Fla. Admin. Code Ann. R. 61N-1.012 - Records of Drugs, Cosmetics and Devices

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(1)

(a) Records to document the movement of drugs, devices or cosmetics must provide a complete audit trail from a person's receipt or acquisition to sale or other disposition of the product or component. A complete audit trail includes records which document each transaction or step in the receipt, manufacture, shipping, transfer, or other steps in the channel of trade of that person, whether or not physical possession or handling of the product or component occurs. At a minimum, records shall consist of invoices from the supplier or source which documents acquisition of each product by the person and invoices of sale or other transfer by the person to the recipient. Retail sales transactions to the consumer of over-the-counter drugs, non-restricted devices, or cosmetics are exempt from the requirements of this rule. Additional recordkeeping is required for persons permitted by the department as further stated in this rule.

(b) A person engaged in the distribution of drugs, devices, or cosmetics is not required to maintain documentation from a common carrier that the designated recipient received the product shipped; however, the person must obtain such documentation from the common carrier and make it available to the department upon specific request of the department.

(2) Any person engaged in the manufacture of prescription drugs, the wholesale distribution of prescription drugs, or otherwise receiving or distributing prescription drugs must maintain records as follows:

(a) For each step in the channel of trade, records containing the information required by section 499.0121(6)(a), F.S., and the Florida permit or license number which authorizes the source to possess and transfer prescription drugs in or into Florida must appear on one document. If delivery of prescription drugs is made to a person other than the purchaser, the name, address or location where the prescription drugs are delivered, and the state license, permit or registration number for that location must be included also.

(b) The state permit or registration number of the purchaser may be omitted if the prescription drugs are exported; but a validated airway bill, bill of lading or other appropriate documentation must be maintained to evidence the exportation of the product.

(d) Records to document the distribution of prescription drugs required by section 499.0121(6), F.S., and this rule are to be created during the transaction (i.e., at the time of order, receipt, processing, picking or shipping) and not retroactively created. A pharmacy or other person authorized to possess prescription drugs that transfers prescription drugs to an establishment performing reverse distribution services or destruction activities must prepare or have prepared an inventory or other record of the prescription drugs so transferred prior to the prescription drugs leaving the premises. In addition to the name, address, and license number of the sender and the name, address, and license number of the receiving establishment, the record must include the elements set forth in paragraph 61N-1.023(3)(a), F.A.C.

(e) Inventory. A complete and accurate record of all stock of prescription drugs on hand must be made annually by establishments permitted under chapter 499, F.S. A physical inventory must be conducted at least annually unless perpetual inventory records are maintained, in which case the physical inventory may be conducted on a biennial basis. Significant inventory discrepancies must be investigated and handled in accordance with written policies and procedures of the establishment. In addition, no later than July 17, 2006, each wholesale distributor shall submit to the department an inventory of drugs it has on hand as of June 30, 2006.

(f) Inventory existing as of June 30, 2006. A wholesale distributor permitted under section 499.012, F.S., that has purchased a prescription drug on or before close of business June 30, 2006, without the pedigree required by section 499.01212, F.S., may distribute such drug provided the wholesale distributor submits to the department an inventory of such drugs no later than July 17, 2006, conforming to paragraph (2)(e), above, and provided further that such drugs are otherwise in compliance with the provisions of sections 499.001 through 499.081, F.S. Inventories shall be submitted to the department in written form, email, facsimile, or electronic media excluding a web page. The department will consider the submittal to be a trade secret as defined by section 812.081(1)(c), F.S., provided that the sending wholesale distributor complies with the requirements of subsections 61N-1.021(1) and (2), F.A.C.

(3) Pedigree Papers.

(a)

1. The pedigree papers required by section 499.01212, F.S., must include either the proprietary name or the generic name with the name of the manufacturer, repackager, or distributor as reflected on the label of the product; dosage form; strength; container size; quantity by lot number; the name and address of each owner of the prescription drug that is required to be identified on the pedigree paper; the name and address of each location from which it was shipped if different from the owner's; and the transaction dates. The pedigree paper must clearly identify the invoice to which it relates; however, if an invoice number has not been generated at the time the pedigree is prepared then an alternate reference number that is easily traceable to the invoice number may be used.

