan, employee welfare benefit plan, policy, or contract for health care services issued, delivered, issued for delivery, or renewed in this state by a …

The purpose of this article is to establish minimum and uniform standards and criteria for the audit of pharmacy records by or on behalf of certain entities. (Act 2012-306, p. 668, §3.)

This article shall apply to any audit of the records of a pharmacy conducted by a managed care company, nonprofit hospital or medical service organization, health benefit plan, third-party payor, pharmacy benefit manager, a health program administered by a department of the state…

(a) The entity conducting an audit shall follow these procedures: (1) The pharmacy contract shall identify and describe in detail the audit procedures. (2) The entity conducting the on-site audit shall give the pharmacy written notice at least two weeks before conducting the init…

(a) Each entity conducting an audit shall establish a written appeals process under which a pharmacy may appeal an unfavorable preliminary audit report to the entity. (b) Following the appeal, if the entity finds that an unfavorable audit report or any portion thereof is unsubsta…

(a) The auditing entity shall not use extrapolation to calculate penalties or amounts to be charged back or recouped unless otherwise required by federal requirements or federal plans. (b) The auditing entity conducting a pharmacy audit shall not compensate an employee or contrac…

This article does not apply to any audit, review, or investigation that involves alleged fraud, willful misrepresentation, or waste abuse. (Act 2012-306, p. 668, §8.)