(A)(1) The following information must be provided to the board with an application for a wholesale distributor permit, and for any subsequent permit renewals:

(a) name, full business address, and telephone number of the applicant;

(b) all trade or business names used by the applicant;

(c) addresses, telephone numbers, and the names of contact persons for the facility used by the applicant for storage, handling, and distribution of drugs;

(d) the type of ownership or operation, i.e., partnership, corporation, or sole proprietorship; and

(e) name of the owner and/or operator of the applicant, including:

(i) if a person, the name, address, and social security number or date of birth, or both, of the person;

(ii) if a partnership, the name, address, and social security number or date of birth, or both, of each partner, and the name of the partnership;

(iii) if a corporation, the name, address, social security number or date of birth, or both, and title of each corporate officer and director, the corporate names, the name of the state of incorporation, and the name of the parent company, if any; the name, address, and social security number of each shareholder owning ten percent or more of the voting stock of the corporation, including over-the-counter stock, unless the stock is traded on a major stock exchange and not over-the-counter;

(iv) if a sole proprietorship, the full name, address, and social security number or date of birth, or both, of the sole proprietor and the name of the business entity.

(2) Changes in any information in this subsection must be submitted to the Board of Pharmacy within thirty days of the change.

(3) Pursuant to Section 40-43-83(E) and Section 40-43-90, the information required for initial permitting or renewal of a permit of a wholesale distributor must be submitted on forms prepared by the Board of Pharmacy or by the National Association of Boards of Pharmacy which shall act as a clearinghouse of applications for the board and must be submitted to the board or NABP accompanied by the applicable fee.

(4) The board may suspend, revoke, deny, or refuse to renew the permit of wholesale drug distributors other than pharmacies dispensing or distributing drugs or devices directly to patients.

(B) 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.

(C) All facilities where drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:

(1) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(2) have storage areas big enough to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

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

(4) be maintained in a clean and orderly condition; and

(5) be free from infestation by insects, rodents, birds, or vermin of any kind.

(D)(1) All facilities used for wholesale drug distribution must be secure from unauthorized entry, access from outside the premises must be kept to a minimum and well controlled, the outside perimeter of the premises must be well lighted, and entry into areas where prescription drugs are held must be limited to authorized personnel.

(2) All facilities must be equipped with an alarm system to detect entry after hours.

(3) All facilities must be equipped with a security system that provides 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.

(E) All drugs must 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 current edition of an official compendium.

If no storage requirements are established for a 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.

Temperature and humidity must be automatically documented by electronic recording devices.

The recordkeeping requirements in subsection (I) must be followed for all stored drugs.

(F) Upon receipt, each outside shipping container must be visually examined for identity and to prevent the acceptance of contaminated drugs or 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.

Each outgoing shipment must be carefully inspected for identity of the drug products and to ensure that there is no delivery of drugs that has been damaged in storage or held under improper conditions.

The recordkeeping requirements in subsection (I) must be complied with for all incoming and outgoing drugs.

(G)(1) Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier.

(2) A drug whose immediate or sealed outer or sealed secondary containers have been opened or used must be identified as such and must be quarantined and physically separated from other drugs until they are either destroyed or returned to the supplier.

(3) If the conditions under which a 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 shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling, as a result of storage or shipping.

(4) The recordkeeping requirements in subsection (I) must be complied with for all outdated, damaged, deteriorated, misbranded, or adulterated drugs.

(H)(1) Wholesale drug distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of drugs. These records shall include:

(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.

(2) Inventories and records must be made available for inspection and photocopying by any authorized official of any governmental agency charged with enforcement of this chapter for a period of two years following disposition of the drugs.

(3) Records described in this subsection 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 kept at a central location apart from the inspection site and not electronically retrievable must be available for inspection within two working days of a request by an authorized official of any governmental agency charged with enforcement of this chapter.

(I) 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 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:

(1) a procedure whereby the oldest approved stock of a drug product is distributed first. The procedure may permit deviation from this requirement if such deviation is temporary and appropriate;

(2) a procedure to be followed for handling recalls and withdrawals of drugs. The procedure must 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 of Pharmacy;

(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 the replacing of existing merchandise with an improved product or new package design;

(3) 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 a strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency;

(4) a procedure to ensure that outdated drugs are segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated drugs which must be maintained for two years after disposition of the outdated drugs.

