Section 1291.330 Recalls and Product Safety

Section 1291.330  Recalls and Product Safety

a)         Voluntary Recalls

1)         Each dispensing

organization shall have policies and procedures governing voluntary recalls of

cannabis products.

2)         All

voluntary recall policies and procedures shall include the following at a

minimum:

A)

A

mechanism reasonably calculated to contact purchasers who have, or likely have,

obtained the product from the dispensary, including information on the policy

for return of the recalled product.

This may include outreach via media,

as necessary and appropriate;

B)

A

mechanism to identify and contact the adult use cultivation center, craft

grower, or infuser that manufactured the cannabis;

C)

Policies

for communicating with the Department, the Department of Agriculture, and the

Department of Public Health within 24 hours of discovering defective or

potentially defective cannabis;

D)        Policies

for the collection of recalled product;

E)

Policies

for destruction of any recalled cannabis product

that comply with Section

1291.325; and

F)         Entry

of recalled product into the State Verification System prior to destruction.

(Section 15-65 of the Act)

3)         Voluntary

recalls may be initiated at any time as determined by the dispensing organization.

b)         Mandatory Recalls

1)         The

Department may require dispensing organizations to conduct a recall of a

cannabis product that is adulterated, misbranded, or otherwise poses a danger

to public safety.

2)         The dispensing

organization shall maintain policies and procedures for a mandatory recall that

shall include, at a minimum:

A)

A

mechanism reasonably calculated to contact purchasers who have, or likely have,

obtained the product from the dispensary, including information on the policy

for return of the recalled product

ed, misbranded, or otherwise poses a danger

to public safety.

2)         The dispensing

organization shall maintain policies and procedures for a mandatory recall that

shall include, at a minimum:

A)

A

mechanism reasonably calculated to contact purchasers who have, or likely have,

obtained the product from the dispensary, including information on the policy

for return of the recalled product.

This may include outreach via media,

as necessary and appropriate;

B)

A

mechanism to identify and contact the adult use cultivation enter, craft

grower, or infuser that manufactured the cannabis;

C)

Policies

for communicating with the Department, the department of Agriculture, and the

Department of Public Health within 24 hours of discovering defective or

potentially defective cannabis;

D)        Policies

for the collection of recalled product;

E)

Policies

for destruction of any recalled cannabis product

that comply with Section

1291.325; and

F)         Entry

of recalled product into the State Verification System prior to destruction.

(Section 15-65 of the Act)

3)         The

Department may issue a mandatory recall and require dispensing organizations to

immediately cease distribution of a cannabis product and recall the cannabis if

the Department determines both of the following:

A)        The

cultivation, manufacture, distribution, or sale of the cannabis or cannabis

product creates or poses an immediate and serious threat to human life or

health; and

B)        A

recall is necessary to ensure the health and safety of affected cannabis

consumers.

4)         The

Department may require a dispensing organization to quarantine product without

destruction for a minimum of 72 hours or until further notice of the

Department, whichever occurs later, if the Department suspects the product is

adulterated, misbranded, or otherwise poses a danger to public safety

recall is necessary to ensure the health and safety of affected cannabis

consumers.

4)         The

Department may require a dispensing organization to quarantine product without

destruction for a minimum of 72 hours or until further notice of the

Department, whichever occurs later, if the Department suspects the product is

adulterated, misbranded, or otherwise poses a danger to public safety.

5)         The

Department may require a dispensing organization to submit cannabis product

that is suspected to be adulterated, defective, misbranded, or otherwise poses

a danger to public safety to laboratory testing from a testing laboratory

approved by the Illinois Department of Agriculture.  If the laboratory testing

demonstrates the cannabis product is safe for consumption the Department may

approve the dispensing organization to move the product back into active stock.

A)        For

the purposes of this Section, "adulterated" shall include, but is not

limited to, cannabis that has been tampered with by having the tamper-proof

seal broken, cannabis that has been altered after it has been packaged, or

cannabis that has materially changed condition since laboratory testing.

B)        For

the purposes of this Section, "defective" shall have the same meaning

as in Section 1291.60.

6)         In

ordering a mandatory recall of cannabis pursuant to this Section, the director

of the Department shall issue an order to that effect, which shall also include

affidavits sufficient to lay out the factual basis for the recall.

7)         Whenever

the Department issues a mandatory recall, an affected dispensing organization

may file a request for hearing within 30 days of the recall.  All requests for

hearing and any associated proceedings shall follow the rules of Practice in

Administrative Hearings at 68 Ill. Adm. Code 1110

which shall also include

affidavits sufficient to lay out the factual basis for the recall.

7)         Whenever

the Department issues a mandatory recall, an affected dispensing organization

may file a request for hearing within 30 days of the recall.  All requests for

hearing and any associated proceedings shall follow the rules of Practice in

Administrative Hearings at 68 Ill. Adm. Code 1110.

A)        In the

event a dispensing organization files a request for hearing, a formal hearing

shall begin within 30 days of the filing of the request and shall be completed

without appreciable delay.

B)        The

Department shall bear the burden of proving the recalled cannabis is defective,

adulterated, misbranded, or otherwise poses a danger to public safety.