Proposed Bill to Increase FDA Authority in Drug Compounding

On September 12, 2013, the Compounding Clarity Act (H.R. 3089) was introduced in the House. [1] This Act is intended to strengthen the Food and Drug Administration’s (FDA) authority over the compounding of drugs in pharmacies. [2] This bill is in response to the 2012 outbreak of fungal meningitis that was caused by contaminated drugs made at the New England Compounding Center (NECC). [3]

Pharmacy compounding is the practice of mixing and altering ingredients of a prescription to meet the needs of an individual patient. [4] Compounding is a very important practice in public health because individuals have specific needs that FDA approved medication does not meet. [5] Licensed pharmacists who are trained in compounding can tailor medication to have custom strengths, flavors, and dosage forms, and even replace or exclude certain ingredients to avoid allergenic conditions. [6]

Under The Compounding Clarity Act, traditional pharmacies would remain under the authority of their respective state boards. [7] This legislation is intended to clarify the authority of the FDA over large scale compounders known as outsourcing facilities. [8] The FDA could then require annual registration, reporting of all drugs compounded, inspections, and enforcement of labeling requirements. [9]

Uniform quality and control in this industry may establish compounded drugs as a viable larger scale tool in the medical field. [10] Rather than tailoring drugs for one specific known patient, drugs could be produced on a larger scale and distributed to hospitals for use with anticipated future patients. [11]

The Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) have voiced concerns about the language in the bill. [12] The primary concern is that outsourcing facilities will not be as limited as intended and that an FDA “blanket authority” over all pharmacies could harm pharmacy-patient care. [13] They believe that the wording is too vague and that outsourcing facilities will still be unregulated in intrastate compounding.  The language could allow outsourcing facilities to compound copies of FDA approved drugs, while still meeting regulations. [14] The vague language would also give the FDA authority over smaller pharmacies, not intended to be encompassed in the bill. [15] Nevertheless,  before the Bill is passed, it is important to address the public health concerns.

 

References

[1] Bronwyn Mixter, House Bill Aims for Stronger Federal Role in Regulation of Drug Compounding. Pharmaceutical Law & Industry Report. Sept. 16, 2013.

[2] Id.

[3] Id.

[4] What is Compounding? Professional Compounding Centers of America, Professional Compounding Centers of America, http://www.pccarx.com/what-is-compounding.

[5] Pharmacy Compounding, U.S. Food & Drug Administration (Sept. 2013),  http://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding.

[6] What is Compounding?, supra.

[7] Mixter, supra.

[8] Id.

[9] Id.

[10] Id.

[11] Id.

[12] Bronwyn Mixter, Biotech, Generic Industries Concerned about Newest Legislation on Rx Compounding. Pharmaceutical Law & Industry Report. Sept. 20, 2013.

[13] Id.

[14] Id.

[15] Id.