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Legislation, Regulation and Advocacy

Compounding Legislation Action Center

Preserving Patient Access to Compounded Medications Act (PPACMA)

Participate in NHIA’s grassroots campaign

NHIA urges you to reach out to your members of Congress to request they cosponsor the Preserving Patient Access to Compounded Medications Act (PPACMA). Please click here to send a letter to your members of Congress on this vital legislation.

NHIA supports the PPACMA, introduced by Congressmen Morgan Griffith (R-VA) and Henry Cuellar (D-TX). This legislation will clarify the federal regulatory role in traditional compounding pharmacy. Since passage of the Drug Quality and Security Act (DQSA) in 2013 there has been a lack of understanding about where federal regulatory oversight of traditional compounding pharmacies begins and ends. Specifically, there are questions regarding the dispensing of compounded product over state lines, inspection standards, and various other provisions.

Important to NHIA and the home and specialty infusion field is clarification of the application of a provision in the DQSA that calls for a Memorandum of Understanding (MOU) between the U.S Food and Drug Administration (FDA) and states regarding the distribution of compounded products over state lines. NHIA has been actively working to ensure that the PPACMA includes a provision to clarify that dispensing over state lines should not be subject to the MOU. NHIA has long argued that dispensing a compounded product to an individual patient pursuant to a prescription is not commonly considered distribution of the product under state and federal law.

The FDA, in its draft MOU released in 2015, included dispensing as an act of distribution. This would have serious implications for home infusion providers since the common business practice of dispensing medications for administration in a patient’s home can occur across a state line from the physical site where the drug is compounded. Specifically, a home infusion pharmacy could not dispense more than 30% of its compounded products over state lines, which would hinder patient access to life-saving medications. This is of particular concern in metropolitan areas and population regions that cross over state lines. We are pleased that the PPACMA will address a long-standing problem with the MOU that NHIA has fought to resolve over the past several years. We know that Congress did not intend to have this provision halt the delivery of home infusion therapy by a provider licensed in the patient’s home state, but whose home infusion pharmacy is in another state. This legislation will once and for all clarify the issue in statute and ensure patients have access to home infusion therapy.

The PPACMA also includes other compounding pharmacy clarifications including:

  • ensuring the allowance of office use compounding when the practice is allowed by state law;
  • clarification that the records exemption during inspections is applied to traditional compounders;
  • adding dietary supplements to bulk drug substances list; and
  • requiring formal rulemaking for the provisions in the legislation.

For a one page description of the legislation click here.

To read NHIA press release click here.

If you have questions regarding this legislation, please contact Kendall Van Pool, NHIA Vice President of Government Affairs, at Kendall.vanpool@nhia.org or (703) 838-2664.

Background

In the wake meningitis outbreak caused by drugs manufactured by the New England Compounding Center (NECC) in Framingham, Massachusetts there has been a call for greater oversight of compounding pharmacies in the U.S.  The National Home Infusion Association (NHIA) believes we should do everything possible to prevent a repeat of the failures of NECC.  We know that the substances produced at NECC have claimed 53 lives and sickened more than 700 people in 20 states.  The NHIA believes that the safety of patients is the first priority for all home infusion providers and as new regulatory structures are considered this should be the first test.  We must also work toward a balanced approach that does not put the availability of services and medications in jeopardy.

The NHIA legislative action center for compounding pharmacy legislation is a clearinghouse of information on legislation and regulation for home infusion providers.  Should issues arise where your grassroots action is needed we will update this page.  We also urge you to sign up for the NHIA ListServ to get regular updates from us on the issue.

Federal Action

The Drug Quality and Security Act

The Drug Quality and Security Act, H.R. 3204 was signed into law by President Obama on November 27, 2013.  This bill contains two titles. Title I, “The Compounding Quality Act,” distinguishes between traditional compounders and outsourcing facilities. It establishes a uniform set of rules for outsourcing facilities while preserving the states’ primary role in traditional pharmacy regulation. Title II, “The Drug Supply Chain Security Act,” provides a uniform, national drug tracing framework to track prescription drugs from the manufacturer to the pharmacy and raises the standards for prescription drug wholesalers across the U.S.

It is important to review the text of Title I with section 503A of the Federal Food, Drug and Cosmetic Act (FFDCA) in mind. 

We have provided the text of section 503A on NHIA’s website and it can be accessed here.

The legislation does not reference section 503A except in the severability clause under section 106 of the legislation.  This section would amend section 503A of the FFDCA by removing the advertising and promotion provisions that the Supreme Court had found unconstitutional years ago and which resulted in a Circuit Court split as to the validity of section 503A—which led to legal uncertainty for the industry and for FDA. By striking the unconstitutional portions of 503A, Congress re-establishes this section as the principal federal recognition that traditional compounding pharmacies will continue to be regulated by the states.  In particular, traditional compounding will remain exempt from certain provisions of the FFDCA relating to drug manufacturing (chiefly cGMP) if performed in compliance with section 503A. 

