The Drug Quality and Security Act: Providing Quality, but Not Security, for Patients

• Author: Logan J. Eliasen
• Position: J.D. Candidate, The University of Iowa College of Law, 2018; B.A., Wheaton College, 2014
• Pages: 1245-1275

1245

The Drug Quality and Security Act:

Providing Quality, but Not Security, for

Patients

Logan J. Eliasen*

ABSTRACT: For millennia, pharmacists have used compounding to produce

individualized medications that meet specific patients’ needs. Because

commercial drugs are not suitable for all patients, some patients rely on

compounding as the only viable way to receive their medications. Since

compounding pharmacies fill a unique need, the FDA has traditionally given

them more freedom from regulation than drug manufacturers. Unfortunately,

some drug manufacturers have masqueraded as compounding pharmacies in

order to take advantage of this freedom. Such abuse has harmed patients, the

most notable occasion being a 2012 meningitis outbreak caused by

contaminated drugs. As a result, Congress enacted the Drug Quality and

Security Act (“DQSA”). This Act was meant to increase regulation over

manufacturers without overburdening compounding pharmacies. However,

two provisions of the Act significantly hamper true compounding pharmacies:

a ban on office use prescriptions and a severe restriction on pharmacies’ ability

to distribute and dispense drugs interstate. Both restrictions prevent patients

from being able to access medications that they need. This Note suggests that

Congress amend the DQSA to allow compounding pharmacies to distribute

some office use prescriptions and remove the restriction on interstate

dispensing.

I.INTRODUCTION ........................................................................... 1246

II. BACKGROUND ............................................................................. 1248

A.WHAT IS COMPOUNDING? ...................................................... 1248

B.THE HISTORY OF COMPOUNDING ........................................... 1250

C.THE FOOD AND DRUG ADMINISTRATION MODERNIZATION

ACT OF 1997 ........................................................................ 1251

D.THE 2012 MENINGITIS OUTBREAK ........................................ 1254

*

J.D. Candidate, The University of Iowa College of Law, 2018; B.A., Wheaton College,

2014. A special thanks to Jim Perry and the rest of my friends at District Drugs and Compounding

Center. Words cannot encapsulate how much I enjoyed working with you.

1246 IOWA LAW REVIEW [Vol. 103:1245

III.THE SCOPE OF THE DRUG QUALITY AND SECURITY ACT ............. 1256

A.SECTION 503b—THE MANUFACTURER PROVISION ................. 1256

B.SECTION 503A—THE COMPOUNDING PHARMACY

PROVISION ............................................................................ 1258

IV.FLAWS IN THE DQSA ................................................................... 1259

A.OFFICE USE PRESCRIPTIONS ................................................... 1260

1.The Need and the Section 503a Ban ......................... 1260

2.How the Section 503a Ban Hurts Patients ................ 1261

B.INTERSTATE DISTRIBUTION .................................................... 1263

1.The Section 503a Distribution Cap ........................... 1263

2.How the Distribution Cap Hurts Patients.................. 1266

3.The Distribution Cap Does Not Increase

Patient Safety ............................................................... 1268

V. SUGGESTED AMENDMENTS TO THE DQSA .................................. 1269

A.OFFICE USE PRESCRIPTIONS ................................................... 1269

B.INTERSTATE DISTRIBUTION .................................................... 1272

1.Removing the Limit on Interstate Distribution

of Patient-Specific Drugs ........................................... 1272

2.Limiting Interstate Distribution of

Non-Patient-Specific Drugs ......................................... 1273

3.Alternatively Raising the Limit on Interstate

Distribution of Patient-Specific Drugs ....................... 1273

VI.CONCLUSION .............................................................................. 1275

I. INTRODUCTION

When it comes to prescription drugs, one size does not fit all. For a variety

of reasons, many patients cannot use the mass-produced medications

dispensed in typical pharmacies.1 These patients rely on pharmaceutical

compounding—a process where a pharmacist creates an individualized

medication to match a patient’s needs.2 A compounding pharmacist from

Texas tells a story of a young autistic patient in need of a compounded

prescription:

His mom came in the store frantic, asking for help, because he would

not take his medicine. It was a fight each and every day for her.

I asked her what his main challenge was with taking the medicine,

and she said texture and taste. Things have to have a certain feel in

1. See infra Part II.A.

2. See infra Part II.A.