Overview of Proposed 21 CFR 205
National Standards for the Licensure of
Wholesale Drug Distributors and Third-Party Logistics Providers
Presenters:
Aaron Weisbuch, Elizabeth Pepinsky, Sara Kim Keller
Office of Drug Security, Integrity, and Response
Office of Compliance
CDER | US FDA
www.fda.gov
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Agenda
• Introduction
• Overview and Definitions
• How to Leave Comments
• Third-Party Logistics Providers (3PLs)
• Licensure Process
• Standards
• Wholesale Drug Distributors (WDDs)
• Licensure Process
• Standards
• Concluding Remarks
www.fda.gov
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Disclaimer
This presentation is intended only to provide a general overview. It
is not intended to be comprehensive nor does it constitute legal
advice. Please refer to appropriate guidelines, regulations, or law
for specific information.
Additional Resources
Updates and links to FDA documents or notices summarized in this
presentation can be found on the DSCSA webpage on FDA’s
website.
Overview and Definitions
www.fda.gov
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The Drug Supply Chain Security Act
DSCSA
• Enacted November 27, 2013.
• Establishes requirement for national licensure standards for wholesale drug
distributors and third-party logistics providers (3PLs).
• Outlines steps to implement enhanced drug distribution security requirements to
identify and trace certain prescription drugs as they are distributed in the U.S.
• Enhances ability to help protect consumers from exposure to drugs that may be
counterfeit, stolen, contaminated, or otherwise harmful.
• Improves detection and removal of potentially dangerous drugs from the drug
supply chain.
www.fda.gov
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Trading Partners under DSCSA
Manufacturers
Repackagers
Wholesale Drug Distributors
(WDDs)
Dispensers (primarily Pharmacies)
Third-party logistics providers (3PLs)
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Wholesale Distributor Definitions
A person (other than a manufacturer, a manufacturer's co-licensed partner, a
third party logistics provider, or repackager) engaged in wholesale
distribution (as defined in section 503(e)(4) of the FD&C Act, as amended
by the Drug Supply Chain Security Act)
Wholesale Distributor
(Section 581(29) of the FD&C Act, as added by DSCSA)
“…distribution of a drug subject to [503(b), i.e., an Rx drug] … to a person
other than a consumer or patient, or receipt of a drug subject to [503(b)]
by a person other than the consumer or patient”
Wholesale Distribution
(Section 503(e)(4) of the FD&C Act)
As encompassed in this definition, includes bulk drug substances
Drug
(Section 201(g) of the FD&C Act)
www.fda.gov
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3PL Definitions
“…an entity that provides or coordinates warehousing, or other logistics services
of a product in interstate commerce on behalf of a manufacturer, wholesale
distributor, or dispenser of a product, but does not take ownership of the
product, nor have responsibility to direct the sale or disposition of the product.”
Third-Party Logistics Provider (3PL)
(Section 581(22) of the FD&C Act, as added by DSCSA)
See proposed 205.3(i):
Other logistics services include services provided by entities that accept or
transfer direct possession of products from that entity’s facility within the United
States and its territories on behalf of a trading partner (e.g., manufacturer,
wholesale distributor, dispenser) but that do not take ownership of the product
nor have the responsibility to direct a product’s sale or disposition.
Other Logistics Services
(Section 581(22) of the FD&C Act)
www.fda.gov
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Proposed section 205.3(k) defines Product as a prescription drug in a finished
dosage form for administration to a patient without substantial further
manufacturing (e.g., capsules, tablets, lyophilized products before
reconstitution).
Definition of Product with Respect to 3PLs
The definition of product proposed here is broader and more inclusive
than that used for purposes of product tracing detailed in section 582
of the FD&C Act as defined in section 581(13) of the FD&C Act.
www.fda.gov
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DSCSA Authority
Section 583 of the FD&C Act - National Standards for Prescription Drug
Wholesale Distributors
Section 583(a) of the FD&C Act, as added by DSCSA, requires that FDA
“establish by regulation the standards for the licensing of persons under section
503(e)(1)… including the revocation, reissuance, and renewal of such license.”
Section 584 of the FD&C Act – National Standards for Third-Party Logistics
Providers
Section 584(d) of FD&C Act, as added by DSCSA, requires that FDA “issue
regulations regarding the standards for licensing under subsection (a), including
the revocation and reissuance of such license, to third-party logistics providers
under this section.”
www.fda.gov
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21 CFR PART 205
National Standards for the Licensure of
Wholesale Drug Distributors
and Third-Party Logistics Providers
Proposed Rule
The proposed rule, when finalized, will establish the national
standards for the licensure of WDDs and 3PLs required under
sections 583 and 584 of the FD&C Act, as added by the DSCSA.
