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The FDA announces the next Pharmacy Compounding Advisory Committee (PCAC) meeting for November 20-21, 2017.
The vast majority of pharmacists are not aware of what all goes on at a PCAC meeting. You are strongly encouraged to go to the following website and look at the meeting materials that will be discussed and voted on during the PCAC meeting.
https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeeting
Materials/Drugs/PharmacyCompoundingAdvisoryCommittee/UCM582870.pdf
The Table of Contents of this document is as follows:
Table of Contents
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| I. Introduction | | 3 |
| A. Bulk Drug Substances That Can Be Used by Compounders under Section 503A | | 3 |
| B. Drug Products and Categories of Drug Products that Present Demonstrable Difficulties for Compounding | | 4 |
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| II. Substances Nominated for Inclusion on the 503A Bulks List (in order of discussion at the meeting) | | 5 |
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| III. Drug Products and Categories of Drug Products That Present Demonstrable Difficulties for Compounding | | 7 |
| A. Liposome Drug Products (Tab 7) | | 7 |
| B. Drug Products Produced Using Hot Melt Extrusion (Tab 8) | | 7 |
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| IV. Draft Points to Consider | | 7 |
Last week, we provided the list of drugs to be discussed. The FDA presentations are contained in the above document, which is 338 pages long. Generally, not all committee members read and study in detail the complete document but depend somewhat on the FDA summaries presented at the meeting. These are usually in-depth presentations by the FDA (generally on why the drug should not be approved for the Bulk Drug Substance list) and time for short rebuttals provided by those that have petitioned for the drug to be included on the Bulk Drug Substance list.
The FDA is recommending to PCAC that the following drugs NOT be allowed:
- Astragalus
- Pregnenolone
- 7-keto dehydroepiandrosterone
- Epigallocatechin
- Resveratrol
The FDA is recommending to PCAC the following drug BE allowed:
Regarding the Difficult to Compound subject, these are often presentations by the pharmaceutical firms that have requested that the products be added to the Difficult to Compound list, oftentimes because they tend to be protecting their own turf and not always being fully educated on the importance of many of these products in individualizing patient care. These presentations also include a lot of negative aspects that are not always related to compounding and make the issue "seem" more difficult than it really is. Regarding the two types of products for discussion:
Liposome Drug Products
This might include ALL products where liposomes are used, topical, oral, injectable, etc. How important are Liposomes in compounding pharmacy today? EXTREMELY IMPORTANT! Think about all the PLO-type products that are compounded.
THE FDA IS RECOMMENDING THAT LIPOSOME DRUG PRODUCTS BE INCLUDED ON THE DIFFICULT TO COMPOUND LIST.
Please note that the FDA discussion involves "injectable liposomes" but the phrase "liposome drug products" is used throughout, which also includes topical, oral, etc. This is an unfair presentation and does not delineate the different dosage forms where liposomes can be used�
Hot Melt Extrusion Products
This is similar to the cold compression method of making suppositories that has been around for over 150 years. It does use heat, and there are many advantages for individualizing patient therapy using hot melt extrusion. It is a technology that has a great future in compounding and is currently being utilized. Also, it is somewhat related to 3D printing that is up and coming and very useful in the future of compounding. It must be available for pharmacists. The International Journal of Pharmaceutical Compounding has published articles on all these topics and their utilization and application for individualized patient care.
THE FDA IS RECOMMENDING THAT HOT MELT EXTRUSION BE INCLUDED ON THE DIFFICULT TO COMPOUND LIST.
In both cases above, these topics have been combined with "nanotechnology," which, by itself, is a separate topic and is not necessarily applicable to both liposomes and extrusion. This is misrepresentation, and liposomes and hot melt extrusion must be considered on their own merits.
What happens is up to you! You can wait and see the minutes of the meeting and see how your profession has been changed, OR you can let your representatives/organizations know how you feel and maybe have an impact on the decisions! Please keep in mind that the FDA and the committee have limited experience/information with which to work and are not aware of all the different aspects of compounding specific medications for individual patient care throughout the entire U.S.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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