Research · 6 min read
When a State Lets a Pharmacist Hand You a Different Product
Substitution is not a pharmacy's discretion in the abstract. Two state codes set out what may be swapped for what, who can block it, whether the price has to fall, and what the label then has to say.
Key takeaways
- California's section 4073 permits selection only of a product matching the prescribed one on active chemical ingredients, strength, quantity, dosage form and generic drug name under a named naming convention.
- A California prescriber blocks substitution by a personal oral or handwritten instruction, or a personally initialled box on paper; an electronic data transmission prescription needs no manual initialling.
- California requires that the selected product cost the patient less, with cost defined to include any professional fee the pharmacist may charge.
- Virginia's section 54.1-3408.04 permits dispensing a biosimilar only where the Food and Drug Administration has licensed it as interchangeable with the prescribed biological product.
- Virginia gives the patient a veto alongside the prescriber's, requires notice before dispensing, and dictates a label reading with the biosimilar's name followed by substituted for and the prescribed product's name.
- Virginia requires both the pharmacist and the prescriber to keep records of an interchangeable biosimilar substitution for not less than two years, and applies the section to nonresident pharmacies shipping into the Commonwealth.
Answer first: the statute defines the swap narrowly
California Business and Professions Code section 4073 states what may be selected and matches five attributes at once. A pharmacist filling a prescription order for a drug product prescribed by its trade or brand name may select another drug product with the same active chemical ingredients, of the same strength, quantity, and dosage form, and of the same generic drug name as determined by the United States Adopted Names and accepted by the federal Food and Drug Administration, of those drug products having the same active chemical ingredients.
Every element of that sentence is a constraint. Same active chemical ingredients. Same strength. Same quantity. Same dosage form. Same generic drug name under a named naming convention, accepted by a named federal agency. A product that differs on any of them is not what the section authorizes a pharmacist to select.
Virginia handles the analogous question for a different category of product in Code section 54.1-3408.04. A pharmacist may dispense a biosimilar that has been licensed by the United States Food and Drug Administration as interchangeable with the prescribed product, subject to two vetoes described below. The same section states the limit plainly: no pharmacist shall dispense a biosimilar in place of a prescribed biological product unless the biosimilar has been licensed as interchangeable with the prescribed biological product by the Food and Drug Administration.
Two limits on what this file establishes. Whether a given medication has a product meeting either description is a fact about that product, not about the statute, and none of these sources answers it. And the two provisions govern different categories — one is about drug products with the same active chemical ingredients, the other about biological products and biosimilars licensed as interchangeable.
Who can stop it, and exactly how
Both states give the prescriber a veto, and both specify the mechanics with unusual precision.
California's section 4073 states that in no case shall a selection be made if the prescriber personally indicates, either orally or in his or her own handwriting, do not substitute, or words of similar meaning. The section then addresses the checkbox: nothing in that subdivision prohibits a prescriber from checking a box on a prescription marked do not substitute, provided that the prescriber personally initials the box or checkmark.
For an electronic prescription the rule is different, and the difference matters for any service that transmits prescriptions electronically. To indicate that a selection shall not be made for an electronic data transmission prescription as defined in the cited section, a prescriber may indicate do not substitute, or words of similar meaning, in the prescription as transmitted by electronic data, or may check a box marked do not substitute. In either instance, it shall not be required that the prohibition on substitution be manually initialed by the prescriber.
So on paper, a checked box needs the prescriber's own initials. Transmitted as electronic data, it does not. California's section 4040 supplies the definition being relied on: an electronic data transmission prescription means any prescription order, other than an electronic image transmission prescription, that is electronically transmitted from a licensed prescriber to a pharmacy.
Virginia gives the veto to two different people. A pharmacist may dispense an interchangeable biosimilar unless the prescriber indicates that such substitute is not authorized by specifying on the prescription brand medically necessary, or the patient insists on the dispensing of the prescribed biological product. In the case of an oral prescription, the prescriber's oral dispensing instructions regarding dispensing of an interchangeable biosimilar shall be followed.