2. A copy of the pedigree paper must be maintained by each wholesale distributor preparing a pedigree paper and by each recipient. This copy may be maintained in an electronic medium that is readily available and easily accessible to the wholesale distributor preparing the pedigree paper; each recipient; and authorized federal, state, and local regulators or law enforcement. If a wholesale distributor serves as the repository of its customer's pedigree, the wholesale distributor must specify on the customer's invoice or other distribution document the method for immediately accessing all pedigrees associated with each prescription drug distributed and must enable access by the persons listed above for the duration of the applicable records retention period.

(b) If a wholesale distributor uses the statement contained in section 499.01212, F.S., "This establishment or a member of my affiliated group purchased the specific unit of the specified drug directly from the manufacturer" the wholesale distributor must provide to the department the names of all members of the affiliated group of which the wholesale distributor is a member and the affiliated group must provide records on prescription drug purchases by the members of the affiliated group not later than 48 hours after the department requests access to such records, regardless of the location where the records are stored.

(c) Beginning July 1, 2006, "Pedigree Paper (Distribution History of Prescription Drugs), " either Form DBPR 2129 effective July 2006, which is incorporated by reference herein, or an electronic record that contains all the elements of Form DBPR 2129 must be used to comply with the requirement in section 499.01212, F.S., for the distribution of a prescription drug. Beginning July 1, 2006, a repackager must use either "Prescription (legend) Drug Pedigree - Repackager" Form DBPR 2135 effective July 2006, which is incorporated by reference herein, or an electronic record that contains all the elements of Form DBPR 2135. A wholesale distributor that further distributes a repackaged prescription drug must include in the pedigree the information related to the repacked drug contained in Form DBPR 2135 or the electronic record that contains all the elements of Form DBPR 2135. These forms may be used prior to July 1, 2006, to comply with the pedigree paper requirements of section 499.01212, F.S., at the discretion of the wholesale distributor. An electronic signature may be used on a pedigree paper. An electronic record must be easily readable or easily rendered in a readable format, and capable of being reproduced in a paper medium. Data on an electronic pedigree may be transmitted via the internet, data communications, a portable medium such as a CD-Rom or smart card or similar devices. Additional information to that required by forms DBPR 2129 and DBPR 2135 may be included on a pedigree provided it does not detract from or confuse the history of the distribution of the drug.

(d) A copy of the pedigree paper must be maintained by each recipient. A copy of the pedigree paper provided to a wholesale distributor must be maintained by the wholesale distributor providing the pedigree paper.

(e) Effective March 1, 2004, a pedigree paper under section 499.01212, F.S., must trace a prescription drug back to the last authorized distributor of record. The department will maintain a database of authorized distributors of record. A prescription drug wholesale distributor that receives or prepares a pedigree paper under section 499.01212, F.S., and this chapter that traces the previous distributions of a prescription drug back to a prescription drug wholesale distributor that is not listed on the department's web site as an authorized distributor of record for the drug's manufacturer for the date in which the transaction occurred must maintain and have available for inspection documentation that supports the fact the prescription drug wholesale distributor is an authorized distributor of record in accordance with the criteria of section 499.01212, F.S.

(f) Returns.

1. When a distribution of a prescription drug by a wholesale distributor to a pharmacy or a health care entity, including a practitioner, licensed and authorized under Florida law to purchase and receive the prescription drug is the result of a mistake in ordering or shipment, the return of that prescription drug by the recipient to the wholesale distributor need not be reflected in a pedigree paper. For purposes of this subparagraph, a mistake in ordering or shipment shall be deemed to have occurred if, within fourteen calendar days after the date of receipt of the original shipment:

a. The recipient ships the specific unit of the prescription drug back to the wholesale distributor from which that specific unit was purchased; or

b. The recipient transmits a documented communication to the wholesale distributor from which the prescription drug was purchased stating the recipient's intent to return the shipment in accordance with the wholesale distributor's prescribed written policies and procedures and the wholesale distributor communicates authorization for return of the product.

2. Any returns to a wholesale distributor that are not within the scope of subparagraph 1. shall be reflected in a pedigree paper for any subsequent wholesale distributions of the returned drug product to the extent required by section 499.01212, F.S.

