AN ACT TO CREATE THE "MISSISSIPPI ACTIVE PHARMACEUTICAL INGREDIENT QUALITY ASSURANCE ACT" WITHIN CHAPTER 21, TITLE 73, MISSISSIPPI CODE OF 1972; TO PROVIDE THAT IT IS UNLAWFUL FOR ANY PERSON OR ENTITY TO ENGAGE IN THE SALE, TRANSFER OR DISTRIBUTION OF A DRUG COMPOUNDED UNDER SECTION 503A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT UNLESS THE COMPOUNDER OF THE DRUG SATISFIES CERTAIN REQUIREMENTS AND STANDARDS RELATING TO BULK DRUG SUBSTANCES; TO SET FORTH PENALTIES FOR VIOLATIONS OF THIS ACT; TO REQUIRE PERSONS OR ENTITIES ENGAGING IN THE SALE, TRANSFER OR DISTRIBUTION OF COMPOUNDED DRUGS TO MAINTAIN ALL RECORDS RELATED TO THE ACQUISITION, EXAMINATION AND TESTING OF THE BULK DRUG SUBSTANCE FOR AT LEAST TWO YEARS AFTER THE EXPIRATION DATE OF THE LAST LOT OF DRUG CONTAINING THE BULK DRUG SUBSTANCE; TO AUTHORIZE THE BOARD OF PHARMACY TO PERFORM INSPECTIONS FOR COMPLIANCE WITH THIS ACT AND TO PROMULGATE RULES AND REGULATIONS NECESSARY TO IMPLEMENT THIS ACT; AND FOR RELATED PURPOSES.
Impact
The regulations introduced by SB2544 will require the Board of Pharmacy to have expanded inspection capabilities to ensure compliance by entities engaging in drug compounding. It obligates these entities to maintain comprehensive records of their bulk drug substances for at least two years after the expiry of the last batch. This increased scrutiny is designed to safeguard public health by ensuring that compounded drugs meet stringent safety and quality metrics, potentially reducing the risk of adverse drug reactions stemming from poorly compounded medications.
Summary
Senate Bill 2544, also known as the Mississippi Active Pharmaceutical Ingredient Quality Assurance Act, aims to enhance the regulation of compounded drugs in the state. It establishes that it is unlawful for any individual or entity to sell, transfer, or distribute compounded drugs unless they adhere to strict standards related to bulk drug substances. This includes compliance with the applicable United States Pharmacopoeia standards and obtaining necessary certifications that ensure the quality and safety of the compounded product.
Contention
There may be concerns regarding the increased regulatory burden on pharmacies and compounding entities due to the stringent requirements for the sale of compounded drugs. The implementation of these regulations could potentially lead to higher operational costs for pharmacies, which may be passed on to consumers. The bill stipulates significant penalties for non-compliance, including substantial fines per dose of illegally compounded drugs and possible revocation of business licenses, raising fears among smaller compounding entities about their ability to maintain compliance and survive financially.
Controlled substances: other; sentencing guidelines for retail sale of products containing ephedrine or pseudoephedrine; modify. Amends sec. 13m, ch. XVII of 1927 PA 175 (MCL 777.13m). TIE BAR WITH: HB 4947'25