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Need for Regulation
Provide certainty and clarity to regulated
industry
Harmonize requirements and standards for
licensure across State lines
Reduce product diversion
Minimize threats to the legitimate supply
chain
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Standards Development
To create the standards proposed in
the regulations, FDA conducted a
comprehensive review of existing
State standards for licensure including
storing, handling, and holding of
prescription drugs, as well as other
nationally recognized standards and
model rules for wholesale distribution
and logistics.
www.fda.gov
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Proposed Effective Dates for
National Licensing Standards
DSCSA Effective Dates
National Licensing Standards
Proposed Implementation Dates
WDD
2 years after the
regulation is finalized
2 years after the regulation is
finalized
3PLs
1 year after the regulation
is finalized
FDA does not intend to enforce
requirements with respect to the
national standards for licensure of
3PLs until 2 years
after the
regulation is finalized
www.fda.gov
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Preemption/Federalism
• FDA interprets section 585(b)(1) of the FD&C Act as preempting States and localities
from establishing or continuing requirements for 3PL or WDD licensure that are
different from the standards and requirements applicable under the regulations
promulgated under sections 584 and amended 503(e) of the FD&C Act.
• As of the publication of the proposed rule, FDA has
withdrawn the portion of the October 2014 draft
guidance, originally titled The Effect of Section 585
of the FD&C Act on Drug Product Tracing and
Wholesale Drug Distributor and Third-Party
Logistics Provider Licensing Standards and
Requirements: Questions and Answers, addressing
preemption with respect to WDD/3PL licensure.
www.fda.gov
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Timing of Preemption
State and local licensure requirements which are
inconsistent with the federal requirements (as
reflected in this regulation) will be preempted only
once this regulation, when finalized, takes effect; until
such time, current State and local licensing of WDDs
and 3PLs may continue.
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• Visit https://www.regulations.gov/document/FDA-2020-N-1663-0001 to find the docket for the
Proposed Rule on Regulations.gov.
How to Comment on the Proposed Regulations
• Click “Comment”
button
• Comment period closes
at 11:59pm EST on
June 6, 2022. Page
provides countdown of
how many days are left
in the comment period
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How to Comment on the Proposed Regulations
Select comment
category from drop
down menu
Type comment in
space provided
www.fda.gov
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How to Comment on the Proposed Regulations
Attach file, if
applicable
Provide email
address
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How to Comment on the Proposed Regulations
Select
identity
Submit
comment
Select box
www.fda.gov
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• Alternatively, visit https://www.federalregister.gov/documents/search and search for "National
Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers“
How to Comment on the Proposed Regulations
• Click “Submit A Formal
Comment”
• Also available via FDA’s
DSCSA page:
https://www.fda.gov/d
rugs/drug-supply-
chain-integrity/drug-
supply-chain-security-
act-dscsa
www.fda.gov
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21 CFR PART 205
National Standards for the Licensure of
Wholesale Drug Distributors
and Third-Party Logistics Providers
Proposed Rule
www.fda.gov
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205.1
Scope
Applies to the licensure of 3PLs
in any State and to any entity
engaging in wholesale
distribution of prescription
drugs in any State
§ 205.1
Scope
Applies to the licensure
of 3PLs in any State and
to any entity engaging in
wholesale distribution
of prescription drugs in
any State
§ 205.2
Purpose
To establish standards,
terms, and conditions
for the licensing of 3PLs
and WDDs by State or
Federal licensing
authorities
§ 205.3
Definitions
Defines key terms
Third-Party Logistics Providers
(3PLs)
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3PL
Licensure Requirement
Proposed 21 CFR 205.4
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3PL Licensure Requirement
No 3PL may conduct 3PL activities unless each facility of
the 3PL is licensed.
3PL must maintain its license in readily retrievable manner
and permit the license’s inspection.
Licenses are facility- and owner- specific and are not
transferrable.
A separate is license required for each facility owned,
rented, or leased by a 3PL.