3. A recipient that returns a prescription drug to the wholesale distributor in accordance with subparagraph 1. or 2. shall verify by written declaration as set forth in section 92.525(2), F.S., a written document submitted with the returned product:

a. That the specific unit (exact unit) being returned was purchased from the receiving wholesale distributor (including the corresponding sales invoice number and the date of the sale from that wholesale distributor to the authorized recipient); and,

b. That the product was or was not stored and shipped in accordance with the requirements of section 499.0121, F.S., and the rules adopted thereunder while in the purchaser's custody and control.

c. The written declaration shall be printed or typed at the end of or immediately below the statements in sub-subparagraphs 3.a. and 3.b. and shall state: "Under penalties of perjury, I declare that I have read the foregoing and that the facts stated in it are true, " followed by the signature of the person making the declaration.

(g) For purposes of section 499.003(31)(b), F.S., a manufacturer or repackager will have uniquely serialized an individual legend drug unit when the unit contains an electronic product code that meets industry standards for that type of legend drug unit. The department will adopt the industry standards for each type of legend drug unit when they are established. One pedigree record may be prepared for a group of serialized legend drugs, provided the only unique characteristic for the pedigree is the serialization codes.

(h) If a manufacturer initiates an electronic pedigree and transmits this information to a wholesale distributor consistent with the standards in sub-subparagraph 61N-1.013(5)(d) 1.f., F.A.C., (and that wholesale distributor provides a pedigree to its customer consistent with the standards in sub-subparagraph 61N-1.013(5)(d) 1.f., F.A.C., the wholesale distributor must transmit the pedigree information initiated by the manufacturer in the pedigree the wholesale distributor provides to its customer.

(i) A wholesale distributor that purchases multiple units of a prescription drug from a manufacturer in one transaction, but receives these units from multiple distribution sites of the manufacturer or on multiple dates from the manufacturer, may reference the first occurrence of receipt in pedigree papers the wholesale distributor prepares for subsequent wholesale distributions unless all applicable information is received from the manufacturer as set forth in paragraph (3)(h), above.

(j) A contract distributor for the manufacturer is deemed an agent of the manufacturer and therefore is not required under Section 499.01212, F.S., to provide a pedigree paper upon distribution of the manufacturer's prescription drug provided the manufacturer retains title to the prescription drug and the contract distributor meets the requirements to be permitted under chapter 499, F.S., as a non-resident prescription drug manufacturer based on its relationship with the manufacturer.

(k) Emergency Distributions. A wholesale distributor may distribute and a purchasing pharmacy or health care practitioner authorized by law to purchase prescription drugs may accept a prescription drug for which a pedigree that complies with section 499.01212, F.S., is not available, when the prescription drug is required immediately to treat a specific patient with a life-threatening medical condition or a medical condition that will result in serious bodily harm. A pharmacist for the purchasing pharmacy, or the health care practitioner, shall supply a statement to the supplying wholesale distributor(s) that the emergency meets this rule paragraph's requirements and the supplying wholesale distributor(s) must maintain such statement in compliance with the timeframes in section 499.0121(6)(b), F.S. The supplying wholesale distributor must otherwise comply fully with all other applicable provisions of sections 499.001 through 499.081, F.S., with respect to such drug.

(4) Retailers of veterinary legend drugs or medical oxygen must also maintain a prescription or other order of an authorized practitioner evidencing the authority of the purchaser or recipient to receive the veterinary legend drug or medical oxygen. A veterinary legend drug retailer must have the prescription prior to delivery of the drug to the customer. In the case of a medical oxygen retailer, the prescription or order for medical oxygen must be in writing and in the possession of the retailer within 30 days of delivery of the drug to the patient. An order or prescription for veterinary legend drugs or medical oxygen does not constitute authority for the retailer to sell to the purchaser beyond 12 months from the date of the original sale.

(5) A copy of the Florida Drug and Cosmetic Act, chapter 499, F.S., and chapter 61N-1, F.A.C., Regulations for Drugs, Devices and Cosmetics, must be at the permitted establishment.

(6)

(a) Records for permittees not physically located within the state may be maintained at a central location outside of the state but must be made available for inspection at a permitted establishment or at the department's address within 2 working days after a request for inspection.

