"Pharmacy compounding continues to play an important role in helping patients and providers advance public health." (Dr. Scott Gottlieb)

The recently released FDA 2018 Compounding Policy Priority Plan provides an overview of the key priorities of the FDA as they continue to implement the federal law on compounding. Many of the priorities are already in progress, and they plan to have them all completed in 2018. Priorities include the following:

• Risk-Based Approach to Manufacturing Standards for Outsourcing Facilities

  The FDA's goal is to make it more efficient and lower cost for more compounding pharmacies to voluntarily meet the higher production standards for 503B outsourcing facilities. In the interim, the FDA is revising the draft guidance to describe a new flexible, risk-based approach to CGMP requirements for outsourcing facilities.

• Restricting Compounding of Drugs that are Essentially Copies of FDA-Approved Drugs

  Two new guidances, one for 503A pharmacies and one for 503B pharmacies, have been released. These guidances will be discussed in more detail over the next two weeks.

• Regulating Compounding from Bulk Drug Substances

  503A compounding facilities are pretty well described and understood, with the bulks list still under development.

  503B outsourcing facilities may use a bulk drug substance to compound a drug that complies with the FD&C Act if the FDA has determined there is a clinical need to compound with the substance and places it on the 503B bulks list, or if the drug compounded appears on the FDA's drug shortage list. The FDA is in the process of preparing the 503B bulks list and has solicited nominations for drugs to be on this list.

• Solidifying FDA's Partnership with State Regulatory Authorities

  The FDA intends to clarify circumstances in which the agency will look primarily to state partners to oversee certain compounding operations. An example would be if the compounded drugs are being distributed intrastate in response to prescriptions for named patients and fall within what's commonly viewed as the practice of pharmacy.

  The FDA plans to issue a significantly revised draft MOU between the FDA and the states regarding compounding under section 503A. The draft MOU addresses the percentage of compounded drugs that could be shipped interstate by 503A compounders and state investigation of complaints.

  Regarding "inordinate amount," the FDA had previously defined "inordinate amount" for states that have entered into the MOU as "an amount of compounded drug product distributed interstate in a given month that is equal or greater to 30% of all drug products dispensed or distributed by the pharmacist, pharmacy, or physician. The revised MOU may change the percentages and conditions to work more closely with the individual states. The goal of the MOU is to serve as a mechanism for the FDA and the states to come to a mutual understanding about what types of activities are primarily overseen at the state versus federal level and should help enhance communications.

• Finalization of Biological Products Guidance and Clarifying Other Policies on Activities that Compounders Undertake

  Policies will be clarified on the "definition of a facility" in section 503B. The question to be addressed is whether an outsourcing facility can be co-located with a 503A pharmacy, and whether an outsourcing facility also can manufacture FDA-approved drugs within the same facility.

• Compliance

  Since enactment of the DQSA, the FDA has:

  • Conducted nearly 500 inspections
  • Issued more than 180 warning letters
  • Issued more than 70 letters referring inspectional findings to state regulatory agencies
  • Overseen more than 150 recalls involving compounded drugs and
  • Worked with the DOJ on multiple civil and criminal enforcement actions

Starting next week, we will begin looking at the following individual Guidances released by the FDA.

A copy of the Plan can be obtained at:

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
PharmacyCompounding/ucm592795.htm

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

Did You Know ...

�that if you don't know where you are going, then any road will get you there? ("Alice in Wonderland")

Tip of the Week

I am often reminded of the poem "Invictus" we had to memorize in high school. The last stanza sometimes makes me think of the pharmacy profession and our loss of control! I'm not really sure we know where we are going and our direction is being externally dictated!

"It matters not how strait the gate,
How charged with punishments the scroll,
I am the master of my fate:
I am the captain of my soul"

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Looking Back

Keep well to the right,
Of the oncoming car,
Get your close shaves,
From the half-pound jar!
     Burma Shave