This chapter applies to the purchasing and distribution of prescription drugs and devices by the Department for public health purposes. In this chapter, the following terms have the meanings indicated. Terms Defined. “Adulterated” means a drug or device where: Any part of the drug or device is filthy, putrid, or a decomposed substance; or The drug or device was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have: Contaminated the drug or device with filth; or Caused the drug or device to be injurious to health. “Board” means the State Board of Pharmacy. “Department” means the Maryland Department of Health. “Misbranded” means a drug or device where: The drug’s or device’s: Labeling is false or misleading in any way; or Labeling or packaging does not conform with Health-General Article, §21-248, Annotated Code of Maryland; The drug or device is in package form and does not bear a label that contains the name and place of business of the manufacturer, packer, or distributor; Any word, statement, or other information required under Health-General Article, Title 21, Subtitle 2, Annotated Code of Maryland, to appear on the drug’s or device’s labeling is not placed prominently on the labeling in a manner that is: Conspicuous as compared with other words, statements, designs, or symbols on the labeling; and In terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use; The drug’s or device’s labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device, adequate directions for the use of the drug or device; The drug’s or device’s labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device, adequate warnings against: The use of the drug or device by anyone suffering from a pathological condition that may cause the drug’s or device’s use to be dangerous to health; The use of the drug or device by a child if the use by a child may be dangerous; and Unsafe dosages, methods of administration, or duration of administration of the drug or device; The drug or device is dangerous to health when used in the dosage, with the frequency, or for the duration specified, recommended, or suggested in the labeling of the drug or device; or The trademark, trade name, imprint, symbol, or other identifying mark of another drug or any likeness of any of these markings of another drug or device is placed on the drug or device or its container with the intent to defraud. “Pedigree” means a record of the tracking of a drug or device through the supply chain, with each trading partner authenticating the drug or device upon receipt and transfer. “Prescription device” means a device required by federal law or regulation to be dispensed only by a prescription. Prescription Drug. “Prescription drug” means a drug required by federal law or regulation to be dispensed only by a prescription. “Prescription drug” includes: A biological product; and Finished dosage forms and bulk drug substances subject to §503(b) of the Federal Food, Drug, and Cosmetic Act. “Prescription drug” does not include: Blood and blood components intended for transfusion; or Biological products that are also medical devices. “Public health purposes” includes the purpose of controlling communicable diseases or environmental health hazards. “Secretary” means the Secretary of Health. The Secretary shall designate one or more Department employee representatives to be responsible for the purchase and distribution of prescription drugs and devices for public health purposes. A designated Department representative shall: Be a merit or contractual employee of the Department employed full time in a managerial level position; Be aware of and knowledgeable about the policies and procedures pertaining to the purchase and distribution of prescription drugs and devices for public health purposes, including applicable State and federal laws; Be actively involved in, and aware of, the daily operation of the Department’s purchasing and distribution of prescription drugs and prescription devices; Be responsible for: Storage and handling as set forth in Regulation .04 of this chapter; Record-keeping requirements as set forth in Regulation .06 of this chapter; and Making records available for inspection; and Meet the following qualifications: Is 21 years old or older; Except for an authorized absence such as sick leave or vacation leave, is physically present at the Department during regular business hours; Does not have any convictions for a violation of any federal, State, or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and Does not have any convictions for a felony under federal, State, or local laws. Storage Facility. A designated Department representative shall store, hold, or handle prescription drugs and devices in a facility that: Is constructed to facilitate: Cleaning; and Maintenance; Has storage areas designed to provide adequate: Equipment; Humidity control; Lighting; Sanitation; Security conditions; Space; Temperature; and Ventilation; Has a secured separate quarantine area for storage of prescription drugs or devices that are: Adulterated; Damaged; Deteriorated; In immediate or sealed secondary containers that have been opened; Misbranded; or Outdated; Is maintained in a clean and orderly condition; and Is free from insects, rodents, birds, or vermin. Storage. A designated Department representative shall store a prescription drug or device at appropriate temperatures and under appropriate conditions in accordance with requirements: If any, on the labeling of the prescription drug or device; or