(b) Records for permittees located in the state or persons located in Florida and required to be permitted under chapter 499, F.S., may be stored by computer or other electronic means at a central location inside or outside of the state, but must be readily available and immediately retrievable, i.e., subject to inspection at the permitted establishment during the inspection.

1. Records that are maintained at a central location within this state must be maintained at an establishment that is permitted pursuant to sections 499.001-.081, F.S., in that person's name.

2. If not maintained at a central location, records must be maintained at the permitted location or, if not otherwise permitted, at the address reflected on the product registration.

3. A permitted establishment in Florida that maintains records at a location outside of the state must have a method, such as computerized access, to make records readily available and immediately retrievable. These records must also be made available at the permitted establishment for copying or reproducing within two working days after a request.

4. An establishment permitted at an address outside of the state must make records available for inspection within two working days after a request.

(d) If hard copies (originals or true copies) of required records are not maintained at the permitted establishment in Florida, the department or Florida Department of Law Enforcement must be able to review automated records for any and all records required to be maintained under chapter 499, F.S., without requesting a specific source, recipient, product, date, etc.

(7) Except as provided in section 499.012(2)(e), F.S., and paragraph (3)(b) of this rule, records of other persons not required to be permitted but subject to regulation under chapter 499, F.S., must be made available to the department or the Florida Department of Law Enforcement within five business days of the request for inspection, copying, or reproduction.

(8) Records involving drugs, devices, or cosmetics may be maintained by electronic methods, such as computers or imaging devices. Originals or true copies of required records documentation must be maintained by the person involved in the transaction, including brokers and agents. If electronic methods are used to maintain records related to prescription drugs and these methods do not maintain a true copy of the original record, such as the actual image of the original document, then the security system of the permittee must provide protection against tampering with computers or electronic records.

(9) Documentation provided to the department pursuant to an inspection may not be altered or defaced in any manner to obstruct or conceal any required or other information recorded on the document.

(10) All required records must be retained for a period of two years following disposition of the drug, device or cosmetic, or three years after the creation of the records, whichever period is longer; and must be available to the department for such period or as long as records are retained if longer. Records must be retained beyond the retention period if the person has been notified that an investigation or inspection has been initiated by the department and the investigation has not been completed when the mandatory retention period expires.

(11) Manufacturers shall maintain formulas of drugs and cosmetics, including all ingredients, and shall make these available to the department upon request, either during an inspection or by certified mail.

(12) An establishment permitted under chapter 499, F.S., that shares a facility with another person or business shall keep all of its operational systems subject to chapter 499, F.S., separate and distinct from the other person or business. A person permitted under chapter 499, F.S., that also conducts other business activities not permitted under chapter 499, F.S., shall keep all of its operational systems subject to chapter 499, F.S., separate and distinct from the other business activities. For the purpose of this rule, those operational systems required to be kept separate and distinct shall mean all records, inventory, storage areas, repackaging operations, quarantine areas, and manufacturing operations, but this rule shall not require separate entrances to the establishment nor partitioning. A Retail Pharmacy Drug Wholesale Distributor however, is not required to maintain its stock of prescription drugs which may be distributed through a wholesale transaction separate from the stock of prescription drugs which may be dispensed by a retail pharmacy.

(13) An establishment permitted to purchase or possess prescription drugs that has no records or has not done any business under the permit that would require such records, shall upon request, provide to the department a written statement to that effect.

(14) The recordkeeping requirements of this subsection do not apply to the prescription dispensing records of a pharmacy or to the patient medical records of a licensed practitioner; however, such records may be required to be produced pursuant to a subpoena issued by the department under section 499.002(3), F.S.

(15) Charitable Donations of Prescription Drug. A physician or other authorized recipient donating prescription drugs, including prescription drug samples, pursuant to section 499.003(53)(b)5., F.S., must prepare and maintain a donation record that includes at a minimum:

(a) The donor's name, address, telephone number, the practitioner's state license number, and D.E.A. number if a controlled substance is donated;

(b) The manufacturer, brand name, strength, and dosage form of the product; the quantity donated by lot number; and the expiration date of the product;

(d) The name, address, and state license number that authorizes the possession of prescription drugs by the charitable organization, if applicable; and,

(e) Within 48 hours of receipt, excluding holidays and weekends, the recipient charitable institution must provide a written receipt to the donor acknowledging receipt of the donated prescription drugs.

