Pharmacy Compounding vs. Manufacturing

FDCA states that pharmacies are exempt from registering as manufacturers if...

they do not manufacture, prepare, propagate, compound or process drugs or devices for sale other than in the regular course of their business or dispensing or selling drugs or devices at retail

pharmacies that repackage __________ products or in any way change the container, wrapper, or labeling of these products for resale must also register as a manufacturer

OTC

pharmacies that resale rx drug products for sale to other healthcare providers must...

register as manufacturers

FDA states that pharmacists who prepare batches of ________________________ are responsible for conforming to CGMP

sterile drug products

which act clarified the distinctions between compounding and manufacturing

FDAMA

FDAMA

Food and Drug Administration Modernization Act

effectively rescinded the CPG by amending the FDCA

FDAMA

how does FDAMA define compounding

combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering a drug or bulk drug substance to create a drug

what is excluded in the FDAMA definition of compounding

mixing reconstitution performed in accordance with the manufacturer's directions when performed on receipt of a prescription for a patient

T/F under § 503A, a pharmacy is exempt from adequate directions for use, CGMP, and new drug requirements if it is for an individual patient based on receipt of a valid prescription and compounded by a licensed pharmacist or physician

T

T/F under § 503A, a pharmacy is exempt from adequate directions for use, CGMP, and new drug requirements if it is compounding for another reseller such as a pharmacy or hospital

F

T/F under § 503A, a pharmacy is exempt from adequate directions for use, CGMP, and new drug requirements if the compounded product is in limited quantity in anticipation of receiving a prescription

T

T/F under § 503A, a pharmacy must adhere to adequate directions for use, CGMP, and new drug requirements if it compounds a product prior to receiving a prescription

F; a pharmacy can compound in anticipation of receipt of a prescription if the amount anticipated is legitimately based on the established practice history between the prescriber, pharmacy, and patients

T/F under § 503A, a pharmacy is exempt from adequate directions for use, CGMP, and new drug requirements if a copy of a drug is compounded to decrease costs for the patient

F; it cannot essentially be a copy of a commercially available product unless occasionaly and in inordinate amounts

under § 503A, a compounded drug is not considered a copy if...

there is a change made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner

T/F under § 503A, if no drug monograph exists for a bulk substance, then it cannot be compounded legally

F; if no monograph exists, the drug must be a component of an FDA approved human drug product or appear on a list of bulk drug substances developed by the FDA by regulation

under § 503A, a pharmacy is exempt from adequate directions for use, CGMP, and new drug requirements if the compounder does not distribute more than _________ of total rx dispensed or distributed by the pharmacy absent a memorandum of understanding between the pharmacy's state and the FDA

5%

requirements under § 503A that were deemed unconstitutional by the Supreme Court

prescription could not be solicited, pharmacies and physicians could promote and advertise that they compound, but that they could not advertise or promote the compounding of any particular drug, class of drug, or type of drug

_____________ resolved the uncertainties in § 503A

Drug Quality and Security Act (DQSA)

which pharmacies are subject to the CPG 2002

pharmacies that are engaging manufacturing and distributing unapproved new drugs clearly outside of traditional pharmacy compounding

after CPG 2002, the FDA sent warning letters to pharmacies that compound _____________________________________

hormonal replacement products

FDA stated that any claims related to the safety and efficacy of compounded HR products are...

unsupported and would be considered false and misleading

FDA warning in regards to Bio-Identical Hormone Replacement Therapy (BHRT)

implies that drugs are identical to hormones made in the body which is misleading

in terms of hormone replacement, FDA warned against the use of compounding products containing ______________ because it is not approved by the FDA

estriol

result of Medical Center Pharmacy v. Gonzales

court found that compounded drugs are not new drugs and that the non advertising provisions are severable

court decision that held that pharmacy compounded drugs are new drugs but are neither uniformly exempt nor subjected to new drug requirements

Medical Center Pharmacy v. Mukasey

results of Medical Center Pharmacy v. Mukasey

compounded drugs are exempt, provided the pharmacy meets all the conditions established in FDAMA

T/F drugs compounded for animal use are considered new drugs

F; the court concluded that the FDA lacked the statutory authority to regulate the traditional pharmacy compounding of animal drugs

reinstated § 503A, striking out the unconstitutional provisions

Drug Quality and Security Act (DQSA)

T/F the DQSA stated that the FDA has authority to regard any drug product compounded by a pharmacy as a new drug

