(a) The purpose of the Medicine Bank is to collect donations of pharmaceuticals and health care supplies and distribute them to Community Health Centers and to various institutional facilities that are government owned and operated as defined in Section 5102 of this Chapter for distribution by the Community Health Centers and these institutional facilities and for dispensing to eligible individuals in need as defined by this Chapter, the Guam MIP law or the Medicaid Poverty Guidelines.

(b) The Medicine Bank is an agent for collection and distribution of such donations to Community Health Centers and other government owned institutional facilities as defined in this Chapter, but not for purposes of filling individual prescriptions for eligible persons. These donations have no actual cash value and can not be considered a liquid asset or inventory. Thus, circumstances affecting the Medicine Bank may necessitate the charging of administrative fees for the distribution of materials. In accordance with the Administrative Adjudication Act, the Director shall determine the fee amount necessary to ensure the continuance of the Medicine Bank and shall promulgate these rules and regulations within ninety (90) days after the enactment of this Act. The Director of the Department of Public Health and Social Services shall assess these fees onto the receiving entities requesting for medicines and supplies and not to eligible individuals. Government institutional facilities, as defined in this Chapter, and any other entity receiving medicines and supplies from the

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Medicine Bank shall not charge or pass the cost of these medicines and supplies onto the eligible individual(s).
(c) The Medicine Bank shall ensure that all material, including prescription drugs, non-prescription drugs, over the counter drugs, medical supplies, and other items shall be identified, dated, and transported to the Medicine Bank in accordance with accepted and required standards established by Guam law, Federal law and/or Federal guidelines to include the United States, Food and Drug Administration. Upon receipt by the Medicine Bank, all medicines and materials will be examined and inspected carefully by the Director of the Department of Public Health and Social Services, or his lawful designee, as the Medicine Bank Director, before further distribution to the Community Health Centers or to the various institutional facilities that are government owned and operated as defined in Section 5102 of this Chapter for the lawful dispensing by these institutional facilities to eligible individuals.
(d) The Medicine Bank shall ensure that each incoming delivery of prescription drugs and other medicines and materials shall be examined to ensure that factory seals are intact. Any products that are found to be damaged, outdated, deteriorated, misbranded, or adulterated, shall be isolated until they can be discarded in accordance with Guam law, Federal law or Federal guidelines.
(e) The Medicine Bank shall ensure that all donated medications will be labeled as required by Guam law, or in the absence of such law then Federal law shall apply. No medication which has been previously dispensed by a practitioner to a private citizen will be accepted. Materials received which are not prescription medicines such as over-the-counter medicines, home health equipment, medical supplies, and any other items, shall also be carefully inspected upon receipt. They must be judged fit for use before being distributed or will be properly disposed of in accordance with Guam law. The Director of the Department of Public Health and Social Services, or his lawful designee, the Medicine Bank Director, in accordance with the Administrative Adjudication Act, shall promulgate rules and regulations and guidelines they deem necessary and appropriate to minimize government liability for distribution of medical equipment. Such rules and regulations may require that medical equipment and supplies are received with the proper and correct operating manual, documentation of maintenance history associated with the equipment, and in the instances in which the equipment is new or never used, the Medicine Bank may require

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that factory information be provided. Proper rules and regulations should be established to ensure that the government and the Medicine Bank shall not be held liable for problems that arise from the use or operation of these items.

(f) The Medicine Bank Director shall ensure that the rooms where the Medicine Bank storage is located shall be secure from unauthorized entry. The Medicine Bank storage rooms are to be entered through a locked door, and keys are to be held only by the Pharmacy Staff and the Medicine Bank Director. The area must be well-lighted and the building must be locked and guarded by security personnel at all times. No controlled substances will be handled by the Medicine Bank. No clients or patients or eligible individuals will come to, or receive donated medicines or materials directly from the Medicine Bank. Dispensing of medicines and supplies received from the Medicine Bank will take place only at Community Health Centers or mobile health units, or the various institutional facilities that are government owned and operated as defined in Section 5102 of this Chapter for the lawful dispensing by these institutional facilities to eligible individuals, and where the pharmaceuticals will be dispensed by licensed practitioners.
(g) All drugs, including prescription drugs without special storage requirements, shall be stored according to United States Pharmacopoeia recommendations, as stated in Chapter 328, or in accordance with accepted standards regarding conditions and temperatures for the storage of drugs.

(h) Careful inventory of all donated pharmaceuticals and other materials shall be maintained and updated, as necessary, upon receipt and distribution. Medicines, and other pharmaceutical supplies and equipment leaving the Medicine Bank will be double-checked for damage and proper identity. Because medications are donated to the Medicine Bank by many
sources, including local doctors== offices, pharmacies, religious and
charitable organizations, the Medicine Bank shall ensure that upon receipt, each medication will be added to the inventory list with the name and address of the donor, date of donation, name of medication, strength, lot number, quantity, and expiration date. Full inventories of available medications will made available to the Community Health Centers and the various institutional facilities that are government owned and operated as defined in Section 5102 of this Chapter, on a regular basis. Community Health Centers and the various institutional facilities that are government owned and operated as defined in Section 5102 of this Chapter, shall then place orders with the Medicine Bank for the medicines available at that

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time. The Medicine Bank will generate a dated record of each distribution to each health center or institutional facility. Oldest stock will be distributed first. Older drugs will be rotated to the front of the shelf as new drugs of the same type are received.

