DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS

 

DIRECTOR’S OFFICE

 

PHARMACY – PROGRAM FOR UTILIZATION OF UNUSED PRESCRIPTION DRUGS

 

Filed with the secretary of state on

 

These rules become effective immediately after filing with the secretary of state unless adopted under section 33, 44, or 45a(9) of the administrative procedures act of 1969,

1969 PA 306, MCL 24.233, 24.244, or 24.245a.  Rules adopted under these sections

become effective 7 days after filing with the secretary of state.

 

(By authority conferred on the director of the department of licensing and regulatory affairs and board of pharmacy by sections 16145(3), 17701, and 17775 of the public health code, 1978 PA 368, MCL 333.16145(3), 333.17701, and 333.17775 and Executive Reorganization Order No. Nos. 1991-9, 1996-2, 2003-1, and 2011-4, MCL 338.3501, 445.2001, 445.2011, and MCL 445.2030)

 

 

R 338.3601, R 338.3603, R 338.3605, R 338.3607, R 338.3609, R 338.3611, R 338.3615,

R 338.3617, R 338.3621, R 338.3625, R 338.3627, R 338.3629, R 338.3631, R 338.3633,  

R 338.3635, R 338.3637, R 338.3639, R 338.3641, and R 338.3643 of the Michigan Administrative Code are amended, R 338.3621a, R 338.3621b, R 338.3621c, and R 338.3621d are added, and R 338.3613, R 338.3619, and R 338.3623 are rescinded, as follows:

                                                                                                                                    

R 338.3601.  Definitions.

  Rule 1. (1) As used in this part these rules:

   (a) "Charitable clinic" means a charitable nonprofit corporation or facility that meets all of the following requirements:

    (i) Is organized as a not-for-profit corporation pursuant to the nonprofit corporation act, 1982 PA 162, MCL 450.2101 to 450.3192.

    (ii) Holds a valid exemption from federal income taxation issued pursuant to section 501(a) of the internal revenue code, 26 USC 501.

    (iii) Is listed as an exempt organization under section 501(c) of the internal revenue code, 26 USC 501.

    (iv) Is organized under or operated as a part of a health facility or agency licensed under article 17 of the code, MCL 333.20101 to 333.20211.

    (v) Provides on an outpatient basis for a period of less than 24 consecutive hours to persons not residing or confined at the facility advice, counseling, diagnosis, treatment, surgery, care, or services relating to the preservation or maintenance of health.

    (vi) Has a licensed pharmacy.

   (ba) “Chemotherapeutic agent” means a chemical agent used for treating various forms of cancer generally by killing the cancer cells.

   (cb) “Code” means the public health code, 1978 PA 368, MCL 333.1101 to 333.25211.

   (dc) "Eligible facility" means a medical institution as that term is defined in R 338.486.

   (ed) “Department” means the department of licensing and regulatory affairs, bureau of health care services.

   (f) "Eligible participant" means an individual who meets all of the following requirements:

    (i) Is a resident of this state.

    (ii) Is eligible to receive medicaid or medicare or has no health insurance and otherwise lacks reasonable means to purchase prescription drugs, as prescribed in these rules.

   (ge) “Hazardous waste” means hazardous waste as that term is defined in R 299.9203.

   (h) "Health professional" means any of the following individuals licensed and authorized to prescribe and dispense drugs or to provide medical, dental, or other health-related diagnoses, care, or treatment within the scope of his or her professional license:

    (i) A physician licensed to practice medicine or osteopathic medicine and surgery under part 170 or 175 of the code, MCL 333.17001 to 333.17088 or 333.17501 to 333.17556.

    (ii) A physician's assistant licensed under part 170, 175, or 180 of the code; MCL 333.17001 to 333.17088, 333.17501 to 333.17556, or 333.18001 to 333.18058.

    (iii) A dentist licensed under part 166 of the code, MCL 333.16601 to 333.16648.

    (iv) An optometrist licensed under part 174 of the code, MCL 333.17404 to 333.17437.

    (v) A pharmacist licensed under part 177 of the code, MCL 333.17701 to 333.17780.

    (vi) A podiatrist licensed under part 180 of the code, MCL 333.18001 to 333.18058.

   (i) "Program" means the statewide unused prescription drug repository and distribution program known as the program for utilization of unused prescription drugs that is established in section 17775 of the code, MCL 333.17775.

