Current through Bulletin 2024-24, December 15, 2024
In accordance with Subsections
58-17b-102(47) and
58-17b-601(1),
the operating standards for Class C pharmacies designated as pharmaceutical
wholesaler/distributor and pharmaceutical manufacturer licensees includes the
following:
(1) Each pharmaceutical
wholesaler or manufacturer that distributes or manufactures drugs or medical
devices in Utah shall be licensed by the Division. A separate license shall be
obtained for each separate location engaged in the distribution or
manufacturing of prescription drugs. Business names cannot be identical to the
name used by another unrelated wholesaler licensed to purchase drugs and
devices in Utah.
(2) Manufacturers
distributing only their own FDA-approved:
(a)
prescription drugs or prescription drugs that are co-licensed products satisfy
the requirement in Subsection (1) by registering their establishment with the
FDA pursuant to 21 CFR Part 207 and submitting the information required by 21
CFR Part 205 including any amendments thereto, to the Division; or
(b) devices or devices that are co-licensed
products, including products packaged with devices, such as convenience kits,
that are exempt from the definition of transaction in 21 USC sec. 360eee(24)(B) (xii-xvi) satisfy the requirement in Subsection (1) by registering their
establishment with the FDA pursuant to 21 CFR.
(3) An applicant for licensure as a
pharmaceutical wholesale distributor shall provide the following minimum
information:
(a) All trade or business names
used by the licensee (including "doing business as" and "formerly known
as");
(b) Name of the owner and
operator of the license as follows:
(i) if a
person, the name, business address, social security number and date of
birth;
(ii) if a partnership, the
name, business address, and social security number and date of birth of each
partner, and the partnership's federal employer identification
number;
(iii) if a corporation, the
name, business address, social security number and date of birth, and title of
each corporate officer and director, the corporate names, the name of the state
of incorporation, federal employer identification number, and the name of the
parent company, if any, but if a publicly traded corporation, the social
security number and date of birth for each corporate officer shall not be
required;
(iv) if a sole
proprietorship, the full name, business address, social security number and
date of birth of the sole proprietor and the name and federal employer
identification number of the business entity;
(v) if a limited liability company, the name
of each member, social security number of each member, the name of each
manager, the name of the limited liability company and federal employer
identification number, and the name of the state where the limited liability
company was organized; and
(c) any other relevant information required
by the Division.
(4) The
licensed facility need not be under the supervision of a licensed pharmacist,
but shall be under the supervision of a designated representative who meets the
following criteria:
(a) is at least 21 years
of age;
(b) has been employed full
time for at least three years in a pharmacy or with a pharmaceutical wholesaler
in a capacity related to the dispensing and distribution of, and recordkeeping
related to prescription drugs;
(c)
is employed by the applicant full time in a managerial level
position;
(d) is actively involved
in and aware of the actual daily operation of the pharmaceutical wholesale
distribution;
(e) is physically
present at the facility during regular business hours, except when the absence
of the designated representative is authorized, including but not limited to,
sick leave and vacation leave; and
(f) is serving in the capacity of a
designated representative for only one licensee at a time.
(5) The licensee shall provide the name,
business address, and telephone number of a person to serve as the designated
representative for each facility of the pharmaceutical wholesaler that engages
in the distribution of drugs or devices.
(6) All pharmaceutical wholesalers and
manufacturer shall publicly display or have readily available all licenses and
the most recent inspection report administered by the Division.
(7) All Class C pharmacies shall:
(a) be of suitable size and construction to
facilitate cleaning, maintenance and proper operations;
(b) have storage areas designed to provide
adequate lighting, ventilation, sanitation, space, equipment and security
conditions;
(c) have the ability to
control temperature and humidity within tolerances required by all prescription
drugs and prescription drug precursors handled or used in the distribution or
manufacturing activities of the applicant or licensee;
(d) provide for a quarantine area for storage
of prescription drugs and prescription drug precursors that are outdated,
damaged, deteriorated, misbranded, adulterated, opened or unsealed containers
that have once been appropriately sealed or closed or in any other way
unsuitable for use or entry into distribution or manufacturing;
(e) be maintained in a clean and orderly
condition; and
(f) be free from
infestation by insects, rodents, birds or vermin of any kind.