Set forth in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF). If no storage requirements are established for a prescription drug or device, a designated Department representative shall hold the prescription drug or device at a controlled room temperature, as defined in an official compendium as set forth in §B(1)(b) of this regulation to help assure that its identity, strength, quality, and purity are not adversely affected. A designated Department representative shall document proper storage of prescription drugs and devices in accordance with the: Use of manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and logs; and Record-keeping requirements in Regulation .06 of this chapter for stored prescription drugs and devices. Examination of Materials. Upon receipt of a prescription drug or device, a designated Department representative shall visually examine each outside shipping container to prevent the acceptance of: An adulterated prescription drug or device; or A prescription drug or device that is otherwise unfit for distribution. A designated Department representative shall examine each prescription drug or device container, as required under §C(1) of this regulation, to ascertain whether there is any damage to the container that would suggest possible contamination or other damage to the contents. A designated Department representative shall carefully inspect each outgoing shipment: For identity of the prescription drug or device being shipped; and To ensure that there is no delivery of a prescription drug or device that has been damaged in storage or held under improper conditions. Each unit of the Department, such as a local health department, that receives delivery of the prescription drug or device shall meet the requirements of this regulation for storage, security, and record keeping. A designated Department representative shall follow the record-keeping requirements in Regulation .06 of this chapter for an incoming and an outgoing prescription drug or device. Security of the Storage Area. A designated Department representative shall ensure that the area where prescription drugs and devices are stored is secure from unauthorized entry as follows: Access from outside the premises is: Kept to a minimum; and Limited to authorized personnel as determined by the designated Department representative; and The storage area is equipped with: A security system that provides protection against theft and diversion; An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting; and A security system that protects the integrity and confidentiality of data and documents. Authorized Access of Storage Area. A designated Department representative shall ensure that the area where prescription drugs and devices are stored: Has a means in place to make the data and documentation required under this chapter readily available to the Board, an agent of the Board, or federal or State law enforcement officials; and Allows for inspection by a Board representative. A designated Department representative shall quarantine and physically separate prescription drugs and devices that are outdated, damaged, deteriorated, misbranded, or adulterated from other prescription drugs and devices until the quarantined and separated prescription drugs and devices are destroyed or returned to their supplier for disposal. A designated Department representative shall identify, mark, quarantine, and physically separate from other prescription drugs and devices those prescription drugs and devices whose immediate or sealed outer or sealed secondary containers have been opened or used, until the prescription drugs and devices are either destroyed or returned to their supplier for disposal. Prescription Drugs. If the conditions under which a prescription drug has been returned by a local health department or a health care provider cast doubt on the prescription drug's safety, identity, strength, quality, or purity, then a designated Department representative shall destroy the prescription drug or return the prescription drug to the supplier, unless examination, testing, or other investigation proves that the prescription drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a prescription drug has been returned by a local health department or a health care provider cast doubt on the prescription drug's safety, identity, strength, quality, or purity, a designated Department representative shall consider, at a minimum, the: Conditions under which the prescription drug has been held, stored, or shipped before or during the return of the prescription drug; and Condition of the prescription drug and its container, carton, or labeling, as a result of storage or shipping. Prescription Devices. If the conditions under which a prescription device has been returned cast doubt on the prescription device's safety, identity, or quality, then a designated Department representative shall destroy or return the prescription device to the supplier, unless examination, testing, or other investigation proves that the prescription device meets appropriate standards of safety, identity, strength, and quality. In determining whether the conditions under which a prescription device has been returned by a local health department or a health care provider cast doubt on the prescription device's safety, identity, or quality, a designated Department representative shall consider, at a minimum, the: Conditions under which the prescription device has been held, stored, or shipped before or