The Florida Senate

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(c)  Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened;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.

(2)  SECURITY.--

(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 wholesaler-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 wholesaler 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. 499.001(31).

(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 either 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 drug 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 drug 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 ss. 499.001-499.081 and must be readily available.

(d)1.  Each person who is engaged in the wholesale distribution of a prescription drug, and who is not an authorized distributor of record for the drug manufacturer's products, must provide to each wholesale distributor of such drug, before the sale is made to such wholesale distributor, a written statement under oath identifying each previous sale of the drug back to the last authorized distributor of record, the lot number of the drug, and the sales invoice number of the invoice evidencing the sale of the drug. The written statement must accompany the drug to the next wholesale distributor. The department shall adopt rules relating to the requirements of this written statement. This paragraph does not apply to a manufacturer unless the manufacturer is performing the manufacturing operation of repackaging prescription drugs.

2.  Each wholesale distributor of prescription drugs must maintain separate and distinct from other required records all statements that are required under subparagraph 1. and paragraph (e).

3.  Each manufacturer of a prescription drug sold in this state must maintain at its corporate offices a current list of authorized distributors and must make such list available to the department upon request.

4.  Each manufacturer shall file a written list of all of the manufacturer's authorized distributors of record with the department. A manufacturer shall notify the department not later than 10 days after any change to the list. The department shall publish a list of all authorized distributors of record on its website.

5.  For the purposes of this subsection, the term "authorized distributors of record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's products. Effective March 1, 2004, an ongoing relationship is deemed to exist when a wholesale distributor, including any affiliated group, as defined in s. 1504 of the Internal Revenue Code, of which the wholesale distributor is a member:

a.  Is listed on the manufacturer's current list of authorized distributors of record.

b.  Annually purchases not less than 90 percent of all of its purchases of a manufacturer's prescription drug products, based on dollar volume, directly from that manufacturer and has total annual prescription drug sales of $100 million or more.

c.  Has reported to the department pursuant to s. 499.012(3)(g)2. that the wholesale distributor has total annual prescription drug sales of $100 million or more, and has a verifiable account number issued by the manufacturer authorizing the wholesale distributor to purchase the manufacturer's drug products directly from that manufacturer and that wholesale distributor makes not fewer than 12 purchases of that manufacturer's drug products directly from the manufacturer using said verifiable account number in 12 months. The provisions of this sub-subparagraph apply with respect to a manufacturer that fails to file a copy of the manufacturer's list of authorized distributors of record with the department by July 1, 2003; that files a list of authorized distributors of record which contains fewer than 10 wholesale distributors permitted in this state, excluding the wholesale distributors described in sub-subparagraph b.; or that, as a result of changes to the list of authorized distributors of record filed with the department, has fewer than 10 wholesale distributors permitted in this state as authorized distributors of record, excluding the wholesale distributors described in sub-subparagraph b.

A wholesale distributor that satisfies the requirements of sub-subparagraph b. or sub-subparagraph c. shall submit to the department documentation substantiating its qualification pursuant to sub-subparagraph b. or sub-subparagraph c. The department shall add those wholesale distributors that the department has determined have met the requirements of sub-subparagraph b. or sub-subparagraph c. to the list of authorized distributors of record on the department's website.

6.  This paragraph expires July 1, 2006.

(e)1.  Notwithstanding paragraph (d), each person who is engaged in the wholesale distribution of a specified drug must provide to each wholesale distributor of such specified drug:

a.  Upon any sale, a written statement that:

(I)  If the establishment is not a member of an affiliated group: "This establishment purchased the specific unit of the specified drug directly from the manufacturer"; or

(II)  If the establishment is a member of an affiliated group: "This establishment or a member of my affiliated group purchased the specific unit of the specified drug directly from the manufacturer"; or

b.  Before the wholesale distribution, a written statement, under oath, that identifies each previous sale of the specific unit of the specified drug back to the manufacturer of the specified drug, the lot number of the specific unit of the specified prescription drug, and the sales invoice number of the invoice evidencing each previous sale of the specific unit of the specified drug. The written statement identifying all sales of such specific unit of the specified drug must accompany the specific unit of the specified drug for each subsequent wholesale distribution of the specific unit of the specified drug to a wholesale distributor.

The department shall adopt rules to administer the requirements of these written statements.

2.  As used in this paragraph, the term "specified drug" means a specific prescription drug on the list of drugs adopted by the department by rule.

