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2011 Florida Statutes
Storage and handling of prescription drugs; recordkeeping.
Storage and handling of prescription drugs; recordkeeping.
499.0121 Storage and handling of prescription drugs; recordkeeping.—The department shall adopt rules to implement this section as necessary to protect the public health, safety, and welfare. Such rules shall include, but not be limited to, requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.
(1) ESTABLISHMENTS.—An establishment at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed must:
(a) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;
(b) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;
(c) Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened;
(d) Be maintained in a clean and orderly condition; and
(e) Be free from infestation by insects, rodents, birds, or vermin of any kind.
(a) An establishment that is used for wholesale drug distribution must be secure from unauthorized entry.
1. Access from outside the premises must be kept to a minimum and be well-controlled.
2. The outside perimeter of the premises must be well-lighted.
3. Entry into areas where prescription drugs are held must be limited to authorized personnel.
(b) An establishment that is used for wholesale drug distribution must be equipped with:
1. An alarm system to detect entry after hours; however, the department may exempt by rule establishments that only hold a permit as prescription drug wholesale distributor-brokers and establishments that only handle medical oxygen; and
2. A security system that will provide suitable protection against theft and diversion. When appropriate, the security system must provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.
(c) Any vehicle that contains prescription drugs must be secure from unauthorized access to the prescription drugs in the vehicle.
(3) STORAGE.—All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the official compendium.
(a) If no storage requirements are established for a prescription drug, the drug may be held at “controlled” room temperature, as defined in the official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.
(b) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, or logs must be used to document proper storage of prescription drugs.
(c) The recordkeeping requirements in subsection (6) must be followed for all stored prescription drugs.
(4) EXAMINATION OF MATERIALS AND RECORDS.—
(a) Upon receipt, each outside shipping container must be visually examined for identity and to prevent the acceptance of contaminated prescription drugs that are otherwise unfit for distribution. This examination must be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.
(b) Each outgoing shipment must be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have expired or been damaged in storage or held under improper conditions.
(c) The recordkeeping requirements in subsection (6) must be followed for all incoming and outgoing prescription drugs.
(d) Upon receipt, a wholesale distributor must review records required under this section for the acquisition of prescription drugs for accuracy and completeness, considering the total facts and circumstances surrounding the transactions and the wholesale distributors involved. This includes authenticating each transaction listed on a pedigree paper, as defined in s. 499.003(37).
(5) RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION DRUGS.—
(a)1. Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier. A quarantine section must be separate and apart from other sections where prescription drugs are stored so that prescription drugs in this section are not confused with usable prescription drugs.
2. Prescription drugs must be examined at least every 12 months, and drugs for which the expiration date has passed must be removed and quarantined.
(b) Any prescription drugs of which the immediate or sealed outer containers or sealed secondary containers have been opened or used must be identified as such and must be quarantined and physically separated from other prescription drugs until they are destroyed or returned to the supplier.
(c) If the conditions under which a prescription drug has been returned cast doubt on the drug’s safety, identity, strength, quality, or purity, the drug must be destroyed or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug’s safety, identity, strength, quality, or purity, the wholesale distributor must consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the conditions of the drug and its container, carton, or labeling, as a result of storage or shipping.
(d) The recordkeeping requirements in subsection (6) must be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs.
(6) RECORDKEEPING.—The department shall adopt rules that require keeping such records of prescription drugs as are necessary for the protection of the public health.
(a) Wholesale distributors must establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records must provide a complete audit trail from receipt to sale or other disposition, be readily retrievable for inspection, and include, at a minimum, the following information:
1. The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;
2. The name, principal address, and state license permit or registration number of the person authorized to purchase prescription drugs;
3. The name, strength, dosage form, and quantity of the drugs received and distributed or disposed of;
4. The dates of receipt and distribution or other disposition of the drugs; and
5. Any financial documentation supporting the transaction.
(b) Inventories and records must be made available for inspection and photocopying by authorized federal, state, or local officials for a period of 2 years following disposition of the drugs or 3 years after the creation of the records, whichever period is longer.
(c) Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means must be readily available for authorized inspection during the retention period. Records that are kept at a central location outside of this state and that are not electronically retrievable must be made available for inspection within 2 working days after a request by an authorized official of a federal, state, or local law enforcement agency. Records that are maintained at a central location within this state must be maintained at an establishment that is permitted pursuant to this part and must be readily available.
(d) Each manufacturer or repackager of medical devices, over-the-counter drugs, or cosmetics must maintain records that include the name and principal address of the seller or transferor of the product, the address of the location from which the product was shipped, the date of the transaction, the name and quantity of the product involved, and the name and principal address of the person who purchased the product.
(e) When pedigree papers are required by this part, a wholesale distributor must maintain the pedigree papers separate and distinct from other records required under this part.
(7) PRESCRIPTION DRUG PURCHASE LIST.—Each wholesale distributor, except for a manufacturer, shall annually provide the department with a written list of all wholesale distributors and manufacturers from whom the wholesale distributor purchases prescription drugs. A wholesale distributor, except a manufacturer, shall notify the department not later than 10 days after any change to either list. Such portions of the information required pursuant to this subsection which are a trade secret, as defined in s. 812.081, shall be maintained by the department as trade secret information is required to be maintained under s. 499.051.