   (j) “Unit dose package” means a package that contains a single dose drug with the name, strength, control number, and expiration date of that drug on the label.

   (k) “Unit of issue package” means a package that provides multiple doses of the same drug, but each drug is individually separated and includes the name, lot number, and expiration date.

   (l) “USP” means the United States Pharmacopeia, published by the United States Pharmacopeial Convention.

   (m) “USP-NF” means the United States Pharmacopeia National Formulary.

   (ln) “Waste disposal facility” means a waste diversion center or disposal facility that is in compliancecomplies with the natural resources and environmental protection act, 1994 PA 451, MCL 324.101 to 324.90106, for processing or disposal.

  (o) “Original sealed and tamper-evident packaging” means unopened “tamper-evident packaging” as defined in USP, Chapter 659, Packaging and Storage Requirements, including, but not limited to, an unopened “unit-dose container,” “multiple-dose container,” as defined in USP, Chapter 659, Packaging and Storage Requirements, and  immediate, secondary, and tertiary packaging.

  (2) Terms defined in the code have the same meaning when used in these rules unless otherwise defined in these rules.

 

R 338.3603.  Eligibility criteria; pharmacy; charitable clinics; requirements; withdrawal.

  Rule 3. (1) To be eligible for participation in the program and accept donated prescription drugs, a pharmacy or charitable clinic shall comply with all applicable federal and state laws, including laws applicable to the storage and distribution of drugs and the appropriate licensure standards, and shall hold an active, nonrestricted, state of Michigan license in this state in good standing.

  (2) Participation in the program is voluntary.

  (3) A pharmacy or charitable clinic may elect to participate in the program and accept donated prescription drugs by providing, on a form provided by the department, written notification to the department of all of the following:

   (a) The name, street address, and telephone number, and license number of the pharmacy licensed under article 15 of the code, MCL 333.16101 to 333.18838, or charitable clinic licensed under article 17 of the code, MCL 333.20101 to 333.22260., and any state of Michigan license or registration number issued to the pharmacy or charitable clinic.

   (b) For a charitable clinic, evidence that the charitable clinic meets the requirements defined in R 338.3601(a) section 17775(2)(c)(i) to (vi) of the code, MCL 333.17775 .

   (c) The name and license number of the responsible pharmacist employed by or under contract with the pharmacy or charitable clinic.

   (d) A statement signed and dated by the responsible pharmacist indicating that the pharmacy or charitable clinic meets the eligibility requirements under this rule and shall comply with the requirements of the program.

  (4) A participating pharmacy or charitable clinic may withdraw from participation in the program at any time by providing written notice to the department on a form provided by the department. All of the following information shall must be included on the notice of withdrawal form:

   (a) Name, address, telephone number, and state of Michigan license or registration number of the participating pharmacy or the charitable clinic.

   (b) Name and dated signature of the responsible pharmacist, attesting that the participating pharmacy or charitable clinic will shall no longer participate in the program.

   (c) Date of withdrawal.

 

R 338.3605  Eligible prescription drugs.

  Rule 5. (1) All non-controlled prescription drugs, except those specified in R 338.3607, that have been approved for medical use in the United States, are listed in the United States pharmacopeia and the national formulary (usp-nf)USP-NF, and meet the criteria for donation established by these rules may be accepted for donation under the program.

  (2)  A new prescription may be transferred to another participating pharmacy or charitable clinic for dispensing.

 

R 338.3607.  Ineligible drugs; controlled substances prohibited.

  Rule 7. (1) The following drugs shall must not be accepted for dispensing under the program:

   (a) Controlled substances, as that term is defined in article 7 of the code, MCL 333.7101 to 333.7545, or by federal law. 

   (b) Expired prescription drugs.

   (c) Drugs that may be dispensed only to a patient registered with the drug’s manufacturer under the Federal Food and Drug Administration’s federal food and drug administration requirements.

   (d) Drugs that have been held outside of a health professional’s control where sanitation and security cannot be assured.

   (e) Compounded drugs.

   (f) Drugs that require storage temperatures other than normal room temperature as specified by the manufacturer or the usp-nf USP-NF shall not be donated or accepted as part of the program. Excluded from this restriction are drugs donated directly from a drug manufacturer or an eligible facility that has ensured the integrity of the drug by enclosing in the donation packaging a USP-recognized method by which the participating pharmacy or charitable clinic can easily detect improper temperature variations.

