The ‘Final Rule’, by its title, sounds rather ominous. When the government institutes regulatory changes, it is often to the lament of affected agencies. This time: not so much. The Final Rule regarding Management Standards for Hazardous Waste Pharmaceuticals is actually overall beneficial to facilities as well as the environment. One of the key focuses of the amendment is how facilities handle expired or unused pharmaceuticals and the compliant storage of hazardous waste pharmaceuticals.
Historically, the most common way of disposing pharmaceuticals has been flushing (pouring down the drain), “Until this final rule, drain disposal has been an allowable disposal method for hazardous waste pharmaceuticals under RCRA…” 84 FR 5816. It was previously thought that this had no impact on our water sources, but the opposite has been scientifically proven. There have been multiple studies performed on the effect of flushing on wildlife, “A study by Karen Kidd et al., in the 22 May 2007 issue of Proceedings of the National Academy of Sciences, showed the collapse of a population of fish in an isolated lake spiked with relatively high levels of the synthetic estrogen 17α-ethinylestradiol.” Lubick, Naomi. “Drugs in the environment: do pharmaceutical take-back programs make a difference?.” Environmental health perspectives vol. 118,5 (2010): A210-4. doi:10.1289/ehp.118-a210 
| List of Potentially Affected Facilities: |
| Drug Wholesalers |
| Supermarkets and Other Grocery (except convenience) Stores. |
| Pharmacies and Drug Stores. |
| Warehouse Clubs and Supercenters. |
| Veterinary Services. |
| Physicians’ Offices. |
| Dentists’ Offices. |
| Other Health Practitioners (e.g., chiropractors). |
| Outpatient Care Centers. |
| Other Ambulatory Health Care Services. |
| Hospitals. |
| Nursing Care Facilities (e.g., assisted living facilities, nursing homes). |
| Continuing Care Retirement Communities (e.g., assisted living facilities with on-site nursing facilities). |
| Reverse Distributors. |
The scientific community has not yet definitively linked the flushing of pharmaceuticals to adverse effects on humans. If these chemicals are being introduced into our drinking water and having profound effects on the wildlife within the drinking water, it is only logical to assume that humans would incur negative consequences as well. Now that an issue has been identified, we must address it: “One way to prevent additional impact to our waters is the cessation or reduction of pharmaceutical drugs disposed of via sewers,” C.G. Daughton, I.S. Ruhoy, Environmental footprint of pharmaceuticals: The significance of factors beyond direct excretion to sewers, Environ. Toxicol. Chem., 28 (2009), pp. 2495-2521, 10.1897/08-382.1.
Another beneficial facet of this amendment is the new guideline on how Nicotine products will be handled. Traditionally, smoking cessation products containing Nicotine qualified as hazardous waste and had to be disposed of as such. Not anymore; from now on, these products are categorized as nonhazardous pharmaceutical waste.
Lastly, this new rule affects how expired medicines are returned. An outdated drug may be returned to a reverse distributor. This is common practice; after August 21, 2019, a drug becomes eligible for return the day it expires or ‘outdates’ (assuming it meets other mitigating factors: “original manufacturer packaging; undispensed; and unexpired or less than a year past expiration” SMITH, CHARLOTTE A. “Countdown to New Drug Waste Rule: EPA’s New Disposal Regulations to Require Operational Changes.” Health Facilities Management, vol. 32, no. 6, July 2019, p. 52. EBSCOhost, search.ebscohost.com/login.aspx?direct=true&db=f5h&AN=137427558&site=eds-live.
The exact dates for when regulations roll out may be affected by state guidelines, so a facility must always be sure to cross-check federal regulations with state level regulations. These changes will take some time for facilities to adjust, but are anticipated to be overall cost-saving. Less training will be needed for staff with the list of hazardous products lessened by the release of Nicotine products for hazardous disposal. Distribution centers may qualify for different (less expensive) licensing options with the removal of Nicotine products from the list. Waste management practices will be more streamlined by the removal of flushing as an option for disposal.
After expiration and before disposal, facilities must still adhere to government regulations of containment.
Schedules I and II
May suffice with safe or steel cabinet:
Safe or cabinet must have following specifications: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques. These includes TL-15 Rated EPA Safes and some agencies may be approved for GSA Approved Class 5 rated containers.
Or if quantities require a vault:
Walls, floors, and ceiling are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with ½ inch steel rods tied 6inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings. Modular vault structures of a UL Class 1 rating are equivalent to 12″ inch poured concrete w/ 4 layers of re-bar per ASTM specifications.
Following specifications: 30 man minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques
One of the following: Electrical lacing of the walls, floor, and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by administration
Schedules III, IV and V
Subject to the same storage security regulations as schedules I and II
May utilize a building used specifically for storage of controlled substances providing the building:
Has an electrical alarm system
Perimeter security during working and non-working hours
Etc.
May store drugs in a cage within a building on the premises
Cage must have walls of no less than No. 10 gauge steel fabric mounted on steel posts
Posts are at least one inch in diameter, set in concrete or installed with lag bolts that are pinned or brazed, and placed no more than ten feet apart with 1 and 1 ½ inch reinforcements every sixty inches
Etc.
Helpful Links:
Code of Federal Regulations: Title 21
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=205.50
EPA: Final Rule
Federal Register
When you’re ready to begin the process of securing your facility, the consultants at KL Security are available to assist. Well versed in government regulations and recent legal mandates, we are prepared to ensure your business will pass requirements.
TOLL FREE 1-866-867-0306
Information has been gathered from sources deemed reliable but not guaranteed and is subject to change without notice. All license information and security measures taken directly from the Code of Federal Regulations: 21CFR205.50 and 84 FR 5816.
