This week, we will look at the last four parts of the current Draft Memorandum of Understanding recently issued by the FDA for public comment.

4. Enforcement Authorities and Legal Status of Agreement
   • The parties recognize that FDA and the State retain the statutory and regulatory authorities provided by the FD&C Act, other Federal statutes and attendant regulations, and State statutes and regulations.
   • Also, this agreement does not restrict FDA or any other Federal agency from taking enforcement action when appropriate or prevent the State from taking enforcement action as appropriate.
   • By signing this MOU, the State affirms that it now possesses and will maintain, at the discretion of the State legislature, the legal authority and the resources necessary to effectively carry out all aspects of this MOU. If this changes, the State will notify the FDA.
   
   
5. Name and Address of Participating Agencies
   • U.S. Food and Drug Administration
   • State

   Also, upon signing this MOU:

   • each party must designate one or more liaisons to act as points of contact,
   • new liaisons may be designated at any time by notifying the other party's liaison(s) in writing, and
   • if a designated liaison cannot fulfill the functions, the parties will name a new liaison with 2 weeks and notify the other party's liaison(s).
   
   
   
6. Period of Agreement
   1. When accepted by both parties, this MOU will be effective from the date of the last signature and will continue until terminated by either party. It may be terminated in writing by either party upon a 30-day notice of termination.
   2. If the State does not adhere to the provisions of this MOU, including conducting investigations of complaints related to compounded drug products distributed outside the State, the MOU may be terminated upon 30-days' notice of termination

   In case of termination, the FDA will post a notice of termination on its Website, and the State will notify all licensed pharmacists, pharmacies, and physicians within the State and advise them that as of 30 days from the date of posting of the termination notice, compounded drug products may be distributed (or cause to be distributed) out-of-State only in quantities that do not exceed 5% of the total prescription orders dispensed or distributed by the licensed pharmacy or physician.

7. Approvals

   Places for signatures, titles and dates.

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

Court Rules Pharmacy Benefit Managers Must Face Lawsuit Over EpiPen Price Hikes
A federal judge in St. Paul, Minnesota has ruled that four pharmacy benefit managers "must face a lawsuit alleging they breached their duties as administrators of employee health-insurance plans' drug benefits by causing Mylan NV to raise the EpiPen allergy medication's price." The companies had asked the court to dismiss the class action claims against them.
ASHP Daily Briefing; Tuesday, October 30, 2018

The FDA Authorizes First DTC Test for Detecting Genetic Variants Associated with Medication Metabolism
The FDA permitted marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test as a direct-to-consumer test for providing information about genetic variants that may be associated with a patient's ability to metabolize some medications to help inform discussions with a healthcare provider. The FDA is authorizing the test to detect 33 variants for multiple genes.

This test is a step forward in making information about genetic variants available directly to consumers and better inform their discussions with their healthcare providers. The test is to be used appropriately because it does not determine whether a medication is appropriate for a patient, does not provide medical advice, and does not diagnose any health conditions. Consumers should not use this test to make treatment decisions on their own. Any medical decisions should be made only after discussing the results with a licensed healthcare provider and results have been confirmed using clinical pharmacogenetic testing.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624753.htm

Note: There is also a warning by the FDA on these genetic tests just released on November 1, 2019 at: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm624725.htm

ER Patients Given Ketamine and Other Drugs in Clinical Trials without Their Consent
A Minneapolis hospital tested powerful antipsychotics and the potent anesthetic ketamine on emergency room patients without their knowledge or consent, violating regulations on human research, federal inspectors have determined. Based on those findings, a health watchdog group on Monday urged federal regulators to suspend all clinical trials at the hospital.
https://www.statnews.com/2018/10/29/er-patients-given-ketamine-powerful-drugs-without-consent/

Radiotherapy Patients Can Safely Use Lotions for Irritated Skin
For years, radiation oncologists have been telling patients to avoid applying topical creams, lotions, or emollients immediately before radiation treatment. That instruction was based on a concern that applying creams could increase the risk for, or worsen, radiation dermatitis or that it would increase the intensity of skin toxicity from the radiation.

A new study published online October 18 in JAMA Oncology challenges that recommendation. Lead author, Brian C. Baumann, MD, a radiation oncologist from Washington University in St. Louis, Missouri, told Medscape Medical News. "But we found that the amount of cream that patients typically apply to their skin was not enough to cause any interference on skin dose," Baumann said.

"This is indeed a good-news study," Chelsea C. Pinnix, MD, PhD, the University of Texas MD Anderson Cancer Center, Houston, who wrote an accompanying editorial, told Medscape Medical News. "Some creams that are commonly used have a low metallic content, so the concern was that the metal in the cream may interact with the x-rays and lead to increased dose," she said. But these researchers "found in the paper that most patients apply these lotions moderately, about 2 millimeters or less in thickness, and so radiation dose is not increased at the skin in most clinical situations. This is a pretty simple, straightforward study, but it does have the ability to really impact practice and treatment recommendations that we make to patients, and that may also improve their experience during radiation treatment," she said.
https://www.medscape.com/viewarticle/904063

Did You Know ...

�that however beautiful the strategy, you should occasionally look at the results? (Winston Churchill)

Tip of the Week

How often do we get so enthralled with our plans that we develop and promote that we are unaware that the end result is not what we anticipated?

A key factor in any "plan" is input from all sides and all viewpoints. With limited input, the "plan" will only be partially successful, cause unintended consequences and result in undesirable and/or dangerous consequences. We have seen this in the setting of national standards for pharmacy compounding over the past several years as evidenced by the huge number of comments received from pharmacists in the "real world" and working directly with patients.

IJPC Now on Facebook and Youtube

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding

View our growing collection of educational and training videos at www.ijpc.com/video or by subscribing to our Youtube channel at https://www.youtube.com/IJPCompounding.

Looking Back

Wild men pulled,
Their whiskers out,
That's what made,
Them wild�No doubt!
     Burma Shave