Par. 2. Section 47.5000D-0 is amended by: a. Removing the entry “§§ 47.5000D-2—47.5000D-4 [Reserved]”. b. Adding entries for §§ 47.5000D-2 and 47.5000D-3 and the entry “§ 47.5000D-4 [Reserved]” in numerical order. The additions read as follows:
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§ 47.5000D-2 Definitions.
(a) Overview.
(b) Definitions.
(1) Applicable percentage.
(2) Applicable sale.
(3) Manufacturer, producer, or importer.
(i) In general.
(ii) Sale made other than on a day described in section 5000D(b).
(iii) Sale made prior to publication of the list of selected drugs under section 1192(a) of the Social Security Act.
(4) Price.
(i) In general.
(ii) Adjustment to amount charged.
(iii) Amount of adjustment.
(iv) Allocation between price and tax.
(5) Sale.
(c) Examples.
(1) Example 1: First sale of units of a designated drug.
(i) Facts.
(ii) Analysis.
(2) Example 2: Manufacturer sale prior to day described in section 5000D(b).
(i) Facts.
(ii) Analysis.
(3) Example 3: Sale made prior to publication of the list of selected drugs.
(i) Facts.
(ii) Analysis.
(4) Example 4: Subsequent sale to relabeler.
(i) Facts.
(ii) Analysis.
(5) Example 5: Importation.
(i) Facts.
(ii) Analysis.
(6) Example 6: Chargeback reimbursement and allocation.
(i) Facts.
(A) Manufacturer sale.
(B) Wholesaler sale and chargeback.
(ii) Analysis.
(A) Bona fide discount, rebate, or allowance.
(B) Allocation of chargeback reimbursement between tax and price.
(d) Severability.
(e) Applicability date.
§ 47.5000D-3 Imposition of section 5000D tax.
(a) Imposition of tax.
(1) In general.
(2) Attachment of tax.
(3) Person liable for tax.
(4) Identification of applicable sales.
(i) In general.
(ii) Books, records, and other information.
(iii) Disregard of Medicare part B sales permissible prior to March 1, 2026.
(iv) Safe harbor.
(A) In general.
(B) No election required.
(C) Must use safe harbor for four consecutive calendar quarters.
(D) Uniform application required.
(E) Updates to safe harbor percentage.
(v) Recalculation of liability not permitted.
(b) Calculation of tax.
(1) In general.
(2) Charging tax as line item; effect on price.
(i) Presumption if no separate charge for tax is made.
(ii) Separately charged tax not part of price.
(3) Example.
(i) Facts.
(ii) Analysis.
(A) In general.
(B) Step 1.
(C) Step 2.
(D) Step 3.
(E) Step 4.
(c) Anti-abuse rule.
(d) Severability.
(e) Applicability date.
§ 47.5000D-4 [Reserved]