(8) WRITTEN POLICIES AND PROCEDURES.—Wholesale distributors must establish, maintain, and adhere to written policies and procedures, which must be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Wholesale distributors must include in their written policies and procedures:
(a) A procedure whereby the oldest approved stock of a prescription drug product is distributed first. The procedure may permit deviation from this requirement, if the deviation is temporary and appropriate.
(b) A procedure to be followed for handling recalls and withdrawals of prescription drugs. Such procedure must be adequate to deal with recalls and withdrawals due to:
1. Any action initiated at the request of the Food and Drug Administration or any other federal, state, or local law enforcement or other government agency, including the department.
2. Any voluntary action by the manufacturer or repackager to remove defective or potentially defective drugs from the market; or
3. Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design.
(c) A procedure to ensure that wholesale distributors prepare for, protect against, and handle any crisis that affects security or operation of any facility if a strike, fire, flood, or other natural disaster, or a local, state, or national emergency, occurs.
(d) A procedure to ensure that any outdated prescription drugs are segregated from other drugs and returned to the manufacturer or repackager or destroyed. This procedure must provide for written documentation of the disposition of outdated prescription drugs. This documentation must be maintained for 2 years after disposition of the outdated drugs.
(9) RESPONSIBLE PERSONS.—Wholesale distributors must establish and maintain lists of officers, directors, managers, designated representatives, and other persons in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.
(10) COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.—A wholesale distributor must operate in compliance with applicable federal, state, and local laws and regulations.
(a) A wholesale distributor must allow the department and authorized federal, state, and local officials to enter and inspect its premises and delivery vehicles, and to audit its records and written operating procedures, at reasonable times and in a reasonable manner, to the extent authorized by law.
(b) A wholesale distributor that deals in controlled substances must register with the Drug Enforcement Administration and must comply with all applicable state, local, and federal laws. A wholesale distributor that distributes any substance controlled under chapter 893 must notify the department when registering with the Drug Enforcement Administration pursuant to that chapter and must provide the department with its DEA number.
(11) SALVAGING AND REPROCESSING.—A wholesale distributor is subject to any applicable federal, state, or local laws or regulations that relate to prescription drug product salvaging or reprocessing.
(12) SHIPPING AND TRANSPORTATION.—The person responsible for shipment and transportation of a prescription drug in a wholesale distribution may use a common carrier; its own vehicle or employee acting within the scope of employment if authorized under s. 499.03 for the possession of prescription drugs in this state; or, in the case of a prescription drug intended for domestic distribution, an independent contractor who must be the agent of the authorized seller or recipient responsible for shipping and transportation as set forth in a written contract between the parties. A person selling a prescription drug for export must obtain documentation, such as a validated airway bill, bill of lading, or other appropriate documentation that the prescription drug was exported. A person responsible for shipping or transporting prescription drugs is not required to maintain documentation from a common carrier that the designated recipient received the prescription drugs; however, the person must obtain such documentation from the common carrier and make it available to the department upon request of the department.
(13) DUE DILIGENCE OF SUPPLIERS.—Prior to purchasing any prescription drugs from another wholesale distributor, a prescription drug wholesale distributor, an out-of-state prescription drug wholesale distributor, or a prescription drug repackager must:
(a) Enter an agreement with the selling wholesale distributor by which the selling wholesale distributor will indemnify the purchasing wholesale distributor for any loss caused to the purchasing wholesale distributor related to the purchase of drugs from the selling wholesale distributor which are determined to be counterfeit or to have been distributed in violation of any federal or state law governing the distribution of drugs.
(b) Determine that the selling wholesale distributor has insurance coverage of not less than the greater of 1 percent of the amount of total dollar volume of the prescription drug sales reported to the department under s. 499.012(8)(g) or $500,000; however the coverage need not exceed $2 million.
(c) Obtain information from the selling wholesale distributor, including the length of time the selling wholesale distributor has been licensed in this state, a copy of the selling wholesale distributor’s licenses or permits, and background information concerning the ownership of the selling wholesale distributor, including the experience of the wholesale distributor in the wholesale distribution of prescription drugs.
(d) Verify that the selling wholesale distributor’s Florida permit is valid.
(e) Inspect the selling wholesale distributor’s licensed establishment to document that it has a policies and procedures manual relating to the distribution of drugs, the appropriate temperature controlled environment for drugs requiring temperature control, an alarm system, appropriate access restrictions, and procedures to ensure that records related to the wholesale distribution of prescription drugs are maintained as required by law:
1. Before purchasing any drug from the wholesale distributor, and at least once each subsequent year; or
2. Before purchasing any drug from the wholesale distributor, and each subsequent year obtain a complete copy of the most recent inspection report for the establishment which was prepared by the department or the regulatory authority responsible for wholesale distributors in the state in which the establishment is located.
