Tuesday, May 9, 2017

Question of the Day May 9, 2017 What Impact or Legal Effect, if any, does the language relating to compounding in the recent funding legislation have? What case law is there addressing whether on Congress can declare what a prior Congress's legislative intent was? Has Congress overstepped its legislative authority? Why or why not?

"The agreement remains concemed with the draft MOU that the FDA proposed under Section 503A of the FDCA. Section 503A distinguishes between "distribution" and "dispensing" for the purposes of the MOU. In the DQSA, Congress only allowed the FDA to regulate "distribution." The MOU appears to exceed the authority granted in the statute by redefining "distribution" in a manner that includes dispensing. Congress did not intend to include dispensing of compounded drugs over state lines within the scope of the MOU. The MOU should not address dispensing of compounded drugs to a patient over state lines if ali other requirements of 503A are met."

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the FDA has proposed draft guidance for industry (#230) for 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issuing draft guidance to address the mixing, diluting, or 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 


"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 
    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."

quoted from https://www.congress.gov/congressional-report/114th-congress/house-report/531/1?q=%7B%22search%22%3A%5B%22H.+Rept.+114-531%22%5D%7D&r=1
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