(8) Each facility used for
wholesale drug distribution or manufacturing of prescription drugs shall:
(a) be secure from unauthorized
entry;
(b) limit access from the
outside to a minimum in conformance with local building codes, life and safety
codes and control access to persons to ensure unauthorized entry is not
made;
(c) limit entry into areas
where prescription drugs, prescription drug precursors, or prescription drug
devices are held to authorized persons who have a need to be in those
areas;
(d) be well lighted on the
outside perimeter;
(e) be equipped
with an alarm system to permit detection of entry and notification of
appropriate authorities at all times when the facility is not occupied for the
purpose of engaging in distribution or manufacturing of prescription drugs;
and
(f) be equipped with security
measures, systems and procedures necessary to provide reasonable security
against theft and diversion of prescription drugs or alteration or tampering
with computers and records pertaining to prescription drugs or prescription
drug precursors.
(9)
Each facility shall provide the storage of prescription drugs, prescription
drug precursors, and prescription drug devices in accordance with the
following:
(a) all prescription drugs and
prescription drug precursors shall be stored at appropriate temperature,
humidity and other conditions in accordance with labeling of such prescription
drugs or prescription drug precursors or with requirements in the
USP-NF;
(b) if no storage
requirements are established for a specific prescription drug, prescription
drug precursor, or prescription drug devices, the products shall be held in a
condition of controlled temperature and humidity as defined in the USP-NF to
ensure that its identity, strength, quality and purity are not adversely
affected; and
(c) there shall be
established a system of manual, electromechanical or electronic recording of
temperature and humidity in the areas in which prescription drugs, prescription
drug precursors, and prescription drug devices are held to permit review of the
record and ensure that the products have not been subjected to conditions that
are outside of established limits.
(10) Each person who is engaged in
pharmaceutical wholesale distribution of prescription drugs for human use that
leave, or have ever left, the normal distribution channel shall, before each
pharmaceutical wholesale distribution of such drug, provide a pedigree to the
person who receives such drug. A retail pharmacy or pharmacy warehouse shall
comply with the requirements of this section only if the pharmacy engages in
pharmaceutical wholesale distribution of prescription drugs. The pedigree
shall:
(a) include all necessary identifying
information concerning each sale in the chain of distribution of the product
from the manufacturer, through acquisition and sale by any pharmaceutical
wholesaler, until sale to a pharmacy or other person dispensing or
administering the prescription drug. At a minimum, the necessary chain of
distribution information shall include:
(i)
name, address, telephone number, and if available, the email address of each
owner of the prescription drug, and each pharmaceutical wholesaler of the
prescription drug;
(ii) name and
address of each location from which the product was shipped, if different from
the owner's;
(iii) transaction
dates;
(iv) name of the
prescription drug;
(v) dosage form
and strength of the prescription drug;
(vi) size of the container;
(vii) number of containers;
(viii) lot number of the prescription
drug;
(ix) name of the manufacturer
of the finished dose form; and
(x)
National Drug Code (NDC) number.
(b) be maintained by the purchaser and the
pharmaceutical wholesaler for five years from the date of sale or transfer and
be available for inspection or use upon a request of an authorized officer of
the law.
