We are now looking at regulations governing and affecting our practice, specifically the NIOSH regulations. Let’s look at the role of NIOSH in pharmaceutical compounding. Due to the length of the documents in this series, we will use an abbreviated approach. For this week, we will look at the following:

I. General Approach to Handling Hazardous Drugs (HDs)
II. Defining Hazardous Drugs
III. How to Generate Your Own List of Hazardous Drugs
IV. References

I. General Approach to Handling Hazardous Drugs (HDs)

NIOSH has categorized HDs into the following three groups:

II. Defining Hazardous Drugs

Those drugs that exhibit one or more of the following six characteristics in humans or animals.

• Carcinogenicity
• Teratogenicity or other developmental toxicity
• Reproductive toxicity
• Organ toxicity at low doses
• Genotoxicity
• Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria

III. How to Generate Your Own List of Hazardous Drugs

• Employers must develop a hazard communication program appropriate for their unique workplaces.
• This involves the identification of all hazardous chemicals.
• The NIOSH list and current updates can be used as a resource.
• Other (SDS, Product labeling, DrugBank, DailyMed, Special Health Warnings, Reports and Case Studies, Evidence-based Recommendations from other facilities can also be used as a resource).

IV. References:

https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf?id=10.26616/NIOSHPUB2016161

Next week, the 5 NIOSH Tables and what can be done with them.

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

Vaping’s Black Market Complicates Efforts to Combat Crises
U.S. health officials are confronting a sprawling black market for vaping products which has resulted in a mysterious lung illness and a surge in teen vaping. Hundreds of vaping brands—containing nicotine, compounds derived from cannabis or other substances—sold online, in vape shops, convenience stores, and marijuana dispensaries are at issue here. Many are compatible with Juul vaporizers and are sold on the black market.

No single product or ingredient has been identified as the cause of the vaping-related illness, which has sickened more than 1,000 people and is linked to at least 19 deaths.
https://www.wsj.com/articles/vapings-black-market-complicates-efforts-to-combat-crises-11570354204?tesla=y

Two International Mail Facilities Inspected by Acting FDA Chief for Illicit Vaping and Opioid Products
The FDA acting head visited two international mail centers this week to examine U.S. efforts to seize foreign shipments of illicit vaping products, fentanyl, and other drugs. FDA Chief Ned Sharpless dropped by facilities at John F. Kennedy International Airport and Secaucus, New Jersey on Monday as federal authorities work to crack down on the large flow of illegal drugs and other substances that are smuggled into the U.S. each year. “It is truly remarkable to have witnessed the stunning volume of parcels that come into a single international mail facility on a single day.�
https://www.cnbc.com/2019/10/09/fda-chief-inspects-major-mail-facilities-for-illicit-vaping-and-opioid-products.html

Kansas Board of Pharmacy Concerned with Patients of Closed Pharmacies
The Kansas Board of Pharmacy proposed a new regulation to the legislative members of the Joint Committee on Administrative Rules and Regulations at the state capitol. The legislators found this regulation to be noncompliant with the law. The board wants to begin notifying patients who have received prescriptions from a pharmacy in the past two years if that pharmacy were to close.

Representative and committee member John Carmichael thinks this is a good idea, but that it is not legal. The Kansas state government recently implemented a law where boards and departments must evaluate the financial impact on businesses before proposing a new rule or regulation, according to Carmichael. Carmichael believes the board did not take into account the financial impact that mailing thousands of notice letters would have on a closing pharmacy. Carmichael recommends the board calculate an estimated cost of sending out these letters and, if the numbers are not too high, the committee will more than likely approve this regulation.
https://www.ksnt.com/capitol-bureau/legislatures-find-ks-board-of-pharmacy-proposed-regulation-illegal/

Did You Know ...

…that George Washington said the following?

“It is better to be alone than in bad company.�

Tip of the Week

We have heard many times the statement often told to young people, “Show me your friends and I can tell you what you will become.� In many ways, this is true. We are influenced by our friends, but we can also influence our friends, depending upon who is the stronger and most determined. We have also heard that “One rotten apple can spoil the whole barrel.� This, too, is true, and it seems to be happening more and more in our society. So, what should we do? Obviously, the best choice is to surround one’s self with hardworking, honest, concerned individuals and contribute to their growth as well as benefiting from their positive influence.

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Looking Back

Angels who guard you
When you drive,
Usually retire at 65…
     Burma-Shave