Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers

Description

The Prescription Drug Marketing Act of 1987 (PDMA), amended by the Prescription Drug Amendments of 1992 (PDA), requires, among other things, that certain wholesalers provide a statement (also known as a pedigree) prior to each wholesale distribution of prescription drugs. This guidance provides questions and answers relating to the requirements set forth in 21 CFR Parts 203 and 205, and other Parts related to the PDMA.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

5

prescription drugs

products subject to DSCSA tracing requirements

prescription drug

Finished dosage form for administration to a patient

Combination Product

Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.

Bulk Drug Substance

Active pharmaceutical ingredients subject to PDMA

Drug Sample

Unit of drug not intended to be sold

Stakeholders

9

manufacturer

Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.

wholesale distributors

Entities subject to verification requirements for saleable returned product

authorized distributor of record

Wholesale distributor with an ongoing relationship with the manufacturer; Wholesaler with a written agreement with a manufacturer (ADR); Wholesaler with an ongoing relationship with a manufacturer.; also referred to as ADR; wholesale distributors with ongoing relationships with manufacturers

wholesale distributor

Entity required to verify saleable returned product.; Required to verify product identifier for saleable returned product

pharmacist

Participant involved in the medication use process and REMS

Contract Manufacturer

External entity responsible for manufacturing activities

NDA-holder

Owner of a New Drug Application

Reverse Distributor

Entity receiving expired or damaged drugs for destruction

Third party logistics providers

Entities that typically act as distributors for manufacturers.

Regulatory Context

Regulatory Activities

2

Enforcement Discretion

FDA intent regarding labeling of single-ingredient sugars and cranberry products; FDA's intent to not pursue actions regarding specific labeling requirements until July 1, 2021.

Wholesale distribution

The distribution of prescription drugs to persons other than a consumer or patient.

Document Types

4

pedigree

Statement provided prior to wholesale distribution of prescription drugs; Statement of origin identifying each prior sale, purchase, or trade of a drug; Statement of origin that identifies each prior sale, purchase, or trade of a drug.; a document identifying previous sales of a drug or its components

written agreement

Agreement between manufacturers or with third parties for data maintenance

invoice

Commercial document that may not satisfy all regulatory recordkeeping requirements.

CPG 160.900

Compliance Policy Guide relating to PDMA pedigree requirements.

Attributes

4

ADR status

The regulatory standing of a wholesaler as an authorized distributor

container size

product characteristic required on a pedigree

dosage

present the proprietary name with the corresponding product characteristics

Lot number

Required information on unit dose blister cell labels

Technical Details

Testing Methods

2

RFID

Radio-frequency identification technology for electronic pedigrees.

Bar codes

Track and trace technology for electronic pedigrees.

Standards & References

External Standards

1

EPCglobal electronic drug pedigree standards

Standards for electronic pedigrees not yet officially adopted by FDA.

Related CFR Sections (6)

21CFR203.50§ 203.50 Requirements for wholesale distribution of prescription drugs.
(a) Identifying statement for sales by unauthorized distributors. Before the completion of any wholesale distribution by a wholesale distributor of a prescription drug for which the seller is not an authorized distributor of record to another wholesale distributor or retail pharmacy, the seller shalRead full regulation →
21CFR203.3§ 203.3 Definitions.
(a) The act means the Federal Food, Drug, and Cosmetic Act, as amended ( 21 U.S.C. 301 et seq. ).Read full regulation →
21CFR203.60§ 203.60 Request and receipt forms, reports, and records.
(a) Use of electronic records, electronic signatures, and handwritten signatures executed to electronic records.Read full regulation →
21CFR201.1§ 201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
(a) A drug or drug product (as defined in § 320.1 of this chapter ) in finished package form is misbranded under section 502 (a) and (b)(1) of the act if its label does not bear conspicuously the name and place of business of the manufacturer, packer, or distributor. This paragraph does not apply toRead full regulation →
21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
21CFR203.1§ 203.1 Scope.
This part sets forth procedures and requirements pertaining to the reimportation and wholesale distribution of prescription drugs, including both bulk drug substances and finished dosage forms; the sale, purchase, or trade of (or the offer to sell, purchase, or trade) prescription drugs, including bRead full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Misbranded drug

26

False or misleading claims concerning the compounder

22

Introduction of misbranded drugs into interstate commerce

2

Introduction of misbranded products into interstate commerce

1

Adulterated under section 501(f)(1)(B)

1

Misbranded under section 502(o)

1

Failure to establish and maintain procedures to control the design

1