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Question: I own a 503A compounding pharmacy. We ship more than 5% of our products outside of Texas where we are located. I'm trying to determine whether Texas has signed an MOU with the FDA regarding this issue. To my understanding, if Texas has not signed an MOU, the FDA can then classify us as an un-registered outsourcing facility. Likely, Texas has NOT signed an MOU. In that case, can you give me any guidance as to how to get this issue before my legislators to get it signed.

 

Answer: The MOU issue is not being enforced at this time by the FDA. They have not finalized the document nor have they provided it to the states for them to sign and have stated that they will not enforce this provision of 503A until after the states have a chance to review the final MOU. When it is finalized, the FDA will announce how long the states have to decide if they want to sign or not and only after that time period, they will begin enforcing the 5% limit. 

 

All of this can be found in this final guidance, and the related paragraphs are copied below – my emphasis added. Please let me know if you have any additional questions. 

 

4. Memorandum of Understanding Between FDA and the States

 

Section 503A(b)(3) of the FD&C Act states that FDA, in consultation with the National Association of Boards of Pharmacy (NABP) will develop a standard MOU for use between FDA and the states that will address the interstate distribution of inordinate amounts of compounded drug products and provide for appropriate investigation by a state agency of complaints relating to compounded drug products distributed outside that state. On January 21, 1999, FDA published a notice in the Federal Register announcing the availability of a draft standard MOU, developed in consultation with the NABP. This draft MOU was not finalized. FDA intends to publish a new draft MOU for comment that will replace the January 1999 draft. 

 

Under section 503A(b)(3)(B)(ii), an individual or firm in a state that does not enter into an MOU with FDA that distributes, or causes to be distributed, compounded drug products out of the state in which they are compounded, can compound for interstate distribution outside the state only 5% of the total prescription orders dispensed or distributed by the individual or firm. FDA does not intend to enforce the 5% limit on interstate distribution until after FDA has finalized an MOU and made it available to the states for their consideration and signature. The Federal Register notice that will announce the availability of the draft MOU will specify a time period during which the MOU will be made available to the states to sign. After this time period expires, FDA intends to begin enforcing the 5% limit in states that have not signed the MOU. 

 
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