  (2) Controlled substances submitted for donation shall must be documented and returned immediately to the eligible facility that donated the drugs.  Both of the following apply:

   (a)  If controlled substances enter the participating pharmacy or charitable clinic and it is not possible or practicable to return the controlled substances to the donating facility, abandoned controlled substances shall must be documented and destroyed pursuant to under the protocols currently used by the participating pharmacy.

   (b) A destruction record shall must be created and maintained for a period of 5 years after destruction for of any a controlled substance substances destroyed. Two years after the date of the destruction, the participating pharmacy or charitable clinic may make an electronic duplicate of the original record that becomes the original record of destruction. A participating pharmacy shall present a paper copy of the electronic duplicate to an authorized agent of the board on request.

 

R 338.3609  Donated prescription drugs; participating pharmacy or charitable clinic

  requirements.

  Rule 9. (1) A participating pharmacy or charitable clinic may accept a prescription drug only if all of the following requirements are met:

   (a) The drug is in its original sealed and tamper-evident packaging. However, a drug in a single-unit dose, unit of issue package, or blister pack with the outside packaging opened may be accepted if the single-unit-dose packaging or unit of issue packaging is unopened.

   (b) The drug has been stored according to manufacturer or usp-nf USP-NF storage requirements.

   (c) The packaging contains the lot number and expiration date of the drug. If the lot number is not retrievable, all specified medications shall must be destroyed in the event of if there is a recall.

   (d) The drug is not expired. has an expiration date that is more than 6 months after the date that the drug was donated.

   (e) The drug does not have any physical signs of tampering or adulteration, and there is no reason to believe that the drug is adulterated.

   (f) The packaging does not have any physical signs of tampering, deterioration, compromised integrity, or adulteration.

  (2) A participating pharmacy or charitable clinic may accept donated prescription drugs from more than 1 eligible facility, provided that if the prescription drugs are donated donating is done pursuant under to the terms of the program.

 

R 338.3611  Donated prescription drugs; eligible facility, manufacturer requirements.

  Rule 11. (1) An eligible facility or manufacturer may donate unused or donated prescription drugs, other than controlled substances, to a participating pharmacy or charitable clinic, if the drug meets the requirements of these rules.

  (2) A manufacturer or its representative may donate prescription drugs in complimentary starter doses, other than controlled substances, to a charitable clinic under the program, if the drug meets the requirements of these rules.

 

R 338.3613  Resident of eligible facility; donations permitted. Rescinded.

  Rule 13. (1) A resident of an eligible facility or the representative or guardian of a resident of an eligible facility may donate unused prescription drugs to be dispensed under the terms of the program.

  (2) A resident of an eligible facility or the resident’s representative or guardian shall complete a resident donation form prior to the eligible facility taking possession of the drugs to be donated.  A copy of the resident donation form shall be sent to the participating pharmacy or charitable clinic with the donated drugs.

  (3) The prescription drugs donated under the method described in this rule shall have originated from the eligible facility, and prescription drugs obtained prior to the resident being admitted to the facility shall not be accepted.

  (4) The prescription drugs donated under the method described in this rule are subject to all the requirements of these rules.

 

R 338.3615  Transfer and shipment of donated drugs; requirements.

  Rule 15. (1) Prior to the initial The eligible facility or manufacturer shall complete and transmit the eligible facility or manufacturer donation form or a substantively similar electronic or physical form in each shipment of donated prescription drugs to the participating pharmacy or charitable clinic.  transfer of donated drugs from an eligible facility or manufacturer to a participating pharmacy or charitable clinic, the eligible facility or manufacturer shall complete the eligible facility donation form.  The eligible facility or manufacturer shall transmit the completed eligible facility donation form to the participating pharmacy or charitable clinic and retain a copy for its records.

  (2) A completed transfer form shall be included in each shipment of donated drugs from an eligible facility or manufacturer to a participating pharmacy or charitable clinic.

  (32) Donated drugs under the program shall must be shipped from the eligible facility or manufacturer to the participating pharmacy or charitable clinic via common or contract carrier.  

 

R 338.3617  Inspection and storage of donated prescription drugs; destruction; recall.