The patient veto in the Virginia provision has no counterpart in the California section quoted here. Under section 54.1-3408.04 the patient's insistence on the prescribed biological product is, by itself, a bar to the substitution.
California attaches a price condition, and it is absolute
Section 4073 makes the selection discretionary for the pharmacist and then imposes a condition that removes the discretion in one direction.
Selection under the section is within the discretion of the pharmacist, except where the prescriber has blocked it. The person who selects the drug product to be dispensed assumes the same responsibility for selecting the dispensed product as would be incurred in filling a prescription for a drug product prescribed by generic name. There shall be no liability on the prescriber for an act or omission by a pharmacist in selecting, preparing, or dispensing a drug product under the section.
Then the condition. In no case shall the pharmacist select a drug product under the section unless the drug product selected costs the patient less than the prescribed drug product. Cost, as used in that subdivision, is defined to include any professional fee that may be charged by the pharmacist.
Two things follow from that definition. The comparison is to what the patient pays, not to what the pharmacy pays or to a published list. And the professional fee is inside the comparison, so a swap that lowers the product price while raising the fee is not obviously satisfying the condition on its face.
The section applies broadly within California. It applies to all prescriptions, including those presented by or on behalf of persons receiving assistance from the federal government or under the state's medical assistance program.
What has to be said, and what has to be written on the label
Both states require the patient to be told, and Virginia specifies the wording that goes on the container.
California's section 4073 states that when a substitution is made under the section, the use of the cost-saving drug product dispensed shall be communicated to the patient, and the name of the dispensed drug product shall be indicated on the prescription label, except where the prescriber orders otherwise.
Virginia's section 54.1-3408.04 sets a sequence. When a pharmacist dispenses an interchangeable biosimilar in place of a prescribed biological product, the pharmacist or his designee shall inform the patient prior to dispensing the interchangeable biosimilar. Prior to dispensing is the operative phrase; the notice is not an after-the-fact entry on a receipt.
The record and label requirements follow. The pharmacist or his designee shall also indicate, unless otherwise directed by the prescriber, on both the record of dispensing and the prescription label, the product name and the name of the manufacturer or distributor of the interchangeable biosimilar.
Virginia then dictates the label formula. Whenever a pharmacist substitutes an interchangeable biosimilar pursuant to a prescription written for a brand-name product, the pharmacist or his designee shall label the drug with the name of the interchangeable biosimilar followed by the words substituted for and the name of the biological product for which the prescription was written.
And it sets a retention period. Records of substitutions of interchangeable biosimilars shall be maintained by the pharmacist and the prescriber for a period of not less than two years from the date of dispensing.
That last requirement binds both ends of the transaction. The prescriber, not only the pharmacy, holds a record of the substitution for at least two years.
Why this reaches a pharmacy in another state, and what it does not settle
A reader might assume a substitution rule inside Virginia's Drug Control Act applies only to pharmacies inside Virginia. Virginia closes that gap in its nonresident pharmacy statute.
Code section 54.1-3434.1 provides that pharmacies subject to that section — pharmacies located outside the Commonwealth that ship, mail, or deliver Schedule II through VI drugs or devices pursuant to a prescription into Virginia — shall comply with the requirements set forth in the interchangeable biosimilar section relating to dispensing an interchangeable biosimilar in the place of a prescribed biological product.
So the notice before dispensing, the record and label entries, the substituted for formula, and the two-year retention period travel with the package to a Virginia patient regardless of where the pharmacy sits.
Three things these sources do not settle, and it is worth being explicit about each. They do not say whether any particular medication has a product that meets California's five-attribute test, or a biosimilar licensed as interchangeable with it — that is a product fact this file makes no claim about. They do not tell a reader whether to accept or refuse a substitution; that is a clinical and personal decision outside the scope of a statute. And they describe two states. A pharmacy dispensing into other states is operating under those states' own substitution rules, which are not quoted here and may differ on every point above, including who may veto and whether a price condition exists at all.
