Congress has introduced the Compounded Drug Access Bill, H.R. 2871. This blog article only addresses the first four sections of H.R. 2871, “Preserving Patient Access to Compounded Medications Act of 2017”.
Here we go again with another introduced bill for pharmacy compounding. This six-page bills title (above) purports to “preserve” patients’ access to compounded drugs and alludes that the current Act Drug Safety and Security Act of 2014 (DQSA) may deny patient access to compounded drugs.
The bill was introduced and referred to the House Energy and Commerce Committee by Representation Morgan Griffith (R-VA). The bill was supported by the National Community Pharmacists Association and addresses office-use compounding when authorized by State law and United States Pharmacopeia or National Formulary monograph requirements.
Section 1 of the bill states that this Act may be cited as the “Preserving Patient Access to Compounded Medications Act of 2017”.
Section 2 is titled Office-Use Compounding When Authorized by State Law and amends section 503A(a) of the Federal Food and Cosmetic Act (21 U.S.C. 353a(a)) by inserting “or drug order for administration to a patient in an office or clinical setting in the first paragraph; striking “or” at the end of the first paragraph; in paragraph 2 striking the period at the end and adding “or;”; and by adding at the end of the new paragraph “ (1) is by (A) a licensed pharmacist or licensed physician pursuant to a valid prescription order or drug order and the compounded drug is distributed or dispensed to a licensed prescriber in accordance with State law, for the administration to a patient in an office or clinical setting”.
Note the changes above include: adding “drug order” which is not a prescription order but allows for anticipatory compounding and “distribution” of drugs and dietary supplements to an office or clinical setting; and under the new paragraph adds drug order and terms of distribute (in addition to dispensing).
Section 3 deals with United States Pharmacopeia or National Formulary Monograph Requirements and adds: “dietary supplements” to the section preceding sub clause (i) dealing with bulk drug substances; language that the bulk drug substance or dietary supplement comply with any section (not just monograph standards) in the USP or NF; and dietary supplement to the paragraph dealing with ingredients that are not a component of an approved drug.
Note that 503A(a) only deals with human drugs, so it must be asked why this bill adds dietary supplements and may allow compounding with components/ingredients that are not part of an approved drug or on a list prepared by the Secretary via any section of the USP or NF?
Section 4 adds definitions for: (1) compounding (same as DQSA); (2) Distribute or Distribution – that states “does not include the act of dispensing of a compounded drug product” from a valid prescription for an identified individual patient; and (3) Dispense – means for a drug product compounded in accordance with this section, the act of the drug product leaving the facility in which it was compounded for delivery to a patient, patient’s agent, or health care facility (including a hospital, physician’s office, or other health care setting) pursuant to a valid prescription order for an identified patient.”
Section 5 deals with Applicability of Records Exemption for Compounding Pharmacies under section 704(a)(2)(A) and Section 6 deals with Regulations – Rules Implementing New Requirements.
If this bill is accepted as is (and that seems unlikely), it would override many of FDA’s stated concerns addressed in guidance documents relative to compounding of drugs and allow for anticipatory compounding/manufacturing of substantial quantities of compounded preparations for distribution without a valid prescription for an individual patient. FDA may still be concerned about the establishment of analytically supported beyond-use dating if not following the requirements of USP and State laws based on the “distribution” of these compounded preparations.
Next steps: Will a companion bill be introduced in the Senate and what will it contain? And what influence will the new FDA Commissioner have on the fate of the bill? We will report on other elements of the proposed legislation and follow its progress in future blogs.