Healthcare Professionals

According to the section 6004 of the ACA, manufacturers and authorized distributors of applicable drugs must submit the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed, aggregated by the name, address, professional designation, signature of the practitioner who made request, and signature of the practitioner or someone designated by the practitioner for receiving the distributed drug samples.

Data points to be disclosed:

• Submission year
• Business name
• Practitioner professional designation
• First name, middle initial, last name of the recipient
• Address
• Drug trade name and dosage
• Package size
• Package/quantity requested
• Package/quantity received
• Signature received

• All Applicable Pharmaceutical Manufacturers defined as:

 “[T]he person who performs all of the following operations that are required to produce the product: (1) Mixing, (2) granulating, (3) milling, (4) molding, (5) lyophilizing, (6) tableting, (7) encapsulating, (8) coating, (9) sterilizing, and (10) filling sterile, aerosol, or gaseous drugs into dispensing containers.”

• All Authorized distributor of record (ADR) defined as:

 “[T]hose distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer’s products.” 

Note: An entity that is an ADR under section 503(d) of the FD&C Act is also an ADR under section 1128H of the SSA.

When a manufacturer and ADR both have records regarding the same drug sample request or distribution, only one of the two entities should submit the required drug sample information to FDA.

1. Sign up for Electronic Submissions Gateway account:
   http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm
2. Submit reports made in XML format to FDA via Gateway. XML schema can be downloaded via 
   http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm292040.htm

https://www.fda.gov/drugs/guidance-compliance-regulatory-information/affordable-care-act-aca-6004

https://www.fda.gov/media/90044/download

https://www.fda.gov/media/127788/download