Proposed §205.4
www.fda.gov
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3PL Licensure
Application Requirements
Proposed 21 CFR 205.5
www.fda.gov
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3PL Licensure: General Application Requirements
Applicant Requirements
Applicant must:
• Be ≥18 years old
• Submit required affidavit and
application information
• Pay licensing fees
Proposed §205.5
www.fda.gov
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3PL Licensure: General Application Requirements
Licensure Application Information
• Applicant name and title
• 3PL name, facility
business address, and
telephone number
• All trade or business
names used by 3PL within
past 7 years
• 3PL facility manager or
designated representative
name, email address, and
telephone number
• Ownership or operation type
• Owner or operator names
• Certain felony convictions
Proposed §205.5
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3PL Licensure: General Application Requirements
Licensure Renewal Requirements
To renew a license, the 3PL must:
• Certify that the 3PL has continued to meet all the standards
and complied with applicable requirements since the previous
license was issued
• Inform licensing authority of any changes to information
previously submitted for which a notification was not already
submitted
Proposed §205.5
www.fda.gov
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3PL Licensure
Federal Licensure Process
Proposed 21 CFR 205.6
www.fda.gov
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3PL Licensure: Federal Licensure Process
Application Filing and Review
3PL submits application to FDA
electronically.
FDA, or Approved Organization
(AO) if applicable, conducts
licensure review.
• Review of submitted
documents
• Facility inspection
Signature and fees
FDA communicates easily correctable
deficiencies found in the application
or the need for more data or
information.
FDA determines whether applicable
requirements are met.
Proposed §205.6
www.fda.gov
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3PL Licensure: Federal Licensure Process
License Issuance
• Upon a determination that the 3PL meets the
applicable requirements under section 584 of
the FD&C Act, and that none of the
disqualifying factors listed in proposed section
205.9(a)(1) are present, FDA will issue a license
to the 3PL.
• License is effective on date of the issuance of
the license certificate.
• License remains valid until date of expiration,
unless suspended or revoked.
Proposed §205.6
www.fda.gov
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3PL Licensure
Changes of Information
Proposed 21 CFR 205.7
www.fda.gov
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For a change in the location of a facility at which 3PL activities are conducted, a new
license and inspection of the facility is required before commencing 3PL activities at
the location.
• Application for a new license must be submitted no later than 90 calendar days
prior to beginning operations at the new location.
For a change in the entity engaged in 3PL activities in a facility, a new license is
required prior to beginning operations.
• The application for a new license must be submitted no later than 30 calendar days
prior to the change of ownership.
• A new inspection may be required.
3PL Licensure
Changes to Information, Location, or Ownership
Proposed §205.7
www.fda.gov
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3PL Licensure
Expiry and Renewal
Proposed 21 CFR 205.8
www.fda.gov
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3PL Licensure
Expiry and Renewal
License Expiration
• 3 years after date issued
License Renewal
• Applications will be accepted within 90
calendar days of expiration
Proposed §205.8
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3PL Licensure
Denial, Suspension, Reinstatement,
Revocation and Voluntary Termination
Proposed 21 CFR 205.9
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3PL Licensure: Negative Licensure Actions
Denial of Application for Licensure
May be initiated by the licensing authority for any of the following reasons:
• Facilities and controls are inadequate to facilitate safe operations
• Methods or procedures do not comply with the requirements for good storage practices
• Personnel do not meet the requirements necessary for good storage practices
• Insufficient information in required written policies and procedures
• Methods or procedures do not comply with the requirements for adequate recordkeeping
• Application contains an untrue statement of material fact
• Failure to permit an adequate opportunity to inspect the facilities, controls, and any records
relevant to the application
For renewal applications
• Failure to report any pertinent change of certain required information
• Failure to comply with annual reporting requirements
Proposed §205.9
www.fda.gov
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3PL Licensure: Negative Licensure Actions
License Suspensions
May be initiated by the
licensing authority upon
reasonable belief that the
licensee has failed to
comply with any of the
standards for receiving
and maintaining licensure
After notice and opportunity to
request a hearing
Immediately if the nature of the
noncompliance at issue would
reasonably be expected to cause an
imminent threat to public heath
Proposed §205.9
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3PL Licensure: Negative Licensure Actions
Reinstatement and Revocation After License Suspension
Reinstatement: A previously suspended license may be
reinstated upon a 3PL’s showing of compliance with
requirements and upon such inspection and examination as the
licensing authority may require.
Revocation: A 3PL license may be revoked if compliance is not
demonstrated or achieved to the licensing authority’s
satisfaction within the time period indicated in the notice of
suspension.
