216-40-15 R.I. Code R. § 1.14

Current through June 12, 2024

Section 216-RICR-40-15-1.14 - Wholesalers Distributors, and Manufacturers

1.14.1Licensure Requirements

A. General Licensure Requirements

1. Pursuant to the provisions of R.I. Gen. Laws §§ 5-19.1-12 and 5-19.1-13:

a. If Rhode Island is the State in which a prescription drug is distributed or is the State from which or into which a prescription drug is distributed by a wholesale distributor, that wholesale distributor may not distribute in or into or out of Rhode Island unless each facility of such wholesale distributor is licensed in Rhode Island.

b. If Rhode Island is the State into which a prescription drug is shipped by a wholesale distributor, that wholesale distributor shall also be licensed as a wholesale distributor by the State from which that wholesale distributor ships.

c. If Rhode Island is the State in which a prescription drug is manufactured or is the State from which or into which a prescription drug of a manufacturer is shipped, this prescription drug may not be manufactured in and/or shipped into or out of Rhode Island unless each facility of such manufacturer is licensed in Rhode Island.

2. Federal Licensure

A manufacturer shall also be licensed as a manufacturer by the Secretary of the U.S. Department of Health and Human Services, Food and Drug Administration;

3. The Board shall have the right to deny a license to an applicant if it determines that the granting of such a license would not be consistent with the public health and safety.

4. A wholesaler distributor or manufacturer license is only valid for the name, ownership and location listed on the license. Changes of name, ownership or location shall require a new license.

5. When wholesale distribution or manufacturing facility operations are conducted at more than one (1) location, each location shall be licensed by the Board.

6. A wholesale distributor or manufacturer shall not operate from a place of residence.

7. A wholesale distributing or manufacturing facility shall be located apart and separate from any retail pharmacy licensed by the Board.

8. Changes in any information required for a wholesale distributor or manufacturer must be reported to the Board, in writing, within ten (10) days (e.g. facility manager, designated representative, telephone number, etc.).

9. Each wholesale distributor or manufacturer facility must publicly display all licenses and have readily available the most recent State and/or Federal inspection reports.

10. Each wholesale distributor or manufacturer shall ship only to the address listed on the purchaser's license

11. Compliance with Federal, State and Local Laws. Each wholesale distributor or manufacturer shall operate in compliance with applicable Federal, State and local laws and Regulations.

a. Each wholesale distributor or manufacturer shall permit the Department, 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 times, and in a reasonable manner, to the extent authorized by law.

b. Each wholesale distributor or manufacturer that deals in controlled substances shall register with the Department, and with the Drug Enforcement Administration (DEA), and shall comply with all applicable State, local and DEA Regulations.

B. Wholesale Distributor Licensure

1. The Department and Board requires the following from each wholesale drug distributor as part of the initial licensing procedure, and as part of any renewal of such license:

a. The applicant's full name, full business address, and telephone number;

b. All trade or business names used by the applicant;

c. The type of ownership (e.g., individual, partnership, limited liability company or corporation);

d. Name(s) of the owner(s) of the applicant including:

(1) If a person; the name, address, Social Security Number and date of birth;

(2) If other than a person; the name, address, and Social Security Number and date of birth of each partner, limited liability company member, or corporate officer and corporate director, and the Federal Employer Identification Number [FEIN];

(3) If a corporation, the State of incorporation; and

(4) If a publicly traded corporation, the information in §1.14.1(B)(1)(d) of this Part is not required for corporate officers and corporate directors.

e. Names of designated representatives and facility managers of the applicant, their Social Security Numbers and date of birth;

f. Proof of licensure by the U.S. Secretary of Health and Human Services, Food and Drug Administration and, if applicable, by the State where the applicant is located (home State);

g. Upon the Board's written request, a list of all manufacturers, wholesale distributors, and dispensers for whom the manufacturer provides services at such facility;

h. Any other information the Board deems necessary to protect the public health and safety; and

i. The initial or renewal licensure fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).

C. Criteria for Renewal of Licensure for Wholesale Distributors

1. The Board shall consider, at a minimum, the following factors in determining the eligibility for, and renewal of, licensure of wholesale distributors:

a. Engaging in any unprofessional conduct as defined in § 1.15 of this Part;

b. Any finding by a law enforcement agency or regulatory agency that the applicant or any of its owners have violated any Federal, State, or local laws or foreign laws;

c. Suspension, revocation or any other sanction against a license currently or previously held by the applicant or any of its owners for violations of State or Federal laws;

d. Any finding that the applicant or any of its owners are guilty of or pleaded guilty or nolo contendere to violating Federal, State, or local criminal laws;

e. The furnishing by the applicant of false or fraudulent material in any application;

f. Failure to maintain and/or make available to the Board or to Federal, State, or local law enforcement officials those records required to be maintained by wholesale distributers;

g. Any licensee who has no record of wholesaler distributions during routine inspection may have its subsequent renewal application referred to the Board for review and possible approval or disapproval, and such review may require the licensee to appear before the Board; and

h. Any other factors or qualifications that the Board considers relevant to and consistent with the public health and safety.