(16) Establishing an ongoing relationship pursuant to section 499.01212, F.S. A wholesale distributor that is not listed as an authorized distributor of record on the list submitted to the department by a prescription drug manufacturer may request the department add the wholesale distributor to the department's website of authorized distributors of record for a drug manufacturer for purposes of the pedigree paper requirements of section 499.01212, F.S., that become effective March 1, 2004, provided that such wholesale distributor satisfies the requirements of paragraph (a) or (b), below.

(a) A wholesale distributor or its affiliated group must submit the information in subparagraphs 1. and 2., below, to document eligibility for inclusion as an authorized distributor of record for a manufacturer of prescription drugs pursuant to section 499.01212, F.S. If the information submitted in subparagraphs 1. and 2., is based on the cumulative activity of an affiliated group, a wholesale distributor or its affiliated group must submit the information in subparagraph 3. below to document the eligibility of the individual wholesale distributor establishment that is a member of the affiliated group to be an authorized distributor of record for a manufacturer of prescription drugs pursuant to section 499.01212, F.S.

1. To document total annual prescription drug sales of $100 million or more submit either:

a. The most recent audited financial report that includes an Income Statement or Statement of Profit/Loss that indicates sales of prescription drugs of at least $100 million. (Note: the statement or notes in the audited financial report must clearly demonstrate the sales amount related to prescription drugs as opposed to other commodities); or

b. A signed attestation from a certified public accountant that the establishment or affiliated group, if applicable, had total annual prescription drug sales of $100 million or more in the most recent fiscal year; or

c. A computerized listing of prescription drug sales transactions during the period 10/1/02 - 9/30/03, or a 12-month period ending on the last day of the most recent calendar quarter, of at least $100 million. This report must be totaled. The detail should include the invoice number, invoice date, customer name, and total invoice amount related to prescription drugs. A statement must be provided that the report documents at least $100 million in prescription drug sales, excluding customer returns; and,

2. For each manufacturer for whom the wholesale distributor claims authorized distributor of record status, submit both subparagraphs a. and b., to document that the wholesale distributor annually purchases not less than 90%, based on dollar volume, of all of its purchases of a manufacturer's prescription drug products directly from that manufacturer.

a. A computerized listing of all of a manufacturer's prescription drugs purchased by the wholesale distributor during the period 10/1/02 - 9/30/03, or a 12-month period ending on the last day of the most recent calendar quarter, regardless of the source of those prescription drugs. This report must be totaled; and,

(I) A computerized listing of all purchases of a manufacturer's prescription drugs directly from the manufacturer during the same time period. This report must be totaled. The detail should include the invoice number, invoice date, and total invoice amount related to prescription drugs. A statement must be provided that the report documents at least 90% of the wholesale distributor's purchases of a manufacturer's prescription drug products directly from that manufacturer, excluding returns to the manufacturer; or

(II) Copies of the manufacturer's sales invoices of prescription drugs to the wholesale distributor. An adding machine tape, or equivalent, must be included that lists each invoice, in order, and provides a total of all invoices submitted. A statement must be provided that the invoices document at least 90% of the wholesale distributor's purchases of a manufacturer's prescription drug products directly from that manufacturer, excluding returns to the manufacturer.

3. Each wholesale distributor establishment that applies to the department to be listed as an authorized distributor of record of a drug manufacturer based upon its affiliated group's ongoing relationship with the manufacturer, or the affiliated group on behalf of each wholesale distributor establishment, must submit the names and address of all member wholesale distributor establishments of the affiliated group. In addition, each wholesale distributor establishment must either:

a. Conduct its prescription drug wholesale activities under an establishment name that incorporates the same business name as the affiliated group upon which the eligibility criteria for the affiliated group was met; or

b. Hold a valid prescription drug wholesale distributor permit or out-of-state prescription drug wholesale distributor permit issued under chapter 499, F.S.