  Rule 17. (1) A Before dispensing a donated drug, a licensed pharmacist, employed by or under contract with the participating pharmacy or charitable clinic, shall inspect donated prescription drugs to determine, in the professional judgment of the pharmacist, that the drugs are not adulterated, are safe and suitable for dispensing, and are eligible drugs. The pharmacist who inspects the drugs shall sign the transfer form included with the shipment of donated drugs attesting to the above.

  (2) The participating pharmacy or charitable clinic shall store donated drugs pursuant to under the manufacturer’s guidelines or usp-nf USP-NF guidelines.  Donated drugs shall must be stored and maintained in a manner that distinguishes them physically or electronically from other non-donated inventory. not be stored with non-donated inventory at any time.

  (3) When If donated drugs are not inspected immediately upon receipt, a participating pharmacy or charitable clinic shall quarantine store the donated prescription drugs separately from all dispensing stock until the donated prescription drugs have been inspected and approved for dispensing under the program.

  (4) A participating pharmacy or charitable clinic shall destroy donated prescription drugs that are not suitable for dispensing pursuant to under the protocols currently established by the pharmacy or charitable clinic for the destruction of prescription drugs.

  (5) A participating pharmacy or charitable clinic shall create and maintain a destruction and disposal record for donated prescription drugs that are destroyed and disposed of as a result of being expired, adulterated, recalled, or otherwise not eligible for dispensing. A participating pharmacy or charitable clinic shall maintain a destruction record for 5 years after destruction of the donated drugs. Two years after the destruction of the donated drugs, the participating pharmacy or charitable clinic may make an electronic duplicate of the original record that becomes the original record. A participating pharmacy or charitable clinic shall present a paper copy of the electronic duplicate to an authorized agent of the board on request.   

  (6) If a participating pharmacy or charitable clinic receives a recall notification, the participating pharmacy or charitable clinic shall perform a uniform destruction of all of the recalled prescription drugs in the participating pharmacy or charitable clinic and complete the destruction record for all donated prescription drugs that are destroyed. The destruction shall must be done pursuant to under the protocols currently established by the pharmacy or charitable clinic for the destruction and disposal of prescription drugs.

  (7) If a recalled drug has been dispensed, the participating pharmacy or charitable clinic shall immediately notify the eligible participant of the recalled drug pursuant to under established drug recall procedures.

  (8) Notwithstanding any rule to the contrary, a participating pharmacy may repackage a donated prescription drug or medical supply as necessary for storage, dispensing, administration, or transfers pursuant to both of the following:

   (a) Repackaged medicine must be labeled with the drug name, strength, and expiration date and must be stored in a separate designated area until inspected and initialed by a pharmacist.

   (b) If multiple packaged donated medicines with varied expiration dates are repackaged together, the shortest expiration date must be used.

 

R 338.3619  Record keeping; inventory; requirements. Rescinded.

  Rule 19. (1) A participating pharmacy or charitable clinic shall keep records in conform with these rules and all applicable federal and state laws, rules, and regulations.

  (2) A participating pharmacy or charitable clinic shall maintain documented policies and procedures that will address all the requirements of these rules. 

  (3) A participating pharmacy or charitable clinic shall document all of the following for each drug accepted for the program:

   (a) Brand name or generic name of the drug.

   (b) Name of the manufacturer or national drug code number (ndc#).

   (c) Quantity and strength of the drug.

   (d) Lot number of medication if available.

   (e) Expiration date of medication.

   (f) Date the drug was donated and the date the drug was subsequently dispensed.

   (g) Name of the eligible facility that donated the drug and the eligible participant subsequently dispensed the drug.

   (h) The prescription from a health care professional.

  (4) All records required for participation in the program shall be maintained separate from other records for 5 years and shall be readily retrievable for inspection at the request of the department or its agent.

 

R 338.3621  Forms; eligible facility donation form, resident donation form, eligible participant form, transfer form, destruction form; general requirements.

  Rule 21. (1) An eligible facility donation form shall include all of the following information:

  (a) An eligible facility’s or manufacturer’s name, address, and telephone number; the name, dated signature, and license number of pharmacist or health care provider authorized to donate the drugs; and, the license number of the facility or manufacturer.

  (b) A statement of the facility’s intent to participate in the program and donate eligible prescription drugs to the participating pharmacy or charitable clinic identified on the form.  