3.a.  A drug may be placed on the list of specified drugs if the department has seized or issued a stop sale notice on the prescription drug because of the adulteration, counterfeiting, or diversion of the prescription drug from the legal channels of distribution for prescription drugs, or the United States Food and Drug Administration, a manufacturer, a wholesale distributor, a law enforcement agency, or a government agency responsible for regulating the sale or distribution of prescription drugs in another state has notified the department in writing or through a website operated by one of said entities that the prescription drug has been adulterated, counterfeited, or diverted from the legal channels of distribution for prescription drugs; and the prescription drug satisfies one of the following criteria:

(I)  The prescription drug is included among the top 150 prescription drugs for which the state has incurred the highest amount of Medicaid claims in the most recently ended state fiscal year;

(II)  The prescription drug is available for normal prescription use in dosages or strengths that have a wholesale cost of $200 or more;

(III)  The prescription drug is used extensively for patients with human immunodeficiency virus, acquired immune deficiency syndrome, cancer, or other serious, life-threatening conditions, where drug nonresponsiveness would not be considered to be medically unusual;

(IV)  The prescription drug is an injectable drug;

(V)  The prescription drug is subject to a special, limited distribution process and is not generally sold to wholesale distributors by the manufacturer of the prescription drug;

(VI)  The department has found not less than five instances where statements required pursuant to paragraph (d) for the prescription drug were not passed on other than because of unintentional oversight, or have been passed on by or to a wholesale distributor and such statements were fraudulent; or

(VII)  A shipment of a prescription drug has been reported to a law enforcement agency as having been stolen or as missing.

b.  A prescription drug may be placed on the list of specified drugs if the prescription drug satisfies any three of the seven criteria set forth in sub-sub-subparagraphs (I)-(VII). However, a prescription drug may not be included on the list of specified drugs if the prescription drug is unlikely to be counterfeited or diverted from the legal channels of distribution for prescription drugs.

c.  Before the department begins the rulemaking process to place a drug on the list of specified drugs, except when the department files a rule under the procedure specified in sub-subparagraph e., the Drug Wholesaler Advisory Council created in s. 499.01211 shall consider whether a prescription drug should be included on or added to the list of specified drugs using the criteria enumerated in sub-subparagraph a. or sub-subparagraph b. and provide a written recommendation adopted by majority vote to the secretary of the department concerning each such drug. This paragraph does not apply to any list of prescription drugs on which the department has begun rulemaking prior to this paragraph becoming law.

d.  When a prescription drug is added to the list of specified drugs, the requirements of this paragraph shall be effective as to the prescription drug beginning 60 days after the effective date of the rule adding the prescription drug to the list, except when the department files a rule under the procedure specified in sub-subparagraph e.

e.(I)  Notwithstanding chapter 120, if the Attorney General or Statewide Prosecutor certifies to the secretary of the department that a prescription drug should be added to the list of specified drugs by emergency rule, the department may proceed to add such drug to the list of specified drugs and the emergency rule shall be effective for a period of 1 year from the date on which the emergency rule is filed, if the department begins the rulemaking process to adopt a permanent rule to place the drug on the list of specified drugs not later than 90 days after the date on which the emergency rule was filed. An emergency rule adding a drug to the list of specified drugs may not be renewed.

(II)  A prescription drug may be placed on the list of specified drugs through the procedure provided in this sub-subparagraph when:

(A)  The prescription drug satisfies any two of the criteria specified in sub-subparagraph a. or sub-subparagraph b.; or

(B)  The prescription drug satisfies any one of the criteria specified in sub-subparagraph a. or sub-subparagraph b. if the prescription drug has not yet become available for wholesale distribution or has been available for wholesale distribution for not more than 60 days.

(III)  Notwithstanding chapter 120, any emergency rule that places a prescription drug on the list of specified drugs may be challenged as being an invalid exercise of the delegated legislative authority only if the department lacks any substantial competent evidence that the prescription drug satisfied the criteria required pursuant to sub-sub-subparagraph (I) or sub-sub-subparagraph (II). Not later than 7 days after any request by any person, the department shall provide such person with the substantial competent evidence that justifies the department's adoption of an emergency rule placing a prescription drug on the list of specified drugs.

(IV)  The department shall notify all prescription drug wholesalers and out-of-state prescription drug wholesalers by electronic means, facsimile, or United States mail and on the bureau's website when any emergency rule is adopted which places a prescription drug on the list of specified drugs. Not later than 7 days after the department adopts an emergency rule placing a prescription drug on the list of specified drugs, wholesalers shall provide the department with the lot numbers and quantities of such prescription drug which the wholesaler owns or has in transit on the date that the department adopted the emergency rule placing the prescription drug on the list of specified drugs.

