Question: What are the new regulations affecting pharmacy from the EPA?

Answer:
There are a number of changes in the federal regulations for the management of hazardous waste pharmaceuticals (Hazardous Drugs‑HDs) by healthcare facilities.

The 135-page rule, “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,� was published in the February 22 Federal Register. Some of the changes are as follows:

1. Sewering: No more sewering, or disposing of HD waste in any form in the water supply, i.e., no flushing or putting it down the sink. This is effective 6 months after publication date and applies to all U.S. healthcare facilities and reverse distributors.
   Note: Effective Date is August 21, 2019.
   
   
2. Empty Containers: Unit-dose containers and stock bottles, dispensing bottles, vials, and ampules that originally held up to 10,000 “pills� or 1 L of material are considered empty when fully dispensed or administered.
   
   An empty container previously holding HDs is NOT considered hazardous waste as long as accepted practices for that type of container were used to remove its contents. This also applies to syringes and IV bags whose contents were fully administered to a patient.
   Note: Triple rinsing of HD containers is no longer required or permitted.
   
   
3. Partial Containers: Containers that are only partially dispensed and that hold HDs must be disposed of as “Noncreditable Hazardous Waste� (NCHW). Other examples of NCHW include
   • Free product samples,
   • investigational drugs,
   • spillage,
   • medications over 1 year past their expiration date,
   • repackaged medications for dispensing,
   • products in damaged packaging, and
   • dispensed medications refused by patients.
   
   
4. NCHW involves medications that have been dispensed and are not in their original packaging. These manipulations affect whether or not a medication will be eligible for credit from the manufacturer or, for OTC products, whether they will be legitimately used, reused, or reclaimed.
   
   
5. Storage: Healthcare facilities can accumulate NCHW pharmaceuticals for up to 365 days. There is no limit for the accumulation of potentially creditable HDs.
   
   
6. Nicotine: The rule distinguishes between Rx and Non-Rx nicotine replacement products. FDA-approved Non-Rx nicotine replacement products (patches, gums, and lozenges) can be discarded as nonhazardous wastes.
   
   
7. Nicotine: Liquid formulations intended for use in electronic nicotine delivery systems (e-cigarettes) are considered hazardous waste, as are nicotine-containing pesticides and nicotine used for research and manufacturing activities.

Some of the provisions in the rule have different effective dates, and some are related to state-level requirements for adopting HD waste management regulations.

Important Note: Learn more about the current EPA, NIOSH, and OSHA and their roles in compounding (and pharmacy in general) and other important topics at the QCS (Quality Compounding Summit) to be held September 5-7 in Nashville, TN.

Register now and save $100 off registration using your speaker registration code “TRUST�.

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

Teen Vaping Tied to Marijuana Use
Adolescents and young adults who have smoked e-cigarettes are more than three times more likely to move on to marijuana than youth who never try vaping, a research review study suggests. Data from 21 previously published studies with more than 128,000 participants ages 10 to 24 were studied. Overall, young people who used e-cigarettes were 3.5 times more likely to use marijuana, the analysis found. Adolescents ages 12 to 17, e-cigarette users were 4.3 times more likely to use marijuana. “E-cigarettes are often considered benign or harmless by youth and their families,� said Dr. Nicholas Chadi, lead author of the study and an assistant professor of pediatrics at Sainte-Justine University Hospital at the University of Montreal in Canada. “What this study suggests is that e-cigarettes (most of which contain nicotine) should be considered harmful, in a similar way as other substances like alcohol and tobacco, which have also been associated with increased marijuana use,�
https://www.reuters.com/article/us-health-kids-smoking/teen-vaping-tied-to-marijuana-use-idUSKCN1V324S

“Juul-alikes� Filling Shelves with Sweet, Teen-friendly Nicotine Flavors
The purveyors of Strawberry Milk, Peach Madness, and Froopy (tastes like Froot Loops) e-cigarette pods are having a very good year. After Juul Labs, under pressure from the FDA, stopped selling most of its hugely popular flavored nicotine pods in stores last fall, upstart competitors swooped in to grab the shelf space. Trumpeting their own fruity and candy-flavored pods as compatible with Juul devices, they have seen their sales soar. When Juul agreed to discontinue store sales of its fruit and dessert flavors, it said it would continue selling them online and strengthen the age verification process on its website. https://www.nytimes.com/2019/08/13/health/juul-flavors-nicotine.html

Did You Know ...

...that, again, it looks as if the big PHARMA companies care very little about patient health and safety?

Tip of the Week

Regarding 503B Outsourcing Facilities, Big PHARMA has worked with Congress to send a letter to the FDA asking for strict adherence to the non-existent “positive list.� This would, in effect, extremely limit the 503B Outsourcing Facilities, as there are no bulk drugs on the “positive list� yet.

Think back to the days when big PHARMA companies were run by physicians, pharmacists, etc. and the patient was very important. Today it seems they are run by individuals with “business degrees,� and the only thing that matters is the “bottom line�! Patients are in BIG TROUBLE when BIG PHARMA and the FDA are not concerned about patient access to needed medications, regardless of whether they are manufactured or compounded.

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Looking Back

My neck was sore
In front before,
And also
Sore behind before!
     Burma-Shave