Wyo. Code R. 059-0001-8
Pharmacy, Board of
Chapter 8: Manuf, Distrib, Wholesaler, Prescript Drug
Effective Date: 11/16/1993 to 06/10/1999
Rule Type: Superceded Rules & Regulations
Reference Number: 059.0001.8.11161993
Section 1. Authority. These regulations are promulgated as authorized by the Act.
Section 2. Purpose. The purpose of this regulation is to implement the 'Prescription Drug Marketing Act of 1987' by providing minimum standards, terms and conditions for the licensing by the Board of persons engaged in wholesale distributions in interstate commerce of prescription drugs.
Section 3. Scope. This Chapter applies to any person, partnership, corporation or business engaging in the wholesale distribution of human prescription drugs either into, out of, or within this State.
Section 4. Definitions.
(a) 'Blood' means whole blood collected from a single donor and processed either for transfusion or further manufacturing.
(b) 'Blood component' means that part of blood separated by physical or mechanical means.
(c) '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.
(d) 'Manufacturer' means anyone who is engaged in the manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling of a prescription drug.
(e) 'Prescription drug' means any drug required to be dispensed only by a prescription, by virtue of the Federal law or regulations, including finished dosage forms and active ingredients subject to section 503(b) of the Federal Food, Drug and Cosmetic Act.
(f) 'Wholesale distributions' means distribution of prescription drugs to persons other than a consumer or patient, but does not include:
(i) The sale, purchase or trade of a drug or an offer to sell, purchase or trade a drug for emergency medical reasons; for purposes of this section, 'emergency medical reasons' includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage, except that the gross dollar value of such transfers shall not exceed five (5) percent of the total prescription drug sales revenue of the transferor pharmacy during any twelve (12) consecutive month period;
(ii) The sale, purchase or trade of a drug, an offer to sell, purchase or trade a drug or the dispensing of a drug pursuant to a prescription;
(iii) The lawful distribution of drug samples by manufacturers representatives or distributors' representatives; or (iv) The sale, purchase or trade of blood and blood components intended for transfusion.
(g) “Wholesale distributor” means anyone engaged in wholesale distribution of prescription drugs, including but not limited to, manufacturers, repackers, own-label distributors, private-label distributors, jobbers, brokers, manufacturers’ and distributors’ warehouses, chain drug warehouses, wholesale drug warehouses, independent wholesale drug traders and retail pharmacies that conduct wholesale distributions.
Section 5. Wholesale_Distributor_Licensing_Requirement. Every wholesale distributor, wherever located, who engages in wholesale distribution into, out of or within this State shall be licensed by the Board in accordance with the laws and regulations of this State before engaging in wholesale distribution of prescription drugs.
(a) The Board shall require the following minimum information from each wholesale drug distributor as part of the initial licensing procedure and as part of any renewal of such license:
(i) The name, full business address and telephone number of the licensee;
(ii) All trade or business names used by the licensee;
(iii) Addresses, telephone numbers and the names of contact persons for the facility used by the licensee for the storage, handling and distribution of prescription drugs;
(iv) The type of ownership or operation, such as partnership, corporation or sole proprietorship; and
(v) The name of the owner and operator of the licensee, including;
(A) If an individual, the name of the individual;
(B) If a partnership, the name of each partner and the name of the partnership;
(C) If a corporation, the name and title of each corporate officer and director, the corporate name, the state of incorporation and the name of the parent company, if any;
(D) If a sole proprietorship, the full name of the sole proprietor and the name of the business entity.
(b) Where operations are conducted at more than one location by a single wholesale distributor, each location shall be licensed by the Board.
(c) Changes in any information required by this Section shall be submitted to the Board within thirty (30) days after the change.
Section 6. Minimum_Qualifications.
(a) The Board shall consider the following factors in determining eligibility for licensure of persons or firms who engage in the wholesale distribution of prescription drugs:
(i) Any convictions of the applicant under any Federal, state or local laws relating to drug samples, wholesale or retail drug distribution or distribution of controlled substances;
(ii) Any felony convictions of the applicant under Federal, state or local laws;
(iii) The applicant’s past experience in the manufacture or distribution of prescription drugs, including controlled substances;
(iv) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;
(v) Suspension or revocation by Federal, state or local agency of any license currently or previously held by the applicant for the manufacture or distribution of any drugs including controlled substances;
(vi) Compliance with licensing requirements under previously granted licenses, if any;
(vii) Compliance with the requirements to maintain and make available to the Board or to Federal, state or local law enforcement officials those records required to be maintained by wholesale drug distributors; and
(viii) Any other factors or qualifications the Board considers relevant to and consistent with public health and safety.
(b) The Board may deny a license to an applicant if it determines that the granting of the license would not be in the public interest.
