The Division proposes the rule amendment to define terms used in the Division’s product tracking and tracing rules which implement federal requirements.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Division of Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.028Product Tracking and Tracing – Definitions.

PURPOSE AND EFFECT: The Division proposes the rule amendment to define terms used in the Division’s product tracking and tracing rules which implement federal requirements.

SUMMARY: The proposed rule amends several definitions within Chapter 61N-1, F.A.C., to implement the requirements of the federal tracking and tracing law.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The agency has determined that this rule will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule.  A SERC has not been prepared by the agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: the economic review conducted by the agency.

Any person who wishes to provide information regarding the statement of estimated regulatory costs, or to provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 499.0121, 499.05 FS

LAW IMPLEMENTED: 499.002, 499.0121, 499.05, 499.052 FS

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Dinah Greene, Operations Review Specialist, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 1940 North Monroe Street Suite 26A, Tallahassee, Florida 32399-1047; 850-717-1802; [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.028 Product Tracking and Tracing - Definitions.

The following definitions apply to the product tracking and tracing requirements set forth in rules 61N-1.029, 61N-1.030, 61N-1.031 and 61N-1.032, F.A.C.

(1) “AFFILIATE” means a business entity that has a relationship with a second business entity if, directly or indirectly:

(a) One business entity controls, or has the power to control, the other business entity; or

(b) A third party controls, or has the power to control, both of the business entities.

(2) “AUTHORIZED” means:

(a) A manufacturer or repackager, registered as a drug establishment with the FDA;

(b) A wholesale distributor, having a valid license under Florida law or federal law, and complying with the licensure reporting requirements under 21 U.S.C. s. 353(e), (as of 12/1/15) which is incorporated by reference herein;

(c) A third-party logistics provider, having a valid license under Florida law or federal law, and complying with the licensure reporting requirements under 21 U.S.C. s. 360eee-3(b) (as of 12/1/15) which is incorporated by reference herein; and

(d) A dispenser, having a valid license under Florida law.

(3) “DISPENSER” means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.  Dispenser does not include a person who dispenses only products to be used in animals when the product is dispensed on the lawful written or oral order of a licensed veterinarian within the context of a veterinarian-client-patient relationship.

(4) “DISPOSITION” means, with respect to a product within the possession or control of an entity, the removal of such product from the pharmaceutical distribution supply chain, which may include disposal or return of the product for disposal or other handling or actions, such as retaining a sample of the product for further additional physical examination or laboratory analysis of the product by a manufacturer or regulatory or law enforcement agency.

(5) “DISTRIBUTE” or “DISTRIBUTION” means to sell, purchase, trade, deliver, handle, store, or receive a product;  The term does not mean to administer or dispense and does not include the billing and invoicing activities that commonly follow a wholesale distribution transaction.

(6) “EXCLUSIVE DISTRIBUTOR” means the wholesale distributor that directly purchased the product from the manufacturer and is the sole distributor of that manufacturer’s product to a subsequent repackager, wholesale distributor, or dispenser.

(7) “GRANDFATHERED” means, with respect to a product, a product that is not labeled with a product identifier and that entered the pharmaceutical distribution supply chain on or before January 1, 2015.

(8)  “HOMOGENOUS CASE” means a sealed case containing only product that has a single National Drug Code number belonging to a single lot.

(9)  “ILLEGITIMATE PRODUCT” means a product that:

(a) Is counterfeit, diverted, or stolen;

(b) Is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(c) Is the subject of a fraudulent transaction; or

(d) Appears unfit for distribution such that the product would likely result in serious adverse health consequences or death to humans.

(10) “LICENSED” means having a valid license in accordance with Florida law.  For the purposes of  61N-1.028, 61N-1.029, 61N-1.030, 61N-1.031 and 61N-1.032, F.A.C., a dispenser is considered “licensed” if the dispenser has a valid license under Florida law.

