CS I Flashcards
Q
A
Those able to collect
DEA registrant
Law enforcement
Others defined by NYSDOH for collecting non controlled
Collection of drugs: NOT included
Vitamins/supplements
Herbs/homeopathic
Cosmetics
Pesticides for pets
Where manufacturer provides their own take back
Veterinary drugs
Injector products, empty medical devices, dialysis supplies
Medical marihuana
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Pharmacies
Group of ≥ pharmacies
under common ownership or management
Franchise agreements
Non-resident pharmacies that provide covered drugs to state residents by mail
Operator
Manufacturer / Drug take back organization that implements an authorized drug take back organization.
Convenience
Certain minimum # of collection receptacles in cities and counties of 125,000 or more
Pharmacies, law enforcement
Requirements for those involved in Drug Take Back Programs
Timelines
Applications
Stakeholders
Outreach activities
Reporting requirements
Pharmacies Engaged in Drug Take Back
Registered in NYS
Maintain on-site receptacle
Laws concerning CS Federal and NYS
Notify BNE within 30 days if D/C
Pharmacies Collection Receptacles
Community:
Located immediate proximity of the registered pharmacy area
Rxs are dispensed
Within site of employees
RHCF
Located in secure area regularly monitored by RHCF
Periodic monitoring
Remove / replace liners
Storage / delivery / acceptance of sealed liners by reverse distributors
Employees may not access or handle any drugs
Report to DOH BNE within 24 hours of any damage / tampering / theft of liners
Must comply with federal regulations
Permanent structure
Securely locked
Liners
Outer receptacle small opening
No removal of inner contents
Sign on outside of receptacle
Pharmacies Liners
Only accessible to employees of pharmacy
Waterproof, tamper evident, tear proof
Removable and sealable
Without touching contents
Opaque
Not x-rayed, analyzed, penetrate
Size indicated on bag
ID#
Removed
Immediately sealed
2 pharmacy employees in community
1 pharmacy & 1 supervisor healthcare professional of RHCF
Must maintain records of dates, names, date of removal, ID# of bags
Community: must be collected by reverse distributor ASAP same business day if possible
Safely secured until then
RHCF: must be collected by reverse distributor ASAP same business day if possible
Not to exceed 3 days
Must obtain approval of resident to dispose
Mail back Programs
Prepaid package or envelopes
Nondescript
Water and spill proof
Tamper evident, tear proof
Unique ID#
Voucher for package or envelopes
Patient education
Safe drug disposal methods
Instructions on mailing
Record
How many years? 5
NYS Drug Take Back Act
Manufacturer, individually or jointly, must pay for all administrative and operational fees associated with the drug take back program:
Collecting
Transporting
Disposing
Of all covered drugs
From pharmacies and other authorized collectors and the recycling or disposal, or both, of packing collected with the covered drug.
Manufacturers must also pay costs incurred by the state in the administration and enforcement of the drug take back program
No manufacturer may charge a point of sale or other fee to consumers or a fee that could be passed onto consumers to recoup their costs of the drug take back program.
Programs must be approved.
Must report to NYS annually.
All costs of pharmacies or other authorized collectors shall be paid or reimbursed by the manufacturer, jointly or individually, as part of the drug take back program.
All drug take back program operators shall notify other potential authorized collectors of the opportunity to serve as an authorized collector for the drug take back program.
Participation of authorized collectors besides pharmacies shall be voluntary
