What the draft MOU says about Investigation of Complaints of human drug products compounded in a state and distributed outside the state

A. Investigation of Complaints

The new draft standard MOU provides that States that enter into the MOU will agree to:

• Investigate complaints relating to human drug products compounded in the State and distributed outside the State, including complaints about adverse drug experiences or certain product quality issues to, among other things, determine whether there is a potential public health risk or safety concern, and confirm that any risk or safety concern is adequately contained;
• As appropriate, take action to ensure that the relevant compounding pharmacy, pharmacist, or physician determines the root cause of the problem and eliminates any public health risk identified in relation to the complaint;
• Notify FDA within 72 hours of any complaints relating to a compounded human drug product distributed outside the State involving a potential public health risk or immediate safety concern, such as a report of a serious adverse drug experience or serious product quality issue, the State's initial assessment of the validity of the complaint, and any actions the State has taken or plans to take to address such complaints;
• Provide FDA with certain information about the complaint, including the following:

○ Name and contact information of the complainant;

○ name and address of the pharmacist/pharmacy/physician that is the subject of the complaint;

○ a description of the complaint, including a description of any compounded drug product that is the subject of the complaint;

○ the State's initial assessment of the validity of the complaint relating to a compounded human drug product distributed outside the State; and

○ a description and date of any actions the State has taken to address the complaint; and

• Maintain records of the complaints it receives, the investigation of each complaint, and any response to or action taken as a result of a complaint, beginning when the State receives notice of the complaint. The draft standard MOU says that the State agrees to maintain these records for at least 3 years, beginning on the date of final action or the date of a decision that the complaint requires no action.

The new draft standard MOU, as compared to the 1999 draft standard MOU, clarifies that the types of complaints of compounded human drug products that should be investigated include any adverse drug experience (not just serious adverse drug experiences, which were identified as an example of the types of complaints to be investigated in the 1999 draft standard MOU) and product quality issues that, if left uncorrected, could lead to potential public health risks or safety concerns. Even nonserious adverse drug experiences and product quality issues can be indicative of problems at a compounding facility that could result in product quality defects leading to serious adverse drug experiences if not corrected. For example, inflammation around the site of an injection can indicate product contamination from inadequate sterile practices at the compounding pharmacy. If the pharmacy has inadequate sterile practices, other more serious contamination could result in serious adverse events.

FDA is clarifying that the complaints that States agree to investigate under the MOU are only those complaints that are made about compounded human drug products distributed outside the State. In contrast to the 1999 draft standard MOU, the new draft standard MOU does not contain a provision that would require the States entering into the MOU with FDA to agree to investigate alleged violations of the FD&C Act. Upon further reflection, FDA has tentatively concluded that it would be more appropriate for FDA to determine whether a particular action is a violation of Federal law. Of course, if any State identifies a potential violation of Federal law, it is encouraged to report it to FDA.

Furthermore, the new draft standard MOU does not include specific directions to the States relating to how to conduct their investigation ofcomplaints. Rather, as recommended by comments previously submitted on the 1999 draft standard MOU, the details of such investigations are left to the States' discretion.Show citation box

States signing the new standard MOU would agree to notify FDA about certain complaints and provide FDA with certain information about the complaint so FDA could investigate the complaint itself, or take other appropriate action. ^[2]

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