(14) DISTRIBUTION REPORTING.—Each prescription drug wholesale distributor, out-of-state prescription drug wholesale distributor, retail pharmacy drug wholesale distributor, manufacturer, or repackager that engages in the wholesale distribution of controlled substances as defined in s. 893.02 shall submit a report to the department of its receipts and distributions of controlled substances listed in Schedule II, Schedule III, Schedule IV, or Schedule V as provided in s. 893.03. Wholesale distributor facilities located within this state shall report all transactions involving controlled substances, and wholesale distributor facilities located outside this state shall report all distributions to entities located in this state. If the prescription drug wholesale distributor, out-of-state prescription drug wholesale distributor, retail pharmacy drug wholesale distributor, manufacturer, or repackager does not have any controlled substance distributions for the month, a report shall be sent indicating that no distributions occurred in the period. The report shall be submitted monthly by the 20th of the next month, in the electronic format used for controlled substance reporting to the Automation of Reports and Consolidated Orders System division of the federal Drug Enforcement Administration. Submission of electronic data must be made in a secured Internet environment that allows for manual or automated transmission. Upon successful transmission, an acknowledgment page must be displayed to confirm receipt. The report must contain the following information:
(a) The federal Drug Enforcement Administration registration number of the wholesale distributing location.
(b) The federal Drug Enforcement Administration registration number of the entity to which the drugs are distributed or from which the drugs are received.
(c) The transaction code that indicates the type of transaction.
(d) The National Drug Code identifier of the product and the quantity distributed or received.
(e) The Drug Enforcement Administration Form 222 number or Controlled Substance Ordering System Identifier on all Schedule II transactions.
(f) The date of the transaction.
The department must share the reported data with the Department of Law Enforcement and local law enforcement agencies upon request and must monitor purchasing to identify purchasing levels that are inconsistent with the purchasing entity’s clinical needs. The Department of Law Enforcement shall investigate purchases at levels that are inconsistent with the purchasing entity’s clinical needs to determine whether violations of chapter 893 have occurred.
(15) DUE DILIGENCE OF PURCHASERS.—
(a) Each prescription drug wholesale distributor, out-of-state prescription drug wholesale distributor, and retail pharmacy drug wholesale distributor must establish and maintain policies and procedures to credential physicians licensed under chapter 458, chapter 459, chapter 461, or chapter 466 and pharmacies that purchase or otherwise receive from the wholesale distributor controlled substances listed in Schedule II or Schedule III as provided in s. 893.03. The prescription drug wholesale distributor, out-of-state prescription drug wholesale distributor, or retail pharmacy drug wholesale distributor shall maintain records of such credentialing and make the records available to the department upon request. Such credentialing must, at a minimum, include:
1. A determination of the clinical nature of the receiving entity, including any specialty practice area.
2. A review of the receiving entity’s history of Schedule II and Schedule III controlled substance purchasing from the wholesale distributor.
3. A determination that the receiving entity’s Schedule II and Schedule III controlled substance purchasing history, if any, is consistent with and reasonable for that entity’s clinical business needs.
(b) A wholesale distributor must take reasonable measures to identify its customers, understand the normal and expected transactions conducted by those customers, and identify those transactions that are suspicious in nature. A wholesale distributor must establish internal policies and procedures for identifying suspicious orders and preventing suspicious transactions. A wholesale distributor must assess orders for greater than 5,000 unit doses of any one controlled substance in any one month to determine whether the purchase is reasonable. In making such assessments, a wholesale distributor may consider the purchasing entity’s clinical business needs, location, and population served, in addition to other factors established in the distributor’s policies and procedures. A wholesale distributor must report to the department any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of the law. The wholesale distributor shall maintain records that document the report submitted to the department in compliance with this paragraph.
(c) A wholesale distributor may not distribute controlled substances to an entity if any criminal history record check for any person associated with that entity shows that the person has been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction related to controlled substances, the practice of pharmacy, or the dispensing of medicinal drugs.
(d) The department shall assess national data from the Automation of Reports and Consolidated Orders System of the federal Drug Enforcement Administration, excluding Florida data, and identify the national average of grams of hydrocodone, morphine, oxycodone, and methadone distributed per pharmacy registrant per month in the most recent year for which data is available. The department shall report the average for each of these drugs to the Governor, the President of the Senate, and the Speaker of the House of Representatives by November 1, 2011. The department shall assess the data reported pursuant to subsection (14) and identify the statewide average of grams of each benzodiazepine distributed per community pharmacy per month. The department shall report the average for each benzodiazepine to the Governor, the President of the Senate, and the Speaker of the House of Representatives by November 1, 2011.
History.—s. 16, ch. 92-69; s. 32, ch. 98-151; ss. 38, 40, ch. 2000-242; ss. 15, 16, 18, ch. 2003-155; s. 86, ch. 2004-5; s. 4, ch. 2004-328; s. 10, ch. 2004-387; s. 3, ch. 2005-248; s. 5, ch. 2006-310; s. 17, ch. 2007-6; s. 13, ch. 2008-207; s. 62, ch. 2009-21; s. 3, ch. 2009-221; s. 40, ch. 2010-161; s. 18, ch. 2011-141.
Note.—Paragraph (6)(d) former s. 499.013(4).