Package Inserts!!

[Guest guest]

Dear All,

A RED FLAG was raised with your comments!!! I am CERTAIN that

package inserts are required with estrogen containing drugs,

including BC Pills....

So I did a search...

My search shows those BC pills that contain estrogen AND progesterone

are exempt, which leads me to believe that any BC Pill that does not

have progesterone, but does have estrogen and any other ingredient is

NOT exempt and therefore MUST have a package insert.

Some one will have to prove this wrong by giving me law other wise I

will go to grave believeing this!

I addition, any and all estrogen containing post menopausal or cancer

treatment etc MUST have a package insert.

Regarding Accutane, I could not find LAW support the requiement

although practice does dictate good prudence/judgemnt to do so.

SEE BELOW:

My google search found this:

http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.g

po.gov/cfr_2002/aprqtr/pdf/21cfr310.515.pdf

§ 310.515 Patient package inserts for

estrogens.

(a) Requirement for a patient package

insert. FDA concludes that the safe and

effective use of drug products containing

estrogens requires that patients

be fully informed of the benefits

and risks involved in the use of these

drugs. Accordingly, except as provided

in paragraph (e) of this section, each

estrogen drug product restricted to

prescription distribution, including

products containing estrogens in fixed

combinations with other drugs, shall

be dispensed to patients with a patient

package insert containing information

concerning the drug's benefits and

risks. An estrogen drug product that

does not comply with the requirements

of this section is misbranded under section

502(a) of the Federal Food, Drug,

and Cosmetic Act.

(e) Exemptions. This section does not apply to estrogen-progestogen

oral contraceptives. Labeling requirements for these products are set

forth in Sec. 310.501.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?

FR=310.515

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 310--NEW DRUGS

Subpart E--Requirements for Specific New Drugs or Devices

Sec. 310.515 Patient package inserts for estrogens.

(a) Requirement for a patient package insert. FDA concludes that

the

safe and effective use of drug products containing estrogens requires

that patients be fully informed of the benefits and risks involved in

the use of these drugs. Accordingly, except as provided in paragraph

(e)

of this section, each estrogen drug product restricted to

prescription

distribution, including products containing estrogens in fixed

combinations with other drugs, shall be dispensed to patients with a

patient package insert containing information concerning the drug`s

benefits and risks. An estrogen drug product that does not comply

with

the requirements of this section is misbranded under section 502(a)

of

the Federal Food, Drug, and Cosmetic Act.

( Distribution requirements. (1) For estrogen drug products,

the

manufacturer and distributor shall provide a patient package insert

in

or with each package of the drug product that the manufacturer or

distributor intends to be dispensed to a patient.

(2) In the case of estrogen drug products in bulk packages

intended

for multiple dispensing, and in the case of injectables in multiple-

dose

vials, a sufficient number of patient labeling pieces shall be

included

in or with each package to assure that one piece can be included with

each package or dose dispensed or administered to every patient. Each

bulk package shall be labeled with instructions to the dispensor to

include one patient labeling piece with each package dispensed or, in

the case of injectables, with each dose administered to the patient.

This section does not preclude the manufacturer or labeler from

distributing additional patient labeling pieces to the dispensor.

(3) Patient package inserts for estrogens dispensed in acute-care

hospitals or long-term care facilities will be considered to have

been

provided in accordance with this section if provided to the patient

before administration of the first estrogen and every 30 days

thereafter, as long as the therapy continues.

© Patient package insert contents. A patient package insert for

an

estrogen drug product is required to contain the following

information:

(1) The name of the drug.

(2) The name and place of business of the manufacturer, packer,

or

distributor.

(3) A statement regarding the benefits and proper uses of

estrogens.

(4) The contraindications to use, i.e., when estrogens should not

be

used.

(5) A description of the most serious risks associated with the

use

of estrogens.

(6) A brief summary of other side effects of estrogens.

(7) Instructions on how a patient may reduce the risks of

estrogen

use.

(8) The date, identified as such, of the most recent revision of

the

patient package insert.

(d) Guidance language. The Food and Drug Administration issues

informal labeling guidance texts under Sec. 10.90((9) of this

chapter

to provide assistance in meeting the requirements of paragraph © of

this section. Requests for a copy of the guidance text should be

directed to the Center for Drug Evaluation and Research, Division of

Metabolism and Endocrine Drug Products (HFD-510), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857.

(e) Exemptions. This section does not apply to estrogen-

progestogen

oral contraceptives. Labeling requirements for these products are set

forth in Sec. 310.501.

(f) Requirement to supplement approved application. Holders of

approved applications for estrogen drug products that are subject to

the

requirements of this section must submit supplements under

Sec. 314.70© of this chapter to provide for the labeling required

by

paragraph (a) of this section. Such labeling may be put into use

without

advance approval by the Food and Drug Administration.

[55 FR 18723, May 4, 1990]

http://www.nacds.org/user-assets/PDF_files/sponsor0402.pdf

While a package insert may be a good idea for users of Accutane I

could not find LAW to support the requirement of a package insert.

However discussion of the SMART program is contained in the package

insert and that is why I believe that so many pharmacists give the

package insert out. I don't blame them! Of course there must be

counseling.

I looked for other drugs that requires package inserts and could find

nothing else.

Respectfully,

Jeanetta Mastron CPhT BSChemistry

Pharmacy Technician Educator

Founder/Owner