Pharmaceutical Waste Solutions
Since 2009, Sharps Compliance has pioneered unused medication disposal solutions for consumers (ultimate users) with the TakeAway Environmental Return System™. We have safely collected and treated over 800,000 pounds of unused medications, removing them from homes and preventing circulation into water supplies. Now, with the release of the updated DEA rules enacting the Secure and Responsible Drug Disposal Act of 2010 (Disposal Act), Sharps Compliance introduces two new solutions (MedSafe® & TakeAway Medication Recovery System™) for the disposal of unused or expired medication, including controlled substances (schedules II-V.) In addition to ultimate user medication disposal, Sharps Compliance can manage pharmaceutical disposal programs for healthcare facilities, retail pharmacies, reverse distributors, clinical trials and pharmaceutical wholesalers. We offer pure destruction services for non-hazardous pharmaceuticals and a mix of mailback and pickup services for RCRA hazardous pharmaceuticals. Contact us today at 800.772.5657 for more information on service options.
Ultimate User Medication Disposal
Our patent-pending MedSafe solution combines the design of the industry's best collection receptacles used in law enforcement for years with the logistics and treatment capabilities of Sharps Compliance. MedSafe is designed for retail pharmacies, long-term care facilities (LTCF), hospitals or clinics with onsite pharmacies, narcotics treatment centers and licensed law enforcement. Under the Disposal Act, these location types can legally manage the disposal of ultimate user, patient dispensed controlled substances (schedules II-V) and non-controlled medications with a single solution. Under the Disposal Act, all collection receptacle programs that include the collection of controlled substances must be managed by a DEA registered collector. Now, retail pharmacies and hospitals or clinics with onsite pharmacies can manage medication collection programs at their LTCF customers’ locations. Long-term care facilities can house a collection receptacle with a DEA approved collector managing the program. The collector can be a local retail pharmacy, a closed-door pharmacy that provides the location’s medications or the LTCF if they have a registered on-site pharmacy. Visit the MedSafe product page for more information.
Takeaway Medication Recovery System™
Our TakeAway Medication Recovery Systems are designed to meet the new DEA rules for controlled substance disposal by ultimate users. They are offered in the popular mailback envelope format or in specially designed boxes. They are perfect for use in hospice and LTCF. They can also be sold in pharmacies and be provided by other entities to consumers to fill and mail right from their homes. All of our TakeAway Medication Recovery Systems are available for sale in our online store or by contacting Sharps Compliance at 800.772.5657 for more information.
Solutions for Healthcare Professionals
DEA Reverse Distribution for Registrants
Sharps Compliance provides DEA registrants with a simple and affordable reverse distribution solution for disposal of unused or expired controlled substances. We offer three convenient sizes (1.25-gallon, 2.5-gallon and 5-gallon) for collecting and returning pharmaceuticals for proper destruction. Reverse distribution is only available for DEA registrant’s inventory of medications and not intended for ultimate user medication disposal, hazardous pharmaceuticals or other biohazardous waste including sharps or soft waste. Shop for systems here.
Systems will only be accepted with approval of a DEA Controlled Substances for Destruction Form.
The management of RCRA pharmaceutical waste including the identification, determination, storage, transportation and treatment, is not the same as management of non-hazardous pharmaceutical waste. Businesses are required to have a comprehensive program for management of hazardous pharmaceutical waste. We assist in helping healthcare facilities and retail pharmacies with waste determination and provide a plan for storage and final treatment.
Noncompliance with hazardous pharmaceutical waste regulations can result in fines of up to $37,500 per day, per incident (ASHP, 2012).
PHARMACEUTICAL WASTE FAQS
WHAT ARE RCRA PHARMACEUTICALS?
RCRA (Resource Conservation and Recovery Act) pharmaceuticals become hazardous waste when deemed nonviable (returned, expired, damaged.) They are considered "listed" wastes. The volume and type of listing can impact storage limits, generator status and requirements for disposal packaging. A proper program for RCRA pharmaceuticals includes written waste determination, storage, transportation and treatment. Contact Sharps Compliance to set up a compliant program today for managing RCRA waste in your healthcare facility or retail pharmacy.
WHAT CAN AND CANNOT GO INTO THE TAKEAWAY MEDICATION RECOVERY SYSTEM ENVELOPES?
- Place all unused medications into this envelope including legally held controlled drugs and narcotics (Schedules II, III, IV and V.)
- Medications should be in their original containers when placed into the TakeAway envelope.
- Liquids must be placed in a sealed plastic bag (e.g. a zip-locked bag) before being placed inside the envelope. No more than four (4) ounces of liquids can be included in each mailing.
- Seal the envelope carefully.
- Take the sealed envelope to a U.S. Post Office or U.S. Postal Service drop box, or simply hand it to your U.S. postal carrier.
- DO NOT mail needles, syringes. lancets, injection pens, medical waste, liquid chemo/cytotoxic drugs or contaminated materials such as gloves, tubing, or IV bags in this envelope. Contact Sharps Compliance at 800.772.5657 for the proper disposal method for these items.
- DO NOT mail trash, aerosol spray cans, batteries, any substance or material that could adversely affect the safety of carriers during transportation, such as flammable, infectious, radioactive, or combustible materials.
- DO NOT mail illicit drugs (Schedule I controlled substances) such as marijuana, cocaine, heroin, methamphetamine.
- DO NOT OVERFILL THE ENVELOPE.
- DO NOT take this filled envelope back to your pharmacy.
Notice 1 - Packages may only be mailed from within the 50 US states, District of Columbia, and Puerto Rico.
