059-8 Wyo. Code R. § 8-4

Current through April 27, 2019

Section 8-4 - Definitions

(a) "Authorized Distributor of Record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's products.

(b) "Common Carrier" means any person or entity who undertakes directly or indirectly to transport property, including prescription drugs, for compensation.

(c) "Designated Representative" means an individual designated by the wholesale distributor and who is actively involved in and aware of the actual daily operation of the wholesale drug distributor at the wholesaler's licensed location.

(d) "Dispenser" means a retail pharmacy, institutional 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 affiliate warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor; and does not include a person who dispenses only products to be used in animals.

(e) "Distribute" or "Distribution" means the sale, purchase, trade, delivery, handling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription.

(f) "Drug" means a substance recognized as a drug in any official compendium as listed in W.S. § 33-24-127, designated for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals.

(g) "Drug Sample" means a unit of a prescription drug that is not intended to be sold but is intended to promote the sale of the drug.

(h) "Food and Drug Administration" (FDA) means a federal agency within the United States Department of Health.

(i) "Illegitimate product" means a product for which credible evidence shows that the product:

(i) Is counterfeit, diverted or stolen;

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

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

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

(j) "Manufacturer's Exclusive Distributor" means an individual or entity who purchased the product directly from the manufacturer and is the sole distributor of that manufacturer's product to a subsequent repackager, wholesale distributor, or dispenser.

(k) "Misbranded" means a drug whose label is false or misleading or the label does not bear the name and address of the manufacturer, packer or distributor and does not have an accurate statement of the quantities of the active ingredients or:

(i) If the advertising or promotion of a compounded drug is false or misleading in any particular; or

(ii) If it is a drug and it fails to bear the product identifier.

(l) "Outsourcing Facility" means a person who registers with the FDA under section 503B of the federal act to compound sterile drugs for human use under the supervision of a pharmacist but without a prescription from a practitioner for a particular patient.

(m) "Prescription Drug" or "Legend Drug" means a drug which, under federal law, is required to be labeled with one of the following statements:

(i) "Caution: Federal law prohibits dispensing without a prescription";

(ii) "Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian"; or

(iii) "Rx Only."

(n) "Product Identifier" means a standardized graphic that includes in both human-readable form and on a machine readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.

(o) "Product Tracing" means a dispenser shall not accept ownership of a product unless the previous owner prior to, or at the time of, the transaction, provides:

(i) Transaction Information (TI);

(ii) Transaction History (TH); and

(iii) Transaction Statement (TS).

(p) "Reverse Processor" 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.

(q) "Suspect Product" means there is reason to believe that such product:

(i) Is potentially counterfeit, diverted or stolen;

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

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

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

(r) "Third Party Logistics Provider" means an entity that provides or coordinates warehousing, distribution, 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 have responsibility to direct the sale or disposition of the product.

(s) "Transaction" in general means the transfer of product between persons in which a change of ownership occurs. The term transaction does not include:

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

(ii) The distribution of a product among hospitals or other health care entities that are under common control;

(iii) The distribution of a product for emergency medical reasons including a public health emergency, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;

(iv) The dispensing of a product pursuant to a prescription;

(v) The distribution of product samples by a manufacturer or a licensed wholesale distributor;

(vi) The distribution of blood or blood components intended for transfusion;

(vii) The distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use;

(viii) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1986 to a nonprofit affiliate of the organization;

(ix) 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 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); or

(x) The dispensing of a product approved under section 512(c) of the Federal Food, Drug, and Cosmetic Act regarding a new animal drug application.

(t) "Transaction History" means a statement in paper or electronic form that includes the transaction information of each prior transaction going back to the manufacturer of the product.

(u) "Transaction Information" means:

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

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

(iii) The national drug code number of the product;

(iv) The container size;

(v) The number of containers;

(vi) The lot number of the product;

(vii) The transaction date;

(viii) The shipment date, if more than twenty-four (24) hours after the transaction date;

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

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

(v) "Transaction Statement" is a statement in paper or electronic form that the entity transferring ownership in a transaction:

(i) Is authorized under federal law;

(ii) Received the product from a person who is authorized as required under federal law;

(iii) Received transaction information and a transaction statement from the prior owner of the product as required by federal law;

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

(v) Had systems and processes in place to comply with verification requirements outlined in federal law;

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

(vii) Did not knowingly alter the transaction history.

(w) "Wholesale Distribution" means the distribution of a drug to a person other than a consumer or patient, or receipt of a drug subject by a person other than the consumer or patient, but does not include:

(i) The intracompany distribution of any drug between members of an affiliate or with a manufacturer;

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

(iii) The distribution of a drug or an offer to distribute a drug for emergency medical reasons, including a public health emergency declaration except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;

(iv) The dispensing of a drug pursuant to a prescription;

(v) The distribution of minimal quantities of drug by a licensed retail pharmacy to a licensed practitioner for office use;

(vi) The distribution of a drug or an offer to distribute a drug by a charitable organization to a nonprofit affiliate of the organization;

(vii) 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;

(viii) The receipt of a drug by an authorized third party logistics provider who does not take ownership of the drug;

(ix) A common carrier that transports a drug who does not take ownership of the drug;

(x) 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);

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

(xii) Facilitating the distribution of a product by providing solely administrative services, including processing of orders and payments.

059-8 Wyo. Code R. § 8-4

Amended, Eff. 10/31/2017.