TITLE 68: PROFESSIONS AND OCCUPATIONS
CHAPTER VII: DEPARTMENT OF PROFESSIONAL REGULATION
SUBCHAPTER b: PROFESSIONS AND OCCUPATIONS
PART 1510
WHOLESALE DRUG DISTRIBUTION LICENSING ACT
CONTENTS
Section
1510.10 Definitions
1510.20 Application for Licensure
1510.30 Personnel
1510.40 Violations and Penalties
1510.50 Minimum Requirements for the Storage
and Handling of Prescription Drugs and for the Establishment and
Maintenance of Prescription
Drug Distribution Records
1510.60 Renewals
1510.65 Fees
1510.70 Granting Variances
AUTHORITY: Implementing the Wholesale Drug Distribution Licensing
Act [225 ILCS 120] and authorized by Section 2105-15(7) of the Civil Administrative
Code of Illinois [20 ILCS 2105/2105(7)].
SOURCE: Emergency rules adopted at 16 Ill. Reg. 12216, effective
July 17, 1992, for a maximum of 150 days; adopted at 16 Ill. Reg. 17077, effective
October 26, 1992; emergency amendments at 27 Ill. Reg. 13639, effective July
24, 2003, for a maximum of 150 days; amended at 27 Ill. Reg. 18997, effective December 5, 2003.
TITLE 68: PROFESSIONS AND OCCUPATIONS
CHAPTER VII: DEPARTMENT OF PROFESSIONAL REGULATION
SUBCHAPTER b: PROFESSIONS AND OCCUPATIONS
PART 1510
WHOLESALE DRUG DISTRIBUTION LICENSING ACT
Section 1510.10 Definitions
"Act" means the Wholesale Drug Distribution Licensing
Act (Ill. Rev. Stat. 1991, ch. 111, Par. 8301-1 et seq.).
"Blood" means whole blood collected from a single
donor and processed either for transfusion or further manufacturing.
"Blood component" means that part of blood separated
by physical or mechanical means.
"Board" means the State Board of Pharmacy.
"Department" means the Department of Professional
Regulation.
"Director" means the Director of the Department of
Professional Regulation.
"Drug sample" means a unit of a prescription drug
that is not intended to be sold and is intended to promote the sale of the
drug.
"Manufacturer" means anyone who is engaged in manufacturing,
preparing, propagating, compounding, processing, packaging, repackaging or
labeling a prescription drug.
"Prescription drug" means any human drug required
by Federal law or regulation to be dispensed only by a prescription, including
finished dosage forms and active ingredients subject to Section 503(b) of
the Federal Food, Drug and Cosmetic Act. [21 U.S.C. 301 et seq. (1976)]
"Wholesale distribution" or "wholesale distributions"
means distribution of prescription drugs to a person other than a consumer
or patient, but does not include:
Intracompany sales, defined as any transaction or transfer between
any division, subsidiary, parent and/or affiliated or related company under
the common ownership and control of a corporate entity;
The purchase or other acquisition by a hospital
or other health care entity that is a member of a group purchasing organization
of a drug for its own use from the group purchasing organization or from other
hospitals or health care entities that are members of such organizations;
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 1954 to a nonprofit affiliate
of the organization to the extent otherwise permitted by law;
The sale, purchase or trade of a drug or an offer
to sell, purchase or trade a drug among hospitals or other health care entities
that are under common control (For purposes of this Section, "common
control" means the power to direct or cause the direction of the management
and policies of a person or an organization, whether by ownership of stock,
voting rights, by contract, or otherwise);
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);
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;
The lawful distribution of drug samples by manufacturers'
representatives or distributors' representatives;
The sale, purchase or trade of blood and blood
components intended for transfusion; or
The sale of prescription drugs by a pharmacy to
practitioners (i.e., licensed physicians, dentists, veterinarians or podiatrists),
providing the sales do not exceed 5% of the annual dollar purchases of prescription
drugs by the pharmacy and providing the pharmacy maintains a log of sales
to practitioners that includes:
Date of sale;
Practitioner's name and address;
Drug and strength;
Size of package; and
Quantity sold.
"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;
warehouses, including manufacturers' and distributors' warehouses, chain drug
warehouses, and wholesale drug warehouses; independent wholesale drug traders;
and retail pharmacies that conduct wholesale distributions.
