GMPs for Compounders

Bethesda, MD
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Pharmacy compounding has become an important means of providing specialized drug products for patients for whom commercially available drug products are not appropriate. Compounding operations may take place in an institutional setting (e.g., hospital, nursing home, etc.), a 503 A or B compounding pharmacy or a conventional pharmacy. Because compounded drug products have not undergone the FDA review and approval process, they have an increased potential to present a risk to the patients who take them. Typically, pharmacists do not receive extensive academic training in compounding operations and the FDA requirements governing compounding, and why these requirements exist. These requirements are intended to ensure that compounded products are safe and effective. There have been numerous inspections of compounding operations which have resulted in adverse regulatory findings (FDA-483 observations and Warning Letters). A number of recalls of compounded drug products have occurred, often due to lack of assurance of sterility.

This training course will provide an overview of the FDA regulatory oversight process, and will discuss FDA’s regulations and guidances which govern the compounding of drug products, especially in outsourcing (503B) operations. The training course will include a review and analysis of actual FDA citations found during inspections of compounding operations and will provide insights into how to avoid adverse regulatory findings and how to respond to them should they occur.

For more options and/or related training courses, please visit the page(s) below.

PDA Compounding Training Courses

  1. Describe FDA’s role and mission and how they accomplish it
  2. Explain FDA’s GMP requirements and the special requirements for compounded drug products
  3. Illustrate how the FDA requirements help ensure compounded drug products which are safe and effective
  4. Recognize how poor compounding practices can impact the quality of compounded drug products
  5. Analyze FDA regulatory findings and prepare an action plan to respond to them

Standard Registration

Member Price


GovernmentMember Only


Health AuthorityMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Day 1

Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD , USA

The following hotels are located near the training course location:

Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814

Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814

Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814

DoubleTree by Hilton Hotel Bethesda
8120 Wisconsin Avenue
Bethesda, MD 20814

Please visit the hotel’s website for more information.

How to Get Here
By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.