during return of the prescription device; and Condition of the prescription device and the device’s container, carton, or labeling, as a result of storage or shipping. A designated Department representative shall follow the record-keeping requirements in Regulation .06 of this chapter for outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs and devices. A designated Department representative shall: Establish and maintain inventories and records of transactions regarding the receipt and distribution or other disposition of prescription drugs and devices; Include the following information in the records required under §A of this regulation: The source of a prescription drug or device, including the: Name and principal address of the seller or transferor; and Address of the location from which a prescription drug or device was shipped; The identity and quantity of the prescription drugs and devices received and distributed or disposed of; The dates of receipt and distribution or other disposition of the prescription drugs and devices; and If required by Health Occupations Article, §12-6C-10, Annotated Code of Maryland, the pedigrees for prescription drugs that are wholesale distributed outside the normal distribution channel; Establish, maintain, and adhere to written policies and procedures addressing the: Receipt, security, storage, inventory, and distribution of prescription drugs and devices; Identifying, recording, and reporting of losses or thefts; and Correcting of errors and inaccuracies in inventories; Include in the written policies and procedures established according to §C of this regulation the following: A procedure by which the oldest approved and unexpired stock of a prescription drug or device is distributed first; Procedures to be followed for handling a recall and withdrawal of a prescription drug or device due to: An action initiated at the request of the United States Food and Drug Administration (FDA) or other federal, State, or local law enforcement or other government agency, including the Maryland Division of Drug Control; A voluntary action by the manufacturer to remove a defective or potentially defective prescription drug or device from the market; and An action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design; A procedure to ensure that the Department is prepared for, protected against, and able to handle a crisis that affects security or operation of a facility if any of the following situations occur: Strike; Fire; Flood; Catastrophic health emergency as defined in Public Safety Article, §14-3A-01, Annotated Code of Maryland; Terrorist activities; Natural disaster; or Other situations of local, State, or national emergency; A procedure to ensure that outdated prescription drugs and devices are segregated from other prescription drugs and devices and either returned to the manufacturer or destroyed; A procedure for: The disposing and destruction of containers, labels, and packaging to ensure that the containers, labels, and packaging cannot be used in counterfeiting activities; and Appropriate witnessing of the destruction of any labels, packaging, immediate containers, or containers in accordance with applicable federal and State requirements; and A procedure for: Identifying, investigating, and reporting prescription drug inventory discrepancies involving counterfeiting, suspicion of counterfeiting, contraband, or suspicion of contraband; and Upon discovery, the reporting of a discrepancy within 5 business days to the Board; Make available inventories and records for inspection and copying by authorized federal or State law enforcement agency officials for a period of 3 years after the date of creation of the inventories and records; Keep the records described in this regulation readily available for inspection by authorized federal, State, or local law enforcement agency officials during the retention period, either: At the inspection site; or So as to be immediately retrievable by computer or other electronic means; Within 5 working days of a request by an authorized official of a federal, State, or local law enforcement agency, make available for inspection records kept at a central location apart from the inspection site and not electronically retrievable; Establish and maintain procedures for reporting counterfeit and contraband or suspected counterfeit and contraband drugs or devices or counterfeiting and contraband or suspected counterfeiting and contraband activities to the Board and the FDA; Maintain a system for the mandatory reporting of significant inventory losses of prescription drugs and devices where it is known or suspected that diversion is occurring to: The Board; The FDA; and Where applicable, the U.S. Drug Enforcement Administration; and Consider the following factors when determining if there has been a significant inventory loss: The schedule of the missing items; The abuse or misuse potential of the missing items; The abuse or misuse potential in the Department’s area of the missing substance; The quantity missing in relation to the total quantity purchased, for example, one tablet per Whether this is the first time a potentially significant inventory loss has occurred; Whether this loss was reported to local law enforcement authorities; and Whether there is a significant resale value of the missing items. Health-General Article, §21-234; Health Occupations Article, §§12-6C-01(u) and 12-6C-03.1; Annotated Code of Maryland Effective date: August 22, 2011 (38:17 Md. R. 1012)