(11) Each
facility shall comply with the following requirements:
(a) in general, each person who is engaged in
pharmaceutical wholesale distribution of prescription drugs shall establish and
maintain inventories and records of all transactions regarding the receipt and
distribution or other disposition of the prescription drugs. These records
shall include pedigrees for all prescription drugs that leave the normal
distribution channel;
(b) upon
receipt, each outside shipping container containing prescription drugs,
prescription drug precursors, or prescription drug devices shall be visibly
examined for identity and to prevent the acceptance of prescription drugs,
prescription drug precursors, or prescription drug devices that are
contaminated, reveal damage to the containers or are otherwise unfit for
distribution:
(i) prescription drugs,
prescription drug precursors, or prescription drug devices that are outdated,
damaged, deteriorated, misbranded, adulterated or in any other way unfit for
distribution or use in manufacturing shall be quarantined and physically
separated from other prescription drugs, prescription drug precursors or
prescription drug devices until they are appropriately destroyed or returned to
their supplier; and
(ii) any
prescription drug or prescription drug precursor whose immediate sealed or
outer secondary sealed container has been opened or in any other way breached
shall be identified as such and shall be quarantined and physically separated
from other prescription drugs and prescription drug precursors until they are
appropriately destroyed or returned to their supplier;
(c) each outgoing shipment shall be carefully
inspected for identity of the prescription drug products or devices and to
ensure that there is no delivery of prescription drugs or devices that have
been damaged in storage or held under improper conditions:
(i) if the conditions or circumstances
surrounding the return of any prescription drug or prescription drug precursor
cast any doubt on the product's safety, identity, strength, quality or purity,
then the drug shall be appropriately destroyed or returned to the supplier,
unless examination, testing or other investigation proves that the product
meets appropriate and applicable standards related to the product's safety,
identity, strength, quality and purity;
(ii) returns of expired, damaged, recalled,
or otherwise non-saleable prescription drugs shall be distributed by the
receiving pharmaceutical wholesale distributor only to the original
manufacturer or a third party returns processor that is licensed as a
pharmaceutical wholesale distributor under this chapter;
(iii) returns or exchanges of prescription
drugs (saleable or otherwise), including any redistribution by a receiving
pharmaceutical wholesaler, shall not be subject to the pedigree requirements,
so long as they are exempt from the pedigree requirement under the FDA's
Prescription Drug Marketing Act guidance or regulations; and
(d) licensee under this Act and
pharmacies or other persons authorized by law to dispense or administer
prescription drugs for use by a patient shall be accountable for administering
their returns process and ensuring that all aspects of their operation are
secure and do not permit the entry of adulterated and counterfeit prescription
drugs.
(12) A
manufacturer or pharmaceutical wholesaler shall furnish prescription drugs only
to a person licensed by the Division or to another appropriate state licensing
authority to possess, dispense or administer such drugs for use by a
patient.
(13) Prescription drugs
furnished by a manufacturer or pharmaceutical wholesaler shall be delivered
only to the business address of a person described in Subsections
R156-17b-102(20)
(c) and R156-17b-615, or to the premises listed on the license, or to an
authorized person or agent of the licensee at the premises of the manufacturer
or pharmaceutical wholesaler if the identity and authority of the authorized
agent is properly established.
(14)
Each facility shall establish and maintain records of all transactions
regarding the receipt and distribution or other disposition of prescription
drugs and prescription drug precursors and shall make inventories of
prescription drugs and prescription drug precursors and required records
available for inspection by authorized representatives of the federal, state
and local law enforcement agencies in accordance with the following:
(a) there shall be a record of the source of
the prescription drugs or prescription drug precursors to include the name and
principal address of the seller or transferor and the address of the location
from which the drugs were shipped;
(b) there shall be a record of the identity
and quantity of the prescription drug or prescription drug precursor received,
manufactured, distributed or shipped or otherwise disposed of by specific
product and strength;
(c) there
shall be a record of the dates of receipt and distribution or other disposal of
any product;
(d) there shall be a
record of the identity of persons to whom distribution is made to include name
and principal address of the receiver and the address of the location to which
the products were shipped;
(e)
inventories of prescription drugs and prescription drug precursors shall be
made available during regular business hours to authorized representatives of
federal, state and local law enforcement authorities;
(f) required records shall be made available
for inspection during regular business hours to authorized representatives of
federal, state and local law enforcement authorities and such records shall be
maintained for a period of two years following disposition of the products;
and
(g) records that are maintained
on site or immediately retrievable from computer or other electronic means
shall be made readily available for authorized inspection during the retention
period; or if records are stored at another location, they shall be made
available within two working days after request by an authorized law
enforcement authority during the two year period of retention.