(c) The licensed wholesale distributor shall employ adequate personnel with the education and experience necessary to safely and lawfully engage in the wholesale distribution of drugs.
(a) All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed or displayed shall:
(i) Be of suitable size and construction to facilitate cleaning, maintenance and proper operations;
(ii) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment and security conditions;
(iii) Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded or adulterated and are in immediate or sealed secondary containers that have been opened;
(iv) Be maintained in a clean and orderly condition; and
(v) Be free from infestation by insects, rodents, birds or vermin of any kind.
(b) All facilities used for wholesale drug distribution shall be secure from unauthorized entry.
(i) Access from outside the premises shall be kept to a minimum and be adequately controlled;
(ii) The outside perimeter of the premises shall be adequately lighted;
(iii) Entry into areas where prescription drugs are held shall be limited to authorized personnel;
(iv) All facilities shall be equipped with an alarm system to detect unauthorized entry; and
(v) All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.
(c) All prescription drugs shall be stored at proper temperatures and under proper conditions in accordance with requirements of the labeling of drugs and with requirements in the current edition of an official compendium.
(i) If no storage requirements are established for a prescription drug, the drug may be held at “controlled” room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality and purity are not adversely affected;
(ii) Appropriate manual, electromechanical or electronic temperature and humidity recording equipment, devices or logs shall be utilized to document proper storage of prescription drugs;
(iii) The recordkeeping requirements of this Chapter shall be applicable to all stored drugs.
(d) Oxygen distributors are exempt from the requirements of Section 7(b)(iv) and (v) and (c) this chapter.
(e) Examination of materials.
(i) Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents;
(ii) Each outgoing shipment shall be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions;
(iii) The recordkeeping requirements of this Chapter shall be applicable to all incoming and outgoing prescription drugs.
(f) Returned, damaged and outdated prescription drugs.
(i) Prescription drugs that are outdated, damaged, deteriorated, misbranded or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to the supplier;
(ii) Prescription drugs whose immediate or sealed outer or secondary containers have been broken or opened shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to the supplier;
(iii) If the conditions under which a prescription drug has been returned raise reasonable doubt on the drug’s safety, identity, strength, quality or purity, then the drug shall be destroyed or returned to the supplier, unless examination, testing or other investigation proves that the drug meets established standards of safety, identity, strength, quality and purity. In determining whether the conditions under which a drug has been returned raise reasonable doubt on the drug’s safety, identity, strength, quality or purity, the wholesale drug distributor shall consider, among other factors, the conditions under which the drug has been held, stored and shipped before and during its return and the condition of the drug and its container, carton or label, as a result of storage and shipping.
(iv) The recordkeeping requirements of this Chapter shall be applicable to all outdated, damaged, deteriorated, misbranded and adulterated prescription drugs.
(a) Recordkeeping.
(i) Wholesale drug distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records shall include the following:
(A) 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;
(B) The identity and quantity of the drugs received and distributed or disposed of; and
(C) The dates of receipt and distribution or other disposition of the drugs.
(ii) Inventories and records shall be made available to the Board and other authorized officials charged with enforcement of these Regulations for a period of two (2) years following disposition of the drugs.
(iii) Records described in this Section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two working days of a request by the Board or authorized officials charged with enforcement of these Regulations.
(b) Wholesale drug distributors shall establish, maintain and adhere to written policies and procedures, which shall 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 shall include in their written policies and procedures the following:
(i) 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 necessary;
(ii) A procedure to be followed for handling recalls and withdrawals of prescription drugs. The procedure shall be adequate to deal with recalls and withdrawals due to:
(A) Any action initiated at the request of the Food and Drug Administration or other Federal, state or local law enforcement or other government agency, including the Board;
(B) Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or
(C) Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design.
(iii) A procedure to ensure that wholesale drug distributors prepare for, protect against and handle any crisis that affects security or operation of any facility in the event of strike, fire, flood or other natural disaster, or other situations of local, state or national emergency; and
(iv) A procedure to ensure that all outdated prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. This documentation shall be maintained for two (2) years after disposition of the outdated drugs.
(c) Responsible persons.
(i) Wholesale drug distributors shall establish and maintain lists of officers, directors, managers and other persons in charge of wholesale drug distribution, storage and handling including a description of their duties and a summary of their qualifications.
(ii) Wholesale drug distributors shall operate in compliance with applicable Federal, state and local laws and regulations.
(A) Wholesale drug distributors shall permit the Board and authorized Federal, state and local law enforcement officials to enter and inspect their premises and delivery vehicles and to audit their records and written operating procedures, at reasonable hours and in a reasonable manner, to the extent authorized by law;
(B) Wholesale drug distributors dealing in controlled substances shall register with the appropriate State controlled substance authority and with the Drug Enforcement Administration and shall comply with applicable Federal, state, local laws and regulations.