Proposed §205.9
www.fda.gov
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3PL Licensure: Negative Licensure Actions
Procedures
See§ 205.9(a)– Denials of application for licensure
See§ 205.9(b) – Suspension of license after notice and
opportunity to request a hearing
See§ 205.9(c) – Immediate suspension of license
See§ 205.9(e) – Revocation of license
Proposed §205.9
www.fda.gov
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3PL Licensure: Other Licensure Actions
Nonrenewal and Voluntary Terminations
Nonrenewal
If a license renewal
application is not submitted
by the date of expiration of
the license, the license will
be considered expired.
Voluntary Termination
A 3PL’s request for
termination must include a
notice of intent to
discontinue 3PL activities and
a waiver of an opportunity for
a hearing.
Proposed §205.9
www.fda.gov
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3PL Licensure
Good Storage Practices for 3PL Facilities
Proposed 21 CFR 205.10
www.fda.gov
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3PL Licensure: Facility
General Requirements for Storage and Handling
• Not a personal residence
• Size, construction, and configuration to ensure:
• Proper storage and distribution
• Cleaning, maintenance, and proper operation
• Maintained in clean and orderly condition
• Sufficient lighting, ventilation, temperature, sanitation, humidity,
space, equipment, and secure conditions
• Defined designated areas that separate saleable products from
products that are unfit for distribution
Proposed §205.10
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3PL Licensure: Facility
Adequate Security
• Secure from unauthorized entry
• Access from outside limited, well controlled, and documented
• Outside perimeter of the premises is well lit
• Alarm to detect and notify entry after hours
• Security system that protects against theft and diversion of
products
Proposed §205.10
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• Calibrated and validated at regular intervals
• Appropriate temperature and humidity recording equipment or
logs to document proper storage
• Timely alert of any deviations from intended storage conditions
3PL Licensure: Facility
Equipment
Proposed §205.10
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3PL Licensure
Personnel Requirements for Good
Storage Practices
Proposed 21 CFR 205.11
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3PL Licensure: Personnel
Personnel Requirements
• Must maintain a list of officers, directors, facility managers,
designated representatives
• Must include description of duties
• Must include summary of their qualifications
Proposed §205.11
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3PL Licensure: Personnel
Facility Manager or Designated Representative Qualification
The facility manager or
designated representative must
have the necessary education,
background, training and
experience to perform assigned
functions.
Proposed §205.11
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3PL Licensure
Facility Manager or Designated Representative
• Serves as the facility manager or designated representative of
such facility manager for only one facility at a time
• Is responsible for managing all daily operations of the facility,
including those duties delegated to other personnel
• Has adequate authority and resources to effectively manage
daily operations
Proposed §205.11
www.fda.gov
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3PL Licensure
Facility Manager or Designated Representative
3PL is prohibited from obtaining or maintaining licensure if the
3PL employs a facility manager or designated representative
who has been:
• Convicted of any felony violation of section 301(i) or (k) of
the FD&C Act
• Convicted of any violation of 18 U.S.C. 1365 relating to
product tampering
Proposed §205.11
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3PL Licensure
Written Policies and Procedures
Proposed 21 CFR 205.12
www.fda.gov
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3PL Licensure: Written Policies & Procedures
Requirements
Proposed §205.12
Proposed Section The 3PL must establish, maintain, and follow written policies and procedures for:
205.12(b) Personnel
205.12(c) Receipt, Security, Storage, Inventory, Shipments, Distribution
205.12(d) Recalled Products
205.12(e) Preparing for Foreseeable Crises
205.12(f) Products that are Unfit for Distribution
205.12(g) Suspect Products
205.12(h) Illegitimate Products
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3PL Licensure
Recordkeeping and Document Maintenance
Proposed 21 CFR 205.13
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Records as outlined in 205.13 must:
• Be readily retrievable and made available to licensing authorities.
• Be securely stored and protected from unauthorized access or
modifications.
• Contain only alterations signed and dated by individual who made
alteration. Must preserve original information and document reason
for alteration.
• Accurately reflect name of 3PL as it appears on the license.