Sources
- California Business and Professions Code section 4073 — drug product selectionThe description of what a pharmacist may select, matching active chemical ingredients, strength, quantity, dosage form and generic drug name as determined by the United States Adopted Names and accepted by the federal Food and Drug Administration; the prescriber's oral or handwritten do not substitute instruction and the personally initialled box on paper; the electronic data transmission alternative and the statement that manual initialling is not required there; the pharmacist's discretion and assumption of responsibility, and the absence of prescriber liability for the pharmacist's act or omission; the requirement that the selected product cost the patient less and the definition of cost as including any professional fee; the application to all prescriptions including federal assistance and the state medical assistance program; and the requirement to communicate the substitution to the patient and indicate the dispensed product's name on the label except where the prescriber orders otherwise.
- California Business and Professions Code section 4040 — definition of prescriptionThe definition of an electronic data transmission prescription as any prescription order, other than an electronic image transmission prescription, that is electronically transmitted from a licensed prescriber to a pharmacy — the definition on which section 4073's electronic do not substitute mechanics rely.
- Code of Virginia section 54.1-3408.04 — Dispensing of interchangeable biosimilars permittedThe permission to dispense a biosimilar licensed by the United States Food and Drug Administration as interchangeable with the prescribed product; the prescriber veto by specifying brand medically necessary and the patient veto by insisting on the prescribed biological product; the rule that oral dispensing instructions be followed for an oral prescription; the prohibition on dispensing a biosimilar not licensed as interchangeable; the duty to inform the patient prior to dispensing; the requirement to record the product name and the manufacturer or distributor on both the dispensing record and the label; the substituted for labeling formula; and the requirement that both pharmacist and prescriber retain records for not less than two years from the date of dispensing.
- Code of Virginia section 54.1-3434.1 — Nonresident pharmacies to register with BoardThe definition of the nonresident pharmacies subject to the section, and the requirement that those pharmacies comply with the requirements of section 54.1-3408.04 relating to dispensing an interchangeable biosimilar in the place of a prescribed biological product.
Frequently asked questions
What can a California pharmacist substitute?
Business and Professions Code section 4073 permits a pharmacist filling a prescription for a drug product prescribed by its trade or brand name to select another drug product with the same active chemical ingredients, of the same strength, quantity and dosage form, and of the same generic drug name as determined by the United States Adopted Names and accepted by the federal Food and Drug Administration. Whether such a product exists for any given medication is a product fact that this file does not assert.
How does a prescriber block a substitution?
In California, section 4073 provides that no selection shall be made if the prescriber personally indicates, orally or in his or her own handwriting, do not substitute or words of similar meaning; a checked box on a paper prescription requires the prescriber's personal initials. For an electronic data transmission prescription, the prescriber may indicate it in the transmitted prescription or check a box, and manual initialling is not required. In Virginia, section 54.1-3408.04 requires the prescriber to specify brand medically necessary on the prescription.
Can a patient refuse a substitution?
Virginia's section 54.1-3408.04 states that a pharmacist may dispense an interchangeable biosimilar unless the prescriber has blocked it or the patient insists on the dispensing of the prescribed biological product. The California section quoted here does not contain an equivalent patient veto; its conditions run to the prescriber's instruction and to the cost requirement.
Does a substitution have to save money?
In California, yes, and the comparison is to what the patient pays. Section 4073 states that in no case shall the pharmacist select a drug product under the section unless the product selected costs the patient less than the prescribed drug product, and defines cost to include any professional fee that may be charged by the pharmacist.
What does the label have to say after a substitution?
California's section 4073 requires the use of the cost-saving drug product to be communicated to the patient and the name of the dispensed product to be indicated on the prescription label, except where the prescriber orders otherwise. Virginia's section 54.1-3408.04 requires the patient to be informed prior to dispensing, the product name and the manufacturer or distributor to appear on both the dispensing record and the label, and the label to read with the name of the interchangeable biosimilar followed by the words substituted for and the name of the product prescribed.
Do these rules apply to a pharmacy outside the state?
Virginia's section 54.1-3434.1 requires nonresident pharmacies subject to that section — those shipping, mailing or delivering Schedule II through VI drugs or devices pursuant to a prescription into the Commonwealth — to comply with the requirements of the interchangeable biosimilar section. The obligations therefore follow a package sent to a Virginia patient.