This week, we will look at the next part of the current Draft Memorandum of Understanding recently issued by the FDA for public comment; specifically the highlighted portion below.

3. Substance of Agreement
   1. Investigation of Complaints Relating to Compounded Drug Products Distributed Outside the State
   2. Distribution of Inordinate Amounts of Compounded Drug Products Interstate
   3. Submission and Disclosure of Information

c. Submission and Disclosure of Information

1. The information submitted to the FDA regarding complaints relating to compounded drug products distributed outside the State or regarding distribution of inordinate amounts of drugs interstate, the following minimum information is required.
   
   
   1. Complaints
      
      
      1. Name and contact information of the complainant;
      2. Name and address of the pharmacy/physician that is the subject of the complaint;
      3. Description of the complaint, including a description of any compounded drug product that is the subject of the complaint;
      4. State's initial assessment of the validity of the complaint; and
      5. Description and date of any actions the State has taken to address the complaint.
      
      
      
   2. Inordinate Amounts
      
      
      1. Name and address of the pharmacy/physician that distributed inordinate amounts of compounded drug products interstate;
      2. The total number of prescription orders for compounded drug products distributed or dispensed intrastate;
      3. The total number of prescription orders for compounded drug products distributed interstate;
      4. The total number of prescription orders for sterile compounded drug products distributed interstate;
      5. The number of States in which the compounding pharmacy or physician is licensed or into which the pharmacy or physician distributes compounded drug products, and
      6. Whether the State inspected for and found during its most recent inspection that the compounding pharmacy or physician distributed compounded human drug products without valid prescription orders for individually identified patients.
   
   
   
2. The parties to this MOU will share information consistent with applicable statutes and regulations. Additional agreements may be required for the following types of information:
   
   
   • Confidential commercial information,
   • Personal privacy information, and
   • Information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations and Trade Secrets, other FOIA exemptions, the FD&C Act, the HIPA, and FDA regulations in parts 20 and 21.

   The FDA agrees that information provided to the FDA by the State, will only be disclosed consistent with applicable Federal law and regulations, etc.

Next week, we will complete our discussion of the Draft Memorandum of Understanding by summarizing Sections IV, V, VI, and VII.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Clinic and In-home Pharmacogenomic Testings are Valuable to Patients
Both clinic and in-home pharmacogenomic testings are valuable to patients. People with either a clinic-based or an in-home pharmacogenomic test were:

• satisfied with the testing experience,
• found the results to be helpful, and
• felt they had a good understanding of the results,

according to the results of a survey published in Pharmacogenomics; some people were concerned with privacy and discrimination issues.

Source: Lemke AA, Hulick PJ, Wake DT et al. Patient perspectives following pharmacogenomics results disclosure in an integrated health system. Pharmacogenomics 2018; 19(4): 321-331.
http://aphadruginfoline.com/pharmacogenomics-corner/both-clinic-and-home-pharmacogenomic-testing-are-valuable-patients

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Due to Small Particulates
Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3-mL vials, as the product has been found to have unidentified small particulate floating in the solution. Lot Number 09042018@2, Exp. 12/03/2018, is the only affected lot.

To date, Promise Pharmacy has not received any reports of adverse events related to this recall. The pharmacy is notifying its prescribers and patients by telephone and mail and is arranging for return/replacement/refund of all recalled product.
https://www.fda.gov/Safety/Recalls/ucm623994.htm

Did You Know ...

�that the importance of "truth" and the tremendous adverse consequences of "lies" is playing out before our eyes on the national and international scenes?

Tip of the Week

The following relationships and decisions built on lies are problematic and will not last!

• Family
• Social
• Business
• Political
• National
• International

Related quotes:

A lie is like a snowball; the longer it is rolled, the larger it is. (Luther)

The telling of a falsehood is like the cut of a sabre (saber); for though the wound may heal, the scar of it will remain. (Saadi)

O what a tangled web we weave, when first we practice to deceive! (Sir Walter Scott)

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Looking Back

If harmony,
Is what
You crave,
Then get
A tuba
     Burma Shave