Description
This guidance document is intended to assist persons reporting drug sample distribution information2 to FDA under section 6004 of the Patient Protection and Affordable Care Act (ACA).
Scope & Applicability
Product Classes
2Unit of prescription drug not intended to be sold
Drugs for which sample information must be reported under ACA
Stakeholders
6authorized distributors of record required to report drug sample data
medical professional requesting HCT/P for urgent need; requesting HCT/P based on urgent medical need
Distributors with an ongoing relationship with a manufacturer
Licensed professional making the drug sample request; Licensed individual who requests drug samples
ADRs required to report drug sample information
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.
Regulatory Context
Attributes
1Information required to be aggregated in the report; Required data element for practitioner identification
Related CFR Sections (4)
- 21CFR203.30§ 203.30 Sample distribution by mail or common carrier.
(a) Requirements for drug sample distribution by mail or common carrier. A manufacturer or authorized distributor of record may distribute a drug sample to a practitioner licensed to prescribe the drug that is to be sampled or, at the written request of a licensed practitioner, to the pharmacy of a 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 →
- 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 →
- 21CFR203.38§ 203.38 Sample lot or control numbers; labeling of sample units.
(a) Lot or control number required on drug sample labeling and sample unit label. The manufacturer or authorized distributor of record of a drug sample shall include on the label of the sample unit and on the outside container or packaging of the sample unit, if any, an identifying lot or control nuRead full regulation →
See Also (5)
- Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers (Status: Final)
- Chapter 1 - General (Status: Final)
- Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics (Status: Final)
- Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry (Status: Draft)
- Identifying Trading Partners Under the Drug Supply Chain Security Act (Status: Draft)