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News
The FDA's Pharmacy Compounding Advisory Committee voted this week to recommend adding methylcobalamin, melatonin, and oxitriptan to the 503A bulks list. They voted no to adding choline. The recommendation now goes to the FDA who gets the final say.
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| The FDA, Part 10 |
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Let's look specifically at the six questions to be used for evaluating whether bHRT drug products and categories of drug products are difficult to compound under sections 503A and 503B of the FD&C Act. We will discuss two questions per week. This week, we will look at questions #1 and #2.
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1. Does the drug product or category of drug products have a complex formulation that presents a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product?
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RESPONSE
Commonly compounded formulations for bHRT preparations include the following:
- Capsules (powder fill, semisolid fill, oil-filled)
- Oral Solutions/Suspensions
- Topical Solutions/Suspensions/Emulsions/Sprays/Drops
- Creams, Ointments, and Gels
- Suppositories/Inserts
- Injections
- Pellets/Implants
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All the above-listed dosage forms are used in compounding bHRT dosage forms as well as hundreds of other compounded drug preparations. The above-listed dosage forms have been compounded for hundreds of years worldwide.
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Pharmacists are educated in the essential theoretical and practical aspects of pharmaceutical dosage forms as well as their composition and preparation/compounding.
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Pharmacists have been compounding the above bHRT dosage forms for over 70 years and the formulations are straightforward and not complex.
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The active pharmaceutical ingredients (APIs) for bHRT products have been official in the USP for over 70 years, but have been compounded longer than that due to the time it takes an ingredient to become official.
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bHRT APIs became official in the U.S. as follows:
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| Estrone | USP XII | 1942 |
| Estriol | USP XII | 1943 (Moved to NF X) |
| Estradiol | USP XIII | 1947 |
| Progesterone | USP XIII | 1947 |
| Testosterone | USP XIV | 1950 |
| Estriol | USP XX | 1980 (Readmitted to USP-Official in 1979) |
It is interesting that both Testosterone and Testosterone Pellets became official at the same time in USP XIV (1950).
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The bHRT formulas contain relatively few ingredients that are commonly available from FDA-registered facilities.
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In conclusion, the compounding of the above dosage forms for bHRT preparations are straightforward and are NOT complex and have actually been compounded for almost a century to meet patients' needs.
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2. Does the drug product or category of drug products have a complex drug delivery mechanism that presents a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product?
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None of the above listed dosage forms have a "complex drug delivery mechanism" but simply release the drug in the body environment when administered.
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Most of the compounded formulations contain only the API(s) and one to three common excipients; some contain more excipients depending upon the formulation.
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The actual compounding of these preparations uses standard and customary compounding processes and procedures. Pellets/Implants (simple compression or molding) and Injections are compounded in 503A facilities meeting USP Chapter <797> or equivalent standards and involve simple formulas, often with only two or three ingredients. The other dosage forms are generally nonsterile and compounded according to USP Chapter <795> or equivalent standards.
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SUMMARY FOR QUESTIONS 1 AND 2 |
| The compounded formulations do NOT have |
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"complex formulations" or
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"complex drug delivery mechanisms"
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| but simply release the drug upon administration or implantation. Decades of safe and successful compounding of bHRT compounds have made life much better for millions of patients. |
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition
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Did You Know...
...the following?
"When people renounce or reject lies, lies simply cease to exist...Like parasites, they can only survive when attached to a person." (Anon)
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Thought of the Week
"We must refuse to live by lies!"
"Lies told by government, media and even scientists are increasingly common!"
"The telling of a falsehood is like the cut of a sabre; 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)
"A lie is like a snowball; the longer it is rolled, the larger it is." (Luther)
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Looking Back
Missin' kissin'?
Perhaps your thrush
Can't get thru
The underbrush, try
Burma-Shave
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