3PL Licensure: Recordkeeping and Document Maintenance
Maintenance, Availability, and Accuracy of Records and
Written Policies and Procedures
Proposed §205.13
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3PL Licensure: Records
Record Retention
3 Years 6 Years
All other records
Records of investigation of
suspect and illegitimate
products and of destroyed,
nonsaleable returned, and
recalled drugs
Proposed §205.13
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3PL Licensure
List of Trading Partners
Proposed 21 CFR 205.14
www.fda.gov
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3PL must provide upon request a list of all trading partners for
which the 3PL conducts 3PL activities
3PL Licensure: Records
List of Trading Partners
Manufacturers WDDs
Repackagers Dispensers
Proposed §205.14
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3PL Licensure
Initial and Annual Reporting to FDA
Proposed 21 CFR 205.15
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3PL Licensure: Reporting Requirements
Required Information
Information to be reported for each 3PL facility separately licensed:
• A complete list of States by which the 3PL facility is licensed
• Includes the corresponding identification number and the expiration
date of each such license
• Name of company as it appears on the license and full business
address
• All trade names or business names under which the 3PL conducts
business
Proposed §205.15
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Timing of reports required to be submitted electronically to FDA
Initial Within 30 calendar days of obtaining initial license
Annual Each calendar year between January 1 and March 31
Significant Disciplinary
Action (initial)
Any Significant Disciplinary Actions that occurred in
previous 12 months
Significant Disciplinary
Action (subsequent)
Within 30 calendar days of a final action taken by a State or
Federal licensing authority
Voluntary withdrawal of
State License
Within 30 calendar days after such withdrawal
Include reasons for withdrawal
3PL Licensure
Reporting Requirements
Proposed §205.15
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3PL Licensure
Inspections
Proposed 21 CFR 205.16
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• Physical inspection prior to issuance of
initial license
• Routine inspection once every 3 years
• If licensed by State, inspection by State or
by a third-party accreditation or service
approved by State licensing authority
• If licensed by FDA, inspection by FDA or by
organization approved by FDA under
proposed section 205.18
3PL Licensure
Inspections
Proposed §205.16
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3PL Licensure: Inspections
Records Availability
Readily available during
inspection
Available within 2 business
days of request
Records kept at the
inspection site or that can
be immediately retrieved
electronically
Records kept at a central
location apart from the
inspection site and not
electronically retrievable
Proposed §205.16
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3PL
Approved Third-Party Organizations
Proposed 21 CFR 205.17: Use of approved third-party organizations
Proposed 21 CFR 205.18: General qualifications of approved organizations
Proposed 21 CFR 205.19: Process and procedures for approval by the
Food and Drug Administration
Wholesale Drug Distributors
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Wholesale Drug Distributor (WDD)
Licensure Requirement
Proposed 21 CFR 205.20
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Wholesale Drug Distributor Licensure
Requirement
WDDs must be licensed
• By the State from which the drug is distributed, or FDA if the State from which
the drug is distributed has not established a licensure requirement in
accordance with the standards set forth in the regulation, and
• By the State into which the drug is distributed if that State requires such a
license
Licensure Term
• 2 years
Renewal Applications
• Can be submitted up to 90 calendar days before date of licensure expiration
Proposed §205.20
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Wholesale Drug Distributor
Surety Bonds
Proposed 21 CFR 205.21
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Wholesale Drug Distributor Licensure
General Application Requirements
Proposed 21 CFR 205.22
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WDD Licensure: General Application Requirements
Applicant Requirements
Applicant must:
• Be ≥18 years old
• Submit required affidavit and
application information
• Pay licensing fees
Proposed §205.22
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WDD Licensure: General Application Requirements
Surety Bond Requirement
The wholesale distributor must furnish a bond or
other equivalent means of security acceptable to
the State with an application for licensure.
Proposed § 205.21 describes the requirements for
requirements for surety bonds.
Proposed §205.22
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WDD Licensure: General Application Requirements
Licensure Application Information
• Applicant name and title
• WDD name, full business address,
and telephone number
• All trade or business names used by
WDD within past 7 years
• Ownership or operation type
• Owner or operator names
• Name, email address, and telephone
number of the designated
representative or facility manager for
the WDD
• Certain felony convictions
• Certain citations or disciplinary actions
within past 7 years
Proposed §205.22
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WDD Licensure: General Application Requirements
Licensure Renewal Requirements
To renew a license, the WDD must submit:
• Certification that the WDD has continued to meet all the
standards and complied with the requirements in 21 CFR Part
205 subpart C since the previous license was issued
• Information about any changes to information previously
submitted for which a notification was not already submitted
Proposed §205.22
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WDD Licensure: General Application Requirements
Licensure Availability
• WDD must maintain its license in readily retrievable
manner.
• WDD must permit inspection:
• By any official, agent, or employee of the
licensing authority.