As distributions of medicine are made to each participating site, receiving staff will check the distribution against a packing list, sign and fax the list back to the Medicine Bank Director. Medicines shall be dispensed by licensed practitioners at the receiving sites.
Medications close to expiration will be distributed only if the requesting health center or institutional facility assures the Medicine Bank staff that the medications are for immediate dispensing and will be consumed by the patient prior to the expiration date. All outdated drugs will be isolated from other drugs and disposed of according to applicable Guam or Federal laws. The inventory record for all outdated drugs will note the disposal or return to manufacturer of each item, and such records shall be maintained for five (5) years as required by Guam and or Federal laws.

The Director of the Department of Public Health and Social Services, or his designee, the Medicine Bank Director, and the appropriate staff shall, conduct a physical inventory several times a year and reconciled with computer inventory records. If a discrepancy is found between the physical and computer inventories, the physical count is definitive. At such times, the computer count may be adjusted to reflect the true count. A list of changes to the computer inventory will be kept and periodically reviewed. Special attention will be paid to instances when the same item repeatedly appears to be short, when only expensive items appear to be missing, where inventory consistently indicates shortages more than overages, or when a pattern of discrepancy emerges at particular times or when particular staff are on duty. At these times, an investigation shall be conducted by the Medicine Bank Director with the assistance of the Guam Police Department.
(i) The Medicine Bank shall comply promptly with all recalls and withdrawals of prescription drugs and over the counter drugs (OTC). Notices of recall or withdrawal of prescription drugs and over the counter drugs are periodically issued by the U. S. Department of Health, the Food and Drug Administration, other Federal, state, or local government agencies, and manufacturers. Additionally, notices of any action undertaken to protect public health and safety, may also be issued by responsible parties. When these notices are received by the Community Health Centers,

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the various institutional facilities that are government owned and operated as defined in Section 5102 of this Chapter for purposes of receiving medicines and supplies from the Medicine Bank, the Department of Public Health and Social Services or the pharmacy, the Pharmacist shall immediately notify the Director of the Medicine Bank, and any affected medicines or other items will be immediately removed from the inventory and destroyed or returned to the supplier. In addition, the Medicine Bank will notify the health centers and the various institutional facilities as defined in Section 5102 that may have received such pharmaceutical or other items from the Medicine Bank, that such pharmaceutical or item is the subject of a recall or withdrawal.

(j) The Medicine Bank will follow disaster plans that are in place for the Department of Public Health and Social Services or other government of Guam agencies. These complete disaster plans will be made available for review in the Medicine Bank Pharmacy and will be carefully followed in the event of an emergency. In addition, the Medicine Bank shall develop and implement special procedures which will address the security of the drugs and pharmaceuticals stored in the Medicine Bank.
Should a crisis occur when the Medicine Bank is closed and no personnel are on duty, the Medicine Bank Pharmacist will be notified immediately by the Medicine Bank staff or Public Health officials. The Medicine Bank Director will also be notified immediately. Either or both of these people will go to the Medicine Bank promptly to assess damage.
If there is physical damage that compromises the integrity of the room in which drugs are stored, all drugs will be immediately removed and relocated to a secure place. If the room appears to continue to be safe, secure and clean, the Medicine Bank will remain where it is.
If the crisis causes the temperature to exceed, or go below permitted levels, all drugs will be discarded. Likewise, all medication damaged by water or fire will be discarded. Any container, which appears to be damaged in any way, will be discarded. All medications discarded will be disposed of properly.

(k) The Medicine Bank office shall establish and maintain a current list of all persons responsible for the distribution, storage and handling of prescription drugs.

A current list of responsible persons, including the Medicine Bank Pharmacist, the Medicine Bank Director, and any other necessary persons will be maintained by the Medicine Bank, including a description of each

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person’s duties with regard to the Medicine Bank, as well as a brief summary of each person’s qualifications. This list will be available for review at all times.

(l) The Director of the Department of Public Health and Social Services shall serve as the Medicine Bank Director or if he is unable to do so, he shall authorize a licensed pharmacist or another individual with the qualifications and knowledge of receiving, distributing, or storing pharmaceuticals, to administer the Medicine Bank.
The Director shall, as he deems necessary and fit to ensure the continuity and meet the services of the Medicine Bank, establish administrative fees, promulgate rules, policies, procedures or regulations in accordance with this Chapter while adhering to the procedures of the Guam Administrative Adjudication Act.