Pharmacy Federal Part 7

503A

- For drug products produced by compounders that are not registered as outsourcing facilities, to be exempt from numerous FDA requirements that manufacturers must comply with (CGMPs, approval process, and labeling), compounders must meet the conditions of section 503A of the new law. This section is important for "traditional compounding".

Section 503B outsourcing facilities

503B - Compounders of sterile human drug products can voluntarily register an "outsourcing facility" (defined as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all the requirements of section 503B). Complying with section 503B should help prevent future compounding tragedies, such as the outbreak of fungal meningitis and other infections that occurred with products compounded and distributed by the New England Compounding Center (NECC) in 2012.

Household substances

A hazardous substance in the federal Hazardous Substances Act An economic poison under the federal Insecticide, Fungicide and Rodenticide Act A food, drug, or cosmetic under the FDCA A household fuel when stored in a portable container

Who is a trading partner?

Dispenser

T/F Drugs can be dispensed in irreversible containers, as long as dispensed in the child-resistant mode

False reversible

Can RX drugs be exempt from the child-resistant packaging requirement?

If either the physician prescribing the drug or the patient receiving the drug requests noncompliant containers Can be oral request, but wise for pharmacist to document request and a signature.

Compounding Nonprescription Products

Must be labeled according to FDA provisions as any other OTC agent Cannot be prepared with any prescription ingredients FDA might intervene if significant health hazards occur and pharmacy compounds on a regular basis

Registering as an outsourcing facility would still require the facility to meet cGMP requirements, outsourcing facilities:

Must comply with CGMP requirements, Will be inspected by FDA according to a risk-based schedule, and Must meet certain other conditions, including: reporting adverse events and providing FDA with certain information about the products they compound; using bulk drug substances / ingredients meeting FDA standards; not compounding drugs that are essentially a copy of one or more approved drugs

Manuf. FDCA Level of Compliance and Enforcement

Must meet all FDCA requirements ex. labeling/new drug approval/cGMPs

T/F All LEGEND drugs and controlled substances must be packaged in child-resistant containers EXCEPT

Nitroglycerine capsulse True

Traditional Pharmacy FDCA Level of Compliance and Enforcement

Not required to meet all FDCA requirements that manufacture is if complies with FDA guidances ex. compounding 503A and repackaging

Outsourcing Facilities FDCA Level of Compliance and Enforcement

Not required to meet all FDCA requirements that manufacturer is if complies with FDA guidances ex. compounding 503B and repackaging

The Act allows manufactures to market one size of an OTC product for elderly or handicapped people in noncompliant packaging

Package must include statement or warning This Package for Households without Young Children or warning Package Not Child Resistant

Poison Prevention Packaging Act

Passed in 1970 by Congress with the intent of protecting children from accidental poisonings with household substances

Drug Supply Chain Security Act (DSCSA; Title II DQSA)

Provide/Keep Product Tracing Information Handle suspect and illegitimate product Confirm authorized trading partners (manufacturers, wholesale distributors, third-party logistics providers

Reconstitution versus Compounding

Reconstitution involves mixing drug products for use by a patient pursuant to manufacturer's instructions Not considered compounding

The poison prevention package act is enforce by

The US Consumer Product Safety Commission

What must compounded products be to be exempt under 503A

The drug product is compounded for an identified individual patient based on the receipt of a valid prescription order The compounding of the drug product is performed by a licensed pharmacist in a licensed pharmacy, or by a licensed physician Anticipatory compounding is permitted in limited quantities (based on the history of receiving valid orders) The product to be compounded complies with USP chapters on compounding using bulk substances The drug product is compounded using bulk drug substances that are manufactured by an establishment that is registered with the FDA The product to be compounded may not use drugs on an FDA list of items that have been withdrawn or removed from the market because they have been found to be unsafe or not effective The compounder cannot compound regularly or in inordinate amounts what are essentially copies of commercially available products The compounder may not distribute more than 5% of the total prescriptions dispensed or distributed by that pharmacy absent a memorandum of understanding (MOU) between their state and the FDA

T/F 503B is not for repackagers or those compounding non-sterile drugs or animal drugs

True

T/F A drug can only be dispersed ONE time in a child resistant container or vial pharmacy must use new lid and vial every fill, unless the vial is glass, then only a new lid is needed

True

T/F Dispensers must have established systems to verify products and handle suspect/illegitmate products

True

T/F Drugs dispensed to institutionalized patients are exempt from the act if they are to be administered the drug by the institutions employees

True

T/F FDA must enhance communication with states regarding compounding and manufacturers matter

True

T/F Pharmacies required to confirm trading partner is authorized through FDA or state authority

True

T/F Quarantine suspect products and investigate to determine if illegitmate; if yes notify FDA and immediate trading partners within 24 hours

True

T/F Trading partners to provide subsequent purchaser with product tracing information which is to be kept by partner for at least 6 years

True

T/F various activities such as repackaging of drugs, resale or distribution of products can place the pharmacy into the realm of being considered something other than a pharmacy

True

What actions are included for violations of the FDCA?

Warning letters seizure of product injuctions and/or criminal prosecution

What must be a a product for anti-tampering

a visual seal/barrier on products to show if it has been opened/tampered with; but applies to consumer products and cosmetics

Registering as an outsourcing facility qualifies for exemptions from:

compounded products having to meet various FDA requirements a manufacturer must satisfy (drug approval requirement and labeling products with adequate directions for use)

Beyond Use Dates

date after which a preparation should not be used

21 CFR 211.132 violations

deemed adulterated and/or misbranded; FBI, FDA and USDA has regulatory authority

Wholesale and Third-party logistics provider licensing

drug distributors to report information to FDA ex license status and contact info TPL to obtain state or fed license

FDA example in guidance

extra diligence when purchasing from new/suspect trading partners; dealing with products with high demand; suspicious products such as missing NDC or Lot#

Exceptions to the anti-tampering act are

lozenges insulin dermatologics

Product Identification

manufacturers and repackagers to put a unique product identifier on certain presription drug packages ex bar code

Pharmacies are exempt from registering as what?

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 of dispensing or selling drugs or devices at retail

Water-containing oral formulations

not later than 14 days when stored at cold temperatures

Water-containing topicals and semi-solid

not later than 30 days

Nonaqueous formulations

not later than the time remaining until the earliest expiration date of any products, or 6 months, whichever is earlier

What is required for most OTC and RX drugs dispensed by pharmacist

placed in child-resistant containers child-resistant containers must be manufactured such that 80% of the children less than 5 years old of age cannot open them, whereas at least 90% of adult can

Detection and response/notification

quarantine and investigate suspect products and notify FDA and other stakeholders

What must be identified?

suspect product reason to believe counterfeit or fraudulent, diverted or stolen; or adulterated or unfit for distribution and could lead to serious adverse health consequences

Product tracing

trading partners manufacturers, wholesale distributors, repackagers, dispensers to provide information about a drug and who handled it each time sold/transferred

Product verification

trading partners to have systems in place to verify the product