F; it stripped FDA authority to do so

the FDA (after implementation of the DQSA) stated that any pharmacies that follow the § 503A requirements fall under state regulatory authority and are exempt from...

federal CGMP, labeling with adequate directions for use, and new drug requirements

outsourcing facility

facility registered with the FDA that has one geographic location engaged in the compounding of sterile drugs and complies with all § 503B requirements

§ 503B requirements

complying with CGMP, permitting FDA inspections according to risk based schedule, prohibiting sale or transfer of compounded products by an entity other than the outsourcing facility, compliance with DQSA labeling, meet certain conditions such as adverse events reporting

section 503B is directed at...

entities compounding and shipping batches of sterile products to other healthcare licensees such as hospitals and clinics not pursuant to patient specific prescriptions

T/F entity that only compounds nonsterile drugs is considered an outsourcing facility

F

T/F outsourcing facilities can dispense compounded drug products to individual patients pursuant to a patient-specific prescription

T

T/F by registering as an outsourcing facility, the entity agrees to have its compounded products regulated under § 503B and can also have a separate area regulated under a § 503A pharmacy

F; it CANNOT have a separate area functioning as a § 503A pharmacy

DQSA requires the FDA to notify ________________ when it takes action against a compounder

state boards

DQSA requires the FDA to publish which 3 drug lists

1. drug products with demonstrable difficulties for compounding

2. drug products withdrawn or removed from the market

3. bulk drug substances for which there is a clinical need that may be used by outsourcing facilities

incentive to register as an outsourcing facility

properly compounded drug product at registered outsourcing facility will be exempt from meeting the adequate directions for use labeling requirements and will not be considered a new drug

T/F registered outsourcing facilities can legally compound drugs and ship them interstate without receiving prescriptions for individual patients but there are quantity limitations

F; there are NO quantity limitations

§ 503A requires that drug products be compounded in compliance with _________________

USP standards

conditions that exclude repackaged products from FDA action under § 503A

- approved prescription drug product

- unapproved prescription drug product that appears on the drug shortage list

- repackaged by or under the direct supervision of a licensed pharmacist

- if repackaged by a pharmacy, it is distributed only after the receipt of a valid prescription for an identified individual patient

- product is assigned a BUD as described in the guidance, unless evidence suggests a shorter BUD would be appropriate

"essentially a copy" FDA definition

same API with same, similar, or easily substitutable dosage strength used by the same route of administration

FDA definition of similar dosage strength

dose within 10% of commercially available product

FDA definition of "regularly or inordinate amounts"

four or fewer prescriptions of essentially a copy in a month

guidance provides that the FDA will not take action if the hospital pharmacy compounds drug products without receiving a prescription or order, provided that:

1. products are distributed only to healthcare entities owned and controlled by the same entity that owns and controls the hospital pharmacy and that are located with a 1 mile radius of the compounding pharmacy

2. drugs are only administered within the healthcare facilities to patients within the facilities, pursuant to a prescription or order

3. The drug products meet all § 503A and other applicable FDCA requirements

§ 503B provides that an outsourcing facility cannot compound drug products using a bulk drug substance, unless...

1. it appears on a list established by the FDA identifying bulk drug substances for which there is a clinical need

2. the drug compounded from the bulk drug substance appears on the drug shortage list. Since 2013, the FDA has invited all interested parties to nominate bulk drug substances for inclusion on the 503B bulk substances list

________________________ that are compounded or repackaged by state licensed nuclear pharmacies are specifically excluded from ______________

radiopharmaceuticals; § 503A

§ 503B applies to the ___________________ of radiopharmaceuticals but not the ____________________

compounding; repackaging

§ 503A allows anticipatory compounding if...

1. compounding is based on a history of the pharmacist or physician receiving prescriptions for the compounded drug

2. the prescriptions have been generated solely with an established relationship between the pharmacist or physician and either the patient for whom the prescription will be provided, or the physician or other practitioner who will write the prescription

FDA holds that the compounder does not exceed a "limited quantity" if...

1. the compounder holds for distribution no more than a 30-day supply of the compounded drug product to fill the prescriptions it has yet to receive

2. the amount of the supply is based on the number of valid prescriptions that the compounder has received for identified patients in a 30-day period over the past year

prior to the passage of the ___________ the FDA regarded any drug compounded by a pharmacy as a new drug

§ 503A

determined that FDA cannot regulate compounded drugs as new drugs as long as certain criteria are met

§ 503A

T/F a pharmacy that compounds for another reseller (such as a pharmacy or hospital) is exempt from adequate directions for use, CGMP, and new drug requirements

F