House Committee Says FDA's Compounding Policies are Overreach

Office-Use, MOU, APIs and Biological Product Guidance are Issues

House appropriators are demanding that FDA dramatically revise its compounding policies, suggesting in report language that the agency overreached its statutory authority by penning a memorandum of understanding that covers dispensing and that the agency went against Congressional intent by prohibiting office-use compounding. The lawmakers ask FDA to revamp the MOU to remove dispensing and to scrap its ban on office-use compounding. The committee report addresses these four issues related to compounding and the FDA: 

Office Use of Compounded Medicine 

"The Committee is concerned that, since passage of the Drug Quality and Security Act (DQSA) of 2013, the FDA has interpreted provisions of Section 503A of the FDCA in a manner inconsistent with its legislative intent and with the agency’s own previous positions. Specifically, the FDA has taken the position that under 503A, a pharmacist may not compound medications prior to receipt of a prescription and transfer the drugs to a requesting physician or other authorized agent of the prescriber for administration to his or her patients without a patient-specific prescription accompanying the medication. This practice, which is often referred to as ‘‘office-use’’ compounding, is authorized in the vast majority of states and was intended to be allowable under DQSA. The Committee is aware that in 2012, prior to passage of the DQSA, FDA was working on a draft compliance policy guide for 503A of the FDCA that provided guidance on how ‘‘office-use’’ compounding could be done consistent with the provisions of 503A. The Committee understands the intent of the DQSA was not to prohibit compounding pharmacists from operation under existing 503A exemptions; therefore, the Committee directs the FDA to issue a guidance document on how compounding pharmacists can continue to engage in ‘‘office-use’’ compounding before the receipt of a patient-specific prescription consistent with the provisions of 503A within 90 days after the enactment of this Act." (Page 64)

Memorandum of Understanding

"The Committee is very concerned with the draft MOU that the FDA has proposed under Section 503A of the FDCA. The proposed MOU would complicate patient and prescriber access to compounded medications, and may have a deleterious effect on small pharmacies. Under the draft MOU, the FDA attempts to describe ‘‘distribution’’ as occurring when ‘‘a compounded human drug product has left the facility in which the drug was compounded.’’ In the DQSA, Congress only allowed the FDA to regulate ‘‘distribution.’’ But the MOU appears to exceed the authority granted in the statue by redefining ‘‘distribution’’ in a manner that includes dispensing—something unprecedented. This overreach could generate exactly the kind of costly and confusing litigation that Congress intended to avoid when it amended and reinstated Section 503A. The Committee expects that, when a final MOU is proposed as a model agreement for the states to consider, that distribution and dispensing are treated as the different and separate activities that they actually are." (Page 68)

Active Pharmaceutical Ingredients List

"The Committee is concerned that the FDA has not yet approved a list of Active Pharmaceutical Ingredients (APIs) for use by compounding pharmacists pursuant to the Drug Quality and Security Act (Public Law 112–43, 127 Stat. 587) and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a et seq.). Within 90 days of enactment of this Act, the FDA shall report to Congress on when its review of proposed APIs pursuant to §503A(1)(a)(iii) will be completed." (Page 62)

Biological Products

"The Committee commends the FDA for issuing draft guidance to address the mixing, diluting, or repackaging of biological products outside the scope of an approved biologics license application. The Committee urges the FDA to finalize the guidance without delay following the public comment period and continues to emphasize the need for close FDA inspection and supervision of large-scale compounding and repackaging of sterile injectable drugs and biological products, particularly products that are administered into areas of the human body where there is tempered immunity, such as the eye or spinal column, to ensure that they are processed in keeping with current good manufacturing practice for sterile products, in particular 21 CFR 200.50 regarding ophthalmic preparations." (Page 62)

Download: 
hrpt-114-hr-fy2016-agriculture.pdf