Notice 2 - Only TakeAway Medication Recovery System envelopes provided by Sharps Compliance Inc. will be accepted for destruction.
WHAT OR WHO IS A DEA COLLECTOR?
A DEA registered collector is a DEA registrant that updates their registration to collector status. Retail pharmacies and hospitals or clinics with on-site pharmacies can update their registration to become collectors and place collection receptacles onsite. Additionally, retail pharmacies, closed-door pharmacies and hospitals or clinics with on-site pharmacies can manage collection receptacle programs for long term care facilities with an updated collector status.
HOW MUCH DOES MEDSAFE COST?
MedSafe is a monthly leased service program that provides the collection receptacle and inner liners for one monthly fixed cost. The monthly cost is based on the collection receptacle size (18-gallon or 38-gallon) and the number of inner liners required in one calendar year. The monthly cost includes the initial shipment of the MedSafe receptacle including one inner liner to the location where it will be installed, shipments of new inner liners based on the service schedule and transportation and destruction of full inner liners.
CAN MEDICATIONS BE COMMINGLED IN A MEDSAFE COLLECTION RECEPTACLE?
YES. Under the Disposal Act, non-controlled, over-the-counter and controlled medications can be commingled in the collection receptacle. Schedule I drugs and hazardous medications are not allowed in the collection receptacle. Contact Sharps at 800.772.5657 for the proper option for disposal of your hazardous medications.
IS YOUR COMPANY AUTHORIZED TO COLLECT AND DISPOSE OF UNUSED, UNWANTED, OR EXPIRED PHARMACEUTICAL INCLUDING CONTROLLED SUBSTANCES FROM ULTIMATE USERS?
YES. Sharps Compliance, Inc. is DEA registered Reverse Distributor and Collector for the disposal of unused, unwanted, or expired pharmaceutical including controlled substances (schedules II-V) from ultimate users. Our MedSafe receptacles are designed for retail pharmacies, long-term care facilities (LTCF), hospitals or clinics with onsite pharmacies, narcotics treatment centers and licensed law enforcement. The MedSafe fully complies with the federal Controlled Substances Act and the Secure and Responsible Drug Disposal Act of 2010. and meets the design specifications established by the DEA (21 CFR § 1317.75):
- (i) A securely locked, substantially constructed container with a permanent outer shell and a removable inner liner as specified in § 1317.60 of this chapter.
- (ii) The outer container shall include a small opening that allows contents to be added to the inner liner, but does not allow removal of the inner liner’s contents;
- (iii) The outer container shall prominently display a sign indicating that only non-controlled drugs and Schedule II, III, IV, or V controlled substances are acceptable (Schedule I controlled substances, controlled substances that are not lawfully possessed by the ultimate user, and other illicit or dangerous substances are not permitted); and
- (iv) Access to the inner liner shall be restricted to authorized employees of the authorized collector.
DESCRIBE THE TYPE (S) OF AUTHORIZED CONTAINERS YOU USE TO COLLECT AND SAFELY TRANSPORT PHARMACEUTICALS.
The Sharps Compliance, Inc., MedSafe Inner Liner is designed to collect, protect and safely transport the pharmaceuticals to our treatment facility. The inner Liner meets the following DEA requirements (21 CFR § 1317.60):
- a) The inner liner shall be waterproof, tamper-evident, and tear-resistant;
- b) The inner liner shall be removable and sealable immediately upon removal without emptying or touching the contents;
- c) The contents of the inner liner shall not be viewable from the outside when sealed;
- d) The size of the inner liner shall be clearly marked on the outside of the liner (e.g., 5 gallons, 10 gallons, etc.); and
- e) The inner liner shall bear a permanent, unique identification number that enables the liner to be tracked.
Additionally, The Company has received a Special Permit (DOT-SP 20284) from the United States Department of Transportation authorizing the use of Sharps Compliance, Inc.’s MedSafe Inner Liner packaging for the transportation of hazardous material pharmaceuticals. Click link below for the Special Permit.
WHAT RECORDS DO YOU MAINTAIN TO COMPLY WITH AND THE DEA REGULATIONS?
Sharps compliance, Inc., maintains records that comply with DEA Recordkeeping Requirements (21 CFR §):
- Date Received
- Date of destruction;
- Method of destruction;
- Name and address of the place of destruction;
- Unique identification number of the inner liner destroyed;
- Size of the inner liner destroyed (e.g., 5 gallons, 10 gallons, etc.); and
- Name and signature of the two authorized employees who witnessed the destruction.
DESCRIBE THE SECURITY CONTROLS FOR CONTROLLED SUBSTANCES.
The Sharps Compliance, Inc., securely stores the Inner Liner containers collected from ultimate users in a manner consistent with the security requirements for Schedule II controlled substances. All Inner Liner containers are stored inside DEA approved vault until prompt on-site destruction can occur. The following describes the safety and security features:
The walls, floors, and ceilings of which vault are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with \1/2\-inch steel rods tied 6 inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings;
The door and frame unit of which vault conform to 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;
The vault is equipped with a "day-gate" which is self-closing and self-locking for use during the hours of operation in which the vault door is open;
The walls are equipped with an alarm, which upon unauthorized entry transmit a signal directly to a central station protection company and State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Administrator may approve, and, if necessary, holdup buttons at strategic points of entry to the perimeter area of the vault;
The door of which vault is equipped with contact switches; and
Vault has complete electrical lacing of the walls, floor and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system to detect illegal entry as may be approved by the Administration.