Pharmacy Practice FAQs

FDA

Adverse Drug Effect Reporting

Q: Does the FDA require pharmacists to provide patients with a toll-free number to report adverse drug effects?

A: Yes. Effective January 1, 2008, FDA required pharmacists to distribute with all prescriptions information alerting patients that they may call a toll-free telephone number to report adverse drug effects to the FDA: Toll-Free Number for Reporting Adverse Effects on Labeling for Human Drug Products

Q: How can I report a potential adverse drug effect to FDA?

A: Pharmacists or members of the public may report a potential adverse drug effect to the FDA by calling 1-800-332-1088, or by submitting a report online here:  MedWatch Online Voluntary Reporting Form.

Clozapine REMS System

Q: What guidance has FDA supplied concerning problems with the clozapine REMS program?

A: On November 2, 2022, FDA advised that is temporarily exercising additional enforcement discretion with respect to certain Clozapine REMS program requirements to ensure continuity of care for patients taking clozapine. FDA is aware health care professionals and patients continue to experience ongoing difficulties with the Clozapine REMS program, including issues with patient access to clozapine for patients recently discharged from an inpatient setting.

To address the concern that inpatient pharmacies are only allowed to dispense a 7-days’ supply of clozapine to the patient upon discharge, FDA does not intend to object if:

• Inpatient pharmacies dispense a days’ supply of clozapine that aligns with the patient’s monitoring frequency (e.g., weekly monitoring = 7 days’ supply, twice monthly monitoring = 14 days’ supply, monthly monitoring = 30 days’ supply) upon discharge from an inpatient facility.

FDA continues to exercise the enforcement discretion announced in November 2021, including that FDA does not intend to object if:

• Pharmacists dispense clozapine without a REMS dispense authorization (RDA).
• Wholesalers ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS.

Abrupt discontinuation of clozapine can result in significant complications for patient treatment. Health care professionals should use their clinical judgment with regard to prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable range.

We understand that difficulties with the Clozapine REMS program have caused frustration and have led to problems with patient access to clozapine. FDA takes these concerns seriously. Continuity of care, patient access to clozapine, and patient safety are our highest priorities. We are working closely with the Clozapine REMS program administrators to address these challenges and to avoid interruptions in patient care.
We encourage pharmacists and prescribers to continue working with the Clozapine REMS to complete certification and prescribers should continue to enroll patients and submit the Patient Status Form.
If you have questions or concerns about the Clozapine REMS Program or its website, please contact FDA at druginfo@fda.hhs.gov, 1-855-543-3784 or 301-796-3400.

FDA’s Intergovernmental Affairs (IGA) staff is here to assist state/local/territorial/tribal officials, including the national associations representing them, on FDA policy-related matters. If you have further questions, please contact FDA’s IGA team at IGA@fda.hhs.gov.

Drug Recalls

Q: Where can I find information about current FDA drug recalls?

A: The FDA’s Drug Safety Communications Resource includes a database of current Drug Recalls

Drug Safety And Availability Resources

Q: Where can I find FDA resources on drug safety and availability?

A: The FDA maintains a Drug Safety and Availability Resource Page.  It provides links to information on drug labeling; REMS programs; post-market studies of drugs’ safety, efficacy, or optimal use; clinical trials; drug-specific safety information; warning letters; recalls; and consumer articles.

Drug Shortages

Q: How can I determine whether a prescription drug product is in shortage?

A: The federal Food and Drug Administration maintains a database listing drugs that are in shortage, the reported reason for the shortage, and the anticipated date that the shortage will resolve.  The database is found here:  FDA Drug Shortage Database

Medication Guides

Q: For which drugs does the FDA require distribution of a Medication Guide?

A: Medication Guides are  part of a drug’s FDA-approved labeling, and must be distributed to patients with the medication:  What Are Medication Guides   The FDA maintains a searchable Medication Guide Database  

Quinine Sulfate
Q: May I dispense quinine sulfate for leg cramps?

A: No.  FDA guidance on the dispensing of quinine products is found here: FDA Quinine Monograph

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