(15) Each facility shall
establish, maintain and adhere to written policies and procedures that shall be
followed for the receipt, security, storage, inventory, manufacturing,
distribution or other disposal of prescription drugs or prescription drug
precursors, including policies and procedures for identifying, recording and
reporting losses or thefts, and for correcting all errors and inaccuracies in
inventories. In addition, the policies shall include the following:
(a) a procedure whereby the oldest approved
stock of a prescription drug or precursor product is distributed or used first
with a provision for deviation from the requirement if such deviation is
temporary and appropriate;
(b) a
procedure to be followed for handling recalls and withdrawals of prescription
drugs adequate to deal with recalls and withdrawals due to:
(i) any action initiated at the request of
the FDA or other federal, state or local law enforcement or other authorized
administrative or regulatory agency;
(ii) any voluntary action to remove defective
or potentially defective drugs from the market; or
(iii) any action undertaken to promote public
health, safety or welfare by replacement of existing product with an improved
product or new package design;
(c) a procedure to prepare for, protect
against or 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;
(d) a procedure to ensure that any outdated
prescription drugs or prescription drug precursors shall be segregated from
other drugs or precursors and either returned to the manufacturer, other
appropriate party or appropriately destroyed;
(e) a procedure for providing for
documentation of the disposition of outdated, adulterated or otherwise unsafe
prescription drugs or prescription drug precursors and the maintenance of that
documentation available for inspection by authorized federal, state or local
authorities for a period of five years after disposition of the
product;
(f) a procedure for
identifying, investigating and reporting significant drug inventory
discrepancies (involving counterfeit drugs suspected of being counterfeit,
contraband, or suspect of being contraband) and reporting of such discrepancies
within three (3) business days to the Division and/or appropriate federal or
state agency upon discovery of such discrepancies; and
(g) a procedure for reporting criminal or
suspected criminal activities involving the inventory of drugs and devices to
the Division, FDA and if applicable, Drug Enforcement Administration (DEA),
within three (3) business days.
(16) Each facility shall establish, maintain
and make available for inspection by authorized federal, state and local law
enforcement authorities, lists of all officers, directors, managers and other
persons in charge which lists shall include a description of their duties and a
summary of their background and qualifications.
(17) Each facility shall comply with laws
including:
(a) operating within applicable
federal, state and local laws and regulations;
(b) permitting the state licensing authority
and authorized federal, state and local law enforcement officials, upon
presentation of proper credentials, to enter and inspect their premises and
delivery vehicles and to audit their records and written operating policies and
procedures, at reasonable times and in a reasonable manner, to the extent
authorized by law; and
(c)
obtaining a controlled substance license from the Division and registering with
the Drug Enforcement Administration (DEA) if they engage in distribution or
manufacturing of controlled substances and shall comply with all federal, state
and local regulations applicable to the distribution or manufacturing of
controlled substances.
(18) Each facility shall be subject to and
shall abide by applicable federal, state and local laws that relate to the
salvaging or reprocessing of prescription drug products.
(19)
(a) A
Class C pharmacy may not be located in the same building as a separately
licensed Class A, B, D, or E pharmacy unless:
(i) the separately licensed pharmacy is a
third-party logistics provider; or
(ii) the two pharmacies are located in
different suites as recognized by the United States Postal Service.
(b) Two Class C pharmacies may be
located at the same address in the same suite if the pharmacies:
(i) are under the same ownership;
(ii) have processes and systems for
separating and securing all aspects of the operation; and
(iii) have traceability with a clear audit
trail that distinguishes a pharmacy's purchases and distributions.