• By any Federal, State, or local agency engaged in
enforcement of laws relating to the distribution
of prescription drugs.
Proposed §205.22
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Wholesale Drug Distributor Licensure
Federal Licensure Process
Proposed 21 CFR 205.23
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WDD Licensure: Federal Licensure Process
Application Filing and Review
WDD submits application to
FDA electronically.
• Required application
information and surety
bond
• Preferred approved
organization for inspection
(if applicable)
• Applicant signature
• Fees
FDA communicates easily
correctable deficiencies
found in the application or
the need for more data or
information.
Proposed §205.23
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WDD Licensure: Federal Licensure Process
License Issuance
• Upon a determination that the WDD meets
the applicable requirements under sections
503(e)(1) and 583 of the FD&C Act, FDA will
issue a license to the WDD.
• License is effective on date of the issuance
of the license certificate.
• License remains valid until date of
expiration, unless suspended or revoked.
Proposed §205.23
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Wholesale Drug Distributor Licensure
Changes to Information
Proposed 21 CFR 205.24
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WDD Licensure
Changes to Information, Location, or Ownership
For a change in the location of a WDD at which wholesale
distribution occurs, an inspection of the new facility is required
prior to commencing wholesale distribution at the location.
For a change to the person engaged in wholesale distribution, a
new license is required prior to beginning operations.
A new inspection of the WDD will be performed at a reasonable time.
Proposed §205.24
Wholesale Distributor Licensure
Key Personnel
Proposed 21 CFR 205.25
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WDD Licensure
Key Personnel (21 CFR 205.3(g))
Responsible for managing operations of the wholesale distributor:
• Principal
• Owner
• Director
• Officer of the wholesale distributor
• Designated representatives
• Individuals authorized to enter areas where prescription drugs
held and are likely to handle prescription drugs as part of their
responsibilities
Proposed §205.25
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WDD Licensure: Key Personnel
Prohibited Persons
• Convicted of any felony for violating section 301(i) or (k) of the
FD&C Act
• Convicted of any felony violation of 18 U.S.C. 1365 relating to
product tampering
• Cited on 2 or more occasions within 7 years for violating
section 583 or section 503(e) of FD&C Act, or State
requirement for licensure that presents threat of serious
adverse health consequences or death to humans
Proposed §205.25
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WDD Licensure: Key Personnel
Qualifications
All key personnel must have
the necessary education,
background, training and
experience to perform
assigned functions.
Proposed §205.25
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WDD Licensure: Key Personnel
Grounds for Denying Licensure Application
If applicant or key personnel:
• Delayed or impeded inspection,
• Omitted material information of furnished false or fraudulent
information in an application, or
• Subject to licensure suspension or revocation for currently or
previously held license for manufacture or distribution of any
drugs.
Proposed §205.25
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WDD Licensure: Key Personnel
List of Personnel & Written Policies and Procedures
List of Personnel Written Policies and Procedures
Must maintain a list of officers, directors, facility
managers, designated representatives, and other key
personnel in charge of wholesale distribution.
Must establish written policies and procedures designed
to ensure qualifications of key personnel are met,
maintained, and documented.
Must include description of duties and summary of their
qualifications.
Must identify personnel who are responsible for:
•Implementing and maintaining facility personnel
requirements,
•Complying with all licensure and reporting
requirements, and
•Ensuring key personnel receive initial and regular
training.
Must be available for review by State or Federal
licensing authority.
Must be available for review by State or Federal
licensing authority.
Proposed §205.25
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WDD Licensure: Key Personnel
Facility Manager or Designated Representative
• Serves as the facility manager for only one facility at a time
• Actively involved in and responsible for managing daily
operations
• Responsible for all facility manager duties that are delegated to
other personnel at facility
• Must submit full set of fingerprints for purposes of conducting
local and national criminal background checks
Proposed §205.25
Wholesale Drug Distributor Licensure
Storage and Handling of Prescription Drugs
for Wholesale Distribution
Proposed 21 CFR 205.26
www.fda.gov
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WDD Licensure: Facility
Systems and Processes
Any wholesale distributor’s facility that is also licensed or
registered as another trading partner (such as a 3PL) and
operating from the same address must have separate systems and
processes in place for their separate functions.
