Question: What is the FDA's current stand on cannabis and cannabis-derived compounds? Part II

Answer:
The following are excerpts from the Statement that was released on December 20, 2018 from the FDA.

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency's regulation of products containing cannabis and cannabis-derived compounds (Cont'd)

"While products containing cannabis and cannabis-derived compounds remain subject to the FDA's authorities and requirements, there are pathways available for those who seek to lawfully introduce these products into interstate commerce. The FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.

These pathways include ways for companies to seek approval from the FDA to market with therapeutic claims a human or animal drug that is derived from cannabis.

+For example, in June 2018, the FDA approved a drug, Epidiolex, that contains cannabis-derived CBD for the treatment of seizures associated with two rare and severe forms of epilepsy. That approval was based on adequate and well-controlled clinical studies, which gives prescribers confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.

+In addition, pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process. However, the FDA would only consider doing so if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients.

+It should also be noted that some foods are derived from parts of the hemp plant that may not contain CBD or THC, meaning that their addition to foods might not raise the same issues as the addition of drug ingredients like CBD and THC. We are able to advance the lawful marketing of three such ingredients today. We are announcing that the agency has completed our evaluation of three Generally Recognized as Safe (GRAS) notices related to hulled hemp seeds, hemp seed protein and hemp seed oil and that the agency had no questions regarding the company's conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims.

Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products."

https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-signing-agriculture-improvement-act-and-agencys

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

Amazon Could Disrupt Pharmacy
Amazon and market disruption have become synonymous, and it looks like that will continue to be the case at least for the near future. A CB Insights research brief outlines the four industries where the online giant?s disruptive intentions are clearest, including:

• Pharmacies
• Small business lending
• Online groceries
• Payments: Giving small merchants a cheaper option

For the full report go to cbinsights.com/research/report/amazon-disruption-industries
https://www.drugstorenews.com/retail-news/pharmacy-among-industries-amazon-could-disrupt/

McKesson Execs Enriched from Generics Price-fixing Scheme
An investor lawsuit says that McKesson is involved in the massive generic drug price-fixing probe that's wrapped up the biggest names in the business, and that executives personally profited off the scheme. McKesson shareholder Jean Henry says the company's board and officers made misleading statements about the company's performance amid a years-long stretch of price-fixing by generic drug companies, and while the company's shares were riding high, thanks to higher drug prices, investors and board members dumped their holdings in a "massive insider trading binge." McKesson's former CEO and chairman, John Hammergren, sold $287 million in shares alone during the period, the lawsuit says. Later, when government attention to generic price-fixing caused drugmakers to lower their prices, McKesson's shares fell, the suit says.
http://www.fiercepharma.com/pharma/mckesson-implicated-generic-drug-price-fixing-scheme-lawsuit-says?

Did You Know ...

...that Mark Twain made the following statement?

"Suppose you were an idiot. And suppose you were a member of Congress. But then I repeat myself."

Tip of the Week

It has never been more evident than now that we need TERM LIMITS for those elected to Congress, both in the House and in the Senate. It's time for a lot of those individuals to pack up, go home, and be forced to live under the laws they have made. For many, it's more a question of a tax-funded "job," doing little, staying out of the spotlight, not rocking the boat, and getting re-elected after taking credit for the work of others during their campaigns! Others like the spotlight but don't always have the intelligence or education to do what they are elected to do!

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