Section 1510.20 Application for Licensure
Every wholesale distributor, wherever located, who engages in
wholesale distribution into, out of, or within Illinois shall be licensed
by the Department in accordance with the Act and this Part before engaging
in wholesale distribution of prescription drugs.
a) The applicant for a license as a wholesale drug
distributor shall file with the Department an application which includes the
following:
1) The name, full business address and telephone
number of the applicant;
2) All trade or business names used by the
applicant;
3) Addresses, telephone numbers and the names
of contact persons at all facilities used by the applicant for the storage,
handling and distribution of prescription drugs;
4) The type of ownership or operation (i.e.,
partnership, corporation or sole proprietorship). If a corporation, a copy
of the Articles of Incorporation; and
5) The names of the owner and/or operator of
the entity, including:
A) The name of the person, if a person;
B) The name of each partner and the
name of the partnership, if a partnership;
C) The name and title of each corporate
officer and director, the corporate names, the name of the state where incorporated
and the name of the parent company, if any, if a corporation; or
D) The full name of the sole proprietor
and the name of the business entity, if a sole proprietorship; and
6) The fee set forth in Section 1510.65.
b) The Department shall consider the following factors
in determining eligibility for licensure of persons who engage in the wholesale
distribution of prescription drugs:
1) Any conviction of the applicant under any
federal, state or local laws relating to drug samples, wholesale or retail
drug distribution, or distribution of controlled substances;
2) Any felony conviction of the applicant under
federal, state or local laws;
3) The applicant's past experience in the manufacture
or distribution of prescription drugs, including controlled substances;
4) The furnishing by the applicant of false
or fraudulent material in any application made in connection with drug manufacturing
or distribution;
5) Suspension or revocation by federal, state
or local government of any license currently or previously held by the applicant
for the manufacture or distribution of any drugs, including controlled substances;
6) Compliance with licensing requirements under
previously granted licenses, if any;
7) Compliance with the requirements to maintain
and/or make available to the state licensing authority or to federal, state
or local law enforcement officials those records required to be maintained
by wholesale drug distributors; and
8) Any other factors or qualifications the
Department considers relevant to and consistent with public health and safety.
c) A separate license is required for each facility
directly or indirectly owned or operated by the same business that distributes
prescription drugs.
d) When the address or name of a facility is changed,
the licensee shall be required to apply for a new license and pay a $100 fee.
If the facility is relocated, the licensee shall also cause the facility to
pass an inspection, meeting all requirements of the Act and this Section.
e) Changes in any information in this Section shall
be submitted to the Department within 45 days after such change.
f) The Department reserves the right to deny a license
to an applicant if it determines that the granting of such a license would
not be in the public interest.
g) The applicant shall retain on premises a copy of
the application and check to the Department to serve as a temporary license
prior to the issuance of a certificate of registration as a Wholesale Drug
Distributor. This is valid for 90 days.
(Source: Amended at 27 Ill. Reg. 18997, effective December 5, 2003)
Section 1510.30 Personnel
The licensed wholesale distributor shall employ personnel with
the education, training and experience necessary to safely and lawfully engage
in the wholesale distribution of drugs. As a condition for receiving and
retaining a wholesale drug distributor license, the licensee shall require
each person employed in any prescription drug wholesale distribution activity
to have education, training and experience, or any combination thereof, sufficient
for that person to perform the assigned functions in such a manner as to provide
assurance that the drug product quality, safety and security will at all times
be maintained as required by law.
Section 1510.40 Violations and Penalties
a) The Department shall have the authority to suspend,
revoke or take other disciplinary action against any licenses granted under
this Part upon conviction of a violation(s) of federal, state or local drug
laws or regulations, and may impose fines or civil penalties not to exceed
$1000 for each violation of this Part. Before any license may be suspended
or revoked, or fines or civil penalties provided for herein may be imposed,
a wholesale distributor shall have a right to prior notice and a hearing pursuant
to 68 Ill. Adm. Code 1110.
b) The Department may suspend or revoke any license
granted under this Part for willful and serious violations of this Part.
