LAWS AND REGULATIONS

Compounding is a founding principle in the practice of pharmacy, and is the art and science of preparing a medication for an individual patient’s needs. Pharmacy compounding has been practiced in the U.S. as early as 1820 when the first United States Pharmacopeia (USP) was published. Since that time, the USP has issued several standards specific to compounding, and those standards have been recognized by the U.S. Food and Drug Administration (FDA) and by over 85% of the state boards of pharmacy.

 

Compounded preparations are available for both humans and animals – and both practices are highly regulated. Compounded medications for humans are regulated primarily by the state boards of pharmacy and also by certain federal provisions implemented by the FDA.  Compounded medications for animals are regulated by state boards of pharmacy.

 

Compounded medications for humans are subject to various provisions within the U.S. Food, Drug, and Cosmetic Act (FDCA).The two most comprehensive pieces of federal legislation specific to compounding are the Food and Drug Modernization Act of 1997 (FDAMA), and the Drug Quality and Security Act (DQSA) which was enacted in 2013.[1] The DQSA provided clarification on FDA’s oversight authority of the traditional practice of pharmacy compounding, addressed in §503A of DQSA, removed the advertising language deemed unconstitutional, and created a new category for ‘outsourcing facilities’ addressed in §503B of DQSA.

 

There are several differences between the 503A and 503B operations.503B outsourcing facilities are entities that can produce a large volume of sterile compounded medications and are under the direct regulation of the FDA.Save My Compounds is most concerned with the traditional practice of pharmacy compounding and will focus on the regulatory framework for 503A entities, which are primarily regulated by state boards of pharmacy.

 

Below is a list of legal and regulatory resources for compounding, and trade groups that work with compounding stakeholders:

 

Drug Quality and Security Act (DQSA) – is the primary federal piece of legislation that provides oversight of pharmacy compounding, and specifically 503A and 503B operations.

 

United States Pharmacopeia (USP) – is a standard-setting organization that has global recognition, and provides standards for identity, strength, quality and purity to improve the quality of medicines, dietary supplements, and food ingredients.

 

International Academy of Compounding Pharmacists (IACP) – is a trade group that represents over 4,000 pharmacists, technicians, students and members of the compounding community who focus on the specialty practice of pharmacy compounding. 

 

Pharmacy Compounding Centers of America (PCCA) – is a company that represents 3,900 member pharmacies, and is a resource for fine chemicals, devices, equipment, training and support on compounding matters.

 

National Community Pharmacists Association (NCPA) – is a trade group that represents over 22,000 pharmacies, and advocate on behalf of independent community pharmacies throughout the U.S.

 

[1] Section 503A was initially included in FDAMA (Pub. L. No. 105-115 (1997)(21 USC §353a); however, due to certain advertising provisions in FDAMA being held unconstitutional in 2002, FDAMA as it related to compounding never went through formal rulemaking. DQSA, Pub. L. No. 113-54 (2013).