  (c) The receiving participating pharmacy’s or charitable clinic’s name, address, and telephone number.

  (d) The name, state of Michigan license number, and dated signature of the responsible pharmacist authorized to receive the donation.

  (e) The date the donation was received.

  (2) A resident donation form shall include all of the following information:

  (a) The eligible facility’s name, address, state of Michigan license or registration number, and telephone number; and the name, dated signature, and license number of pharmacist or health care provider authorized to donate the drugs.

  (b) The resident’s name and dated signature, or the name and dated signature of the resident’s representative or guardian. 

  (c) Attestation to the following statement, “As the legal owner of the listed prescription drug(s), I agree to voluntarily donate the listed eligible unused drugs to the program for utilization of unused prescription drugs.” 

  (d) The drug brand name or generic name, the name of manufacturer or national drug code number (ndc#), the quantity and strength of the drug, and the drug’s expiration date.

  (e) The date of the donation. 

  (f) The name, address, telephone number and state of Michigan license or registration number of the pharmacy or charitable clinic receiving donated unused prescription drug.

  (g) The date the donated drugs are received by the pharmacy or charitable clinic.

  (h) The name, state of Michigan license or registration number, and dated signature of the authorized pharmacist or health care provider receiving the donated prescription drug.

  (3) The eligible participant form shall include all of the following information:

  (a) The participating pharmacy’s or charitable clinic’s name, address, telephone number, state of Michigan license or registration number, and the name, state of Michigan license or registration number, and dated signature of dispensing pharmacist.

  (b) The drug’s brand name or generic name, the name of manufacturer or national drug code number (ndc#), the quantity and strength of the drug, the date the drug was dispensed, and the drug’s expiration date.

  (c) The eligible participant’s name, date of birth, address, and dated signature.

  (d) Attestation of all of the following:

  (i) The eligible participant is a resident of this state.

  (ii) The eligible participant is eligible to receive medicare or medicaid or is uninsured and does not have prescription drug coverage.

  (e) The eligible participant acknowledges that the drugs have been donated.

  (f) The eligible participant consents to a waiver of the requirement for child resistant packaging, as required by the poison prevention packaging act, being 15 U.S.C. §1471−1477.

  (4) The transfer form shall include all of the following information:

  (a) The eligible facility or manufacturer’s name, state of Michigan license or registration number, address, telephone number, and the name, dated signature, and state of Michigan license number of the responsible pharmacist.

  (b) The date of donation.

  (c) The drug’s brand name or generic name, the name of manufacturer or national drug code number (ndc#), the quantity and strength of the drug, and the drug’s expiration date.

  (d) The pharmacist of the eligible facility or manufacturer shall attest to the following statement, “I certify that the prescription drugs listed on this form for donation are eligible for donation and meet the requirements for prescription drugs under the program, including any storage requirements.”

  (e) The receiving participating pharmacy’s or charitable clinic’s name, address, and telephone number, and name and state of Michigan license number of responsible pharmacist authorized to receive the donation.

  (f)  The responsible pharmacist shall sign and date the transfer form attesting to the following statement, “Upon receipt and inspection of the above listed donated prescription drugs, it is in my professional judgment that these drugs are not adulterated, are safe and suitable for dispensing, and are eligible drugs.”

  (5) The destruction form shall include all of the following: 

  (a) The participating pharmacy’s or charitable clinic’s name, state of Michigan license number, address, telephone number, the name, dated signature, and license number of the responsible pharmacist.

  (b) The drug’s brand name or generic name, the name of the manufacturer or national drug code number (ndc#), the quantity and strength of the drug, and the drug’s expiration date.

  (c) The reason for destruction of the drug.

  (d) The name, title, and dated signature of the witness.

  (e) The date of destruction. 

  (f) If off-site disposal is used, the name of the firm destroying or disposing the drug, the name and dated signature of the person at the firm destroying or disposing the drug, and the date of disposal.

  (61) All forms required for participation in the program must be maintained separate from other records for 5 years. and shall be readily retrievable for inspection at the request of the department or its agent. Two years after the record is made, the holder of the record may make an electronic duplicate of the original record that becomes the original record. The holder of the record shall present a paper copy of the electronic duplicate to an authorized agent of the board on request.  

