Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: The purpose of this rule is to authorize
pharmacies to collect medication for purposes of destruction and to establish
requirements for medication collection programs.
(1) Missouri licensed pharmacies may collect
medication from the public for destruction in compliance with this rule.
Pharmacies collecting controlled substances shall comply with all applicable
state and federal controlled substance laws. Pharmacies collecting non-
controlled substances shall comply with sections (2) to (9) of this rule.
Participation in a medication return or destruction program is voluntary. This
rule shall not be construed to require that a licensee or permit holder
participate in or establish a return/destruction program.
(2) Definitions. The following definitions
shall apply for purposes of this rule:
(A)
"Mail"- Mail shall include mailing via the United States Postal Service or
shipping via a common carrier; and
(B) "Nonretrievable"- For the purposes of
destruction, a condition or state to which medication is rendered after
undergoing a process that permanently alters the medication's physical
condition or state through irreversible means and thereby renders the
medication unavailable and unusable for all practical purposes.
(3) Pharmacies may maintain a
collection receptacle or establish an authorized mail-back program to collect
non-controlled medication from the general public for destruction. Collection
receptacles may not be used to dispose of unused/unwanted medication in the
pharmacy's inventory (e.g., outdated drugs, medical waste). Collected
medication shall not be resold or reused.
(A)
Pharmacies collecting medication under this rule shall develop and implement
written policies and procedures governing medication collection which must
include, but not be limited to, authorized destruction procedures and
methods.
(B) This rule does not
preempt or modify return/reuse of medication as authorized by
20 CSR
2220-3.040, the provisions of Chapter 196, RSMo,
governing the Prescription Drug Repository Program, or any provision of state
or federal law governing controlled substances or the destruction, handling, or
transporting of medical or pharmaceutical waste.
(4) Collection Receptacles. Pharmacies that
maintain a collection receptacle to collect non-controlled medication for
destruction must comply with the following:
(A) Collection receptacles must be securely
placed and maintained inside the physical building of the pharmacy in a manner
that prevents theft, diversion, or unauthorized removal. Receptacles must be
securely fastened to a permanent structure. The receptacle must be visible to
pharmacy staff at all times and shall not be located in or near exit
doors;
(B) The receptacle must be a
securely locked, substantially constructed container with a permanent outer
container, and must contain an inner liner that complies with this rule. The
receptacle must have an opening that allows medication to be added to the inner
liner but does not allow the contents of the inner liner to be removed. The
opening must be locked or otherwise made inaccessible to the public so that
drugs cannot be deposited into the collection receptacle when the pharmacy is
closed for business;
(C) A sign
must be prominently displayed on the outer container of the receptacle
indicating that only non-controlled substances may be deposited into the
receptacle. If the receptacle is also used to collect controlled substances,
the required sign must comply with state and federal controlled substance
laws;
(D) Inner liners must be
removable, waterproof, tamper-evident, and tear resistant and must bear a
permanent, unique identification number or identifier that enables the inner
liner to be tracked. The contents of the inner liner shall not be viewable from
the outside;
(E) Inner liners must
be installed or removed from a collection receptacle by or under the
supervision of at least two (2) board licensees or registrants. Inner liners
must be immediately sealed once removed from the receptacle; the sealed inner
liner shall not be opened, x-rayed, analyzed, or otherwise penetrated by the
pharmacy or pharmacy staff. After removal, sealed inner liners pending
destruction may be stored at the pharmacy in a securely locked, substantially
constructed cabinet or in a securely locked room or area with controlled access
for no more than thirty (30) business days; and
(F) Pharmacies must report any theft or
diversion of or from a collection receptacle to the board in writing within
fourteen (14) days in a manner designated by the board.
(5) Mail-Back Programs. Pharmacies may
provide mail-back packages to the public for the purpose of mailing medication
to a collector that is authorized by the Drug Enforcement Administration or
federal law to receive prescription medication for destruction ("an authorized
collector"). Packages may be provided directly by the pharmacy or the
pharmacy's authorized designee, provided the pharmacy is responsible for
ensuring compliance with this section.
(A)
Mail-back packages must be preaddressed with the address of the authorized
collector. The cost of shipping the package shall be postage or otherwise
prepaid. Licensees/permit holders shall not accept any returned mail-back
packages. Packages must be mailed directly to the authorized collector by the
consumer or his/her agent.
(B)
Mail-back packages must be nondescript and shall not include any markings or
other information that might indicate that the package contains medication.
Packages must be water-proof, spill-proof, tamper-evident, tear-resistant, and
sealable.
(C) Mail-back packages
must be provided with instructions for mailing, notice that packages may only
be mailed from within the fifty (50) United States or US territories, and
notice that only packages provided by or on behalf of the pharmacy may be used
to mail medication.
(D) Senders
shall not be required to provide any personally identifiable information when
mailing back medication.
(E)
Mail-back packages must include a unique identification number or other unique
identifier that enables the package to be tracked.