(11) “MANUFACTURER” means:

(a) A person that holds an application approved under 21 U.S.C. 355 (as of 12/1/15) which is incorporated by reference herein or a license issued under section 351 of the Public Health Service Act (42 U.S.C. s. 262) (as of 12/1/15) which is incorporated by reference herein for such product, or if such product is not the subject of an approved application or license, the person who manufactured the product;

(b) A co-licensed partner or affiliate of a person described in 61N-1.028(11)(a) that obtains the product directly from a person described in this paragraph or 61N-1.028(11)(a) or 61N-1.028(11)(c); or

(c) An affiliate of a person described in 61N-1.028(11)(a) or 61N-1.028(11)(b) that receives the product directly from a person described in this paragraph or 61N-1.028(11)(a) or 61N-1.028(11)(b).

(12) “MEDICAL CONVENIENCE KIT” means packages or units that contain combination products as defined in 21 C.F.R. s. 3.2(e)(2) (as of 12/1/15) which is incorporated by reference herein.  A “medical convenience kit” is considered an “exempt medical convenience kit” if it is a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user, and:

(a) The kit is assembled in an establishment that is registered with the Food and Drug Administration as a device manufacturer in accordance with 21 U.S.C. s. 360(b)(2) (as of 12/1/15) which is incorporated by reference herein;

(b) The kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. s. 801 et seq.) (as of 12/1/15) which is incorporated by reference herein or chapter 893, Florida Statutes;

(c) If the kit includes a product:

1. The person that manufacturers the kit purchased the product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer and did not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and

2. The product is:

a. An intravenous solution intended for the replenishment of fluids and electrolytes;

b. A product intended to maintain the equilibrium of water and minerals in the body;

c. A product intended for irrigation or reconstitution;

d. An anesthetic;

e. An anticoagulant;

f. A vasopressor; or

g. A sympathomimetic.

(13) “PACKAGE” means the smallest individual saleable unit of product for distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser of such product.  For purposes of this paragraph, an “individual saleable unit” is the smallest container of product introduced into commerce by the manufacturer or repackager that is intended by the manufacturer or repackager for individual sale to a dispenser.

(14) “PRODUCT” means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) (as of 12/1/15) which is incorporated by reference herein that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 274 of the Atomic Energy Act of 1954 (42 U.S.C. s. 2021) (as of 12/1/15) which is incorporated by reference herein, imaging drugs, an intravenous product described in clause 14., 15. or 16. of suparagraph (25)(b) below, any medical gas (as defined in 21 U.S.C. s. 360ddd) (as of 12/1/15) which is incorporated by reference herein, homeopathic drugs marketed in accordance with applicable guidance under this Act, or a drug compounded in compliance with 21 U.S.C. s. 353a (as of 12/1/15) which is incorporated by reference herein or 21 U.S.C. s. 353b (as of 12/1/15) which is incorporated by reference herein.

(15) “PRODUCT IDENTIFIER” means a standardized graphic that includes, in both human readable form and on a machine-readable data carrier, the standardized numerical identifier, lot number, and expiration date of the product.  Unless authorized by the department, the applicable data shall be included in a 2-dimensional data matrix barcode when affixed to, or imprinted upon a package and homogeneous case.

(16) “QUARANTINE” means the storage or identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use.

(17) “REPACKAGER” means a person who owns or operates an establishment that repacks and relabels a product or package for further sale or distribution without a further transaction.

(18) “RETURN” means providing product to the authorized immediate trading partner from which such product was purchased or received, or to a returns processor or reverse logistics provider for handling of such product.

(19) “RETURN PROCESSOR or REVERSE LOGISTICS PROVIDER” means a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsaleable product received from an authorized trading partner such that the product may be processed for credit to the purchaser, manufacturer, or seller or disposed of for no further distribution.

(20) “SPECIFIC PATIENT NEED” refers to the transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need.

(21) “STANDARDIZED NUMERICAL IDENTIFIER” means a set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the National Drug Code that corresponds to the specific product (including the particular package configuration) combined with a unique alphanumeric serial number of up to 20 characters.

(22) “SUSPECT PRODUCT” means a product for which there is reason to believe that such product:

(a) Is potentially counterfeit, diverted, or stolen;

(b) Is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(c) Is potentially the subject of a fraudulent transaction; or

(d) Appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

(23) “THIRD PARTY LOGISTICS PROVIDER” means an entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor has responsibility to direct the sale or disposition of the product.