(V)  The requirements of subparagraph 1. do not apply to those lot numbers and quantities of a prescription drug which are included on a report filed pursuant to sub-sub-subparagraph (IV), and paragraph (d) shall apply to those lot numbers and quantities of the prescription drug. In addition to the requirements of paragraph (d), any wholesale distributor selling a prescription drug included on a report filed pursuant to sub-sub-subparagraph (IV) shall provide any wholesaler purchasing the prescription drugs with a statement under oath that the prescription drugs are among those included on a report filed pursuant to sub-sub-subparagraph (IV) and with a copy of the report filed by the wholesale distributor with the department for those prescription drugs.

f.  Not less than annually, the council and department shall evaluate whether each prescription drug included on the list of specified drugs should remain on the list. In determining whether a prescription drug should remain on the list of specified drugs, the council and department must consider:

(I)  The availability of generic forms of the drug.

(II)  Changes in the price of the drug since the prescription drug was placed on the list.

(III)  The current status of the drug that caused the department to place the prescription drug on the list of specified drugs.

The council shall provide a written recommendation adopted by majority vote to the secretary of the department concerning each drug that the council recommends be removed from the list of specified drugs.

4.  This paragraph does not apply to a manufacturer; however, a repackager must comply with this paragraph.

5.  This paragraph expires July 1, 2006.

(f)1.  Effective July 1, 2006, each person who is engaged in the wholesale distribution of a prescription drug and who is not the manufacturer of that drug must, before each wholesale distribution of such drug, provide to the person who receives the drug a pedigree paper as defined in s. 499.003(31).

2.  A repackager must comply with this paragraph.

3.  The pedigree paper requirements in this paragraph do not apply to compressed medical gases or veterinary legend drugs.

4.  Each wholesale distributor of prescription drugs must maintain separate and distinct from other required records all statements that are required under subparagraph 1.

5.  In order to verify compliance with subparagraph (d)1., each manufacturer of a prescription drug sold in this state must make available upon request distribution documentation related to its sales of prescription drugs, regardless of whether the prescription drug was sold directly by the manufacturer to a person in Florida.

6.  Subparagraph 1. is satisfied when a wholesale distributor takes title to, but not possession of, a prescription drug and the prescription drug's manufacturer ships the prescription drug directly to a person authorized by law to purchase prescription drugs for the purpose of administering or dispensing the drug, as defined in s. 465.003, or a member of an affiliated group, as described in paragraph (h), with the exception of a repackager.

a.  The wholesale distributor must deliver to the recipient of the prescription drug, within 14 days after the shipment notification from the manufacturer, an invoice and the following sworn statement: "This wholesale distributor purchased the specific unit of the prescription drug listed on the invoice directly from the manufacturer, and the specific unit of prescription drug was shipped by the manufacturer directly to a person authorized by law to administer or dispense the legend drug, as defined in s. 465.003, Florida Statutes, or a member of an affiliated group, as described in s. 499.0121(6)(h), Florida Statutes, with the exception of a repackager." The invoice must contain a unique cross-reference to the shipping document sent by the manufacturer to the recipient of the prescription drug.

b.  The manufacturer of the prescription drug shipped directly to the recipient under this section must provide and the recipient of the prescription drug must acquire, within 14 days after receipt of the prescription drug, a shipping document from the manufacturer that contains, at a minimum:

(I)  The name and address of the manufacturer, including the point of origin of the shipment, and the names and addresses of the wholesaler and the purchaser.

(II)  The name of the prescription drug as it appears on the label.

(III)  The quantity, dosage form, and strength of the prescription drug.

(IV)  The date of the shipment from the manufacturer.

c.  The wholesale distributor must also maintain and make available to the department, upon request, the lot number of such drug if not contained in the shipping document acquired by the recipient.

7.  Failure of the manufacturer to provide, the recipient to acquire, or the wholesale distributor to deliver, the documentation required under subparagraph 6. shall constitute failure to acquire or deliver a pedigree paper under s. 499.0051 Forgery by the manufacturer, the recipient, or the wholesale distributor of the documentation required to be acquired or delivered under subparagraph 6. shall constitute forgery of a pedigree paper under s. 499.0051

8.  The department may, by rule, specify alternatives to compliance with subparagraph 1. for a prescription drug in the inventory of a permitted prescription drug wholesaler as of June 30, 2006, and the return of a prescription drug purchased prior to July 1, 2006. The department may specify time limits for such alternatives.

