Drug Supply Chain Security

amendments to the FDCA that ensured the security of the supply chain

PDMA of 1987 and the Drug Supply Chain Security Act (DSCSA) of 2013

PDMA

Prescription Drug Marketing Act of 1987

the PDMA amends the FDCA to:

- require states to license wholesale distributors of rx drugs

- ban the reimportation of prescription drugs, except by the manufacturer or for emergency use

- ban the sale, trade, or purchase of drug samples

- mandate storage, handling, and recordkeeping requirements for drug samples

- ban trafficking in or counterfeiting of drug coupons

- prohibit the resale of rx drugs purchased by hospitals or healthcare facilities, with certain exceptions

PDMA prohibits the ___________________, ___________________, or ___________________ of samples

sale, purchase, or trade

sample definition

unit of drug intended not to be sold but rather to promote the sale of a drug

why are starter packs not considered samples

they are distributed free to pharmacies by manufacturers and are not considered samples because they are not labeled as such and could be sold

samples can be acquired by...

written request of prescriber on a form that includes information specified by law

T/F as long as a practitioner requests a sample once, then the standing request stays and they do not have to continue submitting requests

F; practitioner must make request each time

T/F hospital and retail pharmacies can receive samples as long as certain conditions are met

F; final regulations clearly do not allow retail pharmacies to receive samples

wholesale distribution

distribution to anyone other than the consumer

pedigree

type of record required by the FDA for wholesalers that are not manufacturers, not authorized by a manufacturer of drug to reduce risk of diverted, unapproved, and/or counterfeit drugs from being introduced into the supply chain

secondary wholesalers

wholesalers not authorized by manufacturer; outnumber authorized wholesalers and are an important part of the drug distribution system

pedigree requirement is limited to ___________________

secondary wholesalers

pedigree includes...

record of ownership back to the original manufacturer

why was the pedigree requirement not implemented

court agreed with secondary wholesaler plaintiffs that if the regulation became effective, they would suffer irreparable harm and the PDMA pedigree requirement likely violates the US Constitution's equal protection clause

DSCSA applies to ____________________

trading partners

trading partners in prescription drug supply chain

manufacturers, wholesalers, repackagers, third-party logistics providers, and dispensers (pharmacies)

trading partners must have systems in place to quarantine, investigate, or notify the FDA of certain other partners of suspect and illegitimate rx drug products no later than ____________ after making the determination

24 hours

exceptions to DSCSA

homeopathic drugs, compounded drugs, radioactive drugs

what is required by the DSCSA

full electronic interoperable product track and trace (pedigree) system that includes transaction information, history, and statement, must be passed, received, and maintained for 6 years by each supply chain partner

product tracing information requirements apply to transactions where prescription drug changes ownership except:

transfer from one pharmacy to another to fulfill specific patient need, distribution in a minimal quantity by a pharmacy to a practitioner for office use, distribution pursuant to sale or merger of a pharmacy, distribution for emergency medical reasons, product returns, transactions with first responders

UPI

unique product identifier

act that allows the Secretary of DHHS to promulgate regulations that facilitate the wholesale importation of prescription medications from Canada

Medication Prescription Drug, Improvement, and Modernization Act (MMA)

patient may import an FDA-approved prescription drug from Canada under which act

Department of Homeland Security Appropriations Act of 2007; only if for personal use and not exceeding a 90 day supply

according to the Department of Homeland Security Appropriations Act of 2007, patient may import an FDA-approved prescription drug from Canada if...

it is for personal use, does not exceed a 90 day supply, not a controlled substance, not a biological product

act that does not allow for a personal use exemption for controlled substances, regardless of the country

Controlled Substances Act

penalties for PDMA violations

up to 10 years in prison, $250,000 fine, or both, for first offenses

manufacturers must affix a _________________ on each individual package and homogenous case by November 2018

uniform product identifier (UPI)