(24) “TRADING PARTNER” means:

(a) A manufacturer, repackager, wholesale distributor, or dispenser from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct ownership of a product; or

(b) A third-party logistics provider from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct possession of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct possession of a product.

(25) “TRANSACTION”.

(a) The term “transaction” means the transfer of product between persons in which a change of ownership occurs.

(b) EXEMPTIONS. The term “transaction” does not include:

1. Intracompany distribution of any product between members of an affiliate or within a manufacturer;

2. The distribution of a product among hospitals or other health care entities that are under common control;

3. The distribution of a product for emergency medical reasons including a public health emergency declaration pursuant to section 319 of the Public Health Service Act (42 U.S.C. s. 247d) (as of 12/1/15) which is incorporated by reference herein, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;

4. The dispensing of a product pursuant to a prescription executed in accordance with 21 U.S.C. s. 353(b)(1) (as of 12/1/15) which is incorporated by reference herein;

5. The distribution of product samples by a manufacturer or a licensed wholesale distributor in accordance with 21 U.S.C. s. 353(d) (as of 12/1/15) which is incorporated by reference herein;

6. The distribution of blood or blood components intended for transfusion;

7. The distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use;

8. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in 26 U.S.C. s. 501(c)(3) (Internal Revenue Code) (as of 12/1/15) which is incorporated by reference herein, to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

9. The distribution of a product pursuant to the sale or merger of a pharmacy or pharmacies or a wholesale distributor or wholesale distributors, except that any records required to be maintained for the product shall be transferred to the new owner of the pharmacy or pharmacies or wholesale distributor or wholesale distributors;

10. The dispensing of a product approved under 21 U.S.C. s. 360b(c) (as of 12/1/15) which is incorporated by reference herein;

11. Products transferred to or from any facility that is licensed by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 274 of the Atomic Energy Act of 1954 (42 U.S.C. s. 2021) (as of 12/1/15) which is incorporated by reference herein;

12. A combination product that is not subject to approval under 21 U.S.C. s. 355 (as of 12/1/15) which is incorporated by reference herein ,or licensure under 42 U.S.C. s. 262 (section 351 of the Public Health Service Act) (as of 12/1/15) which is incorporated by reference herein, and that is:

a. A product comprised of a device and 1 or more other regulated components (such as a drug/device, biologic/device, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

b. 2 or more separate products packaged together in a single package or as a unit and comprised of a drug and device or device and biological product; or

c. 2 or more finished medical devices plus one or more drug or biological products that are packaged together in a “medical convenience kit”;

13. The distribution of an “exempt medical convenice kit” as set forth in 61N-1.028(12), F.A.C.;

14. The distribution of an intravenous product that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids);

15. The distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;

16. The distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;

17. The distribution of a medical gas (as defined in 21 U.S.C. s. 360ddd) (as of 12/1/15) which is incorporated by reference herein; or

18. The distribution or sale of any licensed product under 42 U.S.C. s. 262 ( section 351 of the Public Health Service Act) (as of 12/1/15) which is incorporated by reference herein, that meets the definition of a device under 21 U.S.C. s. 321(h) (as of 12/1/15) which is incorporated by reference herein.

(26) “TRANSACTION HISTORY” means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.  The transaction history for a grandfathered product begins with the owner of the product on January 1, 2015.

(27) “TRANSACTION INFORMATION” means:

(a) The proprietary or established name or names of the product;

(b) The strength and dosage form of the product;

(c) The National Drug Code number of the product;

(d) The container size;

(e) The number of containers;

(f) The lot number of the product;

(g) The date of the transaction;

(h) The date of the shipment, if more than 24 hours after the date of the transaction;

(i) The business name and address of the person from whom ownership is being transferred; and

(j) The business name and address of the person to whom ownership is being transferred.

