Mou meaning
The answer depends upon how many compounded prescriptions you dispense across state lines and whether your state board signs the MOU. If the State becomes aware of a physician distributing any amount interstate or is informed of a complaint or adverse drug experience involving a medication compounded by a physician office, they must notify the appropriate regulator in the state and submit information to the FDA via Information Sharing Network.Complaints and adverse drug experiences and product quality issues that are “serious” must be reported to the FDA within 5 days and an investigation be performed pursuant to established investigatory policies and procedures.On an annual basis, identify, using surveys, review of records during inspections, data submitted to an Information Sharing Network, pharmacies that dispense or distribute inordinate amounts (>50%) of compounded human products interstate.Many states have signaled they have concerns with the document but understand the intentions of the MOU are to protect the public but also ensure access to vital medication.īy signing the MOU, States are agreeing to the following responsibilities: States are currently reviewing the MOU to determine whether or not they will be able to sign it and enter into an agreement with the FDA. This affects 503a pharmacies and medications dispensed across state lines. States have 1 year to sign the MOU before it becomes effective in October, 2021. The FDA has made the MOU available for States to sign effective. The FDA refers to 503a pharmacies as traditional compounding pharmacies that compound in accordance with patient specific prescriptions and are required by the state boards of pharmacy to comply with United States Pharmacopeia (USP) standards. The MOU is a Memorandum of Understanding between the FDA and state boards of pharmacy related to 503a pharmacies and the distribution of compounded drugs to other states.
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Many of you have heard the term MOU before but do you know what it is? Do you know how it may impact the compounding services you provide to your patients?
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Vice Chair of BPS Specialty Council on Compounded Sterile Preparations PharmacyĮVP Pharmacy Regulatory Affairs & Quality Operations The MOU – what is it and what does it mean to Compounding Pharmacies? Request for BPS to Consider a New Specialty.Petitioner's Guide for Recognition of a Pharmacy Practice Specialty.Helpful Tips for International Candidates.Education Documentation Request Form (International Applicants Only).Recertification by Continuing Education.Dual and Multiple Specialty Recertification Offerings.
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