With 503A becoming the national law regarding traditional compounding pharmacies, the bill also creates a new type of compounding entity called an “outsourcing facility.  This option for a facility engaged in compounding of sterile drugs allows the facility to choose to register with the FDA as an outsourcing facility. A facility qualifying as an outsourcing facility, and which chooses to register with FDA, will be exempt from several (but not all) burdensome provisions of the FFDCA.

Under the provision the FDA will make available on their website a list of the name of each outsourcing facility along with the state where the facility is located, whether the facility compounds from bulk drug substances, and whether drugs compounded from bulk are sterile or non-sterile. An outsourcing facility that chooses to register with the FDA must:

  • Give a licensed pharmacist direct oversight over the drugs compounded;
  • Compound only drugs from bulk ingredients that appear on a list developed by the Secretary. This list will be developed through a notice published in the Federal Register following a 60 day comment period, and must take into consideration clinical need;
  • Report to the Secretary upon registering, and every 6 months thereafter, the drugs sold in the previous 6 months;
  • Be inspected by FDA according to a risk-based inspection schedule, and pay annual fees to support such inspections;
  • Report serious adverse event experiences, and conduct follow up investigation and reporting similar to drug manufacturers;
  • Label products with a statement identifying them as a compounded drug and other specified information about the drug.

Drugs removed from the market for safety and effectiveness reasons may not be compounded.

Copies of marketed FDA-approved drugs may not be compounded by an outsourcing facility except in the case of a drug shortage. Products subject to Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use can only be compounded if they otherwise comply with the criteria to qualify for the exceptions and if the compounder shows the Secretary it utilizes controls that are comparable to those in the REMS.

Compounded drugs may only be sold by the outsourcing facility that compounded the drug, and all must be labeled “not for resale”.  An outsourcing facility may or may not be a licensed pharmacy. FDA is responsible for overseeing all drugs compounded in an outsourcing facility.

The annual fee for outsourcing facilities is $15,000 per year with an inflation adjustment. Small businesses, defined as compounding manufacturers with under $1,000,000 in annual gross revenue, pay one-third of that fee. FDA would then adjust the fee for the larger facilities based on the number of small businesses. Fees can only be used for the inspection and regulation of compounding manufacturers.

Aside from the new voluntary outsourcing facility designation, the bill also requires enhanced communication between states and the FDA.  This section would require the Secretary to facilitate meaningful communication between the FDA and the State Boards of Pharmacy about concerns raised, or actions taken, against compounding pharmacies.

NHIA Thoughts and Analysis

In the final hours before the House vote the House and Senate worked out a provision that was requested by NHIA to further clarify the voluntary nature of being an outsourcing facility.  NHIA pushed for this clarification to ensure that the election to be an outsourcing facility would be a voluntary decision by the pharmacy would not be a coerced election by the FDA.

The goal of Congress in creating the new outsourcing facility designation is to create an FDA “good housekeeping seal of approval” scenario.  Congress believes that once this designation is in place the market will demand that facilities seek to be designated as outsourcing facilities to ensure safety.  By “market,” we are referring to payers, accreditation organizations, liability insurers and patient demand.  This may well be an accurate scenario for office use compounders and pharmacies that compound non-patient-specific medications.  However, due to the patient-specific nature of home infusion, the market forces driving the election to become an outsourcing facility may be mis-directed.  Outsourcing facilities would still be subject to the cGMP sterility testing requirements, and the typical sterility testing under cGMP is a minimum 14 day test that is based on a lot testing system.  This is an impossible standard for compounders of patient-specific medication who are trying to address patients’ immediate needs.   Thus, this designation simply will not work for infusion pharmacies.  Throughout this legislative process, Congress clearly did not want to create situations that would disrupt the normal practices of infusion pharmacies.  We will need to continue our dialogue with Congress as the outsourcing designation rolls out in the future to ensure that infusion pharmacies are not pressured to become entities that cannot respond to their patients’ needs.

We would like to also to note there are provisions included in the bill that require the FDA to go through a full rule-making process with comment periods.  This will give NHIA and other stakeholders an opportunity to influence the rule making process. 

Regulatory Action

Shortly after the signing of the Drug Security and Quality Act the FDA released three draft guidances and three rules were published in the Federal Register.  The rules and guidances can be reviewed through the links below. NHIA has reviewed these documents and commented on the rules and guidances that affect home infusion.  NHIA welcomes your thoughts on these guidances and rules.  Please contact Kendall Van Pool at kendall.vanpool@nhia.org with your comments.

NHIA has also contacted the FDA urging the FDA consider the need for 503A facilities when promoting outsourcing facilities:

NHIA Expresses the Need for Traditional Compounding Pharmacies to FDA
Click Here to Read the Letter
February 19, 2014

FDA Responds to NHIA Need for Traditional Compounding Pharmacies Letter
Click Here to Read the Letter
March 27, 2014

State Action

California