Evening star., 1963-02-13
BY WILLIAM GRIGG
star staff Writer

BY WILLIAM GHIGG
star staff Writer
Drug repackaging firms
some Of them fly-by-night
operations in which drug sam
Piles are collected from doctors
offices. or trash cans, for re-
packaging and sale-may soon
have the Food and Drug Ad-
ministration looking over their
shoulders.
Those that operate in inter-
state commerce already are
subject to Federal regulation.
The small firms operating only
In one State are not. There
are cases In which these little
firms have mixed UP drugs-so
that patients got wrong drugs.
But FDA will propose in to-
morrow's Federal Register q
regulation that requires all
manufacturers" Of drugs,
whether in interstate commerce
or not, to register with the
agency by May l.
Seek New Powers
Armed with q list Of all the
repackagers and with their def
milton as manufacturers"
FDA will be able to inspect
these operations to assure they
handle drugs so that they are
not dirtied, mixed-up or al
lowed to deteriorate.
This and q barrage Of other
new drug regulations will be
proposed by FDA in the Federal
Register, the official catalog In
which agencies reveal new
regulations to the general pub
lie and to hundreds Of keen
eyed corporation lawyers.
The advertising regulations
are for prescription drugs only
Advertising claims for new
drugs and antibiotics would be
limited to those referred to on
the drug labeling-which al
ready must have FDA approval.
Lists Side Effects
Ads that tell physicians when
to use o drug and what dosage
to use must also summarize the
drugs side effects. according
to the new proposals.
The proposals also give FDA
the power to accept or reject
the presentation of side effects
and hazard warnings In pre-
scription drug advertising when
these hazards or side effects
are Of special significance.
Except in that circumstance,
FDA would have no power to
censor advertising copy In ad-
vance Of publication.
But, II q manufacturer wants
to assure that his ad won't get
his drug seized, he may ask for
FDA comment on It, the pro-
posed regulations say.
Try TO Sway Buyer
According TO the packaging
psychology Of product differ
entiation," Q product that Is
lust like It's competitors can get
the edge on them with q label
that shouts contains BILGE."
or some fanciful name.
In medicines, the ingredient
may be inert or Just o filler and
the label makes no claims for
it. But, according to theory.
the consumer seeking relief
may be induced to buy the
product containing "bilge" over
an essentially identical product.
He may even be willing to
pay q higher price for the
product with "bilge."
The Food and Drug Admini-
stration will take aim at this
artful dodge with the proposed
regulations. They would bar
"word-smithing" on drug labels.
The invention Of fanciful or
plamorous names for ingredi-
ents, whether active or not,
also would be barred on these
drug labels.
There may be one drawback
Drug investigators have found
that even a plain sugar pill will
give people relief-if they be-
lieve In It. Under the anti
bilge" regulations, this psyche
logical crutch would be gone.
Registration Rule
Proposed regulations for the
registration Of drug manufac-
turers and the proving Of drug
effectiveness also will be pub
lished by the Food and Drug
Administration tomorrow.
The regulations on drug ef-
fectiveness spell out the kind
Of proof manufacturers must
submit to get q new drug re-
leased for sale.
Divided into three separate
sets Of regulations. the pro-
posals are designed to carry
out the 1862 Kefauver-H Harris
amendment to the Food, Drug
and Cosmetic Act. Interested
persons can submit their writ
ten views on the proposals to
FDA. These will be considered
before the regulations go into
effect, FDA Commissioner
George p. LarTick said today
He outlined these features
Of the regulations:
Manufacturers must describe
the facilities they have that
assure the safety. effectiveness
and purity Of drugs being man
ufactured. The firms must also