Proposed §205.26
www.fda.gov
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WDD Licensure: Facility
Suitability for Storage and Handling
• Not a personal residence
• Size, construction, and configuration to ensure:
• Proper distribution
• Cleaning, maintenance, and proper operation
• Maintained in clean and orderly condition
• Sufficient lighting, ventilation, temperature, sanitation, humidity,
space, equipment, and secure conditions
• Defined designated areas that separate saleable prescription drugs
from prescription drugs that are unfit for distribution
Proposed §205.26
www.fda.gov
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WDD Licensure: Facility
Adequate Security
• Secure from unauthorized entry
• Access from outside limited, well controlled, and documented
• Outside perimeter of the premises is well lit
• Entry where drugs are held limited to key personnel
• Security system that protects against theft and diversion of
prescription drugs and accidental or unsanctioned
modifications to data
Proposed §205.26
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• Facility must have equipment that ensures prescription drugs are
properly stored, including:
• Cold storage
• Refrigerators
• Temperature and humidity devices
• Air handling units
• Must be maintained in good repair
• Must be suitable for distribution of prescription drugs
• Facility assessments must be regularly conducted and documented
WDD Licensure: Facility
Equipment
Proposed §205.26
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Establish written procedures to ensure that equipment is installed, maintained,
and repaired by qualified individuals following written procedures
Equipment calibrated and validated at regular intervals
Use:
• Manual, electromechanical, or electronic temperature and humidity
recording equipment or logs must be used to document proper storage
• Monitoring equipment must immediately alert of any deviations from
required storage conditions
WDD Licensure: Facility
Equipment
Proposed §205.26
www.fda.gov
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WDD Licensure: Facility
Written Policies and Procedures
Establish, maintain, and follow
written policies and procedures
for:
• Authorized trading partners
• Facility and equipment
maintenance management
• Transportation
• Examination of Shipping
Containers
• Storage and Handling
• Disposition of Prescription
Drugs
• Preparation for Foreseeable
Crises
WDDs not limited to establishing
written policies and procedures
for the stated functions in
proposed section 205.26(c).
WDD may wish to establish
written policies and procedures
pertaining to other aspects of
wholesale distribution and
staffing of their facilities.
WDDs responsible for contractor
compliance.
WDD must ensure that contractor
abides by applicable written
policies and procedures.
Written policies and procedures
must clearly describe
responsibilities of the WDD and
any contractors used to fulfill the
WDD’s duties.
Proposed §205.26
Wholesale Drug Distributor Licensure
Establishment and Maintenance of Records
of The Distribution of Prescription Drugs
Proposed 21 CFR 205.27
www.fda.gov
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WDD Licensure: Records
Required Records
Documents pertaining
to distribution
Storage & Handling
Security
Inventory
Transport
Shipping
Documents related to
compliance
Written Policies &
Procedures
Instructions
Contracts
Data
Inspection Reports
Any Other Compliance
Documentation
Records of the
distribution of
prescription drugs
Invoices
Purchase Orders
Packing Slips
Shipping Records
Any Other Records of
Distribution
Proposed §205.27
www.fda.gov
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WDD Licensure: Records
Record Retention
3 Years 6 Years
All other records
Records of investigation of
suspect and illegitimate
products and of destroyed,
nonsaleable returned, and
recalled drugs
Proposed §205.27
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Wholesale Drug Distributor Licensure
Inspections
Proposed 21 CFR 205.28
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• Physical inspection prior to issuance of
initial license
• If licensed by State, inspection by State or
by a third-party accreditation or service
approved by State licensing authority
• If licensed by FDA, inspection by FDA or by
organization approved by FDA under
proposed section 205.32
• Routine inspection once every 3 years
WDD Licensure
Inspections
Proposed §205.28
www.fda.gov
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WDD Licensure: Inspections
Records Availability
Readily available during
inspection
Available within 2 business
days of request
Records kept at the
inspection site or that can
be immediately retrieved
electronically
Records kept at a central
location apart from the
inspection site and not
electronically retrievable
Proposed §205.28
www.fda.gov
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Wholesale Drug Distributor Licensure
Reporting Requirements
Proposed 21 CFR 205.29
www.fda.gov
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WDD Licensure: Reporting Requirements
Required Information
Information to be reported for each WDD:
• A complete list of States where the WDD is licensed
• Includes the corresponding identification number and the expiration date of
each such license
• Name of company as it appears on the license and full business address,
and contact information for the facility manager or designated
representative of the WDD