Section 1510.50 Minimum Requirements
for the Storage and Handling of Prescription Drugs and for the Establishment
and
Maintenance of Prescription Drug Distribution Records
The following are minimum requirements for the storage and handling
of prescription drugs, and for the establishment and maintenance of prescription
drug distribution records by wholesale drug distributors and their officers,
agents, representatives and employees:
a) Facilities. All facilities 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, 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.
b) Security. All facilities used for wholesale drug
distribution shall:
1) 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) Be equipped with an alarm system to detect
entry after hours; and
3) 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) 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 requirements
in the current edition of an official compendium.
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, electromechanical, or
electronic temperature and humidity recording equipment, devices and/or logs
shall be utilized to document proper storage of prescription drugs.
3) The recordkeeping requirements in subsection
(f) of this Section shall be followed for all stored drugs.
d) Examination of materials.
1) Upon receipt, each outside shipping container
shall be visually examined to identify the product 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) Each outgoing shipment shall be carefully
inspected to identify 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 recordkeeping requirements in paragraph
(f) of this Section shall be followed for all incoming and outgoing prescription
drugs.
e) 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 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 drugs'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
(f) of this Section shall be followed for all outdated, damaged, deteriorated,
misbranded or adulterated prescription drugs.
f) Recordkeeping.
1) 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 information:
A) The source of the drugs, including
the name and principal address of the seller or transferor, and 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 drug compliance investigators or any authorized
official of any governmental agency charged with enforcement of this Part
for a period of 2 years following disposition of the drugs.
3) 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 2 working days of a request by an authorized official
of any federal, State and local agencies charged with enforcement of this
Part.
g) Written policies and procedures. 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:
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 Department;
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 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.
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 2 years after disposition of the outdated drugs.
h) Responsible persons. 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.
i) Compliance with federal, state, and local laws.
Wholesale drug distributors shall operate in compliance with applicable federal,
state and local laws and regulations.
1) Wholesale drug distributors shall permit
drug compliance investigators of the Department and authorized federal, state
and local law enforcement officials to enter and inspect upon presentation
of appropriate identification, 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.
2) Wholesale drug distributors who deal in
controlled substances shall register with the appropriate state controlled
substance authority and with the Drug Enforcement Administration (DEA), and
shall comply with all applicable state, local and DEA regulations.
j) Salvaging and reprocessing. Wholesale drug distributors
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.
Section 1510.60 Renewals
a) The first renewal period for registration issued
under the Act shall be December 31 of even numbered years. The holder of
a registration may renew such registration 60 days prior to the expiration
date by filing an application with the Department and paying the required
fee set forth in Section 1510.65.
b) It is the responsibility of each registrant to notify
the Department of any change of mailing address. Failure to receive a renewal
form from the Department shall not constitute an excuse for failure to pay
the renewal fee or to renew one's registration.
(Source: Amended at 27 Ill. Reg. 18997, effective December 5, 2003)
Section 1510.65 Fees
The following fees shall be paid to the Department for the administration
of the Act and are not refundable:
a) Application Fees
The fee for application for a certificate of registration
as a wholesale drug distributor is $200.
b) Renewal Fees
The fee for the renewal of a certificate of registration
shall be $200 per year.
c) General Fees
1) The fee for the issuance of a duplicate
license, for the issuance of a replacement license for a license that has
been lost or destroyed or for the issuance of a license with a change of name
or address, other than during the renewal period, is $20. No fee is required
for name and address changes on Department records when no duplicate license
is issued.
2) The fee for a certification of a licensee’s
record for any purpose is $20.
3) The fee for the change of person responsible
for drugs is $50.
4) The fee for a wall certificate showing licensure
shall be the actual cost of producing the certificate.
5) The fee for a roster of persons licensed
as a wholesale drug distributor in this State shall be the actual cost of
producing the roster.
(Source: Added at 27 Ill. Reg. 18997, effective December 5, 2003)
Section 1510.70 Granting Variances
a) The Director of the Department may grant variances
from these rules in individual cases when he/she finds that:
1) The provision from which the variance is
granted is not statutorily mandated;
2) No party will be injured by the granting
of the variance; and
3) The rule from which the variance is granted
would, in the particular case, be unreasonable or unnecessarily burdensome.
b) The Director shall notify the Board of the granting
of such variance, and the reasons therefor, at the next meeting of the Board.
