Chapter 3: The Durham-Humphrey Amendment of 1951

The Durham-Humphrey Amendment of 1951

• Amends Section 502 of the FDCA, establishing different labeling requirements for prescription and nonprescription drugs.

• Created the first statutory distinction between prescription and nonprescription drugs (§ 503; 21 U.S.C. § 353).

• Sponsored by pharmacist legislators Senator Hubert Humphrey and Congressman Carl Durham.

• Legalized verbal prescription transmission and pharmacist's right to honor refills.

• Did not fully appreciate the pharmacist's role in drug therapy.

• Criteria for Prescription Drugs:

  • Drugs that are unsafe for use except under the supervision of a practitioner because of toxicity, method of use, or necessary collateral measures.

  • Drugs limited to use under professional supervision via an approved application under section 505 of the FDCA.

• Court Case - United States v. Article of Drug—Decholin, 264 F. Supp. 473 (E.D. Mich. 1967):

  • The FDA must prove that the toxicity and method of use require practitioner supervision.

  • The FDA must show that necessary collateral measures require supervision.

  • The FDA must demonstrate that the pharmacological and toxic effect of the drug may harm the patient without a physician's direction.

  • The FDA must prove harm from delaying a physician visit, considering seriousness, delay length, label advice quality, and symptom alleviation by the drug.

• Dispensing:

  • Prescription drugs can be dispensed via written or oral prescriptions, with oral prescriptions promptly written and filed.

  • Refills are allowed if authorized in the original prescription or via oral order.

  • The Durham-Humphrey Amendment does not specifically authorize electronic prescriptions (e-prescribing).

  • States have enacted laws and regulations authorizing electronic prescriptions.

  • CMS requires electronic prescribing of controlled substances for Medicare Part D plans as of 2023.

• Labeling Requirements:

  • Exemptions from Section 502 requirements for dispensed prescription drugs, except certain stipulations.

  • Label must not be false or misleading.

  • Drug must not be an imitation drug or sold under another drug's name.

  • Packaging and labeling must meet official compendia standards.

  • Must conform to the Poison Prevention Packaging Act (PPPA).

  • Minimum information required: dispenser's name and address, prescription serial number and date, prescriber's name, patient's name (if stated), directions for use, and cautionary statements.

  • State laws and rules may require additional information, such as the dispensing pharmacist's details, drug expiration date, drug name/strength/quantity, manufacturer/distributor name, and lot/control number.

• Pharmacies may include extra information beyond legal requirements (e.g., patient address, prescriber phone number).

• Standardized Prescription Labels:

  • USP and NABP propose state standards for patient-centered labels.

  • Critical information (patient name, drug details, directions, purpose) should be grouped, prominently displayed, and clear, with appropriate font size.

  • Directions should be standardized with explicit dosage and intervals.

  • Labeling should be in the patient's preferred language when possible.

  • California and New York require label interpretation in multiple languages.

• Other Label Considerations

  • The FDAMA eliminated batch certification requirements for antibiotics and insulin, previously required.

  • Subsection (b)(2) does not exempt drugs dispensed pursuant to diagnosis by mail to protect against fraud.

• Expiration or Beyond-Use Dating:

  • Manufacturers include expiration dates; states often require pharmacists to add expiration or beyond-use dates.

  • USP guidelines state that dispenser shall place a suitable beyond-use date (BUD) on the prescription container.

  • BUD should not exceed the manufacturer's expiration date or one year from dispensing, whichever is earlier, unless specified otherwise.

  • Rite Aid case in California: Suit dropped after Rite Aid was sued for consumer fraud for implementing USP standards.

    • Switch of Prescription Drugs to Over-the-Counter Drugs

    • Subsection 503(b)(3) allows the FDA to switch drugs to OTC status if adequately labeled for self-diagnosis, self-treatment, and self-management, with low misuse/abuse potential, and benefits outweigh risks.

    • Two pathways include the OTC drug review process (monograph) and the new drug application (NDA) process.

    • Most switches now occur through NDA or SNDA, known as RX-to-OTC switches, including full or partial switches.

    • Full switch: seeks to switch completely covered drug product to nonprescription with an efficacy supplement to an approved NDA.

    • Partial switch: seeks to switch some indications of use to nonprescription status while retaining other indications as prescription status with a new NDA.

    • Pharmacists must follow the label, even if a similar product is OTC from another manufacturer.

    • Third Class of Drugs

    • Contemplated since the 1970s, termed "Behind-the-Counter" (BTC) drugs, or drugs that are "Nonprescription Under Conditions of Safe Use."

