Question: What are the FDA priorities for compounding for 2019?

Answer:
The following section is from the statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on the new 2019 efforts to improve the quality of compounded drugs ( released on April 3, 2019). You are encouraged to go to the FDA website below and read the statement in its entirety. Additional sections will be covered each week.

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs

Statement (Opening)

Maintaining Quality Manufacturing and Compliance

Regulating Compounding from Bulk Drug Substances
“Compounders sometimes produce a compounded drug starting from a finished, FDA-approved drug. Other times, they produce drugs using bulk drug substances, also known as active pharmaceutical ingredients. For example, when a patient has an allergy to an ingredient in an FDA-approved drug, a state-licensed pharmacist or physician, or an outsourcing facility, might compound a drug product using a bulk drug substance that does not contain the allergen.

While some bulk drug substances can be used for compounding, other substances may not be suitable to be used for compounding. This may be a result of potential safety concerns raised by these products, or due to availability of a similar FDA-approved drug product that can be used to meet a patient’s medical need.

We’re developing lists of bulk drug substances that compounders can use to compound from. These are the 503A bulks list and 503B bulks list. The names of these lists refer to sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and each list is used by different types of compounders. Section 503A applies to state-licensed pharmacies and physicians that have not registered with FDA as outsourcing facilities. They compound drugs only based on the receipt of a patient-specific prescription and may use bulk drug substances that are components of FDA-approved drugs, or drugs that have an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph. They may also use substances that FDA places on the 503A bulks list. Section 503B applies to outsourcing facilities, which are not subject to the patient-specific prescription requirement that applies to 503A compounders and may compound and distribute drugs for healthcare facilities to hold as office stock. To help protect patients—and the integrity of the drug approval process—section 503B of the FD&C Act limits the bulk drug substances that outsourcing facilities can use in compounding to substances that are used to compound drugs in shortage or that appear on a list developed by the FDA of bulk drug substances for which there is a clinical need.

Earlier this year, we issued a final rule establishing the criteria for evaluating substances nominated for inclusion on the 503A bulks list that state-licensed pharmacists and physicians can use to compound drugs and placing, for the first time, six bulk drug substances on the list.

We plan to build on these actions by issuing another proposed rule to further amend the list of bulk drug substances that 503A compounders can use to compound drugs. This proposed rule, to be issued in 2019, would be based on FDA’s evaluation of additional bulk drug substances nominated for the 503A bulks list, identifying any additional bulk drug substances FDA proposes to add to the list, and also identifying bulk drug substances that the FDA has considered and is proposing not to include on the list of substances from which 503A compounders may use to compound drugs. The agency will continue to consider additional substances nominated by the public for inclusion on this list and will address them in future rules.

We’ve also made a final decision regarding whether to include certain bulk drug substances on the 503B bulks list. The FDA will continue to update this list as it evaluates nominated bulk drug substances. Our recently issued final guidance describes FDA policies for developing the list of bulk drug substances under section 503B. This year, we’ll continue to develop the bulks list for outsourcing facilities to limit compounding from bulk drug substances to circumstances where there’s a clinical need for such products.

We’ll also continue to support research efforts on bulk drug substances with the National Academy of Science, Engineering, and Medicine (NASEM) and through the FDA's Centers of Excellence in Regulatory Science and Innovation with the University of Maryland and Johns Hopkins University. These efforts will help us advance the development of the bulks list. The two ongoing projects Clinical Use of Drugs Including Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities and Bulk Drug Substances Used to Compound Drugs for Patients with Autism Spectrum Disorder (ASD) will help inform the public, and our regulatory decision-making—specifically the agency’s decision about whether to include certain substances on the 503B bulks list. Our collaboration with NASEM will also continue to examine the clinical utility of treating patients with compounded bioidentical hormone therapy products and the available evidence of the safety and effectiveness of multi-ingredient compounded topical pain creams.�

Finalizing our Memorandum of Understanding with the States

Compounding by Hospital and Health Systems

Additional Compounding Priorities

Note: We will continue to provide the text for each of the sections over the next few weeks; meanwhile, the complete statement can be obtained at:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements
/ucm635182.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

News

Effect of Doxepin Mouthwash or Diphenhydramine-Lidocaine-Antacid Mouthwash vs Placebo on Radiotherapy-Related Oral Mucositis Pain--A Randomized Clinical Trial

Question: Does doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash compared with placebo reduce oral mucositis–related pain in patients undergoing radiotherapy for head and neck cancer?

Findings: In this randomized clinical trial that included 275 patients undergoing radiotherapy, the use of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash reduced mucositis pain (defined by the area under the curve and adjusted for baseline pain score) during the first 4 hours after administration by 11.6 and 11.7 points, respectively, compared with 8.7 points for placebo mouthwash; both comparisons with placebo were statistically significant.
https://jamanetwork.com/journals/jama/article-abstract/2730615

Doctors in 5 States Charged with Illegally Prescribing Opioids, Some in Exchange for Cash, Sex
Following undercover investigations by an opioid strike force, the government has charged 60 people in five states with illegally prescribing opioids and other narcotics, some in exchange for cash and sex. Charges were brought against 31 doctors, seven pharmacists, eight nurse practitioners and seven other licensed medical professionals for their alleged participation in the illegal prescribing and distribution of opioids and other drugs. They allegedly were responsible for illegally dispensing 32 million pills and more than 350,000 prescriptions for controlled substances.
https://www.fiercehealthcare.com/practices/major-takedown-doctors-5-states-charged-illegally-prescribing-opioids

Did You Know ...

…that Audrey Hepburn said the following?

“Nothing is impossible: it says itself I’m possible.�

Tip of the Week

This reminds me of the story The Little Engine That Could, published under that title in 1930. It is a story used to teach children the value of optimism and hard work. Actually the phrase “I think I can� was printed in a Swedish journal in 1902, and the “Story of the Engine That Thought it Could� appeared in the New-York Tribune on April 8, 1906 as a part of a sermon.

If you remember, it transforms from “I think I can, I think I can� to “I knew I could, I knew I could!�

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Looking Back

Moonlight and roses,
Whiskers like Moses
Just don’t go together!
     Burma-Shave