  (72) The department shall make available all forms required by the program. The forms shallmust be available at no cost from the Department of Licensing and Regulatory Affairs, Bureau of Professional Licensing Health Care Services, 611 W.West Ottawa St. Street, Lansing, MI Michigan 48909 or on the department’s website at www.michigan.gov/healthlicense https://www.michigan.gov/lara/bureau-list/bpl/resources/special-programs/cancer-drug-repository-program-and-utilization-of-unused-prescription-drugs-program?sc_site=lara. A participant of the program may also use a substantively similar electronic or physical form for all forms required by the program.  

  (3) A participating pharmacy or charitable clinic shall maintain documented policies and procedures that address all the requirements of these rules. 

  (4) A participating pharmacy or charitable clinic shall keep records as required under these rules and all applicable federal and state laws, rules, and regulations.

 

R 338.3621a  Eligible facility donation form, manufacturer donation form; requirements.

  Rule 21a. An eligible facility or manufacturer donation form must include all of the following information:

   (a) The following information for the eligible facility or manufacturer that is donating  prescription drugs:

(i)  The name, address, telephone number, and license number.

(ii) The name, dated signature, and license number of the pharmacist or healthcare provider authorized to make the donation, if applicable.

   (b) A statement of the eligible facility or manufacturer’s intent to participate in the program and donate to the participating pharmacy or charitable clinic identified on the form.  

   (c) The name, address, and telephone number of the participating pharmacy or charitable clinic that is receiving the donation.

   (d) The name, license number, and dated signature of the pharmacist authorized to receive the donation.

   (e) The date the donation was received by the participating pharmacy or charitable clinic.

 

R 338.3621b  Eligible participant form; requirements.

  Rule 21b. The eligible participant form must include all of the following information before receiving the first donated prescription drug:

   (a) An attestation from the eligible participant that includes all the following:

    (i) The eligible participant is a resident of this state.

    (ii) The eligible participant is eligible to receive medicare or medicaid or is uninsured and does not have prescription drug coverage.

   (b) The eligible participant acknowledges that the drug is donated.

   (c) The eligible participant consents to a waiver of the requirement for child resistant packaging, as required by the Poison Prevention Packaging Act of 1970, 15 USC 1471 to 1477.

 

R 338.3621c  Transfer form; requirements.      

  Rule 21c. A participating pharmacy or charitable clinic shall document on a transfer form all of the following for all donations made to the program:

   (a) The following information for each prescription drug:

    (i) Brand name or generic name of the drug.

    (ii) Name of the manufacturer or National Drug Code (NDC) Number.

    (iii) Quantity and strength of the drug.

    (iv) Date the drug was donated.

    (v) Name of the eligible facility that donated the drug.

   (b) The name, address, telephone number, and license number of the participating pharmacy or charitable clinic receiving the donated prescription drug.

   (c) The name and license number of the responsible pharmacist authorized to receive the donated prescription drug.

   (d) An attestation stating that “I certify that the prescription drugs for donation are eligible for donation and meet the requirements for prescription drugs under the program, including storage requirements” made by the pharmacist or facility manager who is responsible or the eligible facility or manufacturer.

 

R 338.3621d  Destruction form; requirements.

  R 21d. The destruction form must include all of the following: 

   (a) The name, address, telephone number, and license number of the participating pharmacy or charitable clinic.

   (b) The name, license number, and dated signature of the responsible pharmacist.

   (c) The following information for each donated prescription drug that is destroyed:

    (i) The brand name or generic name of the drug.

    (ii) The name of manufacturer or NDC number.

    (iii) The quantity and strength of the drug.

 

R 338.3623  Eligible participants; requirements. Rescinded.

  Rule 23. The eligible participant shall complete the eligible participant form attesting to the following statements:

  (a) The eligible participant is a resident of the state of Michigan.

  (b) The eligible participant is eligible to receive medicare or medicaid or does not have insurance or prescription drug coverage.  Verification or written documentation shall not be required.

  (c) The eligible participant acknowledges that the drugs have been donated.

  (d) The eligible participant consents to a waiver of the requirement for child resistant packaging, as required by the poison prevention packaging act, 15 U.S.C.  §1471−1477.  

 

R 338.3625  Dispensing donated prescription drugs; requirements.