(g)  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 paragraph 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

(h)1.  This paragraph applies only to an affiliated group, as defined by s. 1504 of the Internal Revenue Code of 1986, as amended, which is composed of chain drug entities, including at least 50 retail pharmacies, warehouses, or repackagers, which are members of the same affiliated group, if the affiliated group:

a.  Discloses to the department the names of all its members; and

b.  Agrees in writing to provide records on prescription drug purchases by members of the affiliated group not later than 48 hours after the department requests such records, regardless of the location where the records are stored.

2.  Each warehouse within the affiliated group must comply with all applicable federal and state drug wholesale permit requirements and must purchase, receive, hold, and distribute prescription drugs only to a retail pharmacy or warehouse within the affiliated group. Such a warehouse is exempt from providing a pedigree paper in accordance with paragraphs (d), (e), and (f) to its affiliated group member warehouse or retail pharmacy, provided that:

a.  Any affiliated group member that purchases or receives a prescription drug from outside the affiliated group must receive a pedigree paper if the prescription drug is distributed in or into this state and a pedigree paper is required under this section and must authenticate the documentation as required in subsection (4), regardless of whether the affiliated group member is directly subject to regulation under this chapter; and

b.  The affiliated group makes available to the department on request all records related to the purchase or acquisition of prescription drugs by members of the affiliated group, regardless of the location where the records are stored, if the prescription drugs were distributed in or into this state.

3.  If a repackager repackages prescription drugs solely for distribution to its affiliated group members for the exclusive distribution to and among retail pharmacies that are members of the affiliated group to which the repackager is a member:

a.  The repackager must:

(I)  In lieu of the written statement required by paragraph (d), paragraph (e), or paragraph (f), for all repackaged prescription drugs distributed in or into this state, state in writing under oath with each distribution of a repackaged prescription drug to an affiliated group member warehouse or repackager: "All repackaged prescription drugs are purchased by the affiliated group directly from the manufacturer or from a prescription drug wholesaler that purchased the prescription drugs directly from the manufacturer.";

(II)  Purchase all prescription drugs it repackages:

(A)  Directly from the manufacturer; or

(B)  From a prescription drug wholesaler that purchased the prescription drugs directly from the manufacturer; and

(III)  Maintain records in accordance with this section to document that it purchased the prescription drugs directly from the manufacturer or that its prescription drug wholesale supplier purchased the prescription drugs directly from the manufacturer.

b.  All members of the affiliated group must provide to agents of the department on request records of purchases by all members of the affiliated group of prescription drugs that have been repackaged, regardless of the location where the records are stored or where the repackager is located.

(7)  WRITTEN POLICIES AND PROCEDURES.--Wholesale drug 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 drug 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 drug 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 either 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.

(8)  RESPONSIBLE PERSONS.--Wholesale drug 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.

(9)  COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.--A wholesale drug distributor must operate in compliance with applicable federal, state, and local laws and regulations.

(a)  A wholesale drug 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 drug 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 drug 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.

(10)  SALVAGING AND REPROCESSING.--A wholesale drug distributor is subject to any applicable federal, state, or local laws or regulations that relate to prescription drug product salvaging or reprocessing.

(11)  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.

(12)  DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing any prescription drugs from another wholesale drug distributor, a prescription drug wholesaler, an out-of-state prescription drug wholesaler, or a prescription drug repackager must:

(a)  Enter an agreement with the selling wholesale drug distributor by which the selling wholesale drug distributor will indemnify the purchasing wholesale drug distributor for any loss caused to the purchasing wholesale drug distributor related to the purchase of drugs from the selling wholesale drug 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 drug 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(3)(g) or $500,000; however the coverage need not exceed $2 million.

(c)  Obtain information from the selling wholesale drug distributor, including the length of time the selling wholesale drug distributor has been licensed in this state, a copy of the selling wholesale drug distributor's licenses or permits, and background information concerning the ownership of the selling wholesale drug distributor, including the experience of the wholesale distributor in the wholesale distribution of prescription drugs.

(d)  Verify that the selling wholesale drug distributor's Florida permit is valid.

(e)  Inspect the selling wholesale drug 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 drug distributor, and at least once each subsequent year; or

2.  Before purchasing any drug from the wholesale drug 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 drug distributors in the state in which the establishment is located.

History.--s. 16, ch. 92-69; s. 32, ch. 98-151; s. 38, ch. 2000-242; ss. 15, 16, 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.