• All trade names or business names under which the WDD conducts business
• Any significant disciplinary actions taken against the WDD license related to
the distribution of prescription drugs
Proposed §205.29
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Timing of reports required to be submitted electronically to FDA
Initial Within 30 calendar days of obtaining initial license
Annual Each calendar year between January 1 and March 31
Significant Disciplinary
Action (initial)
Any Significant Disciplinary Actions that occurred in 12
months prior to obtaining licensure
Significant Disciplinary
Action (subsequent)
Within 30 calendar days after a final action taken by a State
or Federal licensing authority
Closure of facility
(facility has ceased operations)
Within 30 calendar days after facility has stopped operating
as a WDD
Voluntary withdrawal of
State License
Within 30 calendar days after such withdrawal
Include any reasons for withdrawal
WDD Licensure
Reporting Requirements
Proposed §205.29
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Wholesale Drug Distributor Licensure
Denial, Suspension, Reinstatement,
Revocation, and Voluntary Termination
Notice and opportunity to request a hearing
Proposed 21 CFR 205.30
www.fda.gov
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WDD Licensure: Negative Licensure Actions
Denial of Application for Licensure
• Methods or procedures inadequate to
preserve the safety, identity, strength, quality,
or purity of the prescription drug
• Facilities and controls inadequate to preserve
the safety, identity, strength, quality, or purity
of the prescription drug
• Methods or procedures do not comply with
the requirements for good storage practices
• Personnel do not meet the requirements
necessary for good storage practices
• Insufficient information in required written
policies and procedures
• Methods or procedures do not comply with the
requirements for adequate recordkeeping
• Application contains an untrue statement of
material fact
• Failure to permit an adequate opportunity to
inspect the facilities, controls, and any records
relevant to the application
For renewal applications
• Failure to report to the licensing authority any
pertinent change of certain required information
• Failure to report to the FDA any of the requirements
for annual reporting
May be initiated by the licensing authority for any of the following reasons:
Proposed §205.30
www.fda.gov
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WDD Licensure: Negative Licensure Actions
License Suspensions
May be initiated by the
licensing authority upon
reasonable belief that the
licensee has failed to
comply with any of the
standards for receiving
and maintaining licensure
After notice and opportunity to
request a hearing if the nature of the
noncompliance at issue would likely
compromise the quality of product
or threaten public safety
Immediately if the nature of the
noncompliance at issue would
reasonably be expected to cause an
imminent threat to public health
Proposed §205.30
www.fda.gov
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WDD Licensure: Negative Licensure Actions
Reinstatement and Revocation After License Suspension
Reinstatement: A previously suspended license may be
reinstated upon a WDD’s showing of compliance with
requirements and upon such inspection and examination as the
licensing authority may require.
Revocation: A WDD license may be revoked if compliance is
not demonstrated or achieved to the licensing authority’s
satisfaction within the time period indicated in the notice of
suspension.
Proposed §205.30
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WDD Licensure: Negative Licensure Actions
Procedures
See§ 205.30(a)– Denials of application for licensure
See§ 205.30(b) – Suspension of license after notice and
opportunity to request a hearing
See§ 205.30(c) – Immediate suspension of license
See§ 205.30(e) – Revocation of license
Proposed §205.30
www.fda.gov
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WDD Licensure: Other Licensure Actions
Nonrenewal and Voluntary Terminations
Nonrenewal
If a license renewal
application is not submitted
by the date of expiration of
the license, the license will
be considered expired.
Voluntary Termination
A WDD’s request for
termination must include a
notice of intent to
discontinue prescription drug
wholesale distribution and a
waiver of an opportunity for a
hearing.
Proposed §205.30
www.fda.gov
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Wholesale Drug Distributor
Use of Approved Third-Party Organizations
Proposed 21 CFR 205.31: Use of approved third-party organizations
Proposed 21 CFR 205.32: General qualifications of approved organizations
Proposed 21 CFR 205.33: Process and procedures for approval by
the Food and Drug Administration
www.fda.gov
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FDA Resources
• Proposed Rule: National Standards for the Licensure of Wholesale Drug
Distributors and Third-Party Logistics Providers - Notice of Availability
https://www.federalregister.gov/documents/2022/02/04/2022-01929/national-
standards-for-the-licensure-of-wholesale-drug-distributors-and-third-party-logistics
• DSCSA Main Webpage
https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/Dru
gSupplyChainSecurityAct/default.htm
• DSCSA Regulatory Documents (i.e., regulations, guidances, federal register notices,
pilot programs)
https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/Dru
gSupplyChainSecurityAct/ucm424963.htm