  Rule 25. (1) A participating pharmacy or charitable clinic shall dispense a donated prescription drugs drug in compliance with applicable federal and state laws and regulations for dispensing prescription drugs, including all requirements relating to packaging, labeling, record keeping, drug utilization review, and patient counseling.

  (32) The department and a local participating pharmacy or charitable clinic shall remove any patient identifying information from the package prior to before dispensing the drugs drug.

  (43) A participating pharmacy or charitable clinic shall not resell a  Prescription drugs donated prescription drug under this program shall not be resold; however, a participating pharmacy or charitable clinic may collect a handling fee pursuant to under the terms of R 338.3627.

 

R 338.3627  Handling fee.

  Rule 27. (1) A participating pharmacy or charitable clinic may charge the eligible participant receiving a donated prescription drug a handling fee, not to exceed the reasonable costs of participating in the program, including, but not limited to, the current and anticipated costs of educating eligible donors, providing technical support to participating donors, shipping and handling, labor, storage, licensing, utilities, advertising, technology, supplies, and equipment. a maximum of 300% of the medicaid standard pharmacy dispensing fee as established by the Michigan department of community health, to cover stocking and dispensing costs., provided that the A participating pharmacy or charitable clinic shall use reasonable efforts to ensure the handling fee does not exceed the total cost of obtaining the same drug outside the program.

  (2)  A copy of the medicaid drug dispensing fees can be obtained from the Michigan department Department of Health and Human Services community health, 201 Townsend Street, Lansing, Michigan 48913235 South Grand Avenue, Lansing, Michigan 48933 or on the department’s website at http://www.michigan.gov/mdch/0,1607,7-132-2945_42542_42543_42546_42551-151019--,00.htmlhttps://www.michigan.gov/mdhhs/doing-business/providers/providers/billingreimbursement/pharmacy. 

  (3) A handling fee charged for a donated prescription drug dispensed through the program shall is not be eligible for reimbursement under the medical assistance program.

  (4) The eligible participant shall not be charged a handling fee if the eligible participant is receiving a professional sample whichthat is distributed to patients at the same charitable clinic whom are ineligible for the program without a handling fee.

 

R 338.3629  Donation to other participating pharmacy or charitable clinic. 

  Rule 29. The originating A participating pharmacy or charitable clinic may donate prescription drugs that it has received donated under this the program to other participating pharmacies or charitable clinics for use pursuant to under the program. The participating pharmacy or charitable clinic donating the prescription drugs shall complete a transfer form required under R 338.3621c.

 

R 338.3631  Registry; creation. 

  Rule 31. The department shall establish and maintain a participating pharmacy and charitable clinic registry for the program on the department’s website.  The registry shall must include the name, address, and telephone number of the participating pharmacy’s or charitable clinic’s clinic and name, address, and telephone number, and the contact name of the name of the responsible pharmacist.

 

R 338.3633  Collection of prescription drugs and other medication for destruction and disposal;

  requirements; limitations.

  Rule 33. (1) Pursuant to Under section 17776 of the code, MCL 333.17776, a participating pharmacy or charitable clinic shall accept from any personan individual a prescription drug or any other another medication that is ineligible for distribution under the program for destruction and disposal. 

  (2) Unless permitted allowed by federal law, controlled substances shall must not be collected by a participating pharmacy or charitable clinic for destruction and disposal.

  (3) If a participating pharmacy or charitable clinic accepts a chemotherapeutic agent for destruction, the chemotherapeutic agent shall must not be mixed with other prescription drugs collected for disposal under the program. The chemotherapeutic agent shall must be mixed with the participating pharmacy’s or charitable clinic’s hazardous waste.

 (4) The A participating pharmacy or charitable clinic that collects prescription drugs and other medications for destruction and disposal shall collect the prescription drugs and medications collection shall occur on-site at the participating pharmacy or charitable clinic and shall follow according to these rules and all applicable state and federal laws and regulations.

 

R 338.3635  Collection device; requirements.

  Rule 35. A participating pharmacy or charitable clinic shall utilize a collection device to collect prescription drugs and other medications that are ineligible for distribution under the program for destruction and disposal that meets all of the following criteria requirements:

  (a) Is designed to allow prescription drugs and other medications to be added to the device but allow only authorized personnel to remove the contents from the collection device  to be added to the device but not removed, except by authorized personnel for the purpose of destruction and disposal.

