quoted from https://rules.house.gov/sites/republicans.rules.house.gov/files/115/OMNI/DIVISION%20A-%20AG%20SOM%20OCR%20FY17.pdf
"Animal Drug Compounding.--The Committee is concerned that the FDA has proposed draft guidance for industry (#230) for animal drug compounding that applies Sections 503A and 503B of the FDCA to animal health even though these provisions were written in regard to compounding of human drugs. The Committee is concerned that this will result in confusion in the industry and may result in a misallocation of the resources Congress makes available to the FDA to oversee compounding activities. The Committee expects that any final guidance on animal drug compounding will reference statutory provisions that specifically relate to veterinary practices."
"Biological Products.--The Committee commends the FDA for issuing draft guidance to address the mixing, diluting, or repackaging of biological products outside the scope of an approved biologics license application.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."###"Drug Compounding.--The Committee believes patient access to the right drug at the right time is of utmost importance. In instances where a commercially manufactured drug is not appropriate for a patient for a specific reason, a compounded drug may be the difference between life and death. Since passage of the Drug Quality and Security Act (DQSA) of 2013, the Committee has had concerns that the FDA interpreted provisions of Section 503A of the FDCA in a manner that might jeopardize the availability of compounded medications for ``office use''. The practice of ``office use'' occurs when a compounder will compound a batch of drugs in anticipation of receiving patient-specific prescriptions at a later time. It may also be the case of a doctor in his or her office maintaining compounded drugs on site because it is unsafe or impractical to issue a traditional prescription. This practice is authorized in the vast majority of states and was intended to be allowable under DQSA. The Committee is aware that on April 15, 2016, FDA released a new Draft Guidance on the issue of ``office-use'' compounding. The Committee directs the FDA to issue a Final Guidance that provides for ``office-use'' compounding of drugs, in appropriate circumstances as well as including drugs compounded in anticipation of a prescription for an identified individual patient. Such ``anticipatory'' compounded drugs must be based on the history of previous valid compound prescription orders, and on an established history between the prescriber and the patient and the compounder. Drug Compounding Inspections.--The Committee understands that the FDA is interpreting provisions of Section 503A of the FDCA to inspect state-licensed compounding pharmacies under current Good Manufacturing Practices (cGMPs) instead of under the standards contained in the United States Pharmacopeial Convention (USP) for sterile and non-sterile pharmaceutical compounding or other applicable pharmacy inspection standards adopted by state law or regulation. The Committee reminds the FDA that compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within their states. Compounding pharmacies are more appropriately inspected using USP standards or other pharmacy inspection standards adopted by state law or regulation in the state in which a pharmacy is licensed. Drug Compounding of Allergen Extracts.--The Committee is concerned that proposed changes to general chapter 797 of the USP contradicts the legislative intent of Section 503A of DQSA regarding the practice of ``office-use'' compounding of allergen extracts. The FDA recognizes USP general chapter 797 as federal policy on the practice of drug compounding. The Committee is concerned that the proposed changes to USP general chapter 797 would be inconsistent with its legislative intent of Section 503A and with the agency's own previous positions on the practice of office-use compounding of allergen extracts. It is the sense of the committee that the practice of office-use compounding of allergen extracts by physicians is proven to be both safe and effective for the diagnosis and treatment of allergic conditions. The Committee suggests that the USP work with organizations from the physician and patient communities that represent physicians who regularly engage in office-use compounding of allergen extracts or patients who benefit from such compounding of allergen extracts, to ensure that any changes to USP general chapter 797 regarding office-use compounding of allergen extracts are reflective of the clear legislative intent of Section 503A of the DQSA."