(28) “TRANSACTION STATEMENT” means a statement, in paper or electronic form, that the entity transferring ownership in a transaction:

(a) Is authorized as required under this chapter;

(b) Received the product from a person that is authorized as defined in paragraph 61N-1.028(2);

(c) Received transaction information and a transaction statement from the prior owner of the product, as required under 61N-1.028, 61N-1.029, 61N-1.030, 61N-1.031 and 61N-1.032, F.A.C.;

(d) Did not knowingly ship a suspect or illegitimate product;

(e) Had systems and processes in place to comply with verification requirements under 61N-1.028 , 61N-1.029, 61N-1.030, 61N-1.031 and 61N-1.032, F.A.C.;

(f) Did not knowingly provide false transaction information; and

(g) Did not knowingly alter the transaction history.

The owner of a grandfathered product is exempt from asserting receipt of transaction information and transaction statement from the prior owner.

(29) “VERIFICATION” or “VERIFY” means determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager.

(30) “WHOLESALE DISTRIBUTION” means the distribution of a drug subject to 21 U.S.C. s. 353(b) (as of 12/1/15) which is incorporated by reference herein, to a person other than a consumer or patient, or receipt of a drug subject to 21 U.S.C. s. 353(b) (as of 12/1/15) which is incorporated by reference herein, by a person other than the consumer or patient, but does not include:

(a) Intracompany distribution of any drug between members of an affiliate or within a manufacturer;

(b) The distribution of a drug, or an offer to distribute a drug among hospitals or other health care entities which are under common control;

(c) The distribution of a drug or an offer to distribute a drug for emergency medical reasons, including a public health emergency declaration pursuant to 42 U.S.C. s. 247d (section 319 of the Public Health Service Act) (as of 12/1/15) which is incorporated by reference herein, except that, for purposes of this paragraph, a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;

(d) The dispensing of a drug pursuant to a prescription executed in accordance with 21 U.S.C. s. 353(b)(1) (as of 12/1/15) which is incorporated by reference herein;

(e) The distribution of minimal quantities of drug by a licensed community pharmacy that is a retail pharmacy to a licensed practitioner for office use;

(f) The distribution of a drug or an offer to distribute a drug by a charitable organization to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

(g) The purchase or other acquisition by a dispenser, hospital, or other health care entity of a drug for use by such dispenser, hospital, or other health care entity;

(h) The distribution of a drug by the manufacturer of such drug;

(i) The receipt or transfer of a drug by an authorized third-party logistics provider provided that such third-party logistics provider does not take ownership of the drug;

(j) A common carrier that transports a drug, provided that the common carrier does not take ownership of the drug;

(k) The distribution of a drug, or an offer to distribute a drug by an authorized repackager that has taken ownership or possession of the drug and repacks it in accordance with 21 U.S.C. s. 360eee-1(e) (as of 12/1/15) which is incorporated by reference herein;

(l) Saleable drug returns when conducted by a dispenser;

(m) The distribution of an “exempt medical convenience kit” as set forth in 61N-1.028(12), F.A.C.;

(n) The distribution of an intravenous drug that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids);

(o) The distribution of an intravenous drug used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;

(p) The distribution of a drug that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;

(q) The distribution of medical gas, as defined in 21 U.S.C. s. 360ddd (as of 12/1/15) which is incorporated by reference herein;

(r) Facilitating the distribution of a product by providing solely administrative services, including processing of orders and payments; or

(s) The transfer of a product by a hospital or other health care entity, or by a wholesale distributor or manufacturer operating at the direction of the hospital or other health care entity, to a repackager described in 21 U.S.C. s. 360eee(16)(B) (as of 12/1/15) which is incorporated by reference herein, and registered under 21 U.S.C. s. 360 (as of 12/1/15) which is incorporated by reference herein, for the purpose of repackaging the drug for use by that hospital, or other health care entity and other health care entities that are under common control, if ownership of the drug remains with the hospital or other health care entity at all times.

(31) “WHOLESALE DISTRIBUTOR” means a person, other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider, or repackager, engaged in wholesale distribution.

 

Rulemaking Authority 499.0121, 499.05 FS. Law Implemented 499.002, 499.0121, 499.05, 499.052 FS. History–New ________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE:  Reginald D. Dixon, Director

 

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ken Lawson, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 9, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 30, 2015