D. Manufacturer Licensure

1. The Board requires the following from each manufacturer as part of the initial licensing procedure, and as part of any renewal of such license:

a. The applicant's full name, full business address, and telephone number;

b. All trade or business names used by the applicant;

c. The type of ownership (e.g., individual, partnership, limited liability company or corporation);

d. Name(s) of the owner(s) of the applicant including:

(1) If a person; the name, address, Social Security Number and date of birth;

(2) If other than a person; the name, address, and Social Security Number and date of birth of each partner, limited liability company member, or corporate officer and corporate director, and the Federal Employer Identification Number [FEIN];

(3) If a corporation, the State of incorporation; and

(4) If a publicly traded corporation, the information in §1.14.1(D)(1)(d) is not required for corporate officers and corporate directors.

e. Names of designated representatives and facility managers of the applicant, their Social Security Numbers and date of birth;

f. Proof of licensure by the U.S. Secretary of Health and Human Services, Food and Drug Administration and, if applicable, by the State where the applicant is located (home State);

g. Upon the Board's written request, a list of all manufacturers, wholesale distributors and dispensers for whom the manufacturer provides services at such facility;

h. Any other information the Board deems necessary to protect the public health and safety; and

i. The initial or renewal licensure fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).

E. Criteria for Renewal of Licensure for Manufacturers

1. The Board shall consider, at a minimum, the following factors in determining the eligibility for, and renewal of, licensure of manufacturers:

a. Engaging in any unprofessional conduct as defined in § 1.16 of this Part;

b. Any finding by a law enforcement agency or regulatory agency that the applicant or any of its owners have violated any Federal, State, or local laws or foreign laws;

c. Suspension, revocation or any other sanction against a license currently or previously held by the applicant or any of its owners for violations of State or Federal laws;

d. Any finding that the applicant or any of its owners are guilty of or pleaded guilty or nolo contendere to violating Federal, State, or local criminal laws;

e. The furnishing by the applicant of false or fraudulent material in any application;

f. Failure to maintain and/or make available to the Board or to Federal, State, or local law enforcement officials those records required to be maintained by manufacturers;

g. Any licensee who has no record of manufacturing during routine inspection may have its subsequent renewal application referred to the Board for review and possible approval or disapproval, and such review may require the licensee to appear before the Board; and

h. Any other factors or qualifications that the Board considers relevant to and consistent with the public health and safety.

1.14.2Operational Procedures

A. Diversion Detection and Prevention Plan. Each wholesale distributor or manufacturer shall have and follow a diversion detection and prevention plan that includes all prescription drugs.

B. Written Policies and Procedures. Each wholesale drug distributor or manufacturer 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. Each wholesale distributor or manufacturer shall include, as a minimum, the following items in their written policies and procedures:

1. A procedure whereby the oldest approved stock of a prescription 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 prescription drugs. Such 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 of existing merchandise with an improved product or new package design.

3. A procedure to ensure that each wholesale distributor or manufacturer prepares for, protects against, and handles any crisis that affects security for operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, State, or national emergency.

4. A procedure to ensure that any 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. Personnel. A wholesale distributor or manufacturer shall:

1. Establish and maintain for Board inspection a list of each partner, limited liability company member or corporate officer and corporate director, as well as designated representatives and facility managers, including a description of their duties and a summary of their qualifications;

2. Designate, in writing, a person to serve as the designated facility manager of the wholesale distributor or manufacturer (as appropriate) for each location licensed;

3. Not have as an owner, designated representative, facility manager, or supervising pharmacist anyone:

a. Convicted of any felony for conduct relating to compounding prescription drugs, any felony for violation of 21 U.S.C. §§ 331(i) or (k) or any felony for violation of 18 U.S.C. § 1365 relating to product tampering; or

b. Who has violated Federal or State requirements for licensure that presents a threat of serious adverse health consequences or death to humans.

4. Employ adequate personnel with the education and experience necessary to safely and lawfully engage in acting as a wholesale distributor or manufacturer as applicable.

D. Facilities. Each wholesale distributor or manufacturer at which prescription 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 designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

3. Have a quarantine area for storage of prescription 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.

E. Security

1. Each wholesale distributor or manufacturer shall be secure from unauthorized entry:

a. Access from outside the premises shall be kept to a minimum and be well-controlled;

b. The outside perimeter of the premises shall be well-lighted;

c. Entry into areas where prescription drugs are held shall be limited to authorized personnel.

2. Each wholesale distributor or manufacturer shall be equipped with an alarm system to detect entry after hours.

3. Each wholesale distributor or manufacturer 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.

F. Storage. All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs or with the requirements in the current edition of an official compendium, such as the United States Pharmacopeia, and National Formulary, or their successor agency.

1. 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;

2. Appropriate manual, electro-mechanical, or electronic temperature and humidity recording equipment, devices and/or logs shall be utilized to document proper storage or prescription drugs;

3. The record keeping requirements in §1.14.2(I) of this Part shall be followed for all stored drugs; and

4. Storage shall not include temporary or incidental possession for the purpose of delivery and/or shipment of prescription drugs.

G. Examination of Materials

1. 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.

2. The contents of 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.

3. The record keeping requirements in §1.14.2(I) of this Part shall be followed for all incoming and outgoing prescription drugs.

H. Salvaging, Reprocessing, Returned, Damaged and Outdated Prescription Drugs

1. 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 their supplier.

2. Any prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used, shall be identified as such, and shall be quarantined and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.

3. If the conditions under which a prescription drug has been returned cast 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 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 record keeping requirements in §1.14.2(I) of this Part shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs.

5. Salvaging and Reprocessing. Each wholesale distributor or manufacturer shall be subject to the provisions of any applicable Federal, State, or local laws or Regulations that relate to prescription drug product salvaging or reprocessing, including 21 C.F.R. Parts 207, 210(d), and 211.

I. Record keeping

1. Each wholesale distributor or manufacturer shall establish and maintain inventories and records of all transactions regarding the receipt and distribution of prescription drugs. These records shall include the following information:

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

3. Records described in §1.14.2(I) of this Part 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 (2) working days of a request by an authorized official of any governmental agency charged with enforcement of this Part.

216 R.I. Code R. § 216-RICR-40-15-1.14

Amended effective 5/17/2021
Amended effective 12/8/2022