(6) Long-Term Care Facilities. Pharmacies may
provide and maintain a collection receptacle at a long-term care facility to
collect medication from the public or facility residents for destruction. This
section does not apply to medication collected for return and reuse as
authorized by
20 CSR
2220-3.040.
(A)
Collection receptacles must be securely placed and maintained inside the
physical building of the long-term care facility in a manner that prevents
theft, diversion, or unauthorized removal. Receptacles must be securely
fastened to a permanent structure and must be visible to the facility's staff
at all times. In lieu of fastening to a permanent structure, receptacles that
are not accessible to the public or residents may be stored in a securely
locked room or area with controlled access that is restricted to facility
staff/personnel until transfer to the pharmacy. Collection receptacles shall
not be located in or near exit doors.
(B) Collection receptacles must be a securely
locked, substantially constructed container with a permanent outer container,
and must contain an inner liner that complies with subsections (4)(D) and (E)
of this rule. The receptacle must have an opening that allows medication to be
added to the inner liner but does not allow the contents of the inner liner to
be removed. The opening must be locked or otherwise made inaccessible to the
public so that drugs cannot be deposited into the collection receptacle when
the facility is closed for business.
(C) If the receptacle is accessible to the
public or residents, a sign must be prominently displayed on the outer
container of the receptacle indicating that only non-controlled substances may
be deposited into the receptacle. The required sign must comply with state and
federal controlled substance laws if the receptacle is also used to collect
controlled substances.
(D) The
pharmacy shall be responsible for installing, managing, and maintaining the
receptacle and for the removal, sealing, transfer, and storage of inner liners
and receptacle contents.
(E) Inner
liners may only be installed, removed, and transferred either:
1) by or under the supervision of two (2)
board licensees or registrants acting on behalf of the pharmacy; or
2) by or under the supervision of a board
licensee/registrant and an employee/staff member of the long-term care facility
designated by the pharmacy (e.g., a supervisory charge nurse).
(F) After removal, sealed inner
liners may be stored at the facility in a securely locked, substantially
constructed cabinet or in a securely locked room or area with controlled access
for no more than three (3) business days.
(7) Destruction Methods. Medication collected
for destruction shall be rendered nonretrievable and destroyed in compliance
with all applicable federal and state laws. Medication shall be destroyed in
one (1) of the following ways:
(A) On-site
Destruction: Medication may be destroyed on the physical premises of the
pharmacy, provided two (2) board licensees or registrants must personally
witness the destruction of the medication and handle or observe the handling of
the medication until the substance is rendered non-retrievable; or
(B) Transfer to an Authorized Entity:
Collected medication may be mailed, shipped, or transferred to an entity
authorized to destroy the medication offsite, provided two (2) board licensees
or registrants must witness or observe the mailing, shipping, or transfer. If
medication is transported by the pharmacy to the offsite location, the
medication must be constantly moving towards its final location. Unnecessary
and unrelated stops and stops of an extended duration shall not
occur.
(8) Records.
Except as otherwise provided herein, pharmacies shall maintain a complete and
accurate record of the following for two (2) years:
(A) Inventories. Pharmacies shall conduct an
inventory every twelve (12) months of inner-liners that are present at the
pharmacy or at a long-term care facility that are unused or awaiting
destruction. The inventory shall be documented in writing and must include:
1. The date of the inventory;
2. The number of inner liners present on the
date of the inventory and the size of any inner liners (e.g., five (5) ten-
(10-) gallon liners, etc.);
3. The
unique identification number/identifier of each inner liner, whether unused or
awaiting destruction;
(B) Inner Liners. The pharmacy must maintain
the following written records for inner liners:
1. The unique identification
number/identifier and the size of each unused inner liner (e.g., five- (5-)
gallon, ten- (10-) gallon, etc.);
2. The date each inner liner is installed,
the address of the location where each liner is installed, the unique
identification number/identifier and size of each installed inner liner, and
the names and signatures of the two (2) required witnesses for each
installation; and
3. The date each
inner liner is removed and sealed, the unique identification number/identifier
of each removed inner liner, and the names and signatures of the two (2)
required witnesses for each removal; and
(C) Destruction. The pharmacy must maintain
the following written records:
1. For
medication destroyed on-site of the pharmacy, the date and method of
destruction, the unique identification number/identifier of each inner liner
destroyed, and the names and signatures of the two (2) required witnesses of
the destruction.
2. For medication
destroyed off-site, the date each inner liner was transferred for destruction,
the name and address of each entity to whom each sealed inner liner was
transferred for destruction, the unique identification number/identifier of
each inner liner transferred for destruction, and the name of the two (2)
required witnesses for medication transfer or transport.
(9) Law Enforcement Return
Programs. Licensees/permitholders shall be exempt from compliance with this
rule when participating in medication collection programs conducted by local,
state, or federal law enforcement agencies provided-
(A) Collected medication is placed into a
collection container or area that is under the supervision of law enforcement
personnel at all times;
(B) Law
enforcement personnel are present whenever drugs are collected or on-site;
and
(C) The licensee/permitholder
does not take possession of the collected medications. Collected medications
must remain under the control of, and must be removed by, law
enforcement.
