WHO IS WHO ?
I have a notorious and almost legendary reputation for forgetfulness. I can be halfway through writing a blog and not remember what it was originally about. In fact, if it’s on my computer or tv, for the first time, I will very rarely watch a movie or show to its end, because I can not remember what happened at the beginning. But I think my biggest problem is, trying to remember the names of who the actors play. I think they should show the actors and who they are playing before the movie starts, in the opening credits, not when the movies over.
A THEATRICAL PRODUCTION
So, if you are like me and sometimes suffer from short term memory loss, I was hoping to review the good and the bad actors in the new hazardous waste pharmaceutical final rule. I say actors because when I am reading this new rule, I feel like I am watching a movie. That is because at least five of the major players seem to share the same middle, first or last names.. Don’t worry, I am not going to give you the story line today, only the cast of characters.
IT IS ABOUT DRUGS
Most movies are about the lives of humans, animals or insects, However this new rule is about the death and redemption of pharmaceuticals. Pharmaceuticals are defined as any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system or any liquid nicotine packaged for retail sale for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials). It also includes dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act; prescription drugs, as defined by 21 CFR 203.3, over-the-counter drugs; homeopathic drugs; compounded drugs; investigational new drugs; pharmaceuticals remaining in non-empty containers; personal protective equipment contaminated with pharmaceuticals; and cleaned up materials from spills of pharmaceuticals.
See “Hazardous Waste Pharmaceuticals”, would be the star of this show, this A-lister could only be played by a pharmaceutical that exhibits one or more characteristics identified as ignitable, corrosive, reactive or toxic in EPA 40 CFR part 261 subpart C or is listed in part 261 in the non-specific hazardous waste list, the specific hazardous waste list or the discarded waste chemical list in subpart D.
And what is any good production without a good character actor, the costar, such as the sidekick, a Potentially credible hazardous waste pharmaceutical. This sidekick must be portrayed as a prescription hazardous waste pharmaceutical that has a reasonable expectation to receive manufacturer credit and in original manufacturer packaging (except pharmaceuticals that were subject to a recall), undispensed; and unexpired or less than one year past expiration date.
Then of course there is always a scorned villain, the B-lister, a Non-creditable hazardous waste pharmaceutical. In this blockbuster it would be a prescription hazardous waste pharmaceutical that does not have a reasonable expectation to be eligible for manufacturer credit or a non-prescription hazardous waste pharmaceutical that does not have a reasonable expectation to be legitimately used/reused or reclaimed, like an investigational drug, free samples of pharmaceuticals received by healthcare facilities, residues of pharmaceuticals remaining in empty containers, contaminated personal protective equipment, floor sweepings and cleaned up material from the spills of pharmaceuticals.
Most films, include a couple of lightweight henchmen, so in this production, they would be Non-hazardous waste pharmaceuticals. This type of pharmaceutical is a solid waste, but not a hazardous waste with very few lines in the regulations and Non-pharmaceutical hazardous wastes, a solid waste, that is also a hazardous waste but is not a pharmaceutical.
THE LOVE INTEREST
Finally, the love interest, which is usually portrayed by a femme fatale or big dumb palooka, but in this case, it is an Evaluated hazardous waste pharmaceutical. A prescription hazardous waste pharmaceutical that has been evaluated by a reverse distributor in accordance with § 266.510(a)(3) and will not be sent to another reverse distributor for further evaluation or verification of manufacture credit.
It’s not only the actors, but the production location, that matters. That’s because under the new rule any scenes at a Healthcare facility, would have to be shot at a location that provides preventative, diagnostic, therapeutic, rehabilitative, maintenance, or counseling services and assessments or procedures with respect to the physical or mental condition, or functional status, of a human or animal. This would encompass any backlot locations that distribute, sell or dispense pharmaceuticals, over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals. This would also include wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians' offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies, including both long-term care, and mail-order, retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals.
Whereas, if the script called for a Long-term care facility, the location scouts would have to find a licensed entity that just provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility such as hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities.
DISTRIBUTORS AND CREDITS
This Hazardous waste pharmaceutical regulation also includes distributors and credits, not the film’s distributor or the actor credits but, Reverse distributors. These extras receive and accumulate prescription pharmaceuticals that are Potentially credible hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit, and include forward distributors, third-party logistics providers, and pharmaceutical manufacturers that process prescription pharmaceuticals for the facilitation or verification of manufacturer credit.
And as with any film, there is always a disclaimer at the end, which states that the events presented are fictional and the people, do not Include any that are living or dead. So! Healthcare facilities do not include pharmaceutical manufacturers, reverse distributors or reverse logistics centers. The term Hazardous waste pharmaceutical does not include evaluated hazardous waste pharmaceuticals or non-prescription pharmaceuticals including, over-the-counter drugs, homeopathic drugs and dietary supplements if it has a reasonable expectation of being legitimately used/reused (e.g., lawfully redistributed for its intended purpose) or reclaimed and Long-term care facilities do not include group homes, independent living communities, assisted living facilities, and the independent and assisted living portions of continuing care retirement communities.
Opening night for the new rule is August 21, 2019, I will let you decide if this new rule is a comedy, drama, tragedy or romantic production. So, GO SEE, “THIS NEVER BEFORE SEEN”, “EDGE OF YOUR SEAT”, “INTRIGUING ENTERTAINMENT EXTRAVAGANZA DOUBLE FEATURE” ON A COMPUTER NEAR YOU, by downloading the final rule including it’s preamble at https://www.govinfo.gov/content/pkg/FR-2019-02-22/pdf/2019-01298.pdf .
Thank you for your attendance, readership and support
Robert J Keegan
Publisher, President and Producer
Hazardous Materials Publishing Company
Transportation Skills Programs Inc