Issues

Over the last few years, the compounding profession has enlisted Congress’ help to direct the Food & Drug Administration (FDA) to stop implementing and enforcing the Drug Quality and Security Act (DQSA) in a way that has jeopardized patient access to critical compounded medications. Unfortunately, despite clear directives from Congress in its Appropriations reports, the FDA has continued to take policy positions in guidance for industry and other documents that are inconsistent with the statute, that pre-empt state pharmacy laws, and that assert regulatory authority over the practice of medicine and state ­licensed pharmacies in ways Congress never intended. Our concern: this situation has greatly impacted patient access to vital compounded medications.

Members of Congress are again asking the House Appropriations Committee for their support for inclusion in the FY19 Agriculture, Rural Development, and Food and Drug Administration and Related Agencies Appropriations of report language to again direct the FDA on these matters. Specifically, support has been requested for inclusion of:

• Report language to direct the FDA to allow for the distribution or dispensing of compounded medications by a licensed pharmacist to a licensed physician for administration in an office or clinical setting ("office-use compounding") when done pursuant to state law. FDA should be directed by the committee to rescind the GFI and issue a proposed rule that is consistent with the DQSA.
• Report language to clarify that the sample MOU between FDA and the states on the "interstate distribution of inordinate quantities of compounded medications should not defines the terms "distribute" or "distribution" to include the dispensing of compounded medications pursuant to a prescription order for an identified patient as authorized by state law. FDA should be directed to rescind the current MOU and issue a proposed rule that is consistent with the DQSA. The sample MOU should be finalized in a way that does not define "distribute" in way that gives FDA regulatory authority over the dispensing of medications in a way Congress never intended.
• Report language reminding the FDA that compounding pharmacies are not drug manufacturers subject to current Good Manufacturing Practices (cGMPs) of inspection. They are more appropriately inspected using published USP standards or other applicable pharmacy inspection standards adopted by state law or state regulation in the state in which a pharmacy is licensed. In addition, the Committee should remind the FDA that the records exemption found within 21 U.S. Code § 374 (a) (2)(A) applies to 503A compounding pharmacies.
• Report language reminding the FDA that Congress placed no limitations on the specific USP/NF monographs used in compounding bulk substances, and advises FDA against moving forward with policies that would prohibit "dietary supplement" monographs absent statutory authority to do so, given the long history, tradition and often medical necessity of compounding using USP/NF "dietary" as well as "drug" substances, like methylcobalamin, also known as methyl B-12.
• Report language addressing the fact that the Pharmacy Compounding Advisory Committee (PCAC) established under the DQSA does not have voting members with actual experience in the preparation, prescribing or use of compounded medications and that the criteria by which the PCAC is reviewing drugs does not adhere to congressional intent that drugs that have been used historically be allowed for use unless FDA finds that they present an unacceptable health and safety risk.

Patient access to the compounded medications upon which they rely is of paramount importance to the Alliance for Pharmacy Compounding (APC) . For this reason, ACP has several concerns with the Food & Drug Administration’s (FDA) Pharmacy Compounding Advisory Committee (PCAC).

While encouraged the FDA established PCAC, ACP never has been confident with the process FDA used to assemble the current panel. ACP continues to have serious concerns about the lack of representation of actual practicing compounding pharmacists.

ACP has submitted 24 nominees to the FDA, many with extensive real-life compounding practice experience, and only one was selected. Further the compounding pharmacist nominated and accepted was not granted the ability to vote by FDA. The FDA deemed this pharmacist a non-voting member of the panel. As a result, ACP simply is not confident compounding pharmacists have a real seat at the PCAC table, and has continuing concerns that the Drug Quality and Security Act (DQSA) will not be implemented as Congress intended.

PCAC’s voting trend on bulk substances has further amplified concerns. From a practicing pharmacist’s perspective, the utmost concern is taking care of patients. With the inability to use some of these bulk drug substances, patients will be negatively impacted.

During the passage of the Drug Quality and Security Act (DQSA), six Congressional Statements were read into the record establishing congressional intent that the practice of a State-licensed pharmacist providing compounded medications to a physician or other practitioner for administration to a patient (often called office-use compounding) was to remain allowable under the DQSA.