    • Rationale is that some drugs require pharmacist consultation for safe use.

    • Examples exist presently, including Schedule V drugs as exempt narcotics, pseudoephedrine, and emergency contraceptives.

    • Debate over whether amendment to the Durham-Humphrey Amendment is necessary to establish a third class of drugs on a national basis.

    • FDAMA included provisions for national uniformity of nonprescription drugs, making it unlikely that a state would have the authority to establish a third class of drugs.

    • FDA opposed, but signaled change in 2007 with public meeting for comments on the creation of a BTC class of drugs.

    • The FDA held hearings, and the General Accounting Office issued a report in 2009 comparing U.S. regulation to four European Union countries.

    • In February 2012, the FDA considered nonprescription drugs available under conditions for safe use (specific to drug, pharmacist intervention, or innovative technology).

    • In July 2018, the FDA published draft guidance detailing innovative approaches where OTC drug facts labeling was insufficient for safe use.

    • In June 2022, the FDA proposed a rule for a nonprescription drug product with an Additional Condition for Nonprescription Use (ACNU) for self-selection and use without healthcare practitioner oversight (questionnaire requirement).

    • OTC products with an ACNU will likely not mandate pharmacist involvement.

    • Professional Practice Considerations

    • Prescription Refill Authorization: requires specific authorization from prescriber, physician's employee or agent cannot authorize unless authorized by state law.

    • Prescriptive Authority: determined by state law, pharmacists must know who can prescribe and their scope of authority.

    • State Practice Acts define scope of practice to diagnose and treat, which determines prescriber’s scope of authority.

    • Physicians have broad treatment and prescription authority.

    • Other prescribers such as dentists, veterinarians, and podiatrists, have much narrower treatment and prescriptive authority.

    • Pharmacists not likely held legally accountable if they dispensed the prescription in good faith after making an attempt to ascertain the condition for which the drug was prescribed.

    • Emergency Contraception (Plan B)

    • Has a complex regulatory history, previously pharmacist independent prescriptive authority and a third class of drugs in certain states.

    • The FDA approved Plan B as a prescription-only medication in 1999, and in 2001, organizations requested the FDA to switch it to OTC with no age restrictions, but the FDA rejected the SNDA in 2003.

    • After public outcry, the FDA changed the SNDA approval based on the age of the user rather than for different indications and announced new labeling and sale conditions in 2006 (sold from BTC in pharmacies staffed by a licensed pharmacist).

    • In Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y 2009), the court found the FDA had acted in bad faith rejecting the citizen petition to make Plan B available for all ages.

    • In December 2011, the Commissioner of the FDA approved an SNDA, however, the Secretary of the Department of Health and Human Services (DHHS) overruled the commissioner’s decision.

    • On April 5, 2013, the court required the FDA to make EC available without age or point of sale restrictions and ordered no point of sale restrictions after examining evidence that the current BTC restriction obstructed many women from being able to obtain the product.

    • Currently, a variety of brands of levonorgestrel morning-after pills OTC available without a prescription at pharmacies.

    • Conscientious Objection

    • Whether a pharmacist can refuse to dispense prescriptions due to moral or religious beliefs.

    • Some states require pharmacists to dispense, others have conscience clauses permitting refusal.

    • Pharmacy organizations generally seek compromise between respecting beliefs and ensuring patient access.

    • Documented cases: Noesen v. State, Dept. of Regulation and Licensing, 754 N.W.2d 849 (Wis. 2008) and Stormans, Inc. v. Wiesman, 794 F.3d 1064 (2015).

    • Collaborative Practice Agreements/Statewide Protocols

    • States allow pharmacists to initiate/adjust therapies with physician collaboration, requiring protocols.

    • Statewide protocols permit independent prescribing, such as birth control, Test-to-Treat initiatives, and immunizations.

    • Authority to Dispense Prescription Drugs

    • Determined by states; pharmacists and physicians may dispense.

    • Federal law restricts physician dispensing via Medicare/Medicaid fraud and abuse statutes.

    • Take-Away Points

    • The Durham-Humphrey Amendment established criteria for differentiating drugs and legality of prescriptions and refills.

    • Some states require standardized prescription labels.

    • Pharmacists must comply with state laws, USP, and FDA guidelines in determining drug expiration and BUD.

    • The FDA can switch drugs from prescription to OTC status via OTC drug review (monograph) process, or the NDA process.

    • A

The Durham-Humphrey Amendment of 1951 amended Section 502 of the FDCA, establishing different labeling requirements for prescription and nonprescription drugs