(J) Wholesale distributors shall establish and maintain a current list of officers, directors, managers, and other individuals in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

(K) Wholesale distributors shall permit the Board of Pharmacy 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 times and in a reasonable manner, to the extent authorized by law.

Wholesale distributors that deal in controlled substances shall register with the appropriate state-controlled substance authority and with the Drug Enforcement Administration, and shall comply with all applicable state, local, and DEA requirements.

(L) Wholesale distributors are subject to the provisions of any applicable federal, state, or local laws or regulations that relate to drug product salvaging or reprocessing.

(M) This chapter may not be construed to prevent licensed pharmacists from filling, as otherwise provided by law, prescriptions originating outside the boundaries of this State and official United States government prescriptions issued by authorized governmental officials.

(N)(1) A facility located outside this State, whose primary business is mail order prescription service, shall have a permit issued by the board to ship, mail, or deliver a controlled substance or dangerous drug or device into this State pursuant to a prescription of a licensed practitioner. The facility shall report to the board:

(a) information on the location, names, and titles of all principal corporate officers and pharmacists who are dispensing controlled substances or dangerous drugs or devices to residents of this State. The report must be updated annually and within thirty days of a change of permit holder or pharmacist-in-charge;

(b) that it complies with the applicable laws for operation in the state in which it is located and with the provisions of this section. The facility shall have a valid unexpired license, permit, or registration in compliance with the laws of the state in which it is located and must be constantly under the personal and immediate supervision of a licensed pharmacist. The facility shall submit to the board with its initial application and with each renewal application a copy of its most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which it is located. These inspections are deemed to meet all inspection requirements contained in this chapter;

(c) that it maintains its records of controlled substances or dangerous drugs or devices dispensed to patients in this State so that the records are readily retrievable.

(2) Nothing in this chapter requires that pharmacists employed by facilities located in other states and who are not engaged in the practice of pharmacy in this State be licensed in this State.

(3) If the state in which the facility is located does not establish, by statute or regulation, a ratio describing the number of auxiliary personnel that a pharmacist may supervise, or otherwise define the role of the pharmacist in the compounding and dispensing of prescription drugs, then that facility may not allow a pharmacist to supervise more than two pharmacy technicians at any time in the compounding and dispensing of prescription drugs.

(4) A pharmacy, as described in this section, during its regular hours of operation but not less than six days or forty hours a week, shall provide a toll-free telephone service to facilitate communication between patients in this State and a pharmacist at the pharmacy who has access to their records. This telephone number must be printed on a label affixed to the container for the substance, drug, or device.

(5) The board may deny, revoke, suspend, or otherwise take action against a facility permit issued under the provisions of this section for:

(a) failure to comply with the requirements of:

(i) this section;

(ii) portions of this chapter dealing with prescription drug orders, drug product selection, labeling, patient records, drug review, drug dispensing, patient counseling, emergency refills, and advertisements;

(iii) subchapter 1, Chapter 13, Title 21 (Federal Controlled Substance Act);

(iv) Chapter 2, Title 21 of the Code of Federal Regulations (Federal Controlled Substance Regulation);

(b) conduct which causes serious bodily or serious psychological injury to a resident of this State if the board has referred the matter to the regulatory or licensing agency under which the pharmacy operates in the state in which it is located and that agency fails to initiate an investigation within forty-five days of the referral. The board shall maintain a record of referrals pursuant to this item and action taken on them.

(6) A facility required to obtain a permit pursuant to this subsection but which has not been issued a permit, may not advertise its services in this State, and a resident of this State may not advertise the services for the facility.

(7) A permit issued pursuant to this section is not evidence that the pharmacy is doing business within this State.

(8) A permit issued pursuant to this section is not evidence that the pharmacy is doing business within this State.

HISTORY: 1998 Act No. 366, Section 1; 2002 Act No. 314, Section 8.