Following FDA’s actions which have ignored these Statements on the Record, Congress took many steps to reinforce the bipartisan and bicameral intent for office-use compounding to continue where authorized by State law.

• Questions for the Record were submitted from the House Energy and Commerce Committee following a House Energy and Commerce Hearing entitled, “Reviewing FDA’s Implementation of FDASIA.”
• Questions for the Record were submitted by House Energy and Commerce Members following a Hearing entitled “Improving Predictability and Transparency in DEA and FDA Regulation.”
• A Congressional Letter led by Congressman Michael C. Burgess, M.D., and Congressman Morgan Griffith and signed by more than 30 Representatives was sent to FDA regarding office-use and repackaging.
• A Congressional Letter led by Congressman Buddy Carter to the FDA following-up on office-use compounding questions which were asked during prior House Education and Workforce Committee hearing.
• Congressional appropriations report language within the 2016, 2017 and 2018 FDA Appropriations bills instructed FDA to issue guidance or rulemaking allowing State-licensed compounding pharmacies to provide compounded medications to physicians and providers to be administered to patients.
• Introduction of bipartisan legislation, H.R. 2871, the Preserving Patient Access to Compounded Medications Act, that will address the office-use, MOU, and inspections issues at FDA by clarifying these provisions of the DQSA.

Despite all these actions by Congress, FDA released final guidance in December of 2016 entitled “Prescription Requirement under Section 503A of the Food, Drug, and Cosmetic Act” which expressly prohibits all 503A pharmacies from providing physicians and other practitioners compounded medications to administer to patients. Instead, FDA states within the guidance, the physician will have to send the patient to the pharmacy to pick up the medication and return on a second visit to the physician for the administration of the medication, therefore drastically decreasing patient safety and convenience and increase patient and healthcare costs. It is unacceptable the FDA would ignore Congress and continue to take the position that Section 503A prohibits office-use compounding despite clear congressional intent.

How can the prohibition of Office-use compounding affect the patient?

Office-use enables many physicians to order compounded prescription preparations in their practices to care for patients when manufactured drug products are either unavailable or do not provide the necessary strengths, dosage forms, or combinations of medicines they need.

Repackaging of manufactured drug products for office-use is also done by pharmacists so that medications can be made available in the necessary dosages and strengths for physicians to administer in the office.

Office-use is often used to meet an urgent patient need and these medications are administered to treat viral infections, vitamin deficiencies, and macular degeneration (which if left untreated can cause immediate blindness). They are also used as anesthetic agents for outpatient surgical procedures, and for many other purposes by doctors.

FDA's position has been that the 503B "outsourcing facilities" established by the DQSA can compound and distribute without a prescription and can therefore meet the needs of prescribers and patients for office-use compounding.  However, the reality is that the outsourcing facilities must meet stringent and lengthy cGMP (manufacturer) sterility and testing requirements that make it impossible for them to provide the limited quantities of compounded medications needed by community prescribers for office administration.  The outsourcing facilities are well-suited to provide hospitals and clinics larger volumes of compounded medications, but are not able or not willing to compound limited quantities of office-use medications for community prescribers.

If you're like many patients, your employer has received a letter from their Pharmacy Benefit Manager (PBM), stating that they would no longer cover compounded prescriptions.

Now What?

So what do you do if the compounded medications upon which you depend are no longer covered?

1. 1. Determine if your Prescription Coverage is Affected
   Meet with your Human Resources contact, and review your benefits information. Ask for your Summary of Benefits and Coverage so that you know exactly what your coverage entails.
2. 2. Talk to your Benefits Manager about the Value of Compounded Meds
   Let your Benefits Manager know how important personalized prescriptions are for you and your family. If possible, meet in person with the personnel responsible for making these decisions, and acknowledge that you understand cost-cutting measures are important for the company; but, that the omission of compounded meds would affect your well-being and that of your family's.
   
   Even if you don’t now rely on compounded medicines, you or someone you know might need to in the future.