(b) A wholesale distributor or its affiliated group must submit the information in subparagraphs 1. and 2., below, to document eligibility for inclusion as an authorized distributor of record for a manufacturer of prescription drugs pursuant to section 499.01212, F.S.

1. To document total annual prescription drug sales of $100 million or more submit either:

c. A computerized listing of prescription drug sales transactions during the period 10/1/02 - 9/30/03, or a 12-month period based on the most recent calendar quarter, of at least $100 million. This report must be totaled. The detail should include the invoice number, invoice date, customer name, and total invoice amount related to prescription drugs. A statement must be provided that the report documents at least $100 million in prescription drug sales, excluding customer returns.

2. For each manufacturer for whom the wholesale distributor claims authorized distributor of record status, submit sub-subparagraph a., b., or c., to document that the wholesale distributor has a verifiable account number issued by the manufacturer and has made at least 12 purchases of prescription drugs directly from that manufacturer using the verifiable account number.

a. If the wholesale distributor is a member of an affiliated group and all purchases from that manufacturer are made at a central location for the wholesale distributor, copies of at least 12 invoices dated during the previous 12 months from the date the information is submitted, which invoices document purchases of prescription drugs, at least one unit of which on each invoice was not returned, under that central account number but shipped to the wholesale distributor's address for whom the authorized distributor of record status is claimed. A statement must be provided that the invoices document purchases of prescription drugs for the wholesale distributor for whom the authorized distributor of record status is claimed and that the wholesale distributor did not return to the manufacturer at least one unit of the prescription drugs on each invoice.

b. If the wholesale distributor is a member of an affiliated group and all purchases from that manufacturer are made at a central location and received at a central location for the wholesale distributor, copies of at least 12 invoices dated during the previous 12 months from the date the information was submitted, under the same account number which is clearly assigned to the wholesale distributor at the permitted address. Each invoice must document the purchase of prescription drugs, of which at least one unit identified on the invoice was not returned. A statement must be provided that the invoices document purchases of prescription drugs by that central location and that the central location or wholesale distributor for which the drugs were obtained did not return to the manufacturer at least one unit of the prescription drugs on each invoice, and that the central location shipped at least 12 times to the individual wholesale distributor for whom the authorized distributor of record status is claimed during the 12 months based on the fiscal year or designated timeframe.

c. For all other wholesale distributors, copies of at least 12 invoices dated during the previous 12 months from the date the information was submitted, under the same account number that is clearly assigned to the wholesale distributor at the permitted address. Each invoice must document the purchase of prescription drugs, of which at least one unit identified on the invoice was not returned. A statement must be provided that the invoices document purchases of prescription drugs by that wholesale distributor and that the wholesale distributor did not return to the manufacturer at least one unit of the prescription drugs on each invoice.

(17) For purposes of prescription drugs obtained in "limited quantities" for research and development ("R&D") purposes under sections 499.01(3) and (4)(b), F.S. and paragraph 61N-1.001(2)(n), F.A.C., the records required pursuant to section 499.0121(6), F.S., must identify the R&D requirements, acquisition schedule and use of each drug acquired relative to anticipated and ongoing R&D activities. These records must be created in advance of or within 30 calendar days of the particular R&D activities, and are subject to inspection under section 499.051, F.S. Non-clinical/pre-clinical R&D quantities must be updated annually, and clinical quantities must be updated semiannually. The researcher must maintain all other records required under chapter 499, F.S., including, without limitations, section 499.01(3) or (4)(b), F.S., and applicable federal laws.

Notes

Fla. Admin. Code Ann. R. 61N-1.012

Rulemaking Authority 499.05, 499.0121 FS. Law Implemented 499.01, 499.012, 499.0121, 499.01212, 499.028, 499.04, 499.041, 499.05, 499.051, 499.052, 499.06, 499.066, 499.067 FS.

New 1-1-77, Amended 12-12-82, 7-8-84, 1-30-85, Formerly 10D-45.53, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.053, Amended 1-26-99, 4-17-01, 10-7-03, 1-1-04, 6-15-04, 8-2-04, 1-19-06, 8-6-06, Formerly 64F-12.012 , Amended 3/4/2013, Amended by Florida Register Volume 41, Number 214, November 3, 2015 effective 11/16/2015.

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