There are three "sources" of active pharmaceutical ingredients (APIs) that can be used in pharmaceutical compounding, including:

• Bulk drug substances that comply with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary (NF) monograph, if one exists.
• If a monograph does not exist, the drug substance(s) must be a component of an FDA-approved human drug product.
• If neither of the above, it must appear on a list of bulk drug substances for use in compounding developed by the FDA through regulation.

The topic of this Newsletter is the first "source" of APIs listed above, those that comply with an applicable USP or NF monograph.

Questions have been received from a number of pharmacists practicing where the Board of Pharmacy requires that the same manufacturer / repackager / distributor source of drug used in a stability study to extend the beyond-use date (BUD) of a product be used in the compounding of the specific preparation in order to use the BUD documented in the stability study, even though other manufacturer/repackager/distributor sources are available. This does not make any sense. Regardless of the source of the API, the requirements are the same; the API must comply with the standards of an applicable USP or NF monograph! If not, they cannot be labeled as USP or NF and do not meet the requirements for use in either compounding or manufacturing.

An API from Source A must be identical with the API from Source B, Source C, etc. They must all meet the same USP or NF standards. In fact, many of the distributors of APIs obtain their products from the same source company(ies) for repackaging and distribution. Also, the APIs used in compounding are required to meet the EXACT SAME USP or NF REQUIREMENTS as those used in manufacturing�there can be no difference!

It is a different story involving vehicles, bases, etc. To use a BUD from a valid extended BUD study, the vehicle, base, etc. used in compounding must be the same as that used in the study establishing the BUD.

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

DON'T FORGET!!

TODAY is November 30, 2018 AND the Public Comment Period for USP <797> will close.

The current proposed chapter is posted online with line numbers at
     http://www.uspnf.com/notices/general-chapter-797-proposed-revisions

Submit comments using the form available at
     https://usp.az1.qualtrics.com/jfe/form/SV_3dDhnN2ZVCYh5yJ.

DON'T FORGET!!

News

Is "Deprescribing" the Cure for Polypharmacy Disease?
According to a nationwide survey published in Consumer Reports in August 2017, the number of prescriptions increased 85% over 20 years, while the population only grew by 21%. Polypharmacy carries such a risk for negative outcomes in older adults that it could be seen as a disease. Polypharmacy has the same elements as a disease and comes with risk factors like chronic disease states, polymorbidity, transitions of care, and seeing a number of different prescribers; it also has symptoms or consequences such as nonadherence of other essential medications, cognitive impairment, falls, pill burden, and personal and healthcare financial toxicity. Finally, it can have exacerbating factors, including prescribing cascades, lack of communication among providers, and lack of education for patients.

The cure for polypharmacy, then, is deprescribing, and it should always be part of the good-prescribing continuum.
https://www.pharmacist.com/article/deprescribing-cure-disease-polypharmacy

Regulating PBMs is the Goal of Some Attorneys General
Thirty-three attorneys general filed an amicus brief in the U.S. Supreme Court supporting states' rights to regulate PBMs. The brief argues that the regulation of PBMs is a matter for state authority in protecting the access to and affordability of prescription drugs. "States' experience has been that improving transparency in drug pricing requires regulation of PBMs," the brief says. PBMs feature in almost all of the key transactions that drive the price of a drug. PBMs also face incentives that often do not align with patients' interests in obtaining prescription drugs at reasonable cost.
https://www.daytondailynews.com/news/local/attorneys-general-fighting-for-right-regulate-pharmacy-middlemen/Zw8Qidd9pyiG02tV3Kd2uM/

Questions from Clinicians Reveal Gaps in Genetic Test-related Knowledge
The number of genetic tests on the market continues to increase, while many physicians feel unprepared to order them. Quest Diagnostics has genetic counselors to support physicians and educate them. They offer a report (available below) that reveals the top 10 questions asked of the genetic counselors.
https://cdn2.hubspot.net/hubfs/2913452/4.%20Health%20Systems/18-HS-010-Neurology-Frontline-Report/Quest%20Diagnostics-2018%20Frontline%20Report.pdf

Did You Know ...

�that Winston Churchill said the following?

A lie gets halfway around the world before the truth has a chance to get its pants on.

Tip of the Week

It is truly amazing that something that is undoubtedly false can be taken up by so many, spread so fast, repeated so often, and believed by so many with no one evidently concerned about whether or not it is true! After all, many think that everything they see on the Internet, on television or social media, or hear on the radio is true! I still like the saying on one of the popular television shows that says "Question Everything"!

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Looking Back

This will never,
Come to pass,
A back-seat driver,
Out of gas!
     Burma Shave