  (b) Is labeled pursuant to consistent with all applicable state and federal laws and regulations. and includes the following statements prominently displayed on the collection device, and also in another location near the collection device, “Controlled substances cannot be accepted for destruction and disposal, unless allowed under federal law.” and “Chemotherapeutic agents must not be placed in this collection device.”

  (c) Is lined with a removable liner that is waterproof, tamper-evident, tear resistant, and capable of being sealed. 

  (d) The contents of the liner collection device must shall not be viewable from the outside of the collection device and the size or capacity of the liner shall collection device must be clearly marked on the outside of the liner collection device.  

  (d) Is secured in a manner that will only allow authorized personnel to remove the contents of the container for the purpose of destruction and disposal.

  (e) Uses a design that is Is tamper resistant and is securely locked.

  (f) Is securely fastened to a permanent structure within the designated pharmacy area so that it cannot be removed.

  (g) Is consistently monitored by security features and pharmacy personnel.

  (h) The following statements shall be prominently placed on the collection device and shall be posted as signage near the location of the collection device, “Controlled substances cannot be accepted for destruction and disposal, unless permitted under federal law.” and “Chemotherapeutic agents shall not be placed in this collection device.”

  (i) The collection device for the yellow jug old drugs program operated by the Great Lakes clean water organization is deemed to satisfys the requirements of this rule, provided the participating pharmacy or charitable clinic is a compliant participant in the yellow jugs old drugs program.

 

R 338.3637  Access; destruction of collected drugs.

  Rule 37. (1) A An individual shall access a collection device utilizing a removable liner shall only be accessed for the following purposes:

   (a) To remove the contents to process for safe, effective, and immediate transportation.

   (b) To immediately transfer the contents to a waste disposal facility.

   (c) To immediately transfer the contents to a responsible third party individual for transportation to a waste disposal facility.

  (2) A collection device utilizing a removable liner shall must only be accessed as follows:

   (a) The access shall must be done by two 2 personnel, one 1 of whom shall be is a licensed pharmacist, designated by the participating pharmacy or charitable clinic.

   (b) Upon being accessed, the liner shall must be immediately sealed and the weight of the contents immediately recorded in the destruction and disposal log. A copy of the destruction log shall must be transferred with the sealed contents.

  (3) A collection device for the yellow jug old drugs program operated by the Great Lakes clean water organization shall be weighed at the time the collection device leaves the pharmacy and the weight shall be recorded in the destruction and disposal log. The participating pharmacy or charitable clinic shall comply with all requirements of the yellow jug old drugs program.

  (43) Within 1 year of collection, the contents of the collection device shall must be transferred to a waste disposal facility for destruction.

  (54) The contents of the collection device shall must be destroyed pursuant to under all applicable state and federal laws and regulations.   

 

R 338.3639  Record keeping; policy and procedures; destruction and disposal log. 

  Rule 39. (1) In addition to the policy and procedure requirements in R 338.3617 and R 338.3619, a A participating pharmacy or charitable clinic shall maintain a destruction and disposal log that includes all of the following information:

   (a) The name Name, telephone number, address, and state of Michigan license or registration number of the participating pharmacy or charitable clinic.

   (b) The date Date, time, and weight of the contents of the collection device each time the contents of the collection device are removed for destruction.

   (c) The name, telephone number, and address of any third party the individual who is responsible for transporting the contents to the waste disposal facility.

   (d) The name, telephone number, and address of the waste disposal facility where the contents of the collection device were transferred.

  (2) Copies of all contracts with transporters and waste disposal facilities shall must be stored with the destruction log, as applicable. 

 

R 338.3641  Transportation.

  Rule 41. The contents of the collection device shall must be transferred to a waste disposal facility pursuant to under all applicable state and federal laws and regulations.

 

R 338.3643  Department of health and human services and department of community health;

  inclusion in  rule-making process.

  Rule 43. The department shall notify the director of the department of health and human services and the director of the department of community health of an approved request for rule-making under section 39 of the administrative procedures act of 1969, 1969 PA 306, MCL 24.239, for rule promulgation affecting eligible facilities or mental health or substance abuse clients.  The department of health and human services and the department of community health shall provide any input regarding the rule promulgation to the department within